Author: "Stuart J, Connolly" - Searchworks@Jio Institute Digital Library Search Results

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693 results on '"Stuart J, Connolly"'

1. Optimizing warfarin dosing for patients with atrial fibrillation using machine learning

Author: Jeremy Petch, Walter Nelson, Mary Wu, Marzyeh Ghassemi, Alexander Benz, Mehdi Fatemi, Shuang Di, Anthony Carnicelli, Christopher Granger, Robert Giugliano, Hwanhee Hong, Manesh Patel, Lars Wallentin, John Eikelboom, and Stuart J. Connolly
Subjects: Medicine, Science
Abstract: Abstract While novel oral anticoagulants are increasingly used to reduce risk of stroke in patients with atrial fibrillation, vitamin K antagonists such as warfarin continue to be used extensively for stroke prevention across the world. While effective in reducing the risk of strokes, the complex pharmacodynamics of warfarin make it difficult to use clinically, with many patients experiencing under- and/or over- anticoagulation. In this study we employed a novel implementation of deep reinforcement learning to provide clinical decision support to optimize time in therapeutic International Normalized Ratio (INR) range. We used a novel semi-Markov decision process formulation of the Batch-Constrained deep Q-learning algorithm to develop a reinforcement learning model to dynamically recommend optimal warfarin dosing to achieve INR of 2.0–3.0 for patients with atrial fibrillation. The model was developed using data from 22,502 patients in the warfarin treated groups of the pivotal randomized clinical trials of edoxaban (ENGAGE AF-TIMI 48), apixaban (ARISTOTLE) and rivaroxaban (ROCKET AF). The model was externally validated on data from 5730 warfarin-treated patients in a fourth trial of dabigatran (RE-LY) using multilevel regression models to estimate the relationship between center-level algorithm consistent dosing, time in therapeutic INR range (TTR), and a composite clinical outcome of stroke, systemic embolism or major hemorrhage. External validation showed a positive association between center-level algorithm-consistent dosing and TTR (R2 = 0.56). Each 10% increase in algorithm-consistent dosing at the center level independently predicted a 6.78% improvement in TTR (95% CI 6.29, 7.28; p
Published: 2024
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2. Predictors of Intracranial Hemorrhage Volume Expansion in Patients Receiving Factor Xa Inhibitors in ANNEXA‐4: Time and Severity Matter Most

Author: Mauricio Concha, Lizhen Xu, MacKenzie Horn, Tomoyuki Ohara, Juliet Nakamya, Jan Beyer‐Westendorf, Ashkan Shoamanesh, Alexander Cohen, Per Ladenvall, Stuart J. Connolly, and Andrew M. Demchuk
Subjects: andexanet alfa, anti‐factor Xa activity, direct factor Xa inhibitor reversal, hematoma expansion, intracranial hemorrhage, Neurology. Diseases of the nervous system, RC346-429, Diseases of the circulatory (Cardiovascular) system, RC666-701
Abstract: Background Andexanet alfa, a specific reversal agent for factor Xa inhibitors, resulted in effective hemostasis in 79% of patients with intracranial bleeding in the ANNEXA‐4 (Andexanet Alfa, a Novel Antidote to the Anticoagulation Effects of Factor Xa Inhibitors) trial (NCT02329327). However, little is known about predictors associated with hematoma expansion in patients with factor Xa inhibitor–associated intracranial hemorrhage (ICrH) receiving andexanet alfa. Methods The ANNEXA‐4 trial was a prospective, single‐arm, open‐label study of andexanet alfa in patients with acute major bleeding within 18 hours after taking a factor Xa inhibitor. Hematoma volumes at baseline and 12 hours after andexanet alfa treatment were measured using a computerized‐assisted volumetric method. Univariable and multivariable logistic regression analyses of clinical and nonclinical parameters were performed to identify factors predictive of different volumes of hematoma expansion. To this end, an ICrH Expansion Scale was developed. Results Overall, 305 ANNEXA‐4 study patients with baseline and follow‐up imaging were included, 15.7% of whom showed evidence of any ICrH expansion ≥6‐mL. Patients with ≥6‐mL ICrH expansion had a significantly (P
Published: 2024
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3. Semi-Markov Offline Reinforcement Learning for Healthcare.

Author: Mehdi Fatemi, Mary Wu, Jeremy Petch, Walter Nelson, Stuart J. Connolly, Alexander Benz, Anthony Carnicelli, and Marzyeh Ghassemi
Published: 2022

4. Cost Implications of Left Atrial Appendage Occlusion During Cardiac Surgery: A Cost Analysis of the LAAOS III Trial

Author: Adam Eqbal, Wesley Tong, Andre Lamy, Emilie Belley‐Cote, Domenico Paparella, Alexander Bogachev‐Prokophiev, Alistair G. Royse, Wilko Reents, P. J. Devereaux, Katheryn Brady, Jessica Vincent, Stuart J. Connolly, and Richard P. Whitlock
Subjects: cost analysis, left atrial appendage occlusion, stroke, Diseases of the circulatory (Cardiovascular) system, RC666-701
Abstract: Background The LAAOS III (Left Atrial Appendage Occlusion Study) clinical trial demonstrated that concomitant left atrial appendage (LAA) occlusion leads to a lower risk of ischemic stroke or systemic embolism compared with no occlusion in participants with atrial fibrillation and a CHA2DS2‐VASc score of ≥2 undergoing cardiac surgery for another indication. We report the cost implications of concomitant LAA occlusion during cardiac surgery. Methods and Results Using LAAOS III data, we compared the costs (in US dollars) associated with LAA occlusion to no occlusion from the perspective of the Centers for Medicare and Medicaid Services. We calculated the average cost per participant during the trial by applying Medicare reimbursement costs to cardiovascular events for all trial participants. We conducted sensitivity analyses, varying the cost of stroke ±25% and occlusion technique use. Cost neutrality was defined as a mean cost difference within ±5% of the cost per participant in the no‐occlusion group. Total study cost per participant was $3878 in the LAA occlusion group and $4490 in the no‐occlusion group, a mean difference of −$612 (95% CI, −$1276 to $45). The main drivers of cost savings were fewer stroke events during the trial (mean difference of −$1021). In sensitivity analyses, LAA occlusion was cost saving for suture and stapler techniques but more expensive with closure device. Conclusions Concomitant LAA occlusion was cost saving for participants in LAAOS III. Our findings support concomitant LAA occlusion as an economically dominant strategy for patients with atrial fibrillation and a CHA2DS2‐VASc score of ≥2 undergoing cardiac surgery.
Published: 2023
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5. Andexanet alfa versus four-factor prothrombin complex concentrate for the reversal of apixaban- or rivaroxaban-associated intracranial hemorrhage: a propensity score-overlap weighted analysis

Author: Olivia S. Costa, Stuart J. Connolly, Mukul Sharma, Jan Beyer-Westendorf, Mary J. Christoph, Belinda Lovelace, and Craig I. Coleman
Subjects: Andexanet alfa, Four-factor prothrombin complex concentrate, Direct factor Xa inhibitor reversal, Intracranial hemorrhage, Medical emergencies. Critical care. Intensive care. First aid, RC86-88.9
Abstract: Abstract Background Andexanet alfa is approved (FDA “accelerated approval”; EMA “conditional approval”) as the first specific reversal agent for factor Xa (FXa) inhibitor-associated uncontrolled or life-threatening bleeding. Four-factor prothrombin complex concentrates (4F-PCC) are commonly used as an off-label, non-specific, factor replacement approach to manage FXa inhibitor-associated life-threatening bleeding. We evaluated the effectiveness and safety of andexanet alfa versus 4F-PCC for management of apixaban- or rivaroxaban-associated intracranial hemorrhage (ICH). Methods This two-cohort comparison study included andexanet alfa patients enrolled at US hospitals from 4/2015 to 3/2020 in the prospective, single-arm ANNEXA-4 study and a synthetic control arm of 4F-PCC patients admitted within a US healthcare system from 12/2016 to 8/2020. Adults with radiographically confirmed ICH who took their last dose of apixaban or rivaroxaban 60 mL, or planned surgery within 12 h were excluded. Outcomes were hemostatic effectiveness from index to repeat scan, mortality within 30 days, and thrombotic events within five days. Odds ratios (ORs) with 95% confidence intervals (CI) were calculated using propensity score-overlap weighted logistic regression. Results The study included 107 andexanet alfa (96.6% low dose) and 95 4F-PCC patients (79.3% receiving a 25 unit/kg dose). After propensity score-overlap weighting, mean age was 79 years, GCS was 14, time from initial scan to reversal initiation was 2.3 h, and time from reversal to repeat scan was 12.2 h in both arms. Atrial fibrillation was present in 86% of patients. Most ICHs were single compartment (78%), trauma-related (61%), and involved the intracerebral and/or intraventricular space(s) (53%). ICH size was ≥ 10 mL in volume (intracerebral and/or ventricular) or ≥ 10 mm in thickness (subdural or subarachnoid) in 22% of patients and infratentorial in 15%. Andexanet alfa was associated with greater odds of achieving hemostatic effectiveness (85.8% vs. 68.1%; OR 2.73; 95% CI 1.16–6.42) and decreased odds of mortality (7.9% vs. 19.6%; OR 0.36; 95% CI 0.13–0.98) versus 4F-PCC. Two thrombotic events occurred with andexanet alfa and none with 4F-PCC. Conclusions In this indirect comparison of patients with an apixaban- or rivaroxaban-associated ICH, andexanet alfa was associated with better hemostatic effectiveness and improved survival compared to 4F-PCC. Trial registration NCT02329327; registration date: December 31, 2014.
Published: 2022
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6. Association of body mass index with outcomes in patients with newly diagnosed atrial fibrillation: GARFIELD-AF

Author: Daniela Poli, Sophie Testa, Corrado Lodigiani, Toon Wei Lim, Kevin Jones, Kangning Chen, Hui Li, Hilary Pinnock, Grzegorz Bilo, Hack-Lyoung Kim, Andrew Murray, Bernard J Gersh, Kurt Huber, Robin Fox, Sarah Davies, James Rogers, Morten Schou, Xin Li, Vira Tseluyko, Sergey Popov, Rajeev Gupta, Grzegorz Opolski, Preeti Pandya, Bronte Ayres, Milan Gupta, Peter Hutchinson, Phil Simmons, Andrew Gallagher, Michel Galinier, Franck Paganelli, Jens Kilian, Adam Blenkhorn, Mohamed Ibrahim, Fernando Lanas, Karen Pieper, Eivind Berge, M Clark, Agneta Andersson, Karim Ladha, Bijoy Sinha, Torstein Hole, Dan Atar, Hywel Jones, R Smith, Andrew Ross, Emmanuel Ellie, Paul Evans, Yong Wang, Hiroshi Ono, Tadashi Nakamura, Paul MacDonald, Stephen Rogers, Igor Sibon, Simon Dobson, David Fitzmaurice, Jiyan Chen, Neil Roberts, Pierre Amarenco, Nigel Hart, Giancarlo Agnelli, Georges Mairesse, Pekka Raatikainen, Oleg Sychov, Yasuyuki Suzuki, Bo Liu, Mathieu Zuber, John French, Yuejin Yang, Myeong-Chan Cho, Julian Thompson, Michael Stokes, John W Eikelboom, Mark Richardson, John Matthews, Will Murdoch, Jean-Philippe Neau, Freek Verheugt, Ajay K Kakkar, Giuseppe Ambrosio, Marcin Gruchała, Keith A A Fox, Sunil Kumar, Ruiping Zhao, Patrick Carroll, Masanori Kaneko, Thanh Phan, Ping Yang, Sung-Won Jang, Claire Jones, Mårten Rosenqvist, Johan Engdahl, Debabrata Roy, John Cairns, Ping Chen, Michael Olsen, Paul Angaran, David Russell, Helena Dominguez, Béla Merkely, Joseph Berlingieri, James Bennett, Hugo ten Cate, Hiroshi Yamaguchi, Masahiro Minamoto, Hiroyuki Oda, Toshihiko Shiraiwa, Jonathan Webster, Yukihiro Koretsune, Kotaro Obunai, R Thompson, Yong Seog Oh, Giuliana Guazzaloca, Giuliana Martini, Marc Bonnefoy, Michael Cox, András Nagy, Kazuki Sato, Richard Davies, Daisuke Ikeda, Susumu Suzuki, Hiroki Teragawa, Koji Matsushita, Ying Guo, Catherine Neden, Mark Pugsley, Simon Cartwright, Polly Jacobs, Xiaoshu Cheng, Daniel Nishijima, Sylvia Haas, Vinay Kumar, Saverio Virdone, Jean-Pierre Bassand, Samuel Z Goldhaber, Shinya Goto, Frank Misselwitz, Alexander G G Turpie, Alison Macleod, Karen Forshaw, Mark Boon, Stephen Miller, Simon Wetherell, Moustafa Moustafa, Gaetano Serviddio, Renato Lopes, Kazuo Takei, Hiroaki Nishioka, Mykola Stanislavchuk, C Ramesh, R Kamath, Stuart J Connolly, Nooshin Bazargani, Kevin Douglas, Werner Hacke, Gloria Kayani, Ali Oto, Hiroshi Watanabe, Walter Hermans, Kazuya Murata, Christian Fielder Camm, Marco Moia, Niraj Sharma, Jaeyoung Kim, Walter Abhayaratna, Andriy Yagensky, Hosen Kiat, Wilhelm Haverkamp, Yang Jiao, Hitoshi Kato, Jindrich Spinar, Daniel Theodoro, Philip Cooke, Paolo Golino, Tetsuro Yoshida, Prakash Chandwani, Christine A'Court, Brian Ramjattan, Torbjørn Øien, Toshiyuki Kobayashi, Richard West, Petr Jansky, Seil Oh, Jan Steffel, Martin van Eickels, Hyung-Wook Park, Nam-Ho Kim, Søren Rasmussen, Kazuo Suzuki, David Colquhoun, Hiroshi Ando, Simon Franklin, Tae-Joon Cha, Sang Cheol Bae, Guosheng Fu, Yoshihiro Saito, Heinz Drexel, Michel Martelet, Joseph Mouallem, Nicolas Delarche, Sylvain Destrac, Neil Macey, Andreas Kopf, Masayuki Nakano, Olga Barbarash, Takeshi Inoue, Taro Minagawa, Weihua Li, John Eikelboom, Hiroshi Kubo, Lars Andersson, D Burns, Andrea Podczeck-Schweighofer, Megumi Okada, Massimo Volpe, Takuma Aoyama, Karsten Mueller, Carlos Astudillo, Hiroshi Takeda, Peter Mayer, Jung Hoon Sung, Dinesh Jain, Jung Han Yoon, Alessandro Capucci, Dongryeol Ryu, Kelvin Wong, Hong Euy Lim, Xiaowei Yan, Yusheng Zhao, Yuehui Yin, YUKIHIRO SETA, Taek Jong Hong, MASAKI SHIMOYAMA, Dayi Hu, Junichi Minami, Yuriy Mostovoy, David Foo, Ramazan Topsakal, Zhi-Cheng Jing, Dipen Shah, Kenichi Yamamoto, David Coulshed, Olivier Piot, Ramón Corbalán, Silva Severi, Waldemar Myszka, Mehmet Birhan Yilmaz, Gi-Byoung Nam, Jun Kim, Harald Darius, Jan-Erik Karlsson, PETER VANDERGOTEN, Nasser Taha, Shuta Toru, Jörn Nielsen, Tsutomu Takagi, Koji Higuchi, Steen Husted, Tomohiro Katsuya, Frank Cools, Iveta Petrova, Songkwan Silaruks, GÜNTER LEHMANN, Frederic Casassus, Bernard Crousillat, Bernard Doucet, Jean-Joseph Muller, Grzegorz Raczak, Kazuyuki Saito, Anders Ostrem, Chi Keong Ching, KUNIHIKO YAMAMOTO, John Camm, Carmine Mazzone, Jaemin Shim, Jadwiga Nessler, Jan Vercammen, Marc Delforge, Chong-Jin Kim, Pierre Nazeyrollas, Louise Lumley, Paul Roome, Helen Stoddart, Mark Rickenbach, Paul Mullen, Noriyuki Nakanishi, Gordon Irvine, Paul Conn, Kurt Lenz, Richard Coates, E Fisher, Warwick Coulson, Jiri Lastuvka, Pablo García Pavía, P Jhittay, Philip Saunders, Peter Bernhardt, Wanwarang Wongcharoen, Kentaro Yamamoto, Hector Lucas Luciardi, Harry Gibbs, Marianne Brodmann, Jørn Dalsgaard Nielsen, Hany Ragy, Matyas Keltai, Jitendra Pal Singh Sawhney, Janina Stepinska, Elizaveta Panchenko, Barry Jacobson, Xavier Viñolas, Pantep Angchaisuksiri, Alex Parkhomenko, Huaiqin Zhang, Shiping Cao, Daowen Wang, Guizhou Tao, Yingmin Chen, Shenghu He, Tongguo Wu, Moshui Chen, Longgen Xiong, Praveen Jadhavm, Raghava Sarma, Govind Kulkarni, Rasesh Atulbhai Pothiwala, Mohanan Padinhare Purayil, Kamaldeep Chawla, Veerappa Annasaheb Kothiwale, Bagirath Raghuraman, Vinod Madan Vijan, Jitendra Sawhney, Ganapathi Bantwal, Aziz Khan, Ramdhan Meena, Manojkumar Chopada, Sunitha Abraham, Vikas Bisne, Govindan Vijayaraghavan, Rajashekhar Durgaprasad, Kartikeya Bhargava, Udigala Madappa Nagamalesh, Rajeeve Kumar Rajput, Seishu Kanamori, Koichiro Kumagai, Yosuke Katsuda, Keiki Yoshida, Fumitoshi Toyota, Yuji Mizuno, Ikuo Misumi, Hiroo Noguchi, Shinichi Ando, Tetsuro Suetsugu, Susumu Adachi, Kei Chiba, Hiroaki Norita, Makoto Tsuruta, Takeshi Koyanagi, Takayuki Higashi, Shiro Azakami, Shinichiro Komaki, Kenshi Kumeda, Takashi Murayama, Jun Matsumura, Yurika Oba, Ryuji Sonoda, Kazuo Goto, Kotaro Minoda, Yoshikuni Haraguchi, Hisakazu Suefuji, Hiroo Miyagi, Tsugihiro Nakamura, Hidekazu Nandate, Ryuji Zaitsu, Yoshihisa Fujiura, Akira Yoshimura, Hiroyuki Numata, Jun Ogawa, Yasuyuki Kamogawa, Kinshiro Murakami, Yutaka Wakasa, Masanori Yamasawa, Hiromitsu Maekawa, Sumihisa Abe, Hajime Kihara, Satoru Tsunoda, Katsumi Saito, Hiroki Tachibana, Ichiro Oba, Takashi Kuwahata, Satoshi Higa, Masamichi Gushiken, Takuma Eto, Hidetoshi Chibana, Kazuaki Fujisawa, Yuhei Shiga, Hirokuni Sumi, Toshihisa Nagatomo, Yoshihiko Atsuchi, Toshiro Nagoshi, Kazuhisa Sanno, Fumihiro Hoshino, Naoto Yokota, Masahiro Kameko, Toshifumi Tabuchi, Munesumi Ishizawa, Yoshitake Fujiura, Taku Seto, Tetsu Iwao, Norio Ishioka, Koichi Oshiro, Keizo Tsuchida, Yutaka Hatori, Motoshi Takeuchi, Hiroto Takezawa, Shinjiro Nagano, Masaaki Iwaki, Yuichiro Nakamura, Naomasa Miyamoto, Toshifumi Taguchi, Ko Ashida, Naoto Yoshizawa, Jun Agata, Seishiro Matsukawa, Osamu Arasaki, Shuji Fukuoka, Hirofumi Murakami, Kazuya Mishima, Yoshiki Hata, Ichiro Sakuma, Ichiro Takamura, Mitsuyuki Akutsu, Toshihide Unoki, Yoshinori Go, Makoto Ikemura, Shoji Morii, Shigeru Marusaki, Hideo Doi, Mitsuru Tanaka, Takaaki Kusumoto, Shigeo Kakinoki, Chiga Ogurusu, Masami Nakatsuka, Yutaka Kitami, Yoichi Nakamura, Hiroshi Oda, Rikimaru Oyama, Masato Ageta, Teruaki Mita, Kazuhiko Nagao, Takafumi Mito, Mitsunori Abe, Masako Fujii, Makoto Okawa, Tsuneo Fujito, Toshiya Taniguchi, Tenei Ko, Mizuho Imamaki, Masahiro Akiyama, Takashi Ueda, Hironori Odakura, Masahiko Inagaki, Yoshiki Katsube, Atsuyuki Nakata, Shinobu Tomimoto, Mitsuhiro Shibuya, Kenichiro Ito, Masahiro Matsuta, Motoyuki Ishiguro, Masamichi Wada, Hiroaki Mukawa, Masato Mizuguchi, Fumio Okuda, Teruaki Kimura, Kuniaki Taga, Masaaki Techigawara, Morio Igarashi, Toshihiko Seo, Shinya Hiramitsu, Hiroaki Hosokawa, Mitsumoto Hoshiai, Michitaka Hibino, Koichi Miyagawa, Hideki Horie, Nobuyoshi Sugishita, Yukio Shiga, Akira Soma, Kazuo Neya, Kunio Akahane, Saori Matsui, Hirofumi Kanda, Shiro Nagasaka, Atsushi Taguchi, Akiko Miyashita, Hiroki Sasaguri, Jin Nariyama, Taketo Hatsuno, Takash Iwase, Kazuya Kawai, Tomobumi Kotani, Tsuyoshi Tsuji, Hirosumi Sakai, Kiyoshi Nishino, Kenichi Ikeda, Kazuo Maeda, Tomohiro Shinozuka, Koichi Kawakami, Hiromichi Kitazumi, Mamoru Hamaoka, Jisho Kojima, Akitoshi Sasaki, Yoshihiro Tsuchiya, Tetsuo Betsuyaku, Masaaki Honda, Koichi Hasegawa, Takao Baba, Kazuaki Mineoi, Toshihiko Koeda, Kunihiko Hirasawa, Toshihide Kumazaki, Akira Nakagomi, Eiji Otaki, Takashi Shindo, Hiroyoshi Hirayama, Chikako Sugimoto, Takashi Yamagishi, Ichiro Mizuguchi, Kazunori Sezaki, Isamu Niwa, Ken Takenaka, Osamu Iiji, Koichi Taya, Hitoshi Kitazawa, Samu Ueda, Hirokazu Kakuda, Takuya Ono, Seizo Oriso, Junya Kamata, Toshihiko Nanke, Itaru Maeda, Yoshifusa Matsuura, Yasuyuki Maruyama, Hajime Horie, Tetsutaro Kito, Hiroshi Asano, Masaichi Nakamura, Takashi Washizuka, Tomoki Yoshida, Masato Sawano, Shinichi Arima, Hidekazu Arai, Hisanori Shinohara, Hiroyuki Takai, Nobufusa Furukawa, Akira Ota, Kenji Aoki, Taku Yamamoto, Takeaki Kasai, Shunji Suzuki, Shu Suzuki, Nitaro Shibata, Masayuki Watanabe, Yosuke Nishihata, Toru Arino, Masaki Okuyama, Tetsushi Wakiyama, Tomoko Kato, Yasuo Sasagawa, Takeshi Tana, Yoshihito Hayashi, Shinichi Hirota, Yukihiko Abe, Hirohide Uchiyama, Shuichi Tohyo, Naoto Hanazono, Seiichi Miyajima, Hisashi Shimono, Yasunobu Shozawa, Yawara Niijima, Osamu Murai, Hideko Inaba, Katsumasa Nomura, Masatsugu Nozoe, Toshiyuki Furukawa, Nobuhisa Ito, Shunichi Nagai, Kiyoharu Sato, Shiro Nakahara, Yujin Shimoyama, Naoko Ohara, Teruhiko Kozuka, Hideaki Okita, Masato Endo, Tsutomu Goto, Makoto Hirose, Emiko Nagata, Toshizumi Mori, Shuichi Seki, Katsuhiro Okamoto, Osamu Moriai, Yoko Emura, Tsuyoshi Fukuda, Haruhiko Date, Shuichi Kawakami, Sho Nagai, Yuya Ueyama, Tetsuro Fudo, Mitsuru Imaizumi, Takuo Ogawa, Shunsuke Take, Hideo Ikeda, Norihiko Sakamoto, Kiyomitsu Ikeoka, Nobuo Wakaki, Masatake Abe, Junji Doiuchi, Tetsuya Kira, Masato Tada, Ken Tsuzaki, Naoya Miura, Yasuaki Fujisawa, Wataru Furumoto, Akinori Fujisawa, Ryosai Nakamura, Hiroyasu Komatsu, Rei Fujiki, Shuichi Kawano, Keijiro Nishizawa, Yoji Kato, Junya Azuma, Kiyoshi Yasui, Toshio Amano, Yasuhiro Sekine, Tatsuo Honzawa, Yuichiro Koshibu, Yasuhide Sakamoto, Shingo Miyaguchi, Kojuro Morishita, Yasuko Samejima, Toyoshi Sasaki, Fumiko Iseki, Hiroshi Kano, Yoichi Takagi, Yoko Onuki Pearce, Takayuki Fukui, Toru Nakayama, Hideaki Kanai, Yoshiyuki Kawano, Tetsuji Ino, Hironori Miyoshi, Yasufumi Miyamoto, Masahito Shigekiyo, Shimato Ono, Yutaka Okamoto, Satoshi Ubukata, Kojiro Kodera, Tatsuo Oriuchi, Naoki Matsumoto, Koichi Inagaki, Atsushi Iseki, Tomohiro Yoshida, Toshihiro Goda, Tsukasa Katsuki, Atsushi Sato, Etsuo Mori, Toshio Tsubokura, Hiroshi Shudo, Shunichi Fujimoto, Yoshiyuki Furukawa, Hiroshi Hosokawa, Jun Narumi, Kiichiro Yamamoto, Masaki Owari, Takuya Inakura, Takafumi Anno, Kazuyuki Shirakawa, Tan Yuyang, Hui Nam Park, Woo-Shik Kim, HyeYoung Lee, Dae Hyeok Kim, Dae-Kyeong Kim, Dong Ju Choi, Hui-Kyung Jeon, Dong-Gu Shin, Sang Weon Park, Hoon Ki Park, Sang-Jin Han, Young Keun On, JaeJin Kwak, Seong Hoon Park, Kee-Sik Kim, Byung Chun Jung, Gyo-Seung Hwang, Sakda Rungaramsin, Peerapat Katekangplu, Porames Khunrong, Thanita Bunyapipat, Pinij Kaewsuwanna, Khanchai Siriwattana, Waraporn Tiyanon, Supalerk Pattanaprichakul, Khanchit Likittanasombat, Doungrat Cholsaringkarl, Warangkana Boonyapisit, Sirichai Cheewatanakornkul, Pisit Hutayanon, Seksan Chawanadelert, Pairoj Chattranukulchai, Boonsert Chatlaong, Yingsak Santanakorn, Khompiya Kanokphatcharakun, Piya Mongkolwongroj, Sasivimon Jai-Aue, Ongkarn Komson, Armagan Altun, Ali Aydinlar, Zeki Ongen, Sadik Acikel, Durmus Yildiray Sahin, Ozcan Yilmaz, Hasan Pekdemir, Mesut Demir, Murat Sucu, Levent Sahiner, Murat Ersanli, Ertugrul Okuyan, Dursun Aras, Florencia Rolandi, Adrian Cesar Ingaramo, Gustavo Alberto Sambadaro, Vanina Fernandez Caputi, Hector Luciardi, Sofia Graciela Berman, Pablo Dragotto, Andres Javier Kleiban, Nestor Centurion, Ricardo Dario Dran, Javier Egido, Matias Jose Fosco, Victor Alfredo Sinisi, Luis Rodolfo Cartasegna, Oscar Gomez Vilamajo, Jose Luis Ramos, Sonia Sassone, Gerardo Zapata, Diego Conde, Guillermo Giacomi, Alberto Alfredo Fernandez, Mario Alberto Berli, Fabian Ferroni, Jefferson Jaber, Luciana Vidal Armaganijan, André Steffens, José Márcio Ribeiro, Marcelo Silveira Teixeira, Paulo Rossi, Leonardo Pires, Daniel Moreira, Luiz Bodanese, Marcelo Westerlund Montera, Jamil Abdalla Saad, Euler Roberto Manenti, Alexandre Negri, Carlos Moncada, Dalton Precoma, Fernando Roquette, Gilmar Reis, Estêvão Lanna Figueiredo, Roberto Vieira Botelho, Helius Carlos Finimundi, Adriano Kochi, Fábio Alban, Rogério Tadeu Tumelero, Lilia Maia, Humberto Montecinos, Martín Larico Gómez, Carlos Conejeros, Patricio Marin Cuevas, Alejandro Forero, Claudio Bugueño Gutiérrez, Juan Aguilar, Sergio Potthoff Cardenas, German Eggers, Cesar Houzvic, Carlos Rey, Germán Arriagada, Gustavo Charme Vilches, Raul Leal Cantu, Ricardo Cabrera Jardines, Nilda Espinola Zavaleta, Enrique Lopez Rosas, Gerardo Pozas, Ernesto Cardona Muñoz, Norberto Matadamas Hernandez, Adolfo Leyva Rendon, Norberto Garcia Hernandez, David Lopez Villezca, Carlos Hernandez Herrera, Rodolfo Gaona Rodriguez, Efrain Villeda Espinosa, David Flores Martinez, Jose Velasco Barcena, Omar Fierro Fierro, Ignacio Rodriguez Briones, Humberto Alvarez Lopez, Rafael Olvera Ruiz, Roxana Reyes Sanchez, Roberto Arriaga Nava, Pedro Fajardo Campos, Mario Benavides Gonzalez, Claus Hagn, Johannes Foechterle, Michael Winkler, Bruno Schneeweiss, Alfons Gegenhuber, Wilfried Lang, Sabine Eichinger-Hasenauer, Peter Kaserer, Josef Sykora, Heribert Rasch, Bernhard Strohmer, Luc Capiau, Geert Vervoort, Bart Wollaert, Geert Hollanders, Dirk Faes, Yohan Balthazar, Olivier Xhaet, Harry Striekwold, John Thoeng, Kurt Hermans, Wim Anné, Ivan Blankoff, Michel Beutels, Stefan Verstraete, Philippe Purnode, Pascal Godart, Tim Boussy, Philippe Desfontaines, Alex Heyse, Joeri Voet, Eva Zidkova, Rudolf Spacek, Vilma Machova, Ondrej Ludka, Josef Olsr, Lubos Kotik, Blazej Racz, Richard Ferkl, Jan Hubac, Ilja Kotik, Zdenek Monhart, Hana Burianova, Ondrej Jerabek, Jana Pisova, Vratislav Dedek, Michaela Honkova, Petr Podrazil, Petr Reichert, Miroslav Novak, Vaclav Durdil, Katarina Plocova, Ulrik Hintze, Næstved Sygehus, Arne Bremmelgaard, John Markenvard, Jan Børger, Jorgen Solgaard, Ebbe Eriksen, Thomas Løkkegaard, Michael Bruun, Jacob Mertz, Joël Ohayon, Yannick Gottwalles, Philippe Loiselet, Mohamed Bassel Koujan, André Marquand, Jean-Pierre Cebron, Maxime Guenoun, Dominique Guedj-Meynier, A G Lokesh, James Kadouch, Pierre-Yves Fournier, Jean-Pierre Huberman, Nestor Lemaire, Gilles Rodier, Xavier Vandamme, Marie Hélène Mahagne, Antoine Mielot, Jean-Baptiste Churet, Vincent Navarre, Frederic Sellem, Gilles Monniot, Jean-Paul Boyes, Désiré Obadia, Etienne Bearez, Jean Philippe Brugnaux, Alain Fedorowsky, Jean-Baptiste Berneau, Frédéric Chemin, Sebastien Schellong, Georg Koeniger, Uwe Gerbaulet, Bernd-Thomas Kellner, Thomas Schaefer, Jan Purr, Enno Eißfeller, Heinz-Dieter Zauzig, Peter Riegel, Christoph Axthelm, Gerd-Ulrich Heinz, Holger Menke, Andreas Pustelnik, Stefan Zutz, Wolfgang Eder, Guenter Rehling, Dirk Glatzel, Norbert Ludwig, Petra Sandow, Henning Wiswedel, Cosmas Wildenauer, Steffen Schoen, Toralf Schwarz, Adyeri Babyesiza, Maximilian Kropp, Hans-Hermann Zimny, Friedhelm Kahl, Andreas Caspar, Sabine Omankowsky, Torsten Laessig, Hermann-Josef Hartmann, Hans-Walter Bindig, Gunter Hergdt, Dietrich Reimer, Joachim Hauk, Holger Michel, Praxis Dres, Werner Erdle, Wilfried Dorsch, Janna Dshabrailov, Karl-Albrecht Rapp, Reinhold Vormann, Thomas Mueller, Uwe Horstmeier, Volker Eissing, Heinz Hey, Heinz Leuchtgens, Volker Lilienweiss, Heiner Mueller, Christian Schubert, Herrmann Lauer, Thomas Buchner, Gunter Brauer, Susanne Kamin, Sylvia Baumbach, Muwafeg Abdel-Qader, Hans-Holger Ebert, Carsten Schwencke, Laszlo Karolyi, Britta Sievers, Jens-Uwe Roehnisch, Andras Vertes, Gabor Szantai, Andras Matoltsy, Nikosz Kanakaridisz, Zoltan Boda, Erno Kis, Balazs Gaszner, Ferenc Juhasz, Gizella Juhasz, Sandor Kancz, Zoltan Laszlo, Zsolt May, Ebrahim Noori, Tamas Habon, Peter Polgar, Gabriella Szalai, Sandor Vangel, Gabriella Engelthaler, Judit Ferenczi, Mihaly Egyutt, Leone Maria Cristina, Eros Tiraferri, Rita Santoro, Teresa Maria Caimi, Maria Tessitori, Roberto Cappelli, Roberto Quintavalla, Franco Cosmi, Raffaele Fanelli, Vincenzo Oriana, Raffaele Reggio, Roberto Santi, Leonardo Pancaldi, Jorge Salerno Uriate, Flavia Lillo, Enrico Maria Pogliani, Michele Accogli, Antonio Mariani, Mauro Feola, Arturo Raisaro, Luciano Fattore, Andrea Mauric, Fabrizio Germini, Luca Tedeschi, Maria Settimi, Sergio Nicoli, Paolo Ricciarini, Antonio Argena, Paolo Ronchini, Claudio Bulla, Filippo Tradati, Maria Grazia Bongiorni, Enrico Salomone, Claudio Tondo, Saverio Iacopino, Andreas Lucassen, Henk Adriaansen, Maarten Bongaerts, Mathijs Pieterse, Johannes Herrman, Pieter Hoogslag, Cees Buiks, Per Anton Sirnes, Erik Gjertsen, Knut Erga, Arne Hallaråker, Gunnar Skjelvan, Beraki Ghezai, Arne Svilaas, Peter Christersson, Svein Høegh Henrichsen, Jan Erik Otterstad, Jan Berg-Johansen, Andrzej Gieroba, Malgorzata Biedrzycka, Michal Ogorek, Beata Wozakowska-Kaplon, Krystyna Loboz-Grudzien, Jerzy Kuzniar, Roman Zaluska, Jaroslaw Hiczkiewicz, Lucyna Swiatkowska-Byczynska, Lech Kucharski, Piotr Minc, Maciej Olszewski, Grzegorz Kania, Malgorzata Krzciuk, Zbigniew Lajkowski, Bozenna Ostrowska-Pomian, Jerzy Lewczuk, Elzbieta Zinka, Agnieszka Karczmarczyk, Malgorzata Chmielnicka-Pruszczynska, Iwona Wozniak-Skowerska, Marek Bronisz, Marcin Ogorek, Grazyna Glanowska, Piotr Ruszkowski, Grzegorz Skonieczny, Ryszard Sciborski, Boguslaw Okopien, Piotr Kukla, Krzysztof Galbas, Krzysztof Cymerman, Jaroslaw Jurowiecki, Pawel Miekus, Stanislaw Mazur, Roman Lysek, Jacek Baszak, Teresa Rusicka-Piekarz, Ewa Domanska, Jozef Lesnik, Gadel Kamalov, Dmitry Belenky, Liudmila Egorova, Alexander Khokhlov, Eduard Yakupov, Dmitry Zateyshchikov, Olga Miller, Evgeniy Mazur, Konstantin Zrazhevskiy, Tatyana Novikova, Yulia Moiseeva, Elena Polkanova, Konstantin Sobolev, Maria Rossovskaya, Yulia Shapovalova, Alla Kolesnikova, Konstantin Nikolaev, Oksana Zemlianskaia, Anna Zateyshchikova, Victor Kostenko, Maria Poltavskaya, Anton Edin, Elena Aleksandrova, Oksana Drapkina, Alexander Vishnevsky, Oleg Nagibovich, Petr Chizhov, Svetlana Rachkova, Mikhail Sergeev, Borys Kurylo, Alexey Ushakov, Pere Alvarez Garcia, Luis Tercedor Sanchez, Salvador Tranche Iparraguirre, Pere Toran Monserrat, Emilio Marquez Contreras, Jordi Isart Rafecas, Juan Motero Carrasco, Casimiro Gomez Pajuelo, Angel Grande Ruiz, Jordi Merce Klein, Ines Monte Collado, Herminia Palacin Piquero, Carles Brotons Cuixart, Esther Fernandez Escobar, Cecilia Corros Vicente, Manuel Vida Gutierrez, Francisco Epelde Gonzalo, Encarnacion Martinez Navarro, Maria Barreda Gonzalez, Jose Iglesias Sanmartin, Mercedes Jimenez Gonzalez, Juan Herreros Melenchon, Tomas Ripoll Vera, Manuel Jimenez Navarro, Maria Vazquez Caamano, Gonzalo Marcos Gomez, Andres Iniguez Romo, Alexander Wirdby, Kerstin Henriksson, Micael Elmersson, Arnor Egilsson, Ulf Börjesson, Gunnar Svärd, Anders Lindh, Lars-Bertil Olsson, Mikael Gustavsson, Lars Benson, Claes Bothin, Ali Hajimirsadeghi, Björn Martinsson, Marianne Ericsson, Åke Ohlsson, Håkan Lindvall, Peter Svensson, Katarina Thörne, Hans Händel, Pyotr Platonov, Fredrik Bernsten, Ingar Timberg, Milita Crisby, Lennart Malmqvist, Jörgen Thulin, Aida Hot-Bjelak, Steen Jensen, Per Stalby, Johann Debrunner, Iurii Rudyk, Oleksandr Karpenko, Svitlana Zhurba, Igor Kraiz, Oleksandr Parkhomenko, Iryna Kupnovytska, Nestor Seredyuk, Oleksiy Ushakov, Olena Koval, Igor Kovalskiy, Yevgeniya Svyshchenko, Susanna Tykhonova, Ivan Fushtey, Naresh Chauhan, Daryl Goodwin, Ramila Patel, Bennett Wong, Alex Cameron, Niranjan Patel, M S Kainth, Gill Pickavance, Joanna McDonnell, Laura Handscombe, Trevor Gooding, Helga Wagner, Catherine Bromham, Shoeb Suryani, Bhupinder Sarai, W Willcock, S Sircar, A Gilliand, Roman Bilas, E Strieder, Anne Wakeman, Graham Kirby, Bhaskhar Vishwanathan, Nigel Bird, John Bisatt, Jennifer Litchfield, Tim Fooks, Richard Kelsall, Neil Paul, Elizabeth Alborough, Michael Aziz, Pete Wilson, Sue Fairhead, Hasan Chowan, Gary Taylor, Dawn Tragen, Matt Parfitt, Claire Seamark, Carolyn Paul, Angus Jefferies, Helen Sharp, Claire Giles, Matthew Bramley, Philip Williams, Jehad Aldegather, William Lumb, Phil Evans, Frances Scouller, Yvette Stipp, Philip Pinney, Paul Wadeson, T Railton, Emyr Davies, Jonathan McClure, Marc Jacobs, Claire Hutton, Keith Butter, Susan Barrow, Helen Little, Ulka Choudhary, Ikram Haq, Paul Ainsworth, Phil Weeks, Jane Eden, Lisa Gibbons, Janet Glencross, K Poland, Conor Mulolland, A Warke, Ian Hodgins, Stephen Vercoe, Jayesh Patel, Amar Ali, Nigel De-Sousa, Mark Danielsen, Purnima Sharma, Sophia Galloway, Charlotte Hawkins, Raife Oliver, Martin Aylward, Mira Pattni, Shahid Ahmad, Catherine Rothwell, Fiaz Choudhary, Sabrina Khalaque, Stephanie Short, Sharon Peters, Amy Butler, Steven Coates, Steve Walton, Diane Shepherd, Toh Wong, Melanie Deacon, David Cornelius, Henry Choi, Jon Sumner, Tim Myhill, Salah Estifanos, Diane Geatch, Justin Wilkinson, Richard Veale, Rob Hirst, Kashif Zaman, Catherine Liley, Rebecca Wastling, Paul McEleny, Andre Beattie, Mike Wong, Chaminda Dooldeniya, Greg Rogers, Rajesh Muvva, Matthew Adam, Nicolas Thomas, Rory Reed, Simon Randfield, Ann Flynn, Andrew Halpin, Louise Lomax, Minnal Nadaph, Iain Munro, Jane Goram, John Shewring, Emma Bowen-Simpkins, Bhuwanendu Singh, Penny Astridge, Philip Thomson, Ron Lehman, Andrei Catanchin, David Eccleston, Peter Blombery, Greg Starmer, Margaret Arstall, Maurits Binnekamp, Astin Lee, Robert Luton, Amritanshu Shekhar Pandey, Stephen Cheung, Rolland Leader, Philippe Beaudry, Félix Ayala-Paredes, John Heath, Germain Poirier, Bradley Schweitzer, Reginald Nadeau, Ripple Dhillon, Tomasz Hruczkowski, Andrea Lavoie, Ratika Parkash, James Cha, Benoit Coutu, Jorge Bonet, Saul Vizel, Sameh Fikry, Ahmed Mowafy, Azza Katta, Mazen Tawfik, Moustafa Nawar, Mohamed Sobhy, Tarek Khairy, Ahmed Abd El-Aziz, Ashraf Reda, Atef Elbahry, Mohamed Setiha, Magdi Elkhadem, Adel El-Etreby, David Kettles, Junaid Bayat, Heidi Siebert, Adrian Horak, Ynez Kelfkens, Riaz Garda, Thayabran Pillay, Michele Guerra, Hendrik Theron, Rikus Louw, Deon Greyling, Pindile Mntla, Siddique Ismail, Fayzal Ahmed, Johannes Engelbrecht, Shambu Maharajh, Veronica Ueckermann, Ghazi Yousef, Munther AlOmairi, Rajan Maruthanayagam, Rupesh Singh, Ahmed Naguib, Amrish Agrawal, Mukesh Nathani, Adel Wassef, Scott Beach, Peter Duffy, Stephen Falkowski, Kevin Ferrick, Miguel Franco, Annette Quick, Vance Wilson, Mark Alberts, Edwin Blumberg, Roddy Canosa, Ted Gutowski, Rodney Ison, Jorge Garcia, Howard Noveck, Pamela Rama, Rajneesh Reddy, Marcus Williams, Keith Ferdinand, Ihsan Haque, Robert Mendelson, Sridevi Pitta, Charles Treasure, Cas Cader, Walter Pharr, Alisha Oropallo, George Platt, Jaspal Gujral, James Welker, Firas Koura, Ajay K. Kakkar, A. John Camm, David A. Fitzmaurice, Keith A.A. Fox, Bernard J. Gersh, Samuel Z. Goldhaber, Lorenzo G. Mantovani, Karen S. Pieper, Alexander G.G. Turpie, Freek W.A. Verheugt, Antonio Carlos PereiraBarretto, Stuart J. Connolly, Jean-Yves Le Heuzey, Jitendra Pal SinghSawhney, Carlos JerjesSánchez Díaz, Hugo Ten Cate, Wael Al Mahmeed, Zhiming Yang Li Xue, A.G. Ravi Shankar, Chiei Takanaka Sen Adachi, Rodolfo AndresAhuad Guerrero, Leonel Adalberto Di Paola, DárioCelestino Sobral Filho, Costantino RobertoFrack Costantini, Weimar Kunz SebbaBarrosodeSouzaem, João David deSouzaNeto, José Carlos MouraJorge, Adalberto MenezesLorga Filho, Carlos Henrique DelCarlo, FernandoAugustoAlves da Costa, Gilson Robertode Araújo, Jose FranciscoKerr Saraiva, João CarlosFerreira Braga, Roberto Álvaro RamosFilho, Cláudio MunhozdaFontoura Tavares, CésarCássio Broilo França, Guido BernardoAranha Rosito, João BatistadeMouraXavierMoraes Junior, Roberto Simõesde Almeida, Ney CarterdoCarmo Borges, LuísGustavo Gomes Ferreira, Benjamin AleckJosehStockins Fernandez, CarlosJerjes Sanchez Diaz, Jesus JaimeIllescas Diaz, Maria GuadalupeRamos Zavala, GuillermoAntonio Llamas Esperón, Manuel delosRios Ibarra, LuisRamon Virgen Carrillo, JuanJose Lopez Prieto, Jose LuisLeiva Pons, Carlos GerardoCantu Brito, EduardoJulianJose Roberto ChuquiureValenzuela, Alberto EstebanBazzoni Ruiz, Oscar MartinLopez Ruiz, Jesus DavidMorales Cerda, Axel De Wolf, Carmela Viitanen, Giovanni Di Minno, Raimondo De Cristofaro, Angelo De Blasio, Maria D'Avino, J.H. Ruiter, Coen van Guldener, P.R. Nierop S.H.K., B.E. Groenemeijer, W. Terpstra, L.V.A. Boersma, Wieslaw Supinski Jaroslaw, Roman Libis Vera Eltishcheva, Maria FernandaLopez Fernandez, Luis MiguelRincon Diaz, Luis FernandoIglesias Alonso, Jose RamonGonzalez Juanatey, Joan Bayo iLlibre, Carlos AlexandreAlmeida Fernandez, Juan JoseMontero Alia, Maria AngelsMoleiro Oliva, Maria delMarRodriguez Alvarez, Maria FeArcocha Torres, Miguel AngelPrieto Diaz, Jan Lindén Centrumkliniken, Juerg H. Beer, Colin Bradshaw Cumberlidge, Daniel Jackson Ben Ward, Nick Hargreaves Ben Frankel, William van Gaal, David O'Donnell, Miranda du Preez, Seif Kamal Abou Seif, Mohamed Gamal El Din, Louis van Zyl, Rehana Loghdey Wessel Oosthuysen, Abdullah Al Naeemi, Ehab M. Esheiba, and W. Michael Kutayli
Subjects: Diseases of the circulatory (Cardiovascular) system, RC666-701
Abstract: Objective While greater body mass index (BMI) is associated with increased risk of developing atrial fibrillation (AF), the impact of BMI on outcomes in newly diagnosed AF is unclear. We examine the influence of BMI on outcomes and whether this is modified by sex and evaluate the effect of non-vitamin K oral anticoagulants (NOACs) in patients with high BMI.Methods GARFIELD-AF is a prospective registry of 52 057 newly diagnosed AF patients. The study population comprised 40 482 participants: 703 underweight (BMI
Published: 2022
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7. Incidence and Predictors of Heart Failure in Patients With Atrial Fibrillation

Author: Philipp Krisai, MD, Linda S.B. Johnson, MD, PhD, Giorgio Moschovitis, MD, MSc, Alexander Benz, MD, MSc, Chinthanie Ramasundarahettige, MSc, William F. McIntyre, MD, Jorge A. Wong, MD, MPH, David Conen, MD, MPH, Christian Sticherling, MD, Stuart J. Connolly, MD, and Jeff S. Healey, MD, MSc
Subjects: Diseases of the circulatory (Cardiovascular) system, RC666-701
Abstract: Background: Heart failure (HF) is a frequent cause of hospitalization and death in patients with atrial fibrillation (AF). Identifying AF patients at risk of HF hospitalization could help select individuals for intensive follow-up and treatment. Methods: We pooled data from 3 randomized trials (ACTIVE-A, RE-LY, AVERROES) of AF patients, for derivation and internal validation of a risk score for first HF hospitalization. Secondary endpoints were cardiovascular death and a composite of HF hospitalizations and cardiovascular death. Results: In 23,503 patients, the mean age was 71.3 years, and 62% were male. Over a mean follow-up of 2.0 years, 875 patients (3.7%) experienced their first HF hospitalization, and 1037 patients (4.4%) died from cardiovascular causes. Incidence rates per 100 patient-years were 1.85 for HF hospitalizations, 2.15 for cardiovascular death, and 3.71 for the composite. Independent predictors for HF hospitalizations included the following: increased age, weight, heart rate and serum creatinine level, lower height and systolic blood pressure, diabetes, vascular disease, valvular disease, heart rhythm, left ventricular hypertrophy, and intraventricular conduction delay. The C-statistic (95% confidence intervals by bootstrap simulations) was 0.717 (0.705-0.732). At 2 years of follow-up, the incidence rate of the primary outcome increased across risk-score quintiles: 0.49, 0.87, 1.29, 2.44, and 4.51 per 100 patient-years, respectively. Patients in the highest quintile had an absolute risk of 6.8% for the primary endpoint at 2 years. Conclusions: In a large AF population, new-onset HF was common. A combination of characteristics can identify high-risk patients for whom strategies to prevent HF should be considered. Résumé: Introduction: L’insuffisance cardiaque (IC) est une cause fréquente d’hospitalisation et de décès chez les patients atteints de fibrillation auriculaire (FA). Le repérage des patients atteints de FA exposés au risque d’hospitalisation liée à l’IC pourrait faciliter la sélection des individus pour un suivi et un traitement intensifs. Méthodes: Nous avons regroupé les données de trois essais contrôlés (ACTIVE-A, RE-LY, AVERROES) de patients atteints de FA pour obtenir la dérivation et la validation interne d’un score de risque lors de la première hospitalisation liée à l’IC. Les critères secondaires étaient les décès dus aux maladies cardiovasculaires et le critère composite d’hospitalisations liées à l’IC et de décès dus aux maladies cardiovasculaires. Résultats: L’âge moyen des 23 503 patients, dont 62 % étaient des hommes, était de 71,3 ans. Durant un suivi moyen de 2,0 ans, 875 patients (3,7 %) ont subi leur première hospitalisation liée à l’IC, et 1 037 patients (4,4 %) sont morts de maladies cardiovasculaires. Les taux d’incidence par 100 patients-années étaient de 1,85 pour les hospitalisations liées à l’IC, de 2,15 pour les décès dus aux maladies cardiovasculaires et de 3,71 pour le critère composite. Les prédicteurs indépendants des hospitalisations liées à l’IC étaient les suivants : l’âge avancé, le poids, la fréquence cardiaque et la concentration sérique de la créatinine, la taille inférieure et la pression artérielle systolique, le diabète, les maladies vasculaires, la valvulopathie, le rythme cardiaque, l’hypertrophie ventriculaire gauche et le retard de conduction intraventriculaire. La statistique C (intervalles de confiance à 95 % obtenus par simulations d’auto-amorçage) était de 0,717 (0,705-0,732). Après deux ans de suivi, le taux d’incidence du critère d’évaluation principal augmentait de façon respective dans tous les quintiles de scores de risque : 0,49, 0,87, 1,29, 2,44 et 4,51 par 100 patients-années. Les patients dans le quintile supérieur avaient un risque absolu du critère d’évaluation principal de 6,8 % après deux ans. Conclusions: Dans une vaste population atteinte de FA, l’IC d’apparition récente était fréquente. La combinaison des caractéristiques peut permettre de déterminer les patients exposés à un risque élevé chez lesquels des stratégies de prévention de l’IC devraient être envisagées.
Published: 2021
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8. Response to the Letter by Spurling and Colleagues

Author: Craig I. Coleman, Olivia S. Costa, Stuart J. Connolly, Mukul Sharma, Jan Beyer-Westendorf, Mary J. Christoph-Schubel, and Belinda Lovelace
Subjects: Medical emergencies. Critical care. Intensive care. First aid, RC86-88.9
Published: 2023
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9. Thirty‐day mortality with andexanet alfa compared with prothrombin complex concentrate therapy for life‐threatening direct oral anticoagulant‐related bleeding

Author: Alexander T. Cohen, Megan Lewis, Augusta Connor, Stuart J. Connolly, Patrick Yue, John Curnutte, Raza Alikhan, Peter MacCallum, Joachim Tan, and Laura Green
Subjects: Medical emergencies. Critical care. Intensive care. First aid, RC86-88.9
Abstract: Abstract Objective Compare 30‐day mortality among patients receiving the specific reversal agent andexanet alfa versus replacement prothrombin complex concentrate (PCC) in the management of direct‐acting oral anticoagulant (DOAC)–related bleeds. Methods Two patient‐level datasets were used: ANNEXA‐4, a prospective, single‐arm trial of patients taking apixaban or rivaroxaban who received andexanet alfa and ORANGE, a prospective, observational study of anticoagulated patients in UK hospitals, some of whom received PCC. Patients were propensity score matched based on demographic and clinical characteristics. Subgroup analyses were performed by bleed type (intracranial hemorrhage [ICH], gastrointestinal [GI], other). Relative risk (RR) of all‐cause 30‐day mortality was calculated. Results 322 ANNEXA‐4 patients treated with andexanet alfa (mean age = 77.7 years; 64.9% ICH) were matched with 88 ORANGE patients treated with PCC (mean age = 74.9 years, 67.1% ICH). Adjusted 30‐day mortality for patients treated with andexanet alfa (14.6%) was lower than patients treated with PCC (34.1%; RR, 0.43; 95% CI, 0.29–0.63). In the ICH subgroup, patients treated with andexanet alfa had lower mortality (15.3%) than patients treated with PCC (48.9%; RR, 0.31; 95% CI, 0.20–0.48). Mortality risk was lowest for patients in the GI subgroup but did not differ significantly by treatment (12.2% for andexanet alfa vs 25.0% for PCC; RR, 0.49; 95% CI, 0.21–1.16). Conclusions In this propensity score–matched comparison across 2 independent datasets, adjusted 30‐day mortality rates were lower for patients treated with andexanet alfa than in matched patients receiving PCC. This indirect comparison was limited in that it could not account for several highly predictive variables including GCS score, hematoma volume, and expected survival. Further research is warranted to confirm the mortality differences between reversal/replacement agents for DOAC‐related bleeding.
Published: 2022
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10. Rate, Time Course, and Predictors of Implantable Cardioverter Defibrillator Infections: An Analysis From the SIMPLE Trial

Author: François Philippon, MD, FRCPC, FHRS, FCCS, Gilles E. O’Hara, MD, Jean Champagne, MD, Stefan H. Hohnloser, MD, Michael Glikson, MD, Jörg Neuzner, MD, Philippe Mabo, MD, Xavier Vinolas, MD, Josef Kautzner, MD, Fredrik Gadler, MD, Noa Lashevsky, Stuart J. Connolly, MD, Yan Y. Liu, MSc, and Jeff S. Healey, MD
Subjects: Diseases of the circulatory (Cardiovascular) system, RC666-701
Abstract: Background: The number of implantable cardioverter defibrillator (ICD) infections is increasing due to an increased number of ICD implants, higher-risk patients, and more frequent replacement procedures, which carry a higher risk of infection. Reducing the morbidity, mortality, and cost of ICD-related infections requires an understanding of the current rate of this complication and its predictors. Methods: The Shock Implant Evaluation Trial (SIMPLE) trial randomized 2500 ICD recipients to defibrillation testing or not. Over an average of 3.1 years, patients were seen every 6 months and examined for evidence of ICD infection, which was defined as requiring device removal and/or intravenous antibiotics. Results: Within 24 months, 21 patients (0.8%) developed infection. Fourteen patients (67%) with infection presented within 30 days, 20 patients by 12 months, and only 1 patient beyond 12 months. Univariate analysis demonstrated that patients with primary electrical disorders (3 patients, P = 0.009) and those with a secondary prevention indication (13 patients, P = 0.0009) were more likely to develop infection. Among the 2.2% of patients who developed an ICD wound hematoma, 10.4% developed an infection. Among the 8.3% of patients requiring an ICD reintervention, 1.9% developed an infection. Conclusions: This cohort of ICD recipients at high-volume centres have a low risk of device-related infection. However; strategies to reduce wound hematoma and the need for ICD reintervention could further reduce the rate of infection. Résumé: Contexte: L’incidence des cas d’infection du défibrillateur cardioverteur implantable (DCI) augmente en raison du nombre accru d’implantations, de l’emploi de ces dispositifs chez des patients exposés à un risque très élevé et de l’augmentation de la fréquence des interventions de remplacement, qui sont associées à un plus grand risque d’infections. Pour parvenir à réduire la morbidité, la mortalité et les coûts associés aux infections liées à un DCI, il faut connaître la fréquence de cette complication et les facteurs qui permettent de la prédire. Méthodologie: Lors de l’essai Shock Implant Evaluation Trial (SIMPLE), 2 500 patients ayant reçu un DCI ont été répartis aléatoirement en deux groupes, l’un subissant des tests de défibrillation et l’autre, non. Sur une période de 3,1 ans en moyenne, les patients ont été vus en consultation tous les 6 mois et examinés à la recherche de signes d’infection du DCI, définie comme étant une infection exigeant le retrait du dispositif et/ou l’administration d’antibiotiques par voie intraveineuse. Résultats: Au total, 21 patients (0,8 %) ont présenté une infection dans les 24 mois suivant l’implantation. Quatorze patients (67 %) ont présenté une infection dans les 30 jours suivant l’intervention; à 12 mois, 20 patients avaient présenté une infection. Un seul patient a présenté une infection plus de 12 mois après l’intervention. Les résultats d’une analyse univariée ont démontré qu’une infection était plus probable chez les patients qui présentaient un trouble électrique primaire (3 patients, p = 0,009) et chez ceux qui avaient reçu un dispositif en prévention secondaire (13 patients, p = 0,0009). Parmi les patients qui présentaient un hématome après l’implantation du DCI (2,2 %), 10,4 % ont présenté une infection. Parmi les patients qui ont eu besoin d’une nouvelle intervention relative au DCI (8,3 %), 1,9 % ont présenté une infection. Conclusions: Les patients de cette cohorte ayant reçu un DCI dans des établissements à haut volume étaient exposés à un faible risque d’infection du défibrillateur. Des stratégies visant à réduire les hématomes et la nécessité d’une nouvelle intervention sur les DCI pourraient toutefois contribuer à réduire encore plus la fréquence des infections.
Published: 2020
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11. LVS‐HARMED Risk Score for Incident Heart Failure in Patients With Atrial Fibrillation Who Present to the Emergency Department: Data from a World‐Wide Registry

Author: Linda S. B. Johnson, Jonas Oldgren, Tyler W. Barrett, Candace D. McNaughton, Jorge A. Wong, William F. McIntyre, Clifford L. Freeman, Laura Murphy, Gunnar Engström, Michael Ezekowitz, Stuart J. Connolly, Lizhen Xu, Juliet Nakamya, David Conen, Shrikant I. Bangdiwala, Salim Yusuf, and Jeff S. Healey
Subjects: atrial fibrillation, epidemiology, heart failure, prevention, risk score, risk stratification, Diseases of the circulatory (Cardiovascular) system, RC666-701
Abstract: Background Heart failure (HF) is a common complication to atrial fibrillation (AF), leading to rehospitalization and death. Early identification of patients with AF at risk for HF might improve outcomes. We aimed to derive a score to predict 1‐year risk of new‐onset HF after an emergency department (ED) visit with AF. Methods and Results The RE‐LY AF (Randomized Evaluation of Long‐Term Anticoagulant Therapy) registry enrolled patients with AF presenting to an ED in 47 countries, and followed them for a year. The end point was HF hospitalization and/or HF death. Among 15 400 ED patients, 9765 had no prior HF (mean age, 64.9±14.9 years). Within 1 year, new‐onset HF developed in 6.8% of patients, of whom 21% died of HF. Independent predictors of HF included left ventricular hypertrophy (odds ratio [OR], 1.47; 95% CI, 1.19–1.82), valvular heart disease (OR, 1.55; 95% CI, 1.18–2.04), smoking (OR, 1.42; 95% CI, 1.12–1.78), height (OR, 0.93; 95% CI, 0.90–0.95 per 3 cm), age (OR, 1.11; 95% CI, 1.07–1.15 per 5 years), rheumatic heart disease (OR, 1.77, 95% CI, 1.24–2.51), prior myocardial infarction (OR, 1.85; 95% CI, 1.45–2.36), remaining in AF at ED discharge (OR, 1.86; 95% CI, 1.46–2.36), and diabetes (OR, 1.33; 95% CI, 1.09–1.64). A continuous risk prediction score (LVS‐HARMED [left ventricular, valvular heart disease, smoking or other tobacco use, height, age, rheumatic heart disease, myocardial infarction, emergency department discharge rhythm, and diabetes]) had good discrimination (C statistic, 0.735; 95% CI, 0.716–0.755). Validation was conducted internally using bootstrapping (optimism‐corrected C statistic, 0.705) and externally (C statistic, 0.699). The 1‐year incidence of HF hospitalization and/or HF death across quartile groups of the score was 1.1%, 4.5%, 6.9%, and 14.4%, respectively. LVS‐HARMED also predicted incident stroke (C statistic, 0.753; 95% CI, 0.728–0.778). Conclusions The LVS‐HARMED score predicts new‐onset HF after an ED visit for AF. Preventative strategies should be considered in patients with high LVS‐HARMED HF risk.
Published: 2021
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12. Total events and net clinical benefit of rivaroxaban and aspirin in patients with chronic coronary or peripheral artery disease: The COMPASS trial

Author: Kelley R.H. Branch, Jeffrey L. Probstfield, Jackie Bosch, Deepak L. Bhatt, Aldo P. Maggioni, Eva Muehlhofer, Alvaro Avezum, Petr Widimsky, Stuart J. Connolly, Quilong Yi, Olga Shestakovska, Salim Yusuf, and John W. Eikelboom
Subjects: Cardiology and Cardiovascular Medicine
Published: 2023
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13. High-Sensitivity Estimate of the Incidence of New-Onset Atrial Fibrillation in Critically Ill Patients

Author: William F. McIntyre, MD, Emilie P. Belley-Côté, MD, PHD, Maria E. Vadakken, Anand S. Rai, BHSc, Alexandra P. Lengyel, BHSc, Bram Rochwerg, MD, MSc, Akash K. Bhatnagar, MD, Bishoy Deif, MD, Kevin J. Um, MD, Jessica Spence, MD, PhD, Stuart J. Connolly, MD, MSc, Shrikant I. Bangdiwala, PhD, Purnima Rao-Melacini, MSc, Jeff S. Healey, MD, MSc, and Richard P. Whitlock, MD, PhD
Subjects: Medical emergencies. Critical care. Intensive care. First aid, RC86-88.9
Abstract: Objective:. To estimate the incidence of new-onset atrial fibrillation in critically ill patients. Design:. Prospective cohort. Setting:. Medical-surgical ICU. Subjects:. Consecutive patients without a history of atrial fibrillation but with atrial fibrillation risk factors. Interventions:. Electrocardiogram patch monitor until discharge from hospital or up to 14 days. Measurements and Main Results:. A total of 249 participants (median age of 71 yr [interquartile range] 64–78 yr; 35% female) completed the study protocol of which 158 (64%) were admitted to ICU for medical illness, 78 (31%) following noncardiac surgery, and 13 (5%) with trauma. Median Acute Physiology and Chronic Health Evaluation II score was 16 (interquartile range, 12–22). Median duration of patch electrocardiogram monitoring, ICU, and hospital lengths of stay were 6 (interquartile range, 3–12), 4 (interquartile range, 2–8), and 11 days (interquartile range, 5–23 d), respectively. Atrial fibrillation ≥ 30 seconds was detected by the patch in 44 participants (17.7%), and three participants (1.2%) had atrial fibrillation detected clinically after patch removal, resulting in an overall atrial fibrillation incidence of 18.9% (95% CI, 14.2–24.3%). Total duration of atrial fibrillation ranged from 53 seconds to the entire monitoring time. The proportion of participants with ≥1 episode(s) of ≥6 minute, ≥1 hour, ≥12 hour and ≥24 hour duration was 14.8%, 13.2%, 7.0%, and 5.3%, respectively. The clinical team recognized only 70% of atrial fibrillation cases that were detected by the electrocardiogram patch. Conclusions:. Among patients admitted to an ICU, the incidence of new-onset atrial fibrillation is approximately one in five, although approximately one-third of cases are not recognized by the clinical team.
Published: 2021
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14. Screening of Multiple Biomarkers Associated With Ischemic Stroke in Atrial Fibrillation

Author: Ziad Hijazi, Lars Wallentin, Johan Lindbäck, John H. Alexander, Stuart J. Connolly, John W. Eikelboom, Michael D. Ezekowitz, Christopher B. Granger, Renato D. Lopes, Tymon Pol, Salim Yusuf, Jonas Oldgren, and Agneta Siegbahn
Subjects: atrial fibrillation, biomarkers, ischemic stroke, pathophysiological features, screening, Diseases of the circulatory (Cardiovascular) system, RC666-701
Abstract: Background To explore the pathophysiological features of ischemic stroke in patients with atrial fibrillation (AF), we evaluated the association between 268 plasma proteins and subsequent ischemic stroke in 2 large AF cohorts receiving oral anticoagulation. Methods and Results A case‐cohort sample of patients with AF from the ARISTOTLE (Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation) trial, including 282 cases with ischemic stroke or systemic embolism and a random sample of 4124 without these events, during 1.9 years of follow‐up was used for identification. Validation was provided by a similar case‐cohort sample of patients with AF from the RE‐LY (Randomized Evaluation of Long‐Term Anticoagulation Therapy) trial, including 149 cases with ischemic stroke/systemic embolism and a random sample of 1062 without these events. In plasma obtained before randomization, 268 unique biomarkers were measured with OLINK proximity extension assay panels (CVD II, CVD III, and Inflammation) and conventional immunoassays. The association between biomarkers and outcomes was evaluated by random survival forest and adjusted Cox regression. According to random survival forest or Cox regression analyses, the biomarkers most strongly and consistently associated with ischemic stroke/systemic embolism were matrix metalloproteinase‐9, NT‐proBNP (N‐terminal pro‐B‐type natriuretic peptide), osteopontin, sortilin, soluble suppression of tumorigenesis 2, and trefoil factor‐3. The corresponding hazard ratios (95% CIs) for an interquartile difference were as follows: 1.18 (1.00–1.38), 1.55 (1.28–1.88), 1.28 (1.07–1.53), 1.19 (1.02–1.39), 1.23 (1.05–1.45), and 1.19 (0.97–1.45), respectively. Conclusions In patients with AF, of 268 unique biomarkers, the 6 biomarkers most strongly associated with subsequent ischemic stroke/systemic embolism represent fibrosis/remodeling (matrix metalloproteinase‐9 and soluble suppression of tumorigenesis 2), cardiac dysfunction (NT‐proBNP), vascular calcification (osteopontin), metabolism (sortilin), and mucosal integrity/ischemia (trefoil factor‐3). Registration URL: https://www.clinicaltrials.gov. Unique Identifiers: NCT00412984 and NCT00262600.
Published: 2020
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15. Hypertension prevalence but not control varies across the spectrum of risk in patients with atrial fibrillation: A RE-LY atrial fibrillation registry sub-study.

Author: Finlay A McAlister, Rajibul Mian, Jonas Oldgren, Lars Wallentin, Michael Ezekowitz, Salim Yusuf, Stuart J Connolly, Jeff S Healey, and RE-LY Atrial Fibrillation Registry Investigators
Subjects: Medicine, Science
Abstract: BACKGROUND:Although hypertension is the most common risk factor for atrial fibrillation (AF), whether blood pressure (BP) control varies across the spectrum of stroke risk in patients with AF or by adequacy of their thromboprophylaxis management is unclear. METHODS:We examined data from the RE-LY AF registry conducted at 164 emergency departments (EDs) in 47 countries between December 2007 and October 2011. RESULTS:Of the 15,400 patients in the registry, we analyzed the 9929 (mean age 67.5 years, 51.9% men) with a prior history of AF and complete BP data. While 6508 (66.5%) AF patients had hypertension, the prevalence varied widely depending on comorbidity profiles: from 45.4% in those without other cardiovascular risk factors to 82.5% in those with AF and diabetes. Although 93.9% of AF patients with hypertension were on at least one antihypertensive agent, fewer than half had BP levels ≤ 140/90 with no difference across risk profiles: 45.9% of those with NVAF and CHADS2 scores of 1 and 45.6% of those with NVAF and CHADS2 scores of 2 or more (46.9% and 45.3% for CHA2DS2-VASc scores of 1 versus 2 or more). BP control rates were not significantly better in those NVAF patients receiving guideline concordant thromboprophylaxis management (47.2%, aOR 1.03, 95%CI 0.89-1.20) than in those not receiving guideline-concordant antithrombotic therapy (45.3%). CONCLUSIONS:Hypertension was common in patients with AF but BP control rates were sub-optimal and varied little across the spectrum of stroke risk or by adequacy of thromboprophylaxis. This highlights the need for an increased focus on total atherosclerotic risk rather than just thromboprophylaxis management in AF patients.
Published: 2020
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16. Risk profiles and one-year outcomes of patients with newly diagnosed atrial fibrillation in India: Insights from the GARFIELD-AF Registry

Author: Jitendra PS. Sawhney, Veerappa A. Kothiwale, Vikas Bisne, Rajashekhar Durgaprasad, Praveen Jadhav, Manoj Chopda, Velam Vanajakshamma, Ramdhan Meena, Govindan Vijayaraghavan, Kamaldeep Chawla, Jagan Allu, Karen S. Pieper, A. John Camm, Ajay K. Kakkar, Jean-Pierre Bassand, David A. Fitzmaurice, Samuel Z. Goldhaber, Shinya Goto, Sylvia Haas, Werner Hacke, Lorenzo G. Mantovani, Frank Misselwitz, Alexander G.G. Turpie, Martin van Eickels, Freek W.A. Verheugt, Gloria Kayani, Keith A.A. Fox, Bernard J. Gersh, Hector Lucas Luciardi, Harry Gibbs, Marianne Brodmann, Frank Cools, Antonio Carlos Pereira Barretto, Stuart J. Connolly, Alex Spyropoulos, John Eikelboom, Ramon Corbalan, Dayi Hu, Petr Jansky, Jørn Dalsgaard Nielsen, Hany Ragy, Pekka Raatikainen, Jean-Yves Le Heuzey, Harald Darius, Matyas Keltai, Sanjay Kakkar, Jitendra Pal Singh Sawhney, Giancarlo Agnelli, Giuseppe Ambrosio, Yukihiro Koretsune, Carlos Jerjes Sánchez Díaz, Hugo Ten Cate, Dan Atar, Janina Stepinska, Elizaveta Panchenko, Toon Wei Lim, Barry Jacobson, Seil Oh, Xavier Viñolas, Marten Rosenqvist, Jan Steffel, Pantep Angchaisuksiri, Ali Oto, Alex Parkhomenko, Wael Al Mahmeed, David Fitzmaurice, D.Y. Hu, K.N. Chen, Y.S. Zhao, H.Q. Zhang, J.Z. Chen, S.P. Cao, D.W. Wang, Y.J. Yang, W.H. Li, Y.H. Yin, G.Z. Tao, P. Yang, Y.M. Chen, S.H. He, Ying Wang, Yong Wang, G.S. Fu, X. Li, T.G. Wu, X.S. Cheng, X.W. Yan, R.P. Zhao, M.S. Chen, L.G. Xiong, P. Chen, Y. Jiao, Y. Guo, L. Xue, F.Z. Wang, H. Li, Z.M. Yang, C.L. Bai, J. Chen, J.Y. Chen, X. Chen, S. Feng, Q.H. Fu, X.J. Gao, W.N. Guo, R.H. He, X.A. He, X.S. Hu, X.F. Huang, B. Li, J. Li, L. Li, Y.H. Li, T.T. Liu, W.L. Liu, Y.Y. Liu, Z.C. Lu, X.L. Luo, T.Y. Ma, J.Q. Peng, X. Sheng, X.J. Shi, Y.H. Sun, G. Tian, K. Wang, L. Wang, R.N. Wu, Q. Xie, R.Y. Xu, J.S. Yang, L.L. Yang, Q. Yang, Y. Ye, H.Y. Yu, J.H. Yu, T. Yu, H. Zhai, Q. Zhan, G.S. Zhang, Q. Zhang, R. Zhang, Y. Zhang, W.Y. Zheng, B. Zhou, Z.H. Zhou, X.Y. Zhu, S. Kakkar, J.P.S. Sawhney, P. Jadhav, R. Durgaprasad, A.G. Ravi Shankar, R.K. Rajput, K. Bhargava, R. Sarma, A. Srinivas, D. Roy, U.M. Nagamalesh, M. Chopda, R. Kishore, G. Kulkarni, P. Chandwani, R.A. Pothiwala, M. Padinhare Purayil, S. Shah, K. Chawla, V.A. Kothiwale, B. Raghuraman, G. Vijayaraghavan, V.M. Vijan, G. Bantwal, V. Bisne, A. Khan, J.B. Gupta, S. Kumar, D. Jain, S. Abraham, D. Adak, A. Barai, H. Begum, P. Bhattacharjee, M. Dargude, D. Davies, B. Deshpande, P. Dhakrao, V. Dhyani, S. Duhan, M. Earath, A. Ganatra, S. Giradkar, V. Jain, R. Karthikeyan, L. Kasala, S. Kaur, S. Krishnappa, A. Lawande, B. Lokesh, N. Madarkar, R. Meena, P. More, D. Naik, K. Prashanth, M. Rao, N.M. Rao, N. Sadhu, D. Shah, M. Sharma, P. Shiva, S. Singhal, S. Suresh, V. Vanajakshamma, S.G. Panse, Y. Koretsune, S. Kanamori, K. Yamamoto, K. Kumagai, Y. Katsuda, K. Sadamatsu, F. Toyota, Y. Mizuno, I. Misumi, H. Noguchi, S. Ando, T. Suetsugu, M. Minamoto, Hiroshi Oda, K. Shiraishi, S. Adachi, K. Chiba, H. Norita, M. Tsuruta, T. Koyanagi, H. Ando, T. Higashi, K. Okada, S. Azakami, S. Komaki, K. Kumeda, T. Murayama, J. Matsumura, Y. Oba, R. Sonoda, K. Goto, K. Minoda, Y. Haraguchi, H. Suefuji, H. Miyagi, H. Kato, Tadashi Nakamura, Tsugihiro Nakamura, H. Nandate, R. Zaitsu, Yoshihisa Fujiura, A. Yoshimura, H. Numata, J. Ogawa, H. Tatematsu, Y. Kamogawa, K. Murakami, Y. Wakasa, M. Yamasawa, H. Maekawa, S. Abe, H. Kihara, S. Tsunoda, Katsumi Saito, Kazuyuki Saito, T. Fudo, K. Obunai, H. Tachibana, I. Oba, T. Kuwahata, S. Higa, M. Gushiken, T. Eto, H. Yoshida, D. Ikeda, Yoshitake Fujiura, M. Ishizawa, M. Nakatsuka, K. Murata, C. Ogurusu, M. Shimoyama, M. Akutsu, I. Takamura, F. Hoshino, N. Yokota, T. Iwao, K. Tsuchida, M. Takeuchi, Y. Hatori, Y. Kitami, Yoichi Nakamura, R. Oyama, M. Ageta, Hiroyuki Oda, Y. Go, K. Mishima, T. Unoki, S. Morii, Yuhei Shiga, H. Sumi, T. Nagatomo, K. Sanno, K. Fujisawa, Y. Atsuchi, T. Nagoshi, T. Seto, T. Tabuchi, M. Kameko, K. Nii, K. Oshiro, H. Takezawa, S. Nagano, N. Miyamoto, M. Iwaki, Yuichiro Nakamura, M. Fujii, M. Okawa, Masahiko Abe, Masatake Abe, Mitsunori Abe, T. Saito, T. Mito, K. Nagao, J. Minami, T. Mita, I. Sakuma, T. Taguchi, S. Marusaki, H. Doi, M. Tanaka, T. Fujito, M. Matsuta, T. Kusumoto, S. Kakinoki, K. Ashida, N. Yoshizawa, J. Agata, O. Arasaki, M. Manita, M. Ikemura, S. Fukuoka, H. Murakami, S. Matsukawa, Y. Hata, T. Taniguchi, T. Ko, H. Kubo, M. Imamaki, M. Akiyama, M. Inagaki, H. Odakura, T. Ueda, Y. Katsube, A. Nakata, H. Watanabe, M. Techigawara, M. Igarashi, K. Taga, T. Kimura, S. Tomimoto, M. Shibuya, M. Nakano, K. Ito, T. Seo, S. Hiramitsu, H. Hosokawa, M. Hoshiai, M. Hibino, K. Miyagawa, Hajime Horie, N. Sugishita, Yukio Shiga, A. Soma, K. Neya, Tetsuro Yoshida, Tomoki Yoshida, M. Mizuguchi, M. Ishiguro, T. Minagawa, M. Wada, H. Mukawa, F. Okuda, S. Nagasaka, Y. Abe, Sen Adachi, Susumu Adachi, T. Adachi, K. Akahane, T. Amano, K. Aoki, T. Aoyama, H. Arai, S. Arima, T. Arino, H. Asano, T. Asano, J. Azuma, T. Baba, T. Betsuyaku, H. Chibana, H. Date, J. Doiuchi, Y. Emura, M. Endo, Y. Fujii, R. Fujiki, A. Fujisawa, Y. Fujisawa, T. Fukuda, T. Fukui, N. Furukawa, T. Furukawa, W. Furumoto, T. Goto, M. Hamaoka, N. Hanazono, K. Hasegawa, T. Hatsuno, Y. Hayashi, K. Higuchi, K. Hirasawa, H. Hirayama, M. Hirose, S. Hirota, M. Honda, Hideki Horie, T. Ido, O. Iiji, H. Ikeda, K. Ikeda, K. Ikeoka, M. Imaizumi, H. Inaba, T. Inoue, F. Iseki, A. Ishihara, N. Ishioka, N. Ito, T. Iwase, H. Kakuda, J. Kamata, H. Kanai, H. Kanda, M. Kaneko, H. Kano, T. Kasai, T. Kato, Y. Kato, Y. Kawada, K. Kawai, K. Kawakami, S. Kawakami, T. Kawamoto, S. Kawano, J. Kim, T. Kira, H. Kitazawa, H. Kitazumi, T. Kito, T. Kobayashi, T. Koeda, J. Kojima, H. Komatsu, I. Komatsu, Y. Koshibu, T. Kotani, T. Kozuka, Y. Kumai, T. Kumazaki, I. Maeda, K. Maeda, Y. Maruyama, S. Matsui, K. Matsushita, Y. Matsuura, K. Mineoi, H. Mitsuhashi, N. Miura, S. Miyaguchi, S. Miyajima, H. Miyamoto, A. Miyashita, S. Miyata, I. Mizuguchi, A. Mizuno, T. Mori, O. Moriai, K. Morishita, O. Murai, Sho Nagai, Shunichi Nagai, E. Nagata, H. Nagata, A. Nakagomi, S. Nakahara, M. Nakamura, R. Nakamura, N. Nakanishi, T. Nakayama, R. Nakazato, T. Nanke, J. Nariyama, Y. Niijima, H. Niinuma, Y. Nishida, Y. Nishihata, K. Nishino, H. Nishioka, K. Nishizawa, I. Niwa, K. Nomura, S. Nomura, M. Nozoe, T. Ogawa, N. Ohara, M. Okada, K. Okamoto, H. Okita, M. Okuyama, H. Ono, T. Ono, Y. Onuki Pearce, S. Oriso, A. Ota, E. Otaki, Y. Saito, H. Sakai, N. Sakamoto, Y. Sakamoto, Y. Samejima, Y. Sasagawa, H. Sasaguri, A. Sasaki, T. Sasaki, Kazuki Sato, Kiyoharu Sato, M. Sawano, S. Seki, Y. Sekine, Y. Seta, K. Sezaki, N. Shibata, Y. Shiina, H. Shimono, Y. Shimoyama, T. Shindo, H. Shinohara, R. Shinohe, T. Shinozuka, T. Shirai, T. Shiraiwa, Y. Shozawa, T. Suga, C. Sugimoto, Kazuo Suzuki, Keita Suzuki, Shu Suzuki, Shunji Suzuki, Susumu Suzuki, Y. Suzuki, M. Tada, A. Taguchi, T. Takagi, Y. Takagi, K. Takahashi, S. Takahashi, H. Takai, C. Takanaka, S. Take, H. Takeda, K. Takei, K. Takenaka, T. Tana, G. Tanabe, K. Taya, H. Teragawa, S. Tohyo, S. Toru, Y. Tsuchiya, T. Tsuji, K. Tsuzaki, H. Uchiyama, O. Ueda, Y. Ueyama, N. Wakaki, T. Wakiyama, T. Washizuka, M. Watanabe, T. Yamada, T. Yamagishi, H. Yamaguchi, Kenichi Yamamoto, Kentaro Yamamoto, Kunihiko Yamamoto, T. Yamamoto, M. Yamaura, M. Yamazoe, K. Yasui, Y. Yokoyama, K. Yoshida, T.W. Lim, C.K. Ching, C.G. Foo, J.H. Chow, D.D. Chen, F.R. Jaufeerally, Y.M. Lee, G. Lim, W.T. Lim, S. Thng, S.Y. Yap, C. Yeo, S. Oh, H.N. Pak, J.-B. Kim, J.H. Kim, S.-W. Jang, D.H. Kim, D.R. Ryu, S.W. Park, D.-K. Kim, D.J. Choi, Y.S. Oh, M.-C. Cho, S.-H. Kim, H.-K. Jeon, D.-G. Shin, J.S. Park, H.K. Park, S.-J. Han, J.H. Sung, J.-G. Cho, G.-B. Nam, Y.K. On, H.E. Lim, J.J. Kwak, T.-J. Cha, T.J. Hong, S.H. Park, J.H. Yoon, N.-H. Kim, K.-S. Kim, B.C. Jung, G.-S. Hwang, C.-J. Kim, D.B. Kim, J.J. Ahn, H.J. An, H. Bae, A.L. Baek, W.J. Chi, E.A. Choi, E.H. Choi, H.K. Choi, H.S. Choi, S. Han, E.S. Heo, K.O. Her, S.W. Hwang, E.M. Jang, H.-S. Jang, S. Jang, H.-G. Jeon, S.R. Jeon, Y.R. Jeon, H.K. Jeong, I.-A. Jung, Hyeon Jeong Kim, Hyun Ju Kim, Ji Seon Kim, Jung Sook Kim, J.A. Kim, K.T. Kim, M.S. Kim, Sang Hee Kim, Sang Hyun Kim, Y.-I. Kim, C.S. Lee, E.H. Lee, G.H. Lee, H.Y. Lee, H.-Y. Lee, K.H. Lee, K.R. Lee, M.S. Lee, M.-Y. Lee, R.W. Lee, S.E. Lee, S.H. Lee, S. Lee, W.Y. Lee, I.K. Noh, A.R. Park, B.R. Park, H.N. Park, J.H. Park, M. Park, Y. Park, S.-Y. Seo, J. Shim, J.H. Sim, Y.M. Sohn, W.S. Son, Y.S. Son, H.J. Song, H.K. Wi, J.J. Woo, S. Ye, K.H. Yim, K.M. Yoo, E.J. Yoon, S.Y. Yun, P. Angchaisuksiri, S. Chawanadelert, P. Mongkolwongroj, K. Kanokphatcharakun, S. 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Robiro Robiro, M. Roca, C. Roca Saumell, C. Rodrigo, E. Rodriguez, M. Rodriguez Garcia, S. Saez Jimenez, P. Sanchez Calderon, L. Sanchez Mendez, S. Sanchez Parra, C. Santolaya, M.R. Senan Sanz, A. Seoane Blanco, E. Serralvo, N. Sierra, C. Simon Valero, J. Sorribes Lopez, M. Teixido Fontanillas, M. Terns Riera, G. Tobajas, C. Torres, J. Torres Marques, M. Ubeda Pastor, M. Rosenqvist, A. Wirdby, J. Linden, K. Henriksson, M. Elmersson, A. Egilsson, U. Börjesson, G. Svärd, B. Liu, A. Lindh, L.-B. Olsson, M. Gustavsson, Lars Andersson, Lisbeth Andersson, L. Benson, C. Bothin, A. Hajimirsadeghi, K. Kadir, M. Ericsson, A. Ohlsson, H. Lindvall, P. Svensson, K. Thorne, H. Handel, P. Platonov, B. Eriksson, I. Timberg, K. Romberg, M. Crisby, J.-E. Karlsson, S.A. Jensen, A. Andersson, L. Malmqvist, B. Martinsson, F. Bernsten, J. Engdahl, J. Thulin, A. Hot-Bjelac, P. Stalby, H. Aaröe, E. Ahbeck, H. Ahlmark, F. Al-Khalili, G. Bonkowski, S. Dzeletovic, A.-B. Ekstrand, G.-B. Eriksson, K. Floren, C. Grässjö, S. Hahn, P. Jaensson, B. Jansson, J.-H. Jansson, R.-M. Kangert, A. Koch, D. Kusiak, A. Lettenström, A. Lindberg, C.-J. Lindholm, A. Mannermyr, K. Mansson, M. Millborg, C. Nilsson, A.-M. Ohlin, A. Olofsson, A. Osberg, A. Pedersen, K. Risbecker, K. Rosenberg, J. Samuelsson, M. Shayesteh, K. Skoglund, M. Stjernberg, C. Thorsen, J. Steffel, J.H. Beer, J. Debrunner, D. Amstutz, J. Bruegger, G. Elise, A. Grau, A. Guinand, I. Henriette, E. Saga, S. Winnik, A. Parkhomenko, I. Rudyk, V. Tseluyko, O. Karpenko, S. Zhurba, I. Kraiz, I. Kupnovytska, N. Serediuk, Y. Mostovoy, O. Ushakov, O. Koval, I. Kovalskyi, Y. Svyshchenko, O. Sychov, M. Stanislavchuk, O. Kraydashenko, A. Yagensky, S. Tykhonova, I. Fushtey, R. Belegai, G. Berko, L. Burdeuna, O. Chabanna, I. Daniuk, A. Ivanov, E. Kamenska, P. Kaplan, O. Khyzhnyak, S. Kizim, O. Matova, O. Medentseva, V. Mochonyi, M. Mospan, V. Nemtsova, T. Ovdiienko, O. Palamarchuk, M. Pavelko, R. Petrovskyy, D. Plevak, O. Proshak, S. Pyvovar, L. Rasputina, O. Romanenko, O. Romanova, A. Sapatyi, O. Shumakov, R. Stets, L. Todoriuk, V. Varenov, D. Fitzmaurice, N. Chauhan, D. Goodwin, P. Saunders, R. Evans, J. Leese, P.S. Jhittay, A. Ross, M.S. Kainth, G. Pickavance, J. McDonnell, A. Williams, T. Gooding, H. Wagner, S. Suryani, A. Singal, S. Sircar, R. Bilas, P. Hutchinson, A. Wakeman, M. Stokes, N. Paul, M. Aziz, C. Ramesh, P. Wilson, S. Franklin, S. Fairhead, J. Thompson, V. St Joseph, G. Taylor, D. Tragen, D. Seamark, C. Paul, M. Richardson, A. Jefferies, H. Sharp, H. Jones, C. Giles, M. Page, O. Oginni, J. Aldegather, S. Wetherwell, W. Lumb, P. Evans, F. Scouller, N. Macey, Y. Stipp, R. West, S. Thurston, P. Wadeson, J. Matthews, P. Pandya, A. Gallagher, T. Railton, B. Sinha, D. Russell, J.A. Davies, P. Ainsworth, C.P. Jones, P. Weeks, J. Eden, D. Kernick, W. Murdoch, L. Lumley, R.P. Patel, S.W. Wong, M. Saigol, K. Ladha, K. Douglas, D.F. Cumberlidge, C. Bradshaw, G. Van Zon, K.P. Jones, M.J. Thomas, E. Watson, B. Sarai, N. Ahmad, W. Willcock, J. Cairns, S. Sathananthan, N. de Kare-Silver, A. Gilliland, E. Strieder, A. Howitt, B. Vishwanathan, N. Bird, D. Gray, M. Clark, J. Bisatt, J. Litchfield, E. Fisher, T. Fooks, A.R. Kelsall, E. Alborough, J. Wakeling, M. Parfitt, K. Milne, S. Rogers, R. Priyadharshan, J.L. Oliver, E. Davies, S. Abushal, M. Jacobs, C. Hutton, N.I. Walls, R. Thompson, C. Chigbo, S.M.A. Zaidi, M. Howard, K.C. Butter, S. Barrow, H. Little, I.U. Haq, L. Gibbons, S. Glencross, A.J. McLeod, K. Poland, C. Mulholland, A. Warke, P. Conn, G. Burns, R.N. Smith, S. Lowe, R. Kamath, H.S. Dau, J. Webster, I. Hodgins, S. Vercoe, P.C. Roome, H. Pinnock, J.R.A. Patel, A. Ali, N. Hart, R. Davies, E. Stuart, C.A. Neden, M. Danielsen, R. Heath, P. Sharma, S. Galloway, C. Hawkins, R. Oliver, M. Aylward, S. Mannion, M. Braddick, D. Edwards, A.C. Rothwell, A. Sabir, F. Choudhary, S. Khalaque, A. Wilson, S. Peters, W. Coulson, N. Roberts, A. Heer, S. Coates, B. Ward, D. Jackson, S. Walton, D. Shepherd, M. Sterry, T. Wong, M. Boon, R. Bunney, R. Haria-Shah, R.T. Baron, S. Davies, T. Schatzberger, N. Hargreaves, T. Stephenson, H. Choi, R. Batson, L. Lucraft, T. Myhill, S. Estifano, D. Geatch, J. Wilkinson, R. Veale, K. Forshaw, T. Davies, K. Zaman, P. Vinson, C. Liley, M. Bandrapalli, P. McGinty, R. Wastling, P. McEleny, A. Beattie, P. Cooke, M. Wong, J. Gunasegaram, M. Pugsley, S. Ahmad, C. A'Court, J. Ayers, J. Bennett, S. Cartwright, S. Dobson, C. Dooldeniya, A. Flynn, R. Fox, J. Goram, A. Halpin, A. Hay, P. Jacobs, L. Jeffers, L. Lomax, I. Munro, R. Muvva, M. Nadaph, K. Powell, S. Randfield, D. Redpath, R. Reed, M. Rickenbach, G. Rogers, P.B. Saunders, C. Seamark, J. Shewring, P. Simmons, H. Simper, H. Stoddart, A. Sword, N. Thomas, A. Thomson, H. Gibbs, A. Blenkhorn, B. Singh, W. Van Gaal, W. Abhayaratna, R. Lehman, P. Roberts-Thomson, J. Kilian, D. Coulshed, A. Catanchin, D. Colquhoun, H. Kiat, D. Eccleston, J. French, L. Zimmett, B. Ayres, T. Phan, P. Blombery, D. Crimmins, D. O'Donnell, A. Choi, P. Astridge, M. Arstall, N. Jepson, M. Binnekamp, A. Lee, J. Rogers, G. Starmer, P. Carroll, J. Faunt, A. Aggarwala, L. Barry, C. Batta, R. Beveridge, A. Black, M. Bonner, J. Boys, E. Buckley, M. Campo, L. Carlton, A. Connelly, B. Conway, D. Cresp, H. Dimitri, S. Dixon, M. Dolman, M. Duroux, M. Eskandari, R. Eslick, A. Ferreira-Jardim, T. Fetahovic, D. Fitzpatrick, R. Geraghty, J. Gibbs, T. Grabek, M.H. Modi, K. Hayes, M.P. Hegde, L. Hesketh, B. Hoffmann, B. Jacobson, K. Johnson, C. Juergens, I. Kassam, V. Lawlor, M. Lehman, S. Lehman, D. Leung, S. Mackay, M. MacKenzie, C. McCarthy, C. McIntosh, L. McKeon, H. Morrison, C. Mussap, J.-D. Myers, V. Nagalingam, G. Oldfield, V. O'May, J. Palmer, L. Parsons, K. Patching, T. Patching, V. Paul, M. Plotz, S. Preston, H. Rashad, M. Ratcliffe, S. Raynes, J. Rose, L. Sanders, M. Seremetkoska, H. Setio, S. Shone, P. Shrestha, C. Singh, C. Singleton, N. Stoyanov, S. Sutcliffe, K. Swaraj, J. Tarrant, S. Thompson, I.M. Tsay, M. Vorster, A. Waldman, L. Wallis, E. Wilford, K. Wong, S.J. Connolly, A. Spyropoulos, J. Eikelboom, R. Luton, M. Gupta, A.S. Pandey, S. Cheung, R. Leader, P. Beaudry, F. Ayala-Paredes, J. Berlingieri, J. Heath, G. Poirier, M. Du Preez, R. Nadeau, G. Dresser, R. Dhillon, T. Hruczkowski, B. Schweitzer, B. Coutu, P. Angaran, P. MacDonald, S. Vizel, S. Fikry, R. Parkash, A. Lavoie, J. Cha, B. Ramjattan, J. Bonet, K. Ahmad, L. Aro, T. Aves, K. Beaudry, C. Bergeron, J. Bigcanoe, N. Bignell, L. Breakwell, E. Burke, L. Carroll, B. Clarke, T. Cleveland, S. Daheb, P. Dehghani, I. Denis, Z. Djaidani, P. Dorian, S. Douglass, J. Dunnigan, A. Ewert, D. Farquhar, A. Fearon, L. Ferleyko, D. Fournier, B. Fox, M.-C. Grenier, W. Gulliver, K. Haveman, C. Hines, K. Hines, A.M. Jackson, C. Jean, G. Jethoo, R. Kahlon, S. Kelly, R. Kim, V. Korley, J. Kornder, L. Kwan, J. Largy, C. Lewis, S. Lewis, I. Mangat, R. Moor, J. Navratil, I. Neas, J. Otis, R. Otis, M. Pandey, F. Petrie, A. Pinter, M. Raines, P. Roberts, M. Robinson, G. Sas, S. Schulman, L. Snell, S. Spearson, J. Stevenson, T. Trahey, S. Wong, D. Wright, H. Ragy, A. Abd El-Aziz, S.K. Abou Seif, M.G. El Din, S. El Etriby, A. Elbahry, A. El-Etreby, M. Elkhadem, A. Katta, T. Khairy, A. Mowafy, M. Nawar, A. Ohanissian, A. Reda, M. Reda, H. Salem, N. Sami, S. Samir, M. Setiha, M. Sobhy, A. Soliman, N. Taha, M. Tawfik, E. Zaatout, D. Kettles, J. Bayat, H. Siebert, A. Horak, Y. Kelfkens, R. Garda, T. Pillay, M. Guerra, L. van Zyl, H. Theron, A. Murray, R. Louw, D. Greyling, P. Mntla, V. Ueckermann, R. Loghdey, S. Ismail, F. Ahmed, J. Engelbrecht, A. Ramdass, S. Maharajh, W. Oosthuysen, G. Angel, C. Bester, M. Booysen, C. Boshoff, C. Cannon, S. Cassimjee, C. Chami, G. Conway, A. Davids, L. de Meyer, G. Du Plessis, T. Ellis, L. Henley, M. Karsten, E. Loyd, J. Marks, L. Mavhusa, M. Mostert, A. Page, L. Rikhotso, M. Salie, J. Sasto, F. Shaik, A. Skein, L. Smith, G. Tarr, T. Tau, F. van Zyl, W. Al Mahmeed, G. Yousef, A. Agrawal, M. Nathani, M. Ibrahim, E.M. Esheiba, R. Singh, A. Naguib, M. Abu-Mahfouz, M. Al Omairi, A. Al Naeemi, R. Maruthanayagam, N. Bazargani, A. Wassef, R. Gupta, M. Khan, B. Subbaraman, A. Abdul, A. Al Mulla, S. El Bardisy, P. Haridas, S. Jadhav, K. Magdaluyo, M. Makdad, I. Maqsood, R. Mohamed, N. Sharma, R. Sharma, M. Thanzeel, S.Z. Goldhaber, R. Canosa, P. Rama, E. Blumberg, J. Garcia, P. Mullen, V. Wilson, A. Quick, K. Ferrick, W.M. Kutayli, M. Cox, M. Franco, S. Falkowski, R. Mendelson, M. Williams, S. Miller, S. Beach, A. Alfieri, T. Gutowski, I. Haque, R. Reddy, W. Ahmed, P. Delafontaine, D. Diercks, D. Theodoro, K. Remmel, M. Alberts, R. Ison, H. Noveck, P. Duffy, S. Pitta, D. Nishijima, C. Treasure, N. Asafu-Adjaye, K. Ball, M. Bartlett, M. Bentley, S. Bowers, A. Brown, A. Browne, J. Cameron-Watts, M. Canova, D. Cassidy, K. Cervellione, S. Congal, J. DePauw, A. Dickerson, M. Eley, L. Evans, S. Felpel, K. Ferdinand, D. Fielder, P. Gentry, A. Haideri, F. Hakimi, T. Harbour, E. Hartranft, B. Hawkins, M. Headlee, L. Henson, C. Herrick, T. Hicks, S. Jasinski, A. Jones, L. Jones, P. Jones, S. Karl, M. Keeling, J. Kerr, P. Knowles, J. Langdon, M. Lay, J.A. Lee, T. Lincoln, E. Malone, A. Merliss, D. Merritt, J. Minardo, B. Mooso, C. Orosco, V. Palumbo, M. Parker, T. Parrott, S. Paserchia, G. Pearl, J. Peterson, N. Pickelsimer, T. Purcell, J. Raynor, S. Raziano, C. Richard, T. Richardson, C. Robertson, A. Sage, T. Sanghera, P. Shaw, J. Shoemaker, K. Smith, B. Stephanie, A. Thatcher, H. Theobald, N. Thompson, L. Treasure, T. Tripti, C. Verdi, and V. Worthy
Subjects: Surgery, RD1-811, Diseases of the circulatory (Cardiovascular) system, RC666-701
Abstract: Background: The Global Anticoagulant Registry in the FIELD–Atrial Fibrillation (GARFIELD-AF) is an ongoing prospective noninterventional registry, which is providing important information on the baseline characteristics, treatment patterns, and 1-year outcomes in patients with newly diagnosed non-valvular atrial fibrillation (NVAF). This report describes data from Indian patients recruited in this registry. Methods and results: A total of 52,014 patients with newly diagnosed AF were enrolled globally; of these, 1388 patients were recruited from 26 sites within India (2012–2016). In India, the mean age was 65.8 years at diagnosis of NVAF. Hypertension was the most prevalent risk factor for AF, present in 68.5% of patients from India and in 76.3% of patients globally (P
Published: 2018
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17. Perioperative Safety and Early Patient and Device Outcomes Among Subcutaneous Versus Transvenous Implantable Cardioverter Defibrillator Implantations

Author: Jeff S, Healey, Andrew D, Krahn, Jamil, Bashir, Guy, Amit, François, Philippon, William F, McIntyre, Bernice, Tsang, Jacqueline, Joza, Derek V, Exner, David H, Birnie, Mouhannad, Sadek, Darryl P, Leong, Markus, Sikkel, Victoria, Korley, John L, Sapp, Jean-Francois, Roux, Shun Fu, Lee, Gloria, Wong, Angie, Djuric, Danna, Spears, Sandra, Carroll, Eugene, Crystal, Tom, Hruczkowski, Stuart J, Connolly, Blandine, Mondesert, and Melissa Braga, Gomes
Subjects: Treatment Outcome, Death, Sudden, Cardiac, Risk Factors, Internal Medicine, Humans, Female, Arrhythmias, Cardiac, General Medicine, Defibrillators, Implantable, Heart Arrest
Abstract: Implantable cardioverter defibrillators (ICDs) improve survival in patients at risk for cardiac arrest, but are associated with intravascular lead-related complications. The subcutaneous ICD (S-ICD), with no intravascular components, was developed to minimize lead-related complications.To assess key ICD performance measures related to delivery of ICD therapy, including inappropriate ICD shocks (delivered in absence of life-threatening arrhythmia) and failed ICD shocks (which did not terminate ventricular arrhythmia).Randomized, multicenter trial. (ClinicalTrials.gov: NCT02881255).The ATLAS trial.544 eligible patients (141 female) with a primary or secondary prevention indication for an ICD who were younger than age 60 years, had a cardiogenetic phenotype, or had prespecified risk factors for lead complications were electrocardiographically screened and 503 randomly assigned to S-ICD (251 patients) or transvenous ICD (TV-ICD) (252 patients). Mean follow-up was 2.5 years (SD, 1.1). Mean age was 49.0 years (SD, 11.5).The primary outcome was perioperative major lead-related complications.There was a statistically significant reduction in perioperative, lead-related complications, which occurred in 1 patient (0.4%) with an S-ICD and in 12 patients (4.8%) with TV-ICD (-4.4%; 95% CI, -6.9 to -1.9;At present, the ATLAS trial is underpowered to detect differences in clinical shock outcomes; however, extended follow-up is ongoing.The S-ICD reduces perioperative, lead-related complications without significantly compromising the effectiveness of ICD shocks, but with more early postoperative pain and a trend for more inappropriate shocks.Boston Scientific.
Published: 2022
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18. Rivaroxaban in Rheumatic Heart Disease–Associated Atrial Fibrillation

Author: Stuart J, Connolly, Ganesan, Karthikeyan, Mpiko, Ntsekhe, Abraham, Haileamlak, Ahmed, El Sayed, Alaa, El Ghamrawy, Albertino, Damasceno, Alvaro, Avezum, Antonio M L, Dans, Bernard, Gitura, Dayi, Hu, Emmanuel R, Kamanzi, Fathi, Maklady, Golden, Fana, J Antonio, Gonzalez-Hermosillo, John, Musuku, Khawar, Kazmi, Liesl, Zühlke, Lillian, Gondwe, Changsheng, Ma, Maria, Paniagua, Okechukwu S, Ogah, Onkabetse J, Molefe-Baikai, Peter, Lwabi, Pilly, Chillo, Sanjib K, Sharma, Tantchou T J, Cabral, Wadea M, Tarhuni, Alexander, Benz, Martin, van Eikels, Amy, Krol, Divya, Pattath, Kumar, Balasubramanian, Sumathy, Rangarajan, Chinthanie, Ramasundarahettige, Bongani, Mayosi, Salim, Yusuf, and T, Mpofu
Subjects: Male, Vitamin K, Rheumatic Heart Disease, Anticoagulants, Hemorrhage, General Medicine, Middle Aged, Stroke, Treatment Outcome, Rivaroxaban, Echocardiography, Atrial Fibrillation, Humans, Female, Warfarin, Factor Xa Inhibitors
Abstract: Testing of factor Xa inhibitors for the prevention of cardiovascular events in patients with rheumatic heart disease-associated atrial fibrillation has been limited.We enrolled patients with atrial fibrillation and echocardiographically documented rheumatic heart disease who had any of the following: a CHAOf 4565 enrolled patients, 4531 were included in the final analysis. The mean age of the patients was 50.5 years, and 72.3% were women. Permanent discontinuation of trial medication was more common with rivaroxaban than with vitamin K antagonist therapy at all visits. In the intention-to-treat analysis, 560 patients in the rivaroxaban group and 446 in the vitamin K antagonist group had a primary-outcome event. Survival curves were nonproportional. The restricted mean survival time was 1599 days in the rivaroxaban group and 1675 days in the vitamin K antagonist group (difference, -76 days; 95% confidence interval [CI], -121 to -31; P0.001). A higher incidence of death occurred in the rivaroxaban group than in the vitamin K antagonist group (restricted mean survival time, 1608 days vs. 1680 days; difference, -72 days; 95% CI, -117 to -28). No significant between-group difference in the rate of major bleeding was noted.Among patients with rheumatic heart disease-associated atrial fibrillation, vitamin K antagonist therapy led to a lower rate of a composite of cardiovascular events or death than rivaroxaban therapy, without a higher rate of bleeding. (Funded by Bayer; INVICTUS ClinicalTrials.gov number, NCT02832544.).
Published: 2022
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19. Factor XIa inhibition with asundexian after acute non-cardioembolic ischaemic stroke (PACIFIC-Stroke): an international, randomised, double-blind, placebo-controlled, phase 2b trial

Author: Ashkan Shoamanesh, Hardi Mundl, Eric E Smith, Jaime Masjuan, Ivan Milanov, Teruyuki Hirano, Alina Agafina, Bruce Campbell, Valeria Caso, Jean-Louis Mas, Qiang Dong, Peter Turcani, Hanne Christensen, Jose M Ferro, Roland Veltkamp, Robert Mikulik, Gian Marco De Marchis, Thompson Robinson, Robin Lemmens, Adam Stepien, Stefan Greisenegger, Risto Roine, Laszlo Csiba, Pooja Khatri, Jonathan Coutinho, Arne G Lindgren, Andrew M Demchuk, Pablo Colorado, Bodo Kirsch, Christoph Neumann, Laura Heenan, Lizhen Xu, Stuart J Connolly, Robert G Hart, Neurology, ACS - Atherosclerosis & ischemic syndromes, and ANS - Neurovascular Disorders
Subjects: Male, Anticoagulants, Hemorrhage, Thrombosis, General Medicine, Factor XIa, Brain Ischemia, Stroke, Treatment Outcome, Double-Blind Method, Humans, Female, Platelet Aggregation Inhibitors, Aged, Ischemic Stroke
Abstract: Background: Asundexian (Bayer AG, Leverkusen, Germany), an oral small molecule factor XIa (FXIa) inhibitor, might prevent thrombosis without increasing bleeding. Asundexian's effect for secondary prevention of recurrent stroke is unknown. Methods: In this randomised, double-blind, placebo-controlled, phase 2b dose-finding trial (PACIFIC-Stroke), patients with acute (within 48 h) non-cardioembolic ischaemic stroke were recruited from 196 hospitals in 23 countries. Patients were eligible if they were aged 45 years or older, to be treated with antiplatelet therapy, and able to have a baseline MRI (either before or within 72 h of randomisation). Eligible participants were randomly assigned (1:1:1:1), using an interactive web-based response system and stratified according to anticipated antiplatelet therapy (single vs dual), to once daily oral asundexian (BAY 2433334) 10 mg, 20 mg, or 50 mg, or placebo in addition to usual antiplatelet therapy, and were followed up during treatment for 26–52 weeks. Brain MRIs were obtained at study entry and at 26 weeks or as soon as possible after treatment discontinuation. The primary efficacy outcome was the dose–response effect on the composite of incident MRI-detected covert brain infarcts and recurrent symptomatic ischaemic stroke at or before 26 weeks after randomisation. The primary safety outcome was major or clinically relevant non-major bleeding as defined by International Society on Thrombosis and Haemostasis criteria. The efficacy outcome was assessed in all participants assigned to treatment, and the safety outcome was assessed in all participants who received at least one dose of study treatment. This study is registered with ClinicalTrials.gov, NCT04304508, and is now complete. Findings: Between June 15, 2020, and July 22, 2021, 1880 patients were screened and 1808 participants were randomly assigned to asundexian 10 mg (n=455), 20 mg (n=450), or 50 mg (n=447), or placebo (n=456). Mean age was 67 years (SD 10) and 615 (34%) participants were women, 1193 (66%) were men, 1505 (83%) were White, and 268 (15%) were Asian. The mean time from index stroke to randomisation was 36 h (SD 10) and median baseline National Institutes of Health Stroke Scale score was 2·0 (IQR 1·0–4·0). 783 (43%) participants received dual antiplatelet treatment for a mean duration of 70·1 days (SD 113·4) after randomisation. At 26 weeks, the primary efficacy outcome was observed in 87 (19%) of 456 participants in the placebo group versus 86 (19%) of 455 in the asundexian 10 mg group (crude incidence ratio 0·99 [90% CI 0·79–1·24]), 99 (22%) of 450 in the asundexian 20 mg group (1·15 [0·93–1·43]), and 90 (20%) of 447 in the asundexian 50 mg group (1·06 [0·85–1·32]; t statistic –0·68; p=0·80). The primary safety outcome was observed in 11 (2%) of 452 participants in the placebo group versus 19 (4%) of 445 in the asundexian 10 mg group, 14 (3%) of 446 in the asundexian 20 mg group, and 19 (4%) of 443 in the asundexian 50 mg group (all asundexian doses pooled vs placebo hazard ratio 1·57 [90% CI 0·91–2·71]). Interpretation: In this phase 2b trial, FXIa inhibition with asundexian did not reduce the composite of covert brain infarction or ischaemic stroke and did not increase the composite of major or clinically relevant non-major bleeding compared with placebo in patients with acute, non-cardioembolic ischaemic stroke. Funding: Bayer AG.
Published: 2022
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20. Estimated incidence of previously undetected atrial fibrillation on a 14-day continuous electrocardiographic monitor and associated risk of stroke

Author: William F McIntyre, Jia Wang, Alexander P Benz, Linda Johnson, Stuart J Connolly, Isabelle C Van Gelder, Renato D Lopes, Michael R Gold, Stefan H Hohnloser, Chu Pak Lau, Carsten W Israel, Jorge A Wong, David Conen, Jeff S Healey, and Cardiovascular Centre (CVC)
Subjects: Holter monitor, STRATEGIES, ADHESIVE PATCH, LONG-TERM, Oral anticoagulation, RATIONALE, HIGH-RATE EPISODES, INSERTABLE CARDIAC MONITORS, DEVICE, Risk Assessment, Brain Ischemia, Electrocardiography, DESIGN, Risk Factors, Physiology (medical), Humans, Aged, ORAL ANTICOAGULANTS, Incidence, THROMBOEMBOLIC EVENTS, Anticoagulants, Atrial fibrillation, Stroke, Hypertension, Screening, Cardiology and Cardiovascular Medicine, Simulation
Abstract: Aims There is uncertainty about whether and how to perform screening for atrial fibrillation (AF). To estimate the incidence of previously undetected AF that would be captured using a continuous 14-day ECG monitor and the associated risk of stroke. Methods and results We analysed data from a cohort of patients >65 years old with hypertension and a pacemaker, but without known AF. For each participant, we simulated 1000 ECG monitors by randomly selecting 14-day windows in the 6 months following enrolment and calculated the average AF burden (total time in AF). We used Cox proportional hazards models adjusted for CHA2DS2-VASc score to estimate the risk of subsequent ischaemic stroke or systemic embolism (SSE) associated with burdens of AF > and 6 min was 3.10% (95% CI 2.53–3.72). This was consistent across strata of age and CHA2DS2-VASc scores. Over a mean follow-up of 2.4 years, the rate of SSE among patients with 6 min of AF. Conclusions Approximately 3% of individuals aged >65 years with hypertension may have more than 6 min of AF detected by a 14-day ECG monitor. This is associated with a stroke risk of over 2% per year. Whether oral anticoagulation will reduce stroke in these patients is unknown.
Published: 2022

21. GARFIELD-AF: risk profiles, treatment patterns and 2-year outcomes in patients with atrial fibrillation in Germany, Austria and Switzerland (DACH) compared to 32 countries in other regions worldwide

Author: Sylvia, H, John A, C, Darius, H, Jan, S, Saverio, V, Karen, P, Marianne, B, Sebastian, S, Frank, M, Gloria, K, Kakkar, A, Bassand, J, John Camm, A, Fitzmaurice, D, Fox, K, Gersh, B, Goldhaber, S, Goto, S, Haas, S, Hacke, W, Mantovani, L, Misselwitz, F, Pieper, K, Turpie, A, van Eickels, M, Verheugt, F, Gersh, K, Lucas Luciardi Harry Gibbs, H, Brodmann, M, Cools, F, Carlos Pereira Barretto, A, Connolly, S, Eikelboom, J, Corbalan, R, Jing, Z, Jansky, P, Dalsgaard Nielsen, J, Ragy, H, Raatikainen, P, Le Heuzey, J, Keltai, M, Pal Singh Sawhney, J, Agnelli, G, Ambrosio, G, Koretsune, Y, Jerjes Sánchez Díaz, C, Ten Cate, H, Atar, D, Stepinska, J, Panchenko, E, Wei Lim, T, Jacobson, B, Oh, S, Viñolas, X, Rosenqvist, M, Steffel, J, Angchaisuksiri, P, Oto, A, Parkhomenko, A, Al Mahmeed, W, Hu Kangning Chen, D, Zhao, Y, Zhang, H, Chen, J, Cao, S, Wang, D, Yang, Y, Li, W, Li, H, Yin, Y, Tao, G, Yang, P, Chen, Y, He, S, Wang, Y, Fu, G, Li, X, Wu, T, Cheng, X, Yan, X, Zhao, R, Chen, M, Xiong, L, Chen, P, Jiao, Y, Guo, Y, Xue, L, Yang, Z, Jadhavm Raghava Sarma, P, Kulkarni, G, Chandwani, P, Atulbhai Pothiwala, R, Padinhare Purayil, M, Chawla, K, Annasaheb Kothiwale, V, Raghuraman, B, Madan Vijan, V, Sawhney, J, Bantwal, G, Khan, A, Meena, R, Chopada, M, Abraham, S, Bisne, V, Vijayaraghavan, G, Roy, D, Durgaprasad, R, Ravi Shankar, A, Kumar, S, Jain, D, Bhargava, K, Kumar, V, Madappa Nagamalesh, U, Kumar Rajput, R, Koretsune Seishu Kanamori, Y, Yamamoto, K, Kumagai, K, Katsuda, Y, Yoshida, K, Toyota, F, Mizuno, Y, Misumi, I, Noguchi, H, Ando, S, Suetsugu, T, Minamoto, M, Oda, H, Adachi, S, Chiba, K, Norita, H, Tsuruta, M, Koyanagi, T, Ando, H, Higashi, T, Okada, M, Azakami, S, Komaki, S, Kumeda, K, Murayama, T, Matsumura, J, Oba, Y, Sonoda, R, Goto, K, Minoda, K, Haraguchi, Y, Suefuji, H, Miyagi, H, Kato, H, Nakamura, T, Nandate, H, Zaitsu, R, Fujiura, Y, Yoshimura, A, Numata, H, Ogawa, J, Kamogawa, Y, Murakami, K, Wakasa, Y, Yamasawa, M, Maekawa, H, Abe, S, Kihara, H, Tsunoda, S, Saito, K, Tachibana, H, Oba, I, Kuwahata, T, Higa, S, Gushiken, M, Eto, T, Chibana, H, Fujisawa, K, Shiga, Y, Sumi, H, Nagatomo, T, Atsuchi, Y, Nagoshi, T, Sanno, K, Hoshino, F, Yokota, N, Kameko, M, Tabuchi, T, Ishizawa, M, Ikeda, D, Seto, T, Iwao, T, Ishioka, N, Oshiro, K, Tsuchida, K, Hatori, Y, Takeuchi, M, Takezawa, H, Nagano, S, Iwaki, M, Nakamura, Y, Miyamoto, N, Taguchi, T, Ashida, K, Yoshizawa, N, Agata, J, Matsukawa, S, Arasaki, O, Fukuoka, S, Murakami, H, Mishima, K, Hata, Y, Sakuma, I, Obunai, K, Takamura, I, Akutsu, M, Unoki, T, Go, Y, Ikemura, M, Morii, S, Marusaki, S, Doi, H, Tanaka, M, Kusumoto, T, Kakinoki, S, Ogurusu, C, Murata, K, Shimoyama, M, Nakatsuka, M, Kitami, Y, Oyama, R, Ageta, M, Mita, T, Nagao, K, Mito, T, Minami, J, Abe, M, Fujii, M, Okawa, M, Fujito, T, Taniguchi, T, Ko, T, Kubo, H, Imamaki, M, Akiyama, M, Ueda, T, Odakura, H, Inagaki, M, Katsube, Y, Nakata, A, Tomimoto, S, Shibuya, M, Nakano, M, Ito, K, Matsuta, M, Ishiguro, M, Minagawa, T, Wada, M, Mukawa, H, Mizuguchi, M, Okuda, F, Kimura, T, Taga, K, Techigawara, M, Igarashi, M, Watanabe, H, Seo, T, Hiramitsu, S, Hosokawa, H, Hoshiai, M, Hibino, M, Miyagawa, K, Horie, H, Sugishita, N, Soma, A, Neya, K, Yoshida, T, Akahane, K, Takanaka, C, Matsui, S, Kanda, H, Kaneko, M, Nagasaka, S, Taguchi, A, Toru, S, Miyashita, A, Sasaguri, H, Nariyama, J, Hatsuno, T, Iwase, T, Sato, K, Kawai, K, Kotani, T, Tsuji, T, Sakai, H, Nishino, K, Ikeda, K, Maeda, K, Shinozuka, T, Inoue, T, Kawakami, K, Kitazumi, H, Takagi, T, Hamaoka, M, Kojima, J, Sasaki, A, Tsuchiya, Y, Betsuyaku, T, Higuchi, K, Honda, M, Hasegawa, K, Baba, T, Mineoi, K, Koeda, T, Hirasawa, K, Kumazaki, T, Nakagomi, A, Otaki, E, Shindo, T, Hirayama, H, Sugimoto, C, Yamagishi, T, Mizuguchi, I, Sezaki, K, Niwa, I, Takenaka, K, Iiji, O, Taya, K, Kitazawa, H, Ueda, S, Kakuda, H, Ono, T, Oriso, S, Kamata, J, Nanke, T, Maeda, I, Matsuura, Y, Teragawa, H, Maruyama, Y, Takei, K, Kito, T, Asano, H, Matsushita, K, Nakamura, M, Washizuka, T, Sawano, M, Arima, S, Arai, H, Shinohara, H, Takai, H, Furukawa, N, Ota, A, Aoki, K, Yamamoto, T, Kasai, T, Suzuki, S, Shibata, N, Watanabe, M, Nishihata, Y, Arino, T, Okuyama, M, Wakiyama, T, Kato, T, Sasagawa, Y, Tana, T, Hayashi, Y, Hirota, S, Abe, Y, Saito, Y, Uchiyama, H, Takeda, H, Ono, H, Tohyo, S, Hanazono, N, Miyajima, S, Shimono, H, Aoyama, T, Shozawa, Y, Niijima, Y, Murai, O, Inaba, H, Nomura, K, Nozoe, M, Suzuki, K, Furukawa, T, Shiraiwa, T, Ito, N, Nagai, S, Nakahara, S, Shimoyama, Y, Ohara, N, Kozuka, T, Okita, H, Endo, M, Goto, T, Hirose, M, Nagata, E, Nakanishi, N, Mori, T, Seki, S, Okamoto, K, Moriai, O, Emura, Y, Fukuda, T, Date, H, Kawakami, S, Ueyama, Y, Fudo, T, Imaizumi, M, Ogawa, T, Take, S, Ikeda, H, Nishioka, H, Sakamoto, N, Ikeoka, K, Wakaki, N, Doiuchi, J, Kira, T, Tada, M, Tsuzaki, K, Miura, N, Fujisawa, Y, Furumoto, W, Fujisawa, A, Nakamura, R, Komatsu, H, Fujiki, R, Kawano, S, Nishizawa, K, Kato, Y, Azuma, J, Yasui, K, Amano, T, Sekine, Y, Honzawa, T, Koshibu, Y, Sakamoto, Y, Seta, Y, Miyaguchi, S, Morishita, K, Samejima, Y, Sasaki, T, Iseki, F, Kobayashi, T, Kano, H, Kim, J, Yamaguchi, H, Takagi, Y, Onuki Pearce, Y, Suzuki, Y, Fukui, T, Nakayama, T, Kanai, H, Kawano, Y, Ino, T, Miyoshi, H, Miyamoto, Y, Shigekiyo, M, Ono, S, Okamoto, Y, Ubukata, S, Kodera, K, Oriuchi, T, Matsumoto, N, Inagaki, K, Iseki, A, Goda, T, Katsuki, T, Sato, A, Mori, E, Tsubokura, T, Shudo, H, Fujimoto, S, Katsuya, T, Furukawa, Y, Narumi, J, Owari, M, Inakura, T, Anno, T, Shirakawa, K, Keong Ching Toon Wei Lim, C, Foo, D, Wong, K, Yuyang, T, Oh Hui Nam Park, S, Kim, W, Lee, H, Jang, S, Hyeok Kim, D, Ryu, D, Shim, J, Kim, D, Ju Choi, D, Seog Oh, Y, Cho, M, Kim, H, Jeon, H, Shin, D, Weon Park, S, Ki Park, H, Han, S, Hoon Sung, J, Park, H, Nam, G, Keun On, Y, Euy Lim, H, Kwak, J, Cha, T, Jong Hong, T, Hoon Park, S, Han Yoon, J, Kim, N, Kim, K, Chun Jung, B, Hwang, G, Kim, C, Rungaramsin Peerapat Katekangplu, S, Khunrong, P, Bunyapipat, T, Wongcharoen, W, Kaewsuwanna, P, Siriwattana, K, Tiyanon, W, Pattanaprichakul, S, Likittanasombat, K, Cholsaringkarl, D, Boonyapisit, W, Cheewatanakornkul, S, Silaruks, S, Hutayanon, P, Chawanadelert, S, Chattranukulchai, P, Chatlaong, B, Santanakorn, Y, Kanokphatcharakun, K, Mongkolwongroj, P, Jai-Aue, S, Komson, O, Altun Ali Aydinlar, A, Topsakal, R, Ongen, Z, Acikel, S, Yildiray Sahin, D, Yilmaz, O, Birhan Yilmaz, M, Pekdemir, H, Demir, M, Sucu, M, Sahiner, L, Ersanli, M, Okuyan, E, Aras, D, Rolandi Adrian Cesar Ingaramo, F, Alberto Sambadaro, G, Fernandez Caputi, V, Luciardi, H, Graciela Berman, S, Dragotto, P, Javier Kleiban, A, Centurion, N, Andres Ahuad Guerrero, R, Adalberto Di Paola, L, Dario Dran, R, Egido, J, Jose Fosco, M, Alfredo Sinisi, V, Rodolfo Cartasegna, L, Gomez Vilamajo, O, Luis Ramos, J, Sassone, S, Zapata, G, Conde, D, Giacomi, G, Alfredo Fernandez, A, Alberto Berli, M, Ferroni, F, Celestino Sobral Filho Jefferson Jaber, D, Vidal Armaganijan, L, Roberto Frack Costantini, C, Steffens, A, Kunz Sebba Barroso de Souzaem, W, David de Souza Neto, J, Márcio Ribeiro, J, Silveira Teixeira, M, Rossi, P, Pires, L, Moreira, D, Carlos Moura Jorge, J, Menezes Lorga Filho, A, Bodanese, L, Westerlund Montera, M, Henrique Del Carlo, C, Abdalla Saad, J, Augusto Alves da Costa, F, Lopes, R, Roberto de Araújo, G, Roberto Manenti, E, Francisco Kerr Saraiva, J, Carlos Ferreira Braga, J, Negri, A, Moncada, C, Precoma, D, Roquette, F, Reis, G, Álvaro Ramos Filho, R, Lanna Figueiredo, E, Vieira Botelho, R, Munhoz da Fontoura Tavares, C, Carlos Finimundi, H, Kochi, A, Cássio Broilo França, C, Alban, F, Bernardo Aranha Rosito, G, Batista de Moura Xavier Moraes Junior, J, Tadeu Tumelero, R, Maia, L, Simões de Almeida, R, Carter do Carmo Borges, N, Gustavo Gomes Ferreira, L, Corbalán Benjamin Aleck Joseh Stockins Fernandez, R, Montecinos, H, Lanas, F, Larico Gómez, M, Astudillo, C, Conejeros, C, Marin Cuevas, P, Forero, A, Bugueño Gutiérrez, C, Aguilar, J, Potthoff Cardenas, S, Eggers, G, Houzvic, C, Rey, C, Arriagada, G, Charme Vilches, G, Jerjes Sanchez Diaz Jesus Jaime Illescas Diaz, C, Leal Cantu, R, Guadalupe Ramos Zavala, M, Cabrera Jardines, R, Espinola Zavaleta, N, Lopez Rosas, E, Antonio Llamas Esperón, G, Pozas, G, Cardona Muñoz, E, Matadamas Hernandez, N, Leyva Rendon, A, Garcia Hernandez, N, de los Rios Ibarra, M, Ramon Virgen Carrillo, L, Lopez Villezca, D, Hernandez Herrera, C, Jose Lopez Prieto, J, Gaona Rodriguez, R, Villeda Espinosa, E, Flores Martinez, D, Velasco Barcena, J, Fierro Fierro, O, Rodriguez Briones, I, Luis Leiva Pons, J, Alvarez Lopez, H, Olvera Ruiz, R, Gerardo Cantu Brito, C, Julian Jose Roberto Chuquiure Valenzuela, E, Reyes Sanchez, R, Esteban Bazzoni Ruiz, A, Martin Lopez Ruiz, O, Arriaga Nava, R, David Morales Cerda, J, Fajardo Campos, P, Benavides Gonzalez, M, Brodmann Kurt Lenz, M, Hagn, C, Foechterle, J, Drexel, H, Huber, K, Podczeck-Schweighofer, A, Winkler, M, Schneeweiss, B, Gegenhuber, A, Lang, W, Eichinger-Hasenauer, S, Kaserer, P, Sykora, J, Rasch, H, Strohmer, B, Capiau Geert Vervoort, L, Wollaert, B, Hollanders, G, Vercammen, J, Faes, D, Balthazar, Y, Delforge, M, Xhaet, O, Striekwold, H, Thoeng, J, Hermans, K, Mairesse, G, Anné, W, Blankoff, I, Beutels, M, Verstraete, S, Vandergoten, P, Purnode, P, Godart, P, Boussy, T, Desfontaines, P, Heyse, A, Voet, J, De Wolf, A, Zidkova Petr Jansky, E, Spacek, R, Machova, V, Ludka, O, Olsr, J, Kotik, L, Racz, B, Ferkl, R, Hubac, J, Kotik, I, Monhart, Z, Burianova, H, Jerabek, O, Pisova, J, Petrova, I, Dedek, V, Honkova, M, Podrazil, P, Reichert, P, Spinar, J, Novak, M, Durdil, V, Plocova, K, Lastuvka, J, Nielsen Steen Husted, J, Dominguez, H, Hintze, U, Rasmussen, S, Sygehus, N, Bremmelgaard, A, Markenvard, J, Børger, J, Solgaard, J, Eriksen, E, Løkkegaard, T, Bruun, M, Mertz, J, Schou, M, Olsen, M, Raatikainen Carmela Viitanen, P, Paganelli Joël Ohayon, F, Casassus, F, Galinier, M, Gottwalles, Y, Loiselet, P, Muller, J, 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Iwase, Kazuki Sato, Kazuya Kawai, Tomobumi Kotani, Tsuyoshi Tsuji, Hirosumi Sakai, Kiyoshi Nishino, Kenichi Ikeda, Kazuo Maeda, Tomohiro Shinozuka, Takeshi Inoue, Koichi Kawakami, Hiromichi Kitazumi, Tsutomu Takagi, Mamoru Hamaoka, Jisho Kojima, Akitoshi Sasaki, Yoshihiro Tsuchiya, Tetsuo Betsuyaku, Koji Higuchi, Masaaki Honda, Koichi Hasegawa, Takao Baba, Kazuaki Mineoi, Toshihiko Koeda, Kunihiko Hirasawa, Toshihide Kumazaki, Akira Nakagomi, Eiji Otaki, Takashi Shindo, Hiroyoshi Hirayama, Chikako Sugimoto, Takashi Yamagishi, Ichiro Mizuguchi, Kazunori Sezaki, Isamu Niwa, Ken Takenaka, Osamu Iiji, Koichi Taya, Hitoshi Kitazawa, samu Ueda, Hirokazu Kakuda, Takuya Ono, Seizo Oriso, Junya Kamata, Toshihiko Nanke, Itaru Maeda, Yoshifusa Matsuura, Hiroki Teragawa, Yasuyuki Maruyama, Kazuo Takei, Hajime Horie, Tetsutaro Kito, Hiroshi Asano, Koji Matsushita, Masaichi Nakamura, Takashi Washizuka, Tomoki Yoshida, Masato Sawano, Shinichi Arima, Hidekazu Arai, Hisanori Shinohara, Hiroyuki Takai, Nobufusa Furukawa, Akira Ota, Kentaro Yamamoto, Kenji Aoki, Taku Yamamoto, Takeaki Kasai, Shunji Suzuki, Shu Suzuki, Nitaro Shibata, Masayuki Watanabe, Yosuke Nishihata, Toru Arino, Masaki Okuyama, Tetsushi Wakiyama, Tomoko Kato, Yasuo Sasagawa, Takeshi Tana, Yoshihito Hayashi, Shinichi Hirota, Yukihiko Abe, Yoshihiro Saito, Hirohide Uchiyama, Hiroshi Takeda, Hiroshi Ono, Shuichi Tohyo, Naoto Hanazono, Seiichi Miyajima, Hisashi Shimono, Takuma Aoyama, Yasunobu Shozawa, Yawara Niijima, Osamu Murai, Hideko Inaba, Katsumasa Nomura, Masatsugu Nozoe, Kazuo Suzuki, Toshiyuki Furukawa, Toshihiko Shiraiwa, Nobuhisa Ito, Shunichi Nagai, Kiyoharu Sato, Shiro Nakahara, Yujin Shimoyama, Naoko Ohara, Teruhiko Kozuka, Hideaki Okita, Masato Endo, Tsutomu Goto, Makoto Hirose, Emiko Nagata, Noriyuki Nakanishi, Toshizumi Mori, Shuichi Seki, Katsuhiro Okamoto, Osamu Moriai, Yoko Emura, Tsuyoshi Fukuda, Haruhiko Date, Shuichi Kawakami, Sho Nagai, Yuya Ueyama, Tetsuro Fudo, Mitsuru Imaizumi, Takuo Ogawa, 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Mori, Toshio Tsubokura, Hiroshi Shudo, Shunichi Fujimoto, Tomohiro Katsuya, Yoshiyuki Furukawa, Hiroshi Hosokawa, Jun Narumi, Kiichiro Yamamoto, Masaki Owari, Takuya Inakura, Takafumi Anno, Kazuyuki Shirakawa, Chi Keong Ching Toon Wei Lim, David Foo, Kelvin Wong, Tan Yuyang, Seil Oh Hui Nam Park, Woo-Shik Kim, HyeYoung Lee, Sung-Won Jang, Dae Hyeok Kim, Jun Kim, DongRyeol Ryu, Jaemin Shim, Dae-Kyeong Kim, Dong Ju Choi, Yong Seog Oh, Myeong-Chan Cho, Hack-Lyoung Kim, Hui-Kyung Jeon, Dong-Gu Shin, Sang Weon Park, Hoon Ki Park, Sang-Jin Han, Jung Hoon Sung, Hyung-Wook Park, Gi-Byoung Nam, Young Keun On, Hong Euy Lim, JaeJin Kwak, Tae-Joon Cha, Taek Jong Hong, Seong Hoon Park, Jung Han Yoon, Nam-Ho Kim, Kee-Sik Kim, Byung Chun Jung, Gyo-Seung Hwang, Chong-Jin Kim, Sakda Rungaramsin Peerapat Katekangplu, Porames Khunrong, Thanita Bunyapipat, Wanwarang Wongcharoen, Pinij Kaewsuwanna, Khanchai Siriwattana, Waraporn Tiyanon, Supalerk Pattanaprichakul, Khanchit Likittanasombat, Doungrat 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Ichiro Oba, Takashi Kuwahata, Satoshi Higa, Masamichi Gushiken, Takuma Eto, Hidetoshi Chibana, Kazuaki Fujisawa, Yuhei Shiga, Hirokuni Sumi, Toshihisa Nagatomo, Yoshihiko Atsuchi, Toshiro Nagoshi, Kazuhisa Sanno, Fumihiro Hoshino, Naoto Yokota, Masahiro Kameko, Toshifumi Tabuchi, Munesumi Ishizawa, Yoshitake Fujiura, Daisuke Ikeda, Taku Seto, Tetsu Iwao, Norio Ishioka, Koichi Oshiro, Keizo Tsuchida, Yutaka Hatori, Motoshi Takeuchi, Hiroto Takezawa, Shinjiro Nagano, Masaaki Iwaki, Yuichiro Nakamura, Naomasa Miyamoto, Toshifumi Taguchi, Ko Ashida, Naoto Yoshizawa, Jun Agata, Seishiro Matsukawa, Osamu Arasaki, Shuji Fukuoka, Hirofumi Murakami, Kazuya Mishima, Yoshiki Hata, Ichiro Sakuma, Kotaro Obunai, Ichiro Takamura, Mitsuyuki Akutsu, Toshihide Unoki, Yoshinori Go, Makoto Ikemura, Shoji Morii, Shigeru Marusaki, Hideo Doi, Mitsuru Tanaka, Takaaki Kusumoto, Shigeo Kakinoki, Chiga Ogurusu, Kazuya Murata, Masaki Shimoyama, Masami Nakatsuka, Yutaka Kitami, Yoichi Nakamura, Hiroshi Oda, Rikimaru Oyama, Masato Ageta, Teruaki Mita, Kazuhiko Nagao, Takafumi Mito, Junichi Minami, Mitsunori Abe, Masako Fujii, Makoto Okawa, Tsuneo Fujito, Toshiya Taniguchi, Tenei Ko, Hiroshi Kubo, Mizuho Imamaki, Masahiro Akiyama, Takashi Ueda, Hironori Odakura, Masahiko Inagaki, Yoshiki Katsube, Atsuyuki Nakata, Shinobu Tomimoto, Mitsuhiro Shibuya, Masayuki Nakano, Kenichiro Ito, Masahiro Matsuta, Motoyuki Ishiguro, Taro Minagawa, Masamichi Wada, Hiroaki Mukawa, Masato Mizuguchi, Fumio Okuda, Teruaki Kimura, Kuniaki Taga, Masaaki Techigawara, Morio Igarashi, Hiroshi Watanabe, Toshihiko Seo, Shinya Hiramitsu, Hiroaki Hosokawa, Mitsumoto Hoshiai, Michitaka Hibino, Koichi Miyagawa, Hideki Horie, Nobuyoshi Sugishita, Yukio Shiga, Akira Soma, Kazuo Neya, Tetsuro Yoshida, Kunio Akahane, Sen Adachi, Chiei Takanaka, Saori Matsui, Hirofumi Kanda, Masanori Kaneko, Shiro Nagasaka, Atsushi Taguchi, Shuta Toru, Kazuyuki Saito, Akiko Miyashita, Hiroki Sasaguri, Jin Nariyama, Taketo Hatsuno, Takash Iwase, Kazuki Sato, Kazuya Kawai, Tomobumi Kotani, Tsuyoshi Tsuji, Hirosumi Sakai, Kiyoshi Nishino, Kenichi Ikeda, Kazuo Maeda, Tomohiro Shinozuka, Takeshi Inoue, Koichi Kawakami, Hiromichi Kitazumi, Tsutomu Takagi, Mamoru Hamaoka, Jisho Kojima, Akitoshi Sasaki, Yoshihiro Tsuchiya, Tetsuo Betsuyaku, Koji Higuchi, Masaaki Honda, Koichi Hasegawa, Takao Baba, Kazuaki Mineoi, Toshihiko Koeda, Kunihiko Hirasawa, Toshihide Kumazaki, Akira Nakagomi, Eiji Otaki, Takashi Shindo, Hiroyoshi Hirayama, Chikako Sugimoto, Takashi Yamagishi, Ichiro Mizuguchi, Kazunori Sezaki, Isamu Niwa, Ken Takenaka, Osamu Iiji, Koichi Taya, Hitoshi Kitazawa, samu Ueda, Hirokazu Kakuda, Takuya Ono, Seizo Oriso, Junya Kamata, Toshihiko Nanke, Itaru Maeda, Yoshifusa Matsuura, Hiroki Teragawa, Yasuyuki Maruyama, Kazuo Takei, Hajime Horie, Tetsutaro Kito, Hiroshi Asano, Koji Matsushita, Masaichi Nakamura, Takashi Washizuka, Tomoki Yoshida, Masato Sawano, Shinichi Arima, Hidekazu Arai, Hisanori Shinohara, Hiroyuki Takai, Nobufusa Furukawa, Akira Ota, Kentaro Yamamoto, Kenji Aoki, Taku Yamamoto, Takeaki Kasai, Shunji Suzuki, Shu Suzuki, Nitaro Shibata, Masayuki Watanabe, Yosuke Nishihata, Toru Arino, Masaki Okuyama, Tetsushi Wakiyama, Tomoko Kato, Yasuo Sasagawa, Takeshi Tana, Yoshihito Hayashi, Shinichi Hirota, Yukihiko Abe, Yoshihiro Saito, Hirohide Uchiyama, Hiroshi Takeda, Hiroshi Ono, Shuichi Tohyo, Naoto Hanazono, Seiichi Miyajima, Hisashi Shimono, Takuma Aoyama, Yasunobu Shozawa, Yawara Niijima, Osamu Murai, Hideko Inaba, Katsumasa Nomura, Masatsugu Nozoe, Kazuo Suzuki, Toshiyuki Furukawa, Toshihiko Shiraiwa, Nobuhisa Ito, Shunichi Nagai, Kiyoharu Sato, Shiro Nakahara, Yujin Shimoyama, Naoko Ohara, Teruhiko Kozuka, Hideaki Okita, Masato Endo, Tsutomu Goto, Makoto Hirose, Emiko Nagata, Noriyuki Nakanishi, Toshizumi Mori, Shuichi Seki, Katsuhiro Okamoto, Osamu Moriai, Yoko Emura, Tsuyoshi Fukuda, Haruhiko Date, Shuichi Kawakami, Sho Nagai, Yuya Ueyama, Tetsuro Fudo, Mitsuru Imaizumi, Takuo Ogawa, Shunsuke Take, Hideo Ikeda, Hiroaki Nishioka, Norihiko Sakamoto, Kiyomitsu Ikeoka, Nobuo Wakaki, Masatake Abe, Junji Doiuchi, Tetsuya Kira, Masato Tada, Ken Tsuzaki, Naoya Miura, Yasuaki Fujisawa, Wataru Furumoto, Susumu Suzuki, Akinori Fujisawa, Ryosai Nakamura, Hiroyasu Komatsu, Rei Fujiki, Shuichi Kawano, Keijiro Nishizawa, Yoji Kato, Junya Azuma, Kiyoshi Yasui, Toshio Amano, Yasuhiro Sekine, Tatsuo Honzawa, Yuichiro Koshibu, Yasuhide Sakamoto, Yukihiro Seta, Shingo Miyaguchi, Kojuro Morishita, Yasuko Samejima, Toyoshi Sasaki, Fumiko Iseki, Toshiyuki Kobayashi, Hiroshi Kano, Jaeyoung Kim, Hiroshi Yamaguchi, Yoichi Takagi, Yoko Onuki Pearce, Yasuyuki Suzuki, Takayuki Fukui, Toru Nakayama, Hideaki Kanai, Yoshiyuki Kawano, Tetsuji Ino, Hironori Miyoshi, Yasufumi Miyamoto, Masahito Shigekiyo, Shimato Ono, Yutaka Okamoto, Satoshi Ubukata, Kojiro Kodera, Tatsuo Oriuchi, Naoki Matsumoto, Koichi Inagaki, Atsushi Iseki, Tomohiro Yoshida, Toshihiro Goda, Tsukasa Katsuki, Atsushi Sato, Etsuo Mori, Toshio Tsubokura, Hiroshi Shudo, Shunichi Fujimoto, Tomohiro Katsuya, Yoshiyuki Furukawa, Hiroshi Hosokawa, Jun Narumi, Kiichiro Yamamoto, Masaki Owari, Takuya Inakura, Takafumi Anno, Kazuyuki Shirakawa, Chi Keong Ching Toon Wei Lim, David Foo, Kelvin Wong, Tan Yuyang, Seil Oh Hui Nam Park, Woo-Shik Kim, HyeYoung Lee, Sung-Won Jang, Dae Hyeok Kim, Jun Kim, DongRyeol Ryu, Jaemin Shim, Dae-Kyeong Kim, Dong Ju Choi, Yong Seog Oh, Myeong-Chan Cho, Hack-Lyoung Kim, Hui-Kyung Jeon, Dong-Gu Shin, Sang Weon Park, Hoon Ki Park, Sang-Jin Han, Jung Hoon Sung, Hyung-Wook Park, Gi-Byoung Nam, Young Keun On, Hong Euy Lim, JaeJin Kwak, Tae-Joon Cha, Taek Jong Hong, Seong Hoon Park, Jung Han Yoon, Nam-Ho Kim, Kee-Sik Kim, Byung Chun Jung, Gyo-Seung Hwang, Chong-Jin Kim, Sakda Rungaramsin Peerapat Katekangplu, Porames Khunrong, Thanita Bunyapipat, Wanwarang Wongcharoen, Pinij Kaewsuwanna, Khanchai Siriwattana, Waraporn Tiyanon, Supalerk Pattanaprichakul, Khanchit Likittanasombat, Doungrat Cholsaringkarl, Warangkana Boonyapisit, Sirichai Cheewatanakornkul, Songkwan Silaruks, Pisit Hutayanon, Seksan Chawanadelert, Pairoj Chattranukulchai, Boonsert Chatlaong, Yingsak Santanakorn, Khompiya Kanokphatcharakun, Piya Mongkolwongroj, Sasivimon Jai-Aue, Ongkarn Komson, Armagan Altun Ali Aydinlar, Ramazan Topsakal, Zeki Ongen, Sadik Acikel, Durmus Yildiray Sahin, Ozcan Yilmaz, Mehmet Birhan Yilmaz, Hasan Pekdemir, Mesut Demir, Murat Sucu, Levent Sahiner, Murat Ersanli, Ertugrul Okuyan, Dursun Aras, Florencia Rolandi Adrian Cesar Ingaramo, Gustavo Alberto Sambadaro, Vanina Fernandez Caputi, Hector Luciardi, Sofia Graciela Berman, Pablo Dragotto, Andres Javier Kleiban, Nestor Centurion, Rodolfo Andres Ahuad Guerrero, Leonel Adalberto Di Paola, Ricardo Dario Dran, Javier Egido, Matias Jose Fosco, Victor Alfredo Sinisi, Luis Rodolfo Cartasegna, Oscar Gomez Vilamajo, Jose Luis Ramos, Sonia Sassone, Gerardo Zapata, Diego Conde, Guillermo Giacomi, Alberto Alfredo Fernandez, Mario Alberto Berli, Fabian Ferroni, Dário Celestino Sobral Filho Jefferson Jaber, Luciana Vidal Armaganijan, Costantino Roberto Frack Costantini, André Steffens, Weimar Kunz Sebba Barroso de Souzaem, João David de Souza Neto, José Márcio Ribeiro, Marcelo Silveira Teixeira, Paulo Rossi, Leonardo Pires, Daniel Moreira, José Carlos Moura Jorge, Adalberto Menezes Lorga Filho, Luiz Bodanese, Marcelo Westerlund Montera, Carlos Henrique Del Carlo, Jamil Abdalla Saad, Fernando Augusto Alves da Costa, Renato Lopes, Gilson Roberto de Araújo, Euler Roberto Manenti, Jose Francisco Kerr Saraiva, João Carlos Ferreira Braga, Alexandre Negri, Carlos Moncada, Dalton Precoma, Fernando Roquette, Gilmar Reis, Roberto Álvaro Ramos Filho, Estêvão Lanna Figueiredo, Roberto Vieira Botelho, Cláudio Munhoz da Fontoura Tavares, Helius Carlos Finimundi, Adriano Kochi, César Cássio Broilo França, Fábio Alban, Guido Bernardo Aranha Rosito, João Batista de Moura Xavier Moraes Junior, Rogério Tadeu Tumelero, Lilia Maia, Roberto Simões de Almeida, Ney Carter do Carmo Borges, Luís Gustavo Gomes Ferreira, Ramón Corbalán Benjamin Aleck Joseh Stockins Fernandez, Humberto Montecinos, Fernando Lanas, Martín Larico Gómez, Carlos Astudillo, Carlos Conejeros, Patricio Marin Cuevas, Alejandro Forero, Claudio Bugueño Gutiérrez, Juan Aguilar, Sergio Potthoff Cardenas, German Eggers, Cesar Houzvic, Carlos Rey, Germán Arriagada, Gustavo Charme Vilches, Carlos Jerjes Sanchez Diaz Jesus Jaime Illescas Diaz, Raul Leal Cantu, Maria Guadalupe Ramos Zavala, Ricardo Cabrera Jardines, Nilda Espinola Zavaleta, Enrique Lopez Rosas, Guillermo Antonio Llamas Esperón, Gerardo Pozas, Ernesto Cardona Muñoz, Norberto Matadamas Hernandez, Adolfo Leyva Rendon, Norberto Garcia Hernandez, Manuel de los Rios Ibarra, Luis Ramon Virgen Carrillo, David Lopez Villezca, Carlos Hernandez Herrera, Juan Jose Lopez Prieto, Rodolfo Gaona Rodriguez, Efrain Villeda Espinosa, David Flores Martinez, Jose Velasco Barcena, Omar Fierro Fierro, Ignacio Rodriguez Briones, Jose Luis Leiva Pons, Humberto Alvarez Lopez, Rafael Olvera Ruiz, Carlos Gerardo Cantu Brito, Eduardo Julian Jose Roberto Chuquiure Valenzuela, Roxana Reyes Sanchez, Alberto Esteban Bazzoni Ruiz, Oscar Martin Lopez Ruiz, Roberto Arriaga Nava, Jesus David Morales Cerda, Pedro Fajardo Campos, Mario Benavides Gonzalez, Marianne Brodmann Kurt Lenz, Claus Hagn, Johannes Foechterle, Heinz Drexel, Kurt Huber, Andrea Podczeck-Schweighofer, Michael Winkler, Bruno Schneeweiss, Alfons Gegenhuber, Wilfried Lang, Sabine Eichinger-Hasenauer, Peter Kaserer, Josef Sykora, Heribert Rasch, Bernhard Strohmer, Luc Capiau Geert Vervoort, Bart Wollaert, Geert Hollanders, Jan Vercammen, Dirk Faes, Yohan Balthazar, Marc Delforge, Olivier Xhaet, Harry Striekwold, John Thoeng, Kurt Hermans, Georges Mairesse, Wim Anné, Ivan Blankoff, Michel Beutels, Stefan Verstraete, Peter Vandergoten, Philippe Purnode, Pascal Godart, Tim Boussy, Philippe Desfontaines, Alex Heyse, Joeri Voet, Axel De Wolf, Eva Zidkova Petr Jansky, Rudolf Spacek, Vilma Machova, Ondrej Ludka, Josef Olsr, Lubos Kotik, Blazej Racz, Richard Ferkl, Jan Hubac, Ilja Kotik, Zdenek Monhart, Hana Burianova, Ondrej Jerabek, Jana Pisova, Iveta Petrova, Vratislav Dedek, Michaela Honkova, Petr Podrazil, Petr Reichert, Jindrich Spinar, Miroslav Novak, Vaclav Durdil, Katarina Plocova, Jiri Lastuvka, Jørn Nielsen Steen Husted, Helena Dominguez, Ulrik Hintze, Søren Rasmussen, Næstved Sygehus, Arne Bremmelgaard, John Markenvard, Jan Børger, Jorgen Solgaard, Ebbe Eriksen, Thomas Løkkegaard, Michael Bruun, Jacob Mertz, Morten Schou, Michael Olsen, Pekka Raatikainen Carmela Viitanen, Franck Paganelli Joël Ohayon, Frédéric Casassus, Michel Galinier, Yannick Gottwalles, Philippe Loiselet, Jean-Joseph Muller, Mohamed Bassel Koujan, André Marquand, Sylvain Destrac, Olivier Piot, Nicolas Delarche, Jean-Pierre Cebron, Maxime Guenoun, Dominique Guedj-Meynier, A. 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Lokesh, Mathieu Zuber, Pierre Amarenco, Emmanuel Ellie, James Kadouch, Pierre-Yves Fournier, Jean-Pierre Huberman, Nestor Lemaire, Gilles Rodier, Xavier Vandamme, Igor Sibon, Jean-Philippe Neau, Marie Hélène Mahagne, Antoine Mielot, Marc Bonnefoy, Jean-Baptiste Churet, Vincent Navarre, Frederic Sellem, Gilles Monniot, Jean-Paul Boyes, Bernard Doucet, Michel Martelet, Désiré Obadia, Bernard Crousillat, Joseph Mouallem, Etienne Bearez, Jean Philippe Brugnaux, Alain Fedorowsky, Pierre Nazeyrollas, Jean-Baptiste Berneau, Frédéric Chemin, Sebastien Schellong Harald Darius, Georg Koeniger, Andreas Kopf, Uwe Gerbaulet, Bernd-Thomas Kellner, Thomas Schaefer, Jan Purr, Enno Eißfeller, Heinz-Dieter Zauzig, Peter Riegel, Christoph Axthelm, Gerd-Ulrich Heinz, Holger Menke, Andreas Pustelnik, Stefan Zutz, Wolfgang Eder, Guenter Rehling, Dirk Glatzel, Norbert Ludwig, Petra Sandow, Henning Wiswedel, Cosmas Wildenauer, Steffen Schoen, Toralf Schwarz, Adyeri Babyesiza, Maximilian Kropp, Hans-Hermann Zimny, Friedhelm Kahl, Andreas Caspar, Sabine Omankowsky, Torsten Laessig, Hermann-Josef Hartmann, Gunter Lehmann, Hans-Walter Bindig, Gunter Hergdt, Dietrich Reimer, Joachim Hauk, Holger Michel, Praxis Dres. Werner Erdle, Wilfried Dorsch, Janna Dshabrailov, Karl-Albrecht Rapp, Reinhold Vormann, Thomas Mueller, Peter Mayer, Uwe Horstmeier, Volker Eissing, Heinz Hey, Heinz Leuchtgens, Volker Lilienweiss, Heiner Mueller, Christian Schubert, Herrmann Lauer, Thomas Buchner, Gunter Brauer, Susanne Kamin, Karsten Mueller, Sylvia Baumbach, Muwafeg Abdel-Qader, Hans-Holger Ebert, Carsten Schwencke, Peter Bernhardt, Laszlo Karolyi, Britta Sievers, Wilhelm Haverkamp, Jens-Uwe Roehnisch, Andras Vertes Gabor Szantai, Andras Matoltsy, Nikosz Kanakaridisz, Zoltan Boda, Erno Kis, Balazs Gaszner, Ferenc Juhasz, Gizella Juhasz, Sandor Kancz, Zoltan Laszlo, Zsolt May, Bela Merkely, Ebrahim Noori, Tamas Habon, Peter Polgar, Gabriella Szalai, Sandor Vangel, Andras Nagy, Gabriella Engelthaler, Judit Ferenczi, Mihaly Egyutt, Giuliana Martini Leone Maria Cristina, Eros Tiraferri, Rita Santoro, Sophie Testa, Giovanni Di Minno, Marco Moia, Teresa Maria Caimi, Maria Tessitori, Roberto Cappelli, Daniela Poli, Roberto Quintavalla, Franco Cosmi, Raffaele Fanelli, Vincenzo Oriana, Raffaele Reggio, Roberto Santi, Leonardo Pancaldi, Raimondo De Cristofaro, Giuliana Guazzaloca, Angelo De Blasio, Jorge Salerno Uriate, Flavia Lillo, Enrico Maria Pogliani, Grzegorz Bilo, Michele Accogli, Antonio Mariani, Mauro Feola, Arturo Raisaro, Luciano Fattore, Andrea Mauric, Fabrizio Germini, Luca Tedeschi, Maria Settimi, Sergio Nicoli, Paolo Ricciarini, Antonio Argena, Paolo Ronchini, Claudio Bulla, Filippo Tradati, Massimo Volpe, Maria D’Avino, Maria Grazia Bongiorni, Silva Severi, Alessandro Capucci, Corrado Lodigiani, Enrico Salomone, Gaetano Serviddio, Claudio Tondo, Paolo Golino, Carmine Mazzone, Saverio Iacopino, Hugo ten Cate J. H. Ruiter, Andreas Lucassen, Henk Adriaansen, Maarten Bongaerts, Mathijs Pieterse, Coen van Guldener, Johannes Herrman, S. H. K. P. R. Nierop, Pieter Hoogslag, Walter Hermans, B. E. Groenemeijer, W. Terpstra, Cees Buiks, L. V. A. Boersma, Eivind Berge Per Anton Sirnes, Erik Gjertsen, Torstein Hole, Knut Erga, Arne Hallaråker, Gunnar Skjelvan, Anders Østrem, Beraki Ghezai, Arne Svilaas, Peter Christersson, Torbjørn Øien, Svein Høegh Henrichsen, Jan Erik Otterstad, Jan Berg-Johansen, Janina Stepinska Andrzej Gieroba, Malgorzata Biedrzycka, Michal Ogorek, Beata Wozakowska-Kaplon, Krystyna Loboz-Grudzien, Wieslaw Supinski, Jerzy Kuzniar, Roman Zaluska, Jaroslaw Hiczkiewicz, Lucyna Swiatkowska-Byczynska, Lech Kucharski, Marcin Gruchala, Piotr Minc, Maciej Olszewski, Grzegorz Kania, Malgorzata Krzciuk, Zbigniew Lajkowski, Bozenna Ostrowska-Pomian, Jerzy Lewczuk, Elzbieta Zinka, Agnieszka Karczmarczyk, Malgorzata Chmielnicka-Pruszczynska, Iwona Wozniak-Skowerska, Grzegorz Opolski, Marek Bronisz, Marcin Ogorek, Grazyna Glanowska, Piotr Ruszkowski, Grzegorz Skonieczny, Ryszard Sciborski, Boguslaw Okopien, Piotr Kukla, Krzysztof Galbas, Krzysztof Cymerman, Jaroslaw Jurowiecki, Pawel Miekus, Waldemar Myszka, Stanislaw Mazur, Roman Lysek, Jacek Baszak, Teresa Rusicka-Piekarz, Grzegorz Raczak, Ewa Domanska, Jadwiga Nessler, Jozef Lesnik, Vera Eltishcheva Roman Libis, Gadel Kamalov, Dmitry Belenky, Liudmila Egorova, Alexander Khokhlov, Eduard Yakupov, Dmitry Zateyshchikov, Olga Barbarash, Olga Miller, Evgeniy Mazur, Konstantin Zrazhevskiy, Tatyana Novikova, Yulia Moiseeva, Elena Polkanova, Konstantin Sobolev, Maria Rossovskaya, Yulia Shapovalova, Alla Kolesnikova, Konstantin Nikolaev, Oksana Zemlianskaia, Anna Zateyshchikova, Victor Kostenko, Sergey Popov, Maria Poltavskaya, Anton Edin, Elena Aleksandrova Oksana Drapkina, Alexander Vishnevsky, Oleg Nagibovich, Petr Chizhov, Svetlana Rachkova, Mikhail Sergeev, Borys Kurylo, Alexey Ushakov, Xavier Vinolas Pere Alvarez Garcia, Maria Fernanda Lopez Fernandez, Luis Tercedor Sanchez, Salvador Tranche Iparraguirre, Pere Toran Monserrat, Emilio Marquez Contreras, Jordi Isart Rafecas, Juan Motero Carrasco, Pablo Garcia Pavia, Casimiro Gomez Pajuelo, Luis Miguel Rincon Diaz, Luis Fernando Iglesias Alonso, Angel Grande Ruiz, Jordi Merce Klein, Jose Ramon Gonzalez Juanatey, Ines Monte Collado, Herminia Palacin Piquero, Carles Brotons Cuixart, Esther Fernandez Escobar, Joan Bayo i Llibre, Cecilia Corros Vicente, Manuel Vida Gutierrez, Francisco Epelde Gonzalo, Carlos Alexandre Almeida Fernandez, Encarnacion Martinez Navarro, Juan Jose Montero Alia, Maria Barreda Gonzalez, Maria Angels Moleiro Oliva, Jose Iglesias Sanmartin, Mercedes Jimenez Gonzalez, Maria del Mar Rodriguez Alvarez, Juan Herreros Melenchon, Tomas Ripoll Vera, Manuel Jimenez Navarro, Maria Vazquez Caamano, Maria Fe Arcocha Torres, Gonzalo Marcos Gomez, Andres Iniguez Romo, Miguel Angel Prieto Diaz, Mårten Rosenqvist Alexander Wirdby, Jan Lindén, Kerstin Henriksson, Micael Elmersson, Arnor Egilsson, Ulf Börjesson, Gunnar Svärd, Bo Liu, Anders Lindh, Lars-Bertil Olsson, Mikael Gustavsson, Lars Andersson, Lars Benson, Claes Bothin, Ali Hajimirsadeghi, Björn Martinsson, Marianne Ericsson, Åke Ohlsson, Håkan Lindvall, Peter Svensson, Katarina Thörne, Hans Händel, Pyotr Platonov, Fredrik Bernsten, Ingar Timberg, Milita Crisby, Jan-Erik Karlsson, Agneta Andersson, Lennart Malmqvist, Johan Engdahl, Jörgen Thulin, Aida Hot-Bjelak, Steen Jensen, Per Stalby, Jan Steffel Johann Debrunner, Juerg H. Beer, Dipen Shah, Iurii Rudyk Vira Tseluyko, Oleksandr Karpenko, Svitlana Zhurba, Igor Kraiz, Oleksandr Parkhomenko, Iryna Kupnovytska, Nestor Seredyuk, Yuriy Mostovoy, Oleksiy Ushakov, Olena Koval, Igor Kovalskiy, Yevgeniya Svyshchenko, Oleg Sychov, Mykola Stanislavchuk, Andriy Yagensky, Susanna Tykhonova, Ivan Fushtey, Will Murdoch Naresh Chauhan, Daryl Goodwin, Louise Lumley, Ramila Patel, Philip Saunders, Bennett Wong, Alex Cameron, Niranjan Patel, P. Jhittay, Andrew Ross, M. S. Kainth, Karim Ladha, Kevin Douglas, Gill Pickavance, Joanna McDonnell, Laura Handscombe, Trevor Gooding, Helga Wagner, Colin Bradshaw, Catherine Bromham, Kevin Jones, Shoeb Suryani, Richard Coates, Bhupinder Sarai, W. Willcock, S. Sircar, John Cairns, A. Gilliand, Roman Bilas, E. Strieder, Peter Hutchinson, Anne Wakeman, Michael Stokes, Graham Kirby, Bhaskhar Vishwanathan, Nigel Bird, Paul Evans, M. Clark, John Bisatt, Jennifer Litchfield, E. Fisher, Tim Fooks, Richard Kelsall, Neil Paul, Elizabeth Alborough, Michael Aziz, C. Ramesh, Pete Wilson, Simon Franklin, Sue Fairhead, Julian Thompson, Hasan Chowan, Gary Taylor, Dawn Tragen, Matt Parfitt, Claire Seamark, Carolyn Paul, Mark Richardson, Angus Jefferies, Helen Sharp, Hywel Jones, Claire Giles, Matthew Bramley, Philip Williams, Jehad Aldegather, Simon Wetherell, William Lumb, Phil Evans, Frances Scouller, Neil Macey, Stephen Rogers, Yvette Stipp, Richard West, Philip Pinney, Paul Wadeson, John Matthews, Preeti Pandya, Andrew Gallagher, T. Railton, Emyr Davies, Jonathan McClure, Marc Jacobs, Claire Hutton, R. Thompson, Bijoy Sinha, Keith Butter, Susan Barrow, Helen Little, David Russell, Ulka Choudhary, Ikram Haq, Paul Ainsworth, Claire Jones, Phil Weeks, Jane Eden, Lisa Gibbons, Janet Glencross, Alison MacLeod, K. Poland, Conor Mulolland, A. Warke, Paul Conn, D. Burns, R. Smith, R. Kamath, Jonathan Webster, Ian Hodgins, Stephen Vercoe, Paul Roome, Hilary Pinnock, Jayesh Patel, Amar Ali, Nigel Hart, Richard Davies, Nigel De-Sousa, Catherine Neden, Mark Danielsen, Purnima Sharma, Sophia Galloway, Charlotte Hawkins, Raife Oliver, Martin Aylward, Mira Pattni, Gordon Irvine, Shahid Ahmad, Catherine Rothwell, Fiaz Choudhary, Sabrina Khalaque, Stephanie Short, Sharon Peters, Warwick Coulson, Neil Roberts, Amy Butler Steven Coates, Ben Ward, Daniel Jackson, Steve Walton, Diane Shepherd, Toh Wong, Mark Boon, Melanie Deacon, David Cornelius, Sarah Davies, Ben Frankel, Nick Hargreaves, Henry Choi, Jon Sumner, Tim Myhill, Salah Estifanos, Diane Geatch, Justin Wilkinson, Richard Veale, Karen Forshaw, Rob Hirst, Kashif Zaman, Catherine Liley, Rebecca Wastling, Paul McEleny, Andre Beattie, Philip Cooke, Mike Wong, Mark Pugsley, Chaminda Dooldeniya, Greg Rogers, James Bennett, Polly Jacobs, Rajesh Muvva, Matthew Adam, Robin Fox, Nicolas Thomas, Simon Cartwright, Rory Reed, Simon Randfield, Christine A’Court, Ann Flynn, Andrew Halpin, Simon Dobson, Louise Lomax, Minnal Nadaph, Iain Munro, Jane Goram, Helen Stoddart, Phil Simmons, John Shewring, Emma Bowen-Simpkins, Mark Rickenbach, Adam Blenkhorn Bhuwanendu Singh, Penny Astridge, William van Gaal, Walter Abhayaratna, Philip Thomson, Ron Lehman, Jens Kilian, David Coulshed, Andrei Catanchin, David Colquhoun, Hosen Kiat, David Eccleston, John French, Bronte Ayres, Peter Blombery, Thanh Phan, James Rogers, David O’Donnell, Sang Cheol Bae, Harry Gibbs, Patrick Carroll, Greg Starmer, Margaret Arstall, Maurits Binnekamp, Astin Lee, John Eikelboom Robert Luton, Milan Gupta, Amritanshu Shekhar Pandey, Stephen Cheung, Rolland Leader, Philippe Beaudry, Félix Ayala-Paredes, Joseph Berlingieri, John Heath, Germain Poirier, Miranda du Preez, Bradley Schweitzer, Reginald Nadeau, Ripple Dhillon, Tomasz Hruczkowski, Andrea Lavoie, Ratika Parkash, James Cha, Benoit Coutu, Paul MacDonald, Brian Ramjattan, Jorge Bonet, Saul Vizel, Paul Angaran, Sameh Fikry, Ahmed Mowafy Azza Katta, Mazen Tawfik, Moustafa Nawar, Mohamed Sobhy, Seif Kamal Abou Seif, Tarek Khairy, Ahmed Abd El-Aziz, Nasser Taha, Ashraf Reda, Atef Elbahry, Mohamed Setiha, Mohamed Gamal El Din, Magdi Elkhadem, Adel El-Etreby, David Kettles Junaid Bayat, Heidi Siebert, Adrian Horak, Ynez Kelfkens, Riaz Garda, Thayabran Pillay, Michele Guerra, Louis van Zyl, Hendrik Theron, Andrew Murray, Rikus Louw, Deon Greyling, Pindile Mntla, Siddique Ismail, Fayzal Ahmed, Johannes Engelbrecht, Shambu Maharajh, Wessel Oosthuysen, Rehana Loghdey, Veronica Ueckermann, Wael AlAl Mahmeed AbdullahNaeemi, Ghazi Yousef, Nooshin Bazargani, Munther AlOmairi, Rajan Maruthanayagam, Rupesh Singh, Ahmed Naguib, Mohamed Ibrahim, Amrish Agrawal, Mukesh Nathani, Ehab M. Esheiba, Adel Wassef, Rajeev Gupta, Michael Cox Scott Beach, Peter Duffy, Stephen Falkowski, Kevin Ferrick, Miguel Franco, W. Michael Kutayli, Annette Quick, Niraj Sharma, Vance Wilson, Stephen Miller, Mark Alberts, Edwin Blumberg, Roddy Canosa, Ted Gutowski, Rodney Ison, Jorge Garcia, Paul Mullen, Howard Noveck, Pamela Rama, Rajneesh Reddy, Marcus Williams, Daniel Nishijima, Keith Ferdinand, Ihsan Haque, Robert Mendelson, Sridevi Pitta, Daniel Theodoro, Charles Treasure, Moustafa Moustafa, Cas Cader, Walter Pharr, Alisha Oropallo, George Platt, Jaspal Gujral, James Welker, and Firas Koura
Abstract: Background: The Global Anticoagulant Registry in the FIELD–Atrial Fibrillation (GARFIELD-AF) is a worldwide non-interventional study of stroke prevention in patients with non-valvular AF. Methods and results: 52,080 patients with newly diagnosed AF were prospectively enrolled from 2010 to 2016. 4121 (7.9%) of these patients were recruited in DACH [Germany (n = 3567), Austria (n = 465) and Switzerland (n = 89) combined], and 47,959 patients were from 32 countries in other regions worldwide (ORW). Hypertension was most prevalent in DACH and ORW (85.3% and 75.6%, respectively). Diabetes, hypercholesterolaemia, carotid occlusive disease and vascular disease were more prevalent in DACH patients vs ORW (27.6%, 49.4%, 5.8% and 29.0% vs 21.7%, 40.9%, 2.8% and 24.5%). The use of non-vitamin K antagonist oral anticoagulants (NOACs) increased more in DACH over time. Management of vitamin K antagonists was suboptimal in DACH and ORW (time in therapeutic range of INR ≥ 65% in 44.6% and 44.4% of patients or ≥ 70% in 36.9% and 36.0% of patients, respectively). Adjusted rates of cardiovascular mortality and MI/ACS were higher in DACH while non-haemorrhagic stroke/systemic embolism was lower after 2-year follow-up. Conclusions: Similarities and dissimilarities in AF management and clinical outcomes are seen in DACH and ORW. The increased use of NOAC was associated with a mismatch of risk-adapted anticoagulation (over-and-undertreatment) in DACH. Suboptimal control of INR requires educational activities in both regional groups. Higher rates of cardiovascular death in DACH may reflect the higher risk profile of these patients and lower rates of non-haemorrhagic stroke could be associated with increased NOAC use. Graphical abstract: [Figure not available: see fulltext.].
Published: 2023

22. Cardiac Biomarkers and Left Ventricular Hypertrophy in Relation to Outcomes in Patients With Atrial Fibrillation: Experiences From the RE‐LY Trial

Author: Ziad Hijazi, Paolo Verdecchia, Jonas Oldgren, Ulrika Andersson, Gianpaolo Reboldi, Giuseppe Di Pasquale, Giovanni Mazzotta, Fabio Angeli, John W. Eikelboom, Michael D. Ezekowitz, Stuart J. Connolly, Salim Yusuf, and Lars Wallentin
Subjects: atrial fibrillation, biomarker, left ventricular hypertrophy, risk prediction, Diseases of the circulatory (Cardiovascular) system, RC666-701
Abstract: Background Cardiac biomarkers and left ventricular hypertrophy (LVH) are related to the risk of stroke and death in patients with atrial fibrillation. We investigated the interrelationship between LVH and cardiac biomarkers and their independent associations with outcomes. Methods and Results Plasma samples were obtained at baseline in 5275 patients with atrial fibrillation in the RE‐LY (Randomized Evaluation of Long‐Term Anticoagulation Therapy) trial. NT‐proBNP (N‐terminal pro‐B‐type natriuretic peptide), cardiac troponin I and T, and growth differentiation factor‐15 were determined using high‐sensitivity (hs) assays. LVH was defined by ECG. Cox models were adjusted for baseline characteristics, LVH, and biomarkers. LVH was present in 1257 patients. During a median follow‐up of 2.0 years, 165 patients developed a stroke and 370 died. LVH was significantly (P
Published: 2019
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23. Dose-limiting, adverse event-associated bradycardia with β-blocker treatment of atrial fibrillation in the GENETIC-AF trial

Author: Michiel Rienstra, Debra Marshall, William T. Abraham, Michel White, Ian A. Carroll, Sophia P. Huebler, Ryan Aleong, Dirk J. van Veldhuisen, Stephen B. Wilton, William H. Sauer, Stuart J. Connolly, Jonathan P. Piccini, Inder S. Anand, Christopher M. O'Connor, Jeff S. Healey, Christopher Dufton, Michael R. Bristow, and Cardiovascular Centre (CVC)
Subjects: Bradycardia, medicine.medical_specialty, business.industry, Bucindolol, Atrial fibrillation, medicine.disease, chemistry.chemical_compound, chemistry, Heart failure, Internal medicine, Heart rate, Cardiology, cardiovascular system, Medicine, Sinus rhythm, cardiovascular diseases, Electrical conduction system of the heart, medicine.symptom, business, Metoprolol, medicine.drug, circulatory and respiratory physiology
Abstract: Background: Heart failure (HF) patients with atrial fibrillation (AF) often have conduction system disorders, which may be worsened by β-blocker therapy.Objective: In a post hoc analysis we examined the prevalence of bradycardia and its association with adverse events (AEs) and failure to achieve target dose in the GENETIC-AF trial.Methods: Patients randomized to metoprolol (n = 125) or bucindolol (n = 131) entering 24-week efficacy follow-up and receiving study medication were evaluated. Bradycardia was defined as an electrocardiogram (ECG) heart rate (HR) Results: Mean HR in sinus rhythm (SR) was 62.6 ± 12.5 bpm for metoprolol and 68.3 ± 11.1 bpm for bucindolol (P < .0001), but in AF HRs were not different (87.5 bpm vs 89.7 bpm, respectively). Episodes per patient for bucindolol vs metoprolol were 0.82 vs 2.08 (P < .001) for bradycardia and 0.24 vs 0.57 for severe bradycardia (P < .001), with 98.9% of the episodes occurring in SR. Patients experiencing bradycardia had a 4.15-fold higher prevalence of study medication dose reduction (P Conclusion: In AF-prone HF patients bradycardia may limit the effectiveness of β blockers, and this property is agent-dependent.
Published: 2022
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24. Prospective long-term follow-up of silicone-polyurethane–insulated implantable cardioverter-defibrillator leads

Author: Stuart J. Connolly, Jeff S. Healey, Ellison Themeles, John A. Cairns, Andrew E. Epstein, and Kumar Balasubramanian
Subjects: medicine.medical_specialty, business.industry, medicine.medical_treatment, Hazard ratio, Odds ratio, Implantable cardioverter-defibrillator, Confidence interval, Interquartile range, Emergency medicine, medicine, Cardiology and Cardiovascular Medicine, Lead (electronics), Adverse effect, Prospective cohort study, business
Abstract: Background St Jude Medical (now Abbott) Optim-insulated implantable cardioverter-defibrillator (ICD) leads were expected to overcome problems with insulation abrasion and externalized conductors in earlier models. Long-term follow-up is essential to the evaluation of lead performance. Objective To determine in a prospective cohort of Optim-insulated ICD leads, the rates of all-cause mechanical failure and its subtypes (conductor fracture, insulation abrasion, externalized conductors and other mechanical failures) and electrical dysfunction adjudicated as non-mechanical failure. Methods Abbott established 3 prospective registries, enrolling 11,155 leads among 10,872 patients beginning in 2006. There was standardized baseline documentation, 6-monthly follow-up, adverse events reporting and documentation of lead revision or inactivation, study withdrawal and death or transplant. The Population Health Institute (McMaster University) reviewed database functions, adjudicated all potential mechanical lead failures and conducted independent data analyses. Results During a median follow-up of 4.6 yr., there were 171 mechanical failures (1.53%, 95.4% freedom from failure by 12 yr.). There were no significant differences in survival among Durata DF4 and DF1 and Riata ST Optim leads. The year-to-year rate of failure of leads increased over time. There were 69 electrical dysfunctions (0.62%, 98.8% freedom from failure by 12 yr.) adjudicated as non-mechanical failure. Conclusion During follow-up as long as 12 yr. (median 4.6 yr.), Optim-insulated leads had low rates of mechanical failure and electrical dysfunction. . Independent analyses provide reliable data on the long-term outcomes essential to analyzing ICD lead performance.
Published: 2022
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25. Frequency and Patterns of Brain Infarction in Patients With Embolic Stroke of Undetermined Source: NAVIGATE ESUS Trial

Author: Mukul Sharma, Eric E. Smith, Lesly A. Pearce, Ashkan Shoamanesh, Kanjana S. Perera, Shelagh B. Coutts, Dorte Damgaard, Sebastian F. Ameriso, Joung-Ho Rha, Boris Modrau, Byung-Woo Yoon, Marina Romano, Steven R. Messé, Jessica Barlinn, Johann Lambeck, Feryal Saad, Scott D. Berkowitz, Hardi Mundl, Stuart J. Connolly, Robert G. Hart, T.S. Field, G.J. Stotts, D.J. Gladstone, S.J. Phillips, A. Sharrief, C. Holmstedt, N. Vora, C. Wilson, B.M. Coull, A. de Havenon, L.A. Birnbaum, N. Patel, M.S. Hussain, D. Greer, S. Chen, S. Kittner, D. Mehta, T. Lowenkopf, R. Sawyer, V. Babikian, R. Zweifler, D.L. Tirschwell, C. Sila, C. Zhang, K-S. Hong, K. Oh, J.H. Heo, H-J. Bae, M.S. Park, J.S. Kim, C-S. Chung, B-C. Lee, G.P. Povedano, J.J. Martin, G.M. Bruera, L.V. Jure, J. Marti-Fabregas, I.C. Naranjo, J.M.R. Moreno, P.C. Portela, M. Gomis, J. Serena, H. Christensen, T. Christensen, S. Knecht, M. Endres, J. Berrouschot, F. Schlachetzki, S. Wunderlich, P. Kraft, P. Guyler, RC. Veltkamp, M. Burn, K. Rashed, M.J. Macleod, C. Canepa, J. Selvarajah, D. Hargroves, Y. Behnam, T.G. Robinson, L. Roveri, G. Lembo, D.S. Toni, V. Monzani, A. Cavallini, D. Popov, M. Friedrich, C. Minelli, C. Moro, R.J. Gagliardi, A. Bacellar, R. Mikulik, J. Eckstein, G. Panczel, N. Szegedi, and M.J. O’Donnell
Subjects: Brain Infarction, Male, medicine.medical_specialty, Internationality, Tobacco use, Cohort Studies, Magnetic resonance imaging, Double-Blind Method, Rivaroxaban, Internal medicine, medicine, Humans, In patient, cardiovascular diseases, Aged, Advanced and Specialized Nursing, Aspirin, medicine.diagnostic_test, business.industry, Anti-Inflammatory Agents, Non-Steroidal, Middle Aged, Magnetic Resonance Imaging, Embolic stroke, Stroke, Intracranial Embolism, Brain infarction, Cardiology, Female, Neurology (clinical), Cardiology and Cardiovascular Medicine, business, Factor Xa Inhibitors, medicine.drug
Abstract: Background and Purpose: The spectrum of brain infarction in patients with embolic stroke of undetermined source (ESUS) has not been well characterized. Our objective was to define the frequency and pattern of brain infarcts detected by magnetic resonance imaging (MRI) among patients with recent ESUS participating in a clinical trial. Methods: In the NAVIGATE ESUS trial (New Approach Rivaroxaban Inhibition of Factor Xa in a Global Trial Versus ASA to Prevent Embolism in Embolic Stroke of Undetermined Source), an MRI substudy was carried out at 87 sites in 15 countries. Participants underwent an MRI using a specified protocol near randomization. Images were interpreted centrally by those unaware of clinical characteristics. Results: Among the 918 substudy cohort participants, the mean age was 67 years and 60% were men with a median (interquartile range) of 64 (26–115) days between the qualifying ischemic stroke and MRI. On MRI, 855 (93%) had recent or chronic brain infarcts that were multiple in 646 (70%) and involved multiple arterial territories in 62% (401/646). Multiple brain infarcts were present in 68% (510/755) of those without a history of stroke or transient ischemic attack before the qualifying ESUS. Prior stroke/transient ischemic attack ( P 0 ( P P =0.01) were associated with multiple infarcts. Topographically, large and/or cortical infarcts were present in 89% (757/855) of patients with infarcts, while in 11% (98/855) infarcts were exclusively small and subcortical. Among those with multiple large and/or cortical infarcts, 57% (251/437) had one or more involving a different vascular territory from the qualifying ESUS. Conclusions: Most patients with ESUS, including those without prior clinical stroke or transient ischemic attack, had multiple large and/or cortical brain infarcts detected by MRI, reflecting a substantial burden of clinical stroke and covert brain infarction. Infarcts most frequently involved multiple vascular territories. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT02313909.
Published: 2022
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26. Andexanet Alfa for Specific Anticoagulation Reversal in Patients with Acute Bleeding during Treatment with Edoxaban

Author: Alexander P, Benz, Lizhen, Xu, John W, Eikelboom, Saskia, Middeldorp, Truman J, Milling, Mark, Crowther, Patrick, Yue, Pamela, Conley, Genmin, Lu, Stuart J, Connolly, Vascular Medicine, ACS - Pulmonary hypertension & thrombosis, and ARD - Amsterdam Reproduction and Development
Subjects: Aged, 80 and over, Male, Pyridines, Vascular damage Radboud Institute for Health Sciences [Radboudumc 16], Hemorrhage, Thrombosis, Hematology, bleeding, Anticoagulation Reversal, Recombinant Proteins, Thiazoles, andexanet alfa, Factor Xa, edoxaban, Humans, Female, reversal, intracranial hemorrhage, Factor Xa Inhibitors
Abstract: Background Andexanet alfa (andexanet) is approved for specific anticoagulation reversal in patients with life-threatening or uncontrolled bleeding during treatment with rivaroxaban or apixaban. There is limited experience with andexanet in patients with acute bleeding on edoxaban. Methods Patients with acute major bleeding within 18 hours of edoxaban intake were prospectively enrolled. Patients received a bolus and 2-hour follow-on infusion of andexanet. The co-primary efficacy outcomes were change in antifactor Xa activity and the percentage of patients achieving excellent or good hemostasis, 12 hours after andexanet treatment. Efficacy was analyzed in patients with confirmed major bleeding and baseline antifactor Xa activity ≥40 ng/mL. Safety was analyzed in all patients. Results Thirty-six patients (mean age: 82 years, 61.1% male and 91.7% with atrial fibrillation) with acute major bleeding on edoxaban received andexanet. The primary site of bleeding was intracranial in 29 patients (80.6%). In the efficacy population (n = 28), median antifactor Xa activity decreased from 121.1 (interquartile range [IQR]: 70.3–202.4) ng/mL at baseline to 24.0 (IQR: 77.7–83.7) ng/mL at the end of andexanet bolus (median decrease: 68.9%, 95% confidence interval [CI]: 56.1–77.7%). Excellent or good hemostasis at 12 hours was achieved in 78.6% (95% CI: 59.0–91.7%) of patients. Within 30 days, four patients (11.1%) experienced a thrombotic event and four others (11.1%) died. Conclusion In patients with acute major bleeding on edoxaban, andexanet significantly decreased antifactor Xa activity. Hemostatic efficacy was similar to that observed in patients with bleeding on rivaroxaban or apixaban. Thrombotic events occurred at a rate expected in such patients.
Published: 2022

27. Final Study Report of Andexanet Alfa for Major Bleeding with Factor Xa Inhibitors

Author: Truman J. Milling, Saskia Middeldorp, Lizhen Xu, Bruce Koch, Andrew Demchuk, John W. Eikelboom, Peter Verhamme, Alexander T. Cohen, Jan Beyer-Westendorf, C. Michael Gibson, Jose Lopez-Sendon, Mark Crowther, Ashkan Shoamanesh, Michiel Coppens, Jeannot Schmidt, Pierre Albaladejo, Stuart J. Connolly, R. Anand, A. Bastani, C. Clark, M. Concha, J. Cornell, K. Dombrowski, G. Fermann, J. Fulmer, J. Goldstein, D. Kereiakes, T. Milling, D. Pallin, N. Patel, M. Refaai, M. Rehman, A. Schmaier, E. Schwarz, W. Shillinglaw, M. Spohn, T. Takata, A. Venkat, J. Welker, I. Welsby, J. Wilson, L. Van Keer, F. Verschuren, M. Blostein, J. Eikelboom, K. Althaus, J. Berrouschot, G. Braun, T. Doeppner, R. Dziewas, S. Genth-Zotz, P. Greinacher, F. Hamann, F. Hanses, W. Heide, B. Kallmuenzer, P. Kermer, S. Poli, G. Royl, S. Schellong, S. Schnupp, J. Schwarze, C. Spies, G. Thomalla, M. von Mering, K. Weissenborn, F. Wollenweber, C. Gumbinger, U. Jaschinski, M. Maschke, H-C. Mochmann, W. Pfeilschifter, C. Pohlmann, R. Zahn, P. Bouzat, J. Schmidt, C. Vallejo, B. Floccard, M. Coppens, S. van Wissen, E. Arellano-Rodrigo, E. Valles, R. Alikhan, K. Breen, R. Hall, M. Crowther, P. Albaladejo, A. Cohen, A.M. Demchuk, D.G. Wyse, D.A. Garcia, M. Prins, J. Nakamya, H.R. Büller, K. W. Mahaffey, J. H. Alexander, J.A. Cairns, R.G. Hart, C.D. Joyner, G.E. Raskob, S. Schulman, R. Veltkamp, B. Meeks, E. Zotova, S. Ahmad, T. Pinto, K. Baker, A. Dykstra, I. Holadyk-Gris, A. Malvaso, Vascular Medicine, ACS - Pulmonary hypertension & thrombosis, ARD - Amsterdam Reproduction and Development, ACS - Amsterdam Cardiovascular Sciences, Infectious diseases, AII - Infectious diseases, AII - Inflammatory diseases, and APH - Global Health
Subjects: clinical trials, All institutes and research themes of the Radboud University Medical Center, cohort studies, Physiology (medical), Vascular damage Radboud Institute for Health Sciences [Radboudumc 16], factor Xa inhibitors, ddc:610, Cardiology and Cardiovascular Medicine, gastrointestinal hemorrhage, intracranial hemorrhage
Abstract: Background: Andexanet alfa is a modified recombinant inactive factor Xa (FXa) designed to reverse FXa inhibitors. ANNEXA-4 (Andexanet Alfa, a Novel Antidote to the Anticoagulation Effects of Factor Xa Inhibitors) was a multicenter, prospective, phase-3b/4, single-group cohort study that evaluated andexanet alfa in patients with acute major bleeding. The results of the final analyses are presented. Methods: Patients with acute major bleeding within 18 hours of FXa inhibitor administration were enrolled. Co-primary end points were anti-FXa activity change from baseline during andexanet alfa treatment and excellent or good hemostatic efficacy, defined by a scale used in previous reversal studies, at 12 hours. The efficacy population included patients with baseline anti-FXa activity levels above predefined thresholds (≥75 ng/mL for apixaban and rivaroxaban, ≥40 ng/mL for edoxaban, and ≥0.25 IU/mL for enoxaparin; reported in the same units used for calibrators) who were adjudicated as meeting major bleeding criteria (modified International Society on Thrombosis and Haemostasis definition). The safety population included all patients. Major bleeding criteria, hemostatic efficacy, thrombotic events (stratified by occurring before or after restart of either prophylactic [ie, a lower dose, for prevention rather than treatment] or full-dose oral anticoagulation), and deaths were assessed by an independent adjudication committee. Median endogenous thrombin potential at baseline and across the follow-up period was a secondary outcome. Results: There were 479 patients enrolled (mean age, 78 years; 54% male; 86% White); 81% were anticoagulated for atrial fibrillation, and the median time was 11.4 hours since last dose, with 245 (51%) on apixaban, 176 (37%) on rivaroxaban, 36 (8%) on edoxaban, and 22 (5%) on enoxaparin. Bleeding was predominantly intracranial (n=331 [69%]) or gastrointestinal (n=109 [23%]). In evaluable apixaban patients (n=172), median anti-FXa activity decreased from 146.9 ng/mL to 10.0 ng/mL (reduction, 93% [95% CI, 94–93]); in rivaroxaban patients (n=132), it decreased from 214.6 ng/mL to 10.8 ng/mL (94% [95% CI, 95–93]); in edoxaban patients (n=28), it decreased from 121.1 ng/mL to 24.4 ng/mL (71% [95% CI, 82–65); and in enoxaparin patients (n=17), it decreased from 0.48 IU/mL to 0.11 IU/mL (75% [95% CI, 79–67]). Excellent or good hemostasis occurred in 274 of 342 evaluable patients (80% [95% CI, 75–84]). In the safety population, thrombotic events occurred in 50 (10%) patients; in 16 patients, these occurred during treatment with prophylactic anticoagulation that began after the bleeding event. No thrombotic episodes occurred after oral anticoagulation restart. Specific to certain populations, reduction of anti-FXa activity from baseline to nadir significantly predicted hemostatic efficacy in patients with intracranial hemorrhage (area under the receiver operating characteristic curve, 0.62 [95% CI, 0.54–0.70]) and correlated with lower mortality in patients P =0.022; unadjusted P =0.003). Median endogenous thrombin potential was within the normal range by the end of andexanet alfa bolus through 24 hours for all FXa inhibitors. Conclusions: In patients with major bleeding associated with the use of FXa inhibitors, treatment with andexanet alfa reduced anti-FXa activity and was associated with good or excellent hemostatic efficacy in 80% of patients. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT02329327.
Published: 2023

28. Abstract WP126: Predictors Of Intracranial Hemorrhage Volume Expansion In Patients Receiving Factor Xa Inhibitors In The Annexa-4 Trial

Author: Mauricio Concha, Lizhen Hu, MacKenzie Horn, Tomoyuki Ohara, Juliet Nakamya, Jan Beyer, Askan Shoamanesh, Alexander T Cohen, Per Ladenvall, Stuart J Connolly, and Andrew M Demchuk
Subjects: Advanced and Specialized Nursing, Neurology (clinical), Cardiology and Cardiovascular Medicine
Abstract: Introduction: Andexanet, a specific reversal agent for FXa inhibitors, showed an effective hemostasis in 82% of patients with major bleeding in the ANNEXA-4 trial. However, little is known about the predictors associated with hematoma expansion in patients with FXa inhibitor-associated intracranial hemorrhage (ICrH) receiving andexanet. Methods: ANNEXA-4 was a prospective, single-arm, open-label study of andexanet in patients with acute major bleeding within 18h after taking a FXa inhibitor. Hematoma volumes at baseline and 12h after andexanet treatment were measured utilizing a computerized-assisted volumetric method. Univariate and multivariate logistic regression analyses of baseline clinical and non-clinical parameters were performed to identify factors predictive of different volumes of hematoma expansion. Results: A total of 305 patients with both baseline and follow-up imaging were included (mean age 80 years; 60.2% with intracerebral hemorrhage; 55.4% taking apixaban; 32.5% taking rivaroxaban). Overall median baseline hematoma volume was 10.4 mls (IQR 2.7-28.1) and time from symptom onset to baseline CT was 3.3h (1.5-6.8). Mean baseline anti-FXa activity levels were 148 ng/mL (SD 107.5). In follow up scans, 48 cases (15.7%) showed evidence of ICrH expansion ≥6 mls. Utilizing a four category ICrH Expansion Scale as the dependent variable, ordinal logistic regression identified Glasgow Coma Scale (GCS) score (OR 0.79; 95% CI 0.64-0.97), baseline ICrH volume (OR 1.02; 95% CI 1.01-1.04) and time from symptom onset to CT (OR 0.73 (0.53-0.99) as significant predictors of ICrH expansion. Baseline anti-FXA activity (OR 1.54; 95% CI 0.95-2.51; p value 0.08) and multiple compartment ICrH (OR 2.32; 95% CI 0.98-5.51; p value 0.06) showed trend as predictors of ICrH expansion. ICrH expansion dichotomized by ≥6 mls or Conclusions: Shorter time from onset of symptoms to CT, lower GCS score and larger hematoma volumes at presentation increased the probability of ICrH expansion in FXa-associated ICrH treated with andexanet. These findings can inform the eligibility criteria of clinical trials targeting hemostatic efficacy in patients with FXa-associated ICrH.
Published: 2023
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29. Individual net clinical outcome with oral anticoagulation in atrial fibrillation using the ABC-AF risk scores

Author: Ziad Hijazi, Johan Lindbäck, Jonas Oldgren, Alexander P. Benz, John H. Alexander, Stuart J. Connolly, John W. Eikelboom, Christopher B. Granger, Renato D. Lopes, Agneta Siegbahn, and Lars Wallentin
Subjects: Kardiologi, Cardiac and Cardiovascular Systems, Cardiology and Cardiovascular Medicine
Abstract: Background Decisions on stroke prevention strategies in patients with atrial fibrillation (AF) depend on the perceived risks of stroke and bleeding with different antithrombotic treatment strategies. The study objectives were to evaluate net clinical outcome with oral anticoagulation (OAC) for the individual patient with AF and to identify clinically relevant thresholds for OAC treatment. Methods Patients with AF receiving OAC treatment in the randomized ARISTOTLE and RE-LY trials, with available biomarkers for calculation of ABC-AF scores at baseline, were included (n = 23,121). Observed 1-year risk on OAC was compared with predicted 1-year risk if the same patients would not have received OAC using the ABC-AF scores calibrated for aspirin. Net clinical outcome was defined as the sum of stroke and major bleeding risks. Results The ratio between the 1-year incidence of major bleeding and stroke/systemic embolism events ranged from 1.4 to 10.6 according to different ABC-AF risk profiles. Net clinical outcome analyses showed that in patients with an ABC-AF-stroke risk >1% per year on OAC (>3% without OAC), treatment with OAC consistently provides larger net clinical benefit than no-OAC treatment. In patients with an ABC-AF-stroke risk
Published: 2023

30. Apixaban-Calibrated Anti-FXa Activity in Relation to Outcome Events and Clinical Characteristics in Patients with Atrial Fibrillation: Results from the AVERROES Trial

Author: Vinai C. Bhagirath, John W. Eikelboom, Jack Hirsh, Michiel Coppens, Jeffrey Ginsberg, Thomas Vanassche, Fei Yuan, Noel Chan, Salim Yusuf, and Stuart J. Connolly
Subjects: apixaban, fibrillation, hemorrhage, systemic embolism, Diseases of the circulatory (Cardiovascular) system, RC666-701
Abstract: Abstract Background In patients with nonvalvular atrial fibrillation (AF), apixaban is given in doses of 5 or 2.5 mg twice daily, according to clinical characteristics. The usual on-treatment range of apixaban drug levels, as determined by apixaban-calibrated anti-factor Xa (anti-Xa) activity, has previously been measured in small cohorts; however, the association between anti-Xa activity and clinical outcomes and the predictors of variability in anti-Xa activity have not been well studied in the AF population. Methods and Results Anti-Xa activity was measured before taking the morning dose, 3 months after enrollment in the AVERROES study using a calibrated anti-Xa assay (Rotachrom). Patients with two of the following criteria—age >80; weight 133 μg/L—received 2.5 mg twice daily (n = 145), while all others received 5 mg twice daily (n = 2,247). A total of 2,392 patients were included, with median follow-up of 1.1 years. Median apixaban anti-Xa activity was 122 ng/mL (interquartile range [IQR]: 63–198 ng/mL) for the entire group; 99 ng/mL (IQR: 60–146 ng/mL) for the 2.5-mg group; and 125 ng/mL (IQR: 64–202 ng/mL) for the 5-mg group (p = 0.003). A relationship was evident between bleeding and anti-Xa activity (p = 0.01), which was driven by minor bleeding. No relationship was evident between major bleeding or stroke/systemic embolism and anti-Xa activity. In those receiving the 5-mg dose, estimated glomerular filtration rate, sex, and age had the strongest association with anti-Xa activity. Conclusion There is considerable variability in anti-Xa activity among AF patients receiving apixaban. Rates of major bleeding and stroke/systemic embolism were low irrespective of anti-Xa activity. Clinical Trial Registration ClinicalTrials.gov NCT00496769; https://clinicaltrials.gov/ct2/show/NCT00496769.
Published: 2017
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31. Cardiovascular consequences of discontinuing low-dose rivaroxaban in people with chronic coronary or peripheral artery disease

Author: Scott D. Berkowitz, John W. Eikelboom, Victor Aboyans, Petr Widimsky, Stuart J. Connolly, Eva Muehlhofer, Gilles R. Dagenais, Salim Yusuf, Keith A.A. Fox, Leanne Dyal, Deepak L. Bhatt, Jeffrey L. Probstfield, Bernhard R Winkelmann, Jacqueline Bosch, and Darryl P. Leong
Subjects: Male, medicine.medical_specialty, Acute coronary syndrome, peripheral vascular diseases, Myocardial Infarction, Coronary Disease, 030204 cardiovascular system & hematology, clinical, acute coronary syndrome, Coronary artery disease, Peripheral Arterial Disease, 03 medical and health sciences, 0302 clinical medicine, Fibrinolytic Agents, Rivaroxaban, Internal medicine, Antithrombotic, medicine, Humans, 030212 general & internal medicine, Myocardial infarction, Mortality, Stroke, Aged, Ischemic Stroke, Aspirin, Duration of Therapy, Drug Substitution, business.industry, medicine.disease, stroke, Cardiac Risk Factors and Prevention, Discontinuation, Outcome and Process Assessment, Health Care, Withholding Treatment, Cardiology, Drug Therapy, Combination, Female, pharmacology, Drug Monitoring, Cardiology and Cardiovascular Medicine, business, coronary artery disease, medicine.drug
Abstract: ObjectiveIn patients with chronic coronary or peripheral artery disease enrolled in the Cardiovascular Outcomes for People Using Anticoagulation Strategies trial, randomised antithrombotic treatments were stopped after a median follow-up of 23 months because of benefits of the combination of rivaroxaban 2.5 mg two times per day and aspirin 100 mg once daily compared with aspirin 100 mg once daily. We assessed the effect of switching to non-study aspirin at the time of early stopping.MethodsIncident composite of myocardial infarction, stroke or cardiovascular death was estimated per 100 person-years (py) during randomised treatment (n=18 278) and after study treatment discontinuation to non-study aspirin (n=14 068).ResultsDuring randomised treatment, the combination compared with aspirin reduced the composite (2.2 vs 2.9/100 py, HR: 0.76, 95% CI 0.66 to 0.86), stroke (0.5 vs 0.8/100 py, HR: 0.58, 95% CI 0.44 to 0.76) and cardiovascular death (0.9 vs 1.2/100 py, HR: 0.78, 95% CI 0.64 to 0.96). During 1.02 years after early stopping, participants originally randomised to the combination compared with those randomised to aspirin had similar rates of the composite (2.1 vs 2.0/100 py, HR: 1.08, 95% CI 0.84 to 1.39) and cardiovascular death (1.0 vs 0.8/100 py, HR: 1.26, 95% CI 0.85 to 1.86) but higher stroke rate (0.7 vs 0.4/100 py, HR: 1.74, 95% CI 1.05 to 2.87) including a significant increase in ischaemic stroke during the first 6 months after switching to non-study aspirin.ConclusionDiscontinuing study rivaroxaban and aspirin to non-study aspirin was associated with the loss of cardiovascular benefits and a stroke excess.Trial registration numberNCT01776424.
Published: 2021
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32. Device-Detected Atrial Fibrillation Before and After Hospitalisation for Noncardiac Surgery or Medical Illness: Insights From ASSERT

Author: Emilie P. Belley-Côté, Stefan H. Hohnloser, Stuart J. Connolly, William F. McIntyre, Alessandro Capucci, Jeff S. Healey, Jia Wang, Alexander P. Benz, Michael R. Gold, Richard P. Whitlock, Carsten W. Israel, Jorge A. Wong, Chu-Pak Lau, Philip J. Devereaux, and David Conen
Subjects: Male, Pacemaker, Artificial, medicine.medical_specialty, 030204 cardiovascular system & hematology, Asymptomatic, 03 medical and health sciences, 0302 clinical medicine, Medical illness, Internal medicine, Atrial Fibrillation, Prevalence, medicine, Humans, 030212 general & internal medicine, Stroke, Aged, Aged, 80 and over, business.industry, Atrial fibrillation, Perioperative, Odds ratio, medicine.disease, Confidence interval, Defibrillators, Implantable, Hospitalization, Surgical Procedures, Operative, Female, medicine.symptom, Cardiology and Cardiovascular Medicine, business, Noncardiac surgery
Abstract: Background Atrial fibrillation (AF) is often detected during hospitalisation for surgery or medical illness and is often assumed to be due to the acute condition. Methods The Asymptomatic Atrial Fibrillation and Stroke Evaluation in Pacemaker Patients and the Atrial Fibrillation Reduction Atrial Pacing Trial (ASSERT) study enrolled patients ≥ 65 years old without AF. Pacemakers or implantable cardioverter-defibrillators recorded device-detected AF. We identified participants who were hospitalised and compared the prevalence of AF before and after hospitalisation. Results Among 2580 participants, 436 (16.9%) had a surgical or medical hospitalisation. In the 30 days following a first hospitalisation, 43 participants (9.9%, 95% confidence interval [CI] 7.2%-13.1%) had > 6 minutes of device-detected AF; 20 (4.6%, 95% CI 2.8%-7.0%) had > 6 hours. More participants had AF > 6 minutes in the 30 days following hospitalisation compared with the period 30-60 days before hospitalisation (9.9% vs 4.4%; P 6 hours (4.6% vs 2.3%, P = 0.03). Roughly half of participants with device-detected AF in the 30 days following hospitalisation had at least 1 episode of the same duration in the 6 months before (50% [95% CI 31.3%-68.7%] for > 6 min; 68.8% [95% CI 41.3%-89.0%] for > 6 h). Those with AF in the 30 days following hospitalisation were more likely to have had AF in the past (adjusted odds ratio [OR] 7.2, 95% CI 3.2-15.8 for > 6 min; adjusted OR 32.6, 95% CI 10.3-103.4 for > 6 h). Conclusions The prevalence of device-detected AF increases around the time of hospitalisation for noncardiac surgery or medical illness. About half of patients with AF around the time of hospitalisation previously had similar episodes.
Published: 2021
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33. Derivation and validation of a two‐variable index to predict 30‐day outcomes following heart failure hospitalization

Author: Urun Erbas Oz, Tauben Averbuch, Stuart J. Connolly, Harriette G.C. Van Spall, Richard Perez, Shun Fu Lee, Mamas A. Mamas, and Dennis T. Ko
Subjects: medicine.medical_specialty, Index (economics), Aftercare, 030204 cardiovascular system & hematology, Patient Readmission, 03 medical and health sciences, 0302 clinical medicine, RA0421, Internal medicine, Original Research Articles, medicine, Diseases of the circulatory (Cardiovascular) system, Humans, 030212 general & internal medicine, Derivation, Original Research Article, Care Transitions, Aged, Retrospective Studies, Heart Failure, business.industry, External validation, Regression analysis, Length of Stay, RC666, medicine.disease, Derivation cohort, Risk prediction, Patient Discharge, Heart failure, RC666-701, Cohort, Cardiology and Cardiovascular Medicine, business, Emergency Service, Hospital, RA, Readmission
Abstract: Background\ud The LACE index—length of stay (L), acuity (A), Charlson co-morbidities (C), and emergent visits (E)—predicts 30-day outcomes following heart failure (HF) hospitalization but is complex to score. A simpler LE index (length of stay and emergent visits) could offer a practical advantage in point-of-care risk prediction.\ud \ud Methods and results\ud This was a sub-study of the patient-centred care transitions in HF (PACT-HF) multicentre trial. The derivation cohort comprised patients hospitalized for HF, enrolled in the trial, and followed prospectively. External validation was performed retrospectively in a cohort of patients hospitalized for HF. We used log-binomial regression models with LACE or LE as the predictor and either 30-day composite all-cause readmission or death or 30-day all-cause readmission as the outcomes, adjusting only for post-discharge services. There were 1985 patients (mean [SD] age 78.1 [12.1] years) in the derivation cohort and 378 (mean [SD] age 73.1 [13.2] years) in the validation cohort. Increments in the LACE and LE indices were associated with 17% (RR 1.17; 95% CI 1.12, 1.21; C-statistic 0.64) and 21% (RR 1.21; 95% CI 1.15, 1.26; C-statistic 0.63) increases, respectively, in 30-day composite all-cause readmission or death; and 16% (RR 1.16; 95% CI 1.11, 1.20; C-statistic 0.64) and 18% (RR 1.18; 95% CI 1.13, 1.24; C-statistic 0.62) increases, respectively, in 30-day all-cause readmission. The LE index provided better risk discrimination for the 30-day outcomes than did the LACE index in the external validation cohort.\ud \ud Conclusions\ud The LE index predicts 30-day outcomes following HF hospitalization with similar or better performance than the more complex LACE index.
Published: 2021

34. PO-01-185 TEMPORAL RELATIONSHIP BETWEEN SUBLINICAL ATRIAL FIBRILLATION AND HEART FAILURE: INSIGHTS FROM ASSERT

Author: Jorge A. Wong, Jia Wang, PJ Devereaux, William F. McIntyre, David Conen, Stuart J. Connolly, and Jeffrey S. Healey
Subjects: Physiology (medical), Cardiology and Cardiovascular Medicine
Published: 2023
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35. Individual Patient Data from the Pivotal Randomized Controlled Trials of Non-Vitamin K Antagonist Oral Anticoagulants in Patients with Atrial Fibrillation (COMBINE AF): Design and Rationale

Author: Kaiyuan Hua, Jonas Oldgren, Anthony P. Carnicelli, Manesh R. Patel, Lars Wallentin, John H. Alexander, Combine Af Investigators, Christian T. Ruff, Renato D. Lopes, Daniel M. Wojdyla, Robert P. Giugliano, Stuart J Connolly, Christopher B. Granger, John W. Eikelboom, Stefan H. Hohnloser, Hwanhee Hong, David A. Morrow, and Jonathan P. Piccini
Subjects: medicine.medical_specialty, Aspirin, medicine.drug_class, business.industry, Warfarin, Atrial fibrillation, 030204 cardiovascular system & hematology, Vitamin K antagonist, medicine.disease, law.invention, 03 medical and health sciences, 0302 clinical medicine, Clinical research, Randomized controlled trial, law, Meta-analysis, medicine, 030212 general & internal medicine, Cardiology and Cardiovascular Medicine, Intensive care medicine, business, Stroke, medicine.drug
Abstract: Background Non-vitamin K antagonist oral anticoagulants (NOACs) are the preferred class of medications for prevention of stroke and systemic embolism in patients with atrial fibrillation unless contraindications exist. Five large, international, randomized, controlled trials of NOACs versus either warfarin or aspirin have been completed to date. Design COMBINE AF incorporates de-identified individual patient data from 77,282 patients with atrial fibrillation at risk for stroke randomized to NOAC, warfarin, or aspirin from 5 pivotal randomized controlled trials. All patients randomized in the constituent trials are included. Variables common to ≥3 of the constituent trials are included in the master database. Individual trial data sets from the 4 coordinating centers were combined at the Duke Clinical Research Institute. The final database will be securely shared with the 4 academic coordinating centers. The combined master database will be used to perform statistical analyses aimed at better understanding underlying risk factors and outcomes in patients with atrial fibrillation treated with oral anticoagulants, with a special focus on patient subgroups and uncommon outcomes. The initial analysis from COMBINE AF will be a network meta-analysis investigating the relative efficacy and safety of pooled higher-dose NOACs versus pooled lower-dose NOACs versus warfarin with respect to multiple time-to-event efficacy and safety outcomes. COMBINE AF is registered with PROSPERO (CRD42020178771). Conclusion In conclusion, COMBINE AF provides a rich and robust database consisting of individual patient data and will offer opportunities to investigate oral anticoagulants across many patient subgroups. Data sharing and collaboration across academic institutions and investigators will serve as overarching themes.
Published: 2021
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36. Hemostatic Efficacy and Anti-FXa (Factor Xa) Reversal with Andexanet Alfa in Intracranial Hemorrhage: ANNEXA-4 Substudy

Author: John W. Eikelboom, Elena Zotova, Saskia Middeldorp, Andrew M. Demchuk, Pamela B. Conley, Tomoyuki Ohara, John T. Curnutte, Truman J. Milling, Mark Crowther, Stuart J. Connolly, Lizhen Xu, Peter Verhamme, Juliet Nakamya, Patrick Yue, Jose Lopez-Sendon, Joshua N. Goldstein, Vascular Medicine, ACS - Pulmonary hypertension & thrombosis, and ARD - Amsterdam Reproduction and Development
Subjects: Male, Pyridones, Vascular damage Radboud Institute for Health Sciences [Radboudumc 16], 030204 cardiovascular system & hematology, Pharmacology, law.invention, 03 medical and health sciences, 0302 clinical medicine, Rivaroxaban, law, Humans, Medicine, Aged, Aged, 80 and over, Advanced and Specialized Nursing, Hemostasis, Blood Coagulation Factor Inhibitors, business.industry, Anti fxa, Recombinant Proteins, andexanet alfa, Factor Xa, Recombinant DNA, Pyrazoles, direct factor Xa inhibitor reversal, Female, Neurology (clinical), Cardiology and Cardiovascular Medicine, business, Intracranial Hemorrhages, 030217 neurology & neurosurgery, intracranial hemorrhage, Andexanet alfa, medicine.drug
Abstract: Background and Purpose: Andexanet alfa is a recombinant modified human FXa (factor Xa) developed to reverse FXa inhibition from anticoagulants. Hemostatic efficacy and reversal of anti-FXa activity with andexanet were assessed in patients from the ANNEXA-4 study (Andexanet Alfa, a Novel Antidote to the Anticoagulation Effects of FXa Inhibitors) with intracranial hemorrhage (ICrH). Methods: ANNEXA-4 was a single-arm study evaluating andexanet in patients presenting with major bleeding ≤18 hours after taking an FXa inhibitor. Patients received a bolus plus 2-hour infusion of andexanet. Brain imaging in patients with ICrH was performed at baseline and at 1 and 12 hours postandexanet infusion. Coprimary efficacy outcomes were change in anti-FXa activity and hemostatic efficacy at 12 hours (excellent/good efficacy defined as ≤35% increase in hemorrhage volume/thickness). Safety outcomes included occurrence of thrombotic events and death at 30 days. Results: A total of 227 patients with ICrH were included in the safety population (51.5% male; mean age 79.3 years) and 171 in the efficacy population (99 spontaneous and 72 traumatic bleeds). In efficacy evaluable patients, excellent/good hemostasis 12 hours postandexanet occurred in 77 out of 98 (78.6%) and in 58 out of 70 (82.9%) patients with spontaneous and traumatic bleeding, respectively. In the subanalysis by FXa inhibitor treatment group in the efficacy population, median of percent change in anti-FXa from baseline to nadir showed a decrease of 93.8% for apixaban-treated patients (n=99) and by 92.6% for rivaroxaban-treated patients (n=59). Within 30 days, death occurred in 34 out of 227 (15.0%) patients and thrombotic events occurred in 21 out of 227 (9.3%) patients (safety population). Conclusions: Andexanet reduced anti-FXa activity in FXa inhibitor-treated patients with ICrH, with a high rate of hemostatic efficacy. Andexanet may substantially benefit patients with ICrH, the most serious complication of anticoagulation. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT02329327.
Published: 2021
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37. Rivaroxaban 2.5 mg Twice Daily Plus Aspirin Reduces Venous Thromboembolism in Patients With Chronic Atherosclerosis

Author: Nana Pogosova, Jacqueline Bosch, Deepak L. Bhatt, Keith A.A. Fox, Stuart J. Connolly, Marco Alings, Peter Verhamme, Eva Muehlhofer, Olga Shestakovska, Salim Yusuf, and John W. Eikelboom
Subjects: Peripheral Arterial Disease, Aspirin, Rivaroxaban, Physiology (medical), Humans, Drug Therapy, Combination, Venous Thromboembolism, Cardiology and Cardiovascular Medicine, Atherosclerosis, Platelet Aggregation Inhibitors, Factor Xa Inhibitors
Published: 2022

38. Efficacy and safety of dronedarone by atrial fibrillation history duration: Insights from the <scp>ATHENA</scp> study

Author: Valérie Corp dit Genti, Nassir F. Marrouche, Carina Blomström-Lundqvist, Mattias Wieloch, Stuart J. Connolly, Stefan H. Hohnloser, and Andrew Koren
Subjects: Male, medicine.medical_specialty, Randomization, Clinical Investigations, 030204 cardiovascular system & hematology, Placebo, Electrocardiography, 03 medical and health sciences, 0302 clinical medicine, dronedarone, duration of atrial fibrillation history, Heart Rate, Recurrence, Internal medicine, Atrial Fibrillation, Post-hoc analysis, medicine, Humans, atrial fibrillation, Cardiac and Cardiovascular Systems, 030212 general & internal medicine, Aged, Kardiologi, business.industry, Hazard ratio, Atrial fibrillation, antiarrhythmic therapy, General Medicine, medicine.disease, Confidence interval, Dronedarone, Treatment Outcome, atrial flutter, Cardiology, Female, Cardiology and Cardiovascular Medicine, business, Anti-Arrhythmia Agents, Atrial flutter, medicine.drug
Abstract: Background: Atrial fibrillation/atrial flutter (AF/AFL) burden increases with increasing duration of AF/AFL history. Hypothesis: Outcomes with dronedarone may also be impacted by duration of AF/AFL history. Methods: In this post hoc analysis of ATHENA, efficacy and safety of dronedarone vs placebo were assessed in groups categorized by time from first known AF/AFL episode to randomization (ie, duration of AF/AFL history)
Published: 2020
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39. Rivaroxaban for Prevention of Covert Brain Infarcts and Cognitive Decline

Author: Dragos Vinereanu, Georg Ertl, Stefan Störk, Deepak L. Bhatt, Nana Pogosova, John Varigos, Aldo P. Maggioni, Yan Liang, Andrew Tonkin, Stuart J. Connolly, Lars Rydén, Amparo Casanova, Jacqueline Bosch, Alvaro Avezum, Kelley R. Branch, Leanne Dyal, Rafael Diaz, Kevin W Reeh, Robert G. Hart, Keith A.A. Fox, Katalin Keltai, Patricio Lopez-Jaramillo, Mukul Sharma, Martin O'Donnell, Matyas Keltai, Eva Lonn, Lisheng Liu, Jun Zhu, Jeffrey L. Probstfield, Gilles R. Dagenais, Leopoldo S. Piegas, Scott D. Berkowitz, Salim Yusuf, Eric E. Smith, John W. Eikelboom, and Jae-Hyung Kim
Subjects: Brain Infarction, Male, medicine.medical_specialty, Infarction, White matter, Physical medicine and rehabilitation, Rivaroxaban, medicine, Humans, Cognitive Dysfunction, Cognitive decline, Stroke, Aged, Advanced and Specialized Nursing, Aspirin, business.industry, Brain, Cognition, Middle Aged, medicine.disease, Magnetic Resonance Imaging, Treatment Outcome, medicine.anatomical_structure, Covert, Drug Therapy, Combination, Female, Neurology (clinical), Cardiology and Cardiovascular Medicine, business, Platelet Aggregation Inhibitors, Factor Xa Inhibitors, medicine.drug
Abstract: Background and Purpose: Covert brain infarcts are associated with cognitive decline. It is not known whether therapies that prevent symptomatic stroke prevent covert infarcts. COMPASS compared rivaroxaban with and without aspirin with aspirin for the prevention of stroke, myocardial infarction, and vascular death in participants with stable vascular disease and was terminated early because of benefits of rivaroxaban 2.5 mg twice daily plus aspirin over aspirin. We obtained serial magnetic resonance imagings and cognitive tests in a consenting subgroup of COMPASS patients to examine treatment effects on infarcts, cerebral microbleeds, and white matter hyperintensities. Methods: Baseline and follow-up magnetic resonance imagings were completed in 1445 participants with a mean (SD) interval of 2.0 (0.7) years. Whole-brain T1, T2 fluid-attenuated inversion recovery, T2* sequences were centrally interpreted by blinded, trained readers. Participants had serial measurements of cognition and function. The primary end point was the proportion of participants with incident covert infarcts. Secondary end points were the composite of clinical stroke and covert brain infarcts, cerebral microbleeds, and white matter hyperintensities. Results: At baseline, 493 (34.1%) participants had infarcts. Incident covert infarcts occurred in 55 (3.8%) participants. In the overall trial rivaroxaban plus aspirin reduced ischemic stroke by 49% (0.7% versus 1.4%; hazard ratio [95% CI], 0.51 [0.38–0.68]). In the magnetic resonance imaging substudy the effects of rivaroxaban+aspirin versus aspirin were: covert infarcts: 2.7% versus 3.5% (odds ratio [95% CI], 0.77 [0.37–1.60]); Covert infarcts or ischemic stroke: 2.9% versus 5.3% (odds ratio [95% CI], 0.53 [0.27–1.03]). Incident microbleeds occurred in 6.6% of participants and 65.7% of participants had an increase in white matter hyperintensities volume with no effect of treatment for either end point. There was no effect on cognitive tests. Conclusions: Covert infarcts were not significantly reduced by treatment with rivaroxaban and aspirin but estimates for the combination of ischemic stroke and covert infarcts were consistent with the effect on ischemic stroke in the overall trial. Registration: URL: https://www.clinicaltrials.gov . Unique identifier: NCT01776424.
Published: 2020
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40. Serial measurement of interleukin‐6 and risk of mortality in anticoagulated patients with atrial fibrillation: Insights from ARISTOTLE and RE‐LY trials

Author: John D. Horowitz, Elaine M. Hylek, Lars Wallentin, Ulrika Andersson, Julia Aulin, John H. Alexander, Bernard J. Gersh, Ziad Hijazi, Stuart J. Connolly, Jonas Oldgren, Agneta Siegbahn, Renato D. Lopes, Salim Yusuf, Michael D. Ezekowitz, and Christopher B. Granger
Subjects: anticoagulants, medicine.medical_specialty, Pyridones, 030204 cardiovascular system & hematology, Risk Assessment, 03 medical and health sciences, 0302 clinical medicine, Interquartile range, Internal medicine, Atrial Fibrillation, medicine, Risk of mortality, Humans, atrial fibrillation, Cardiac and Cardiovascular Systems, Stroke, Kardiologi, Interleukin-6, Proportional hazards model, business.industry, interleukin-6, Hazard ratio, Anticoagulants, Atrial fibrillation, Hematology, medicine.disease, mortality, stroke, Confidence interval, Treatment Outcome, inflammation, Cardiology, Apixaban, Warfarin, business, medicine.drug
Abstract: BACKGROUND: The inflammatory biomarker interleukin-6 (IL-6) is associated with mortality in atrial fibrillation (AF). OBJECTIVE: To investigate if repeated IL-6 measurements improve the prognostication for stroke or systemic embolism, major bleeding, and mortality in anticoagulated patients with AF. METHODS: IL-6 levels by ELISA were measured at study entry and at 2 months in 4830 patients in the Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation (ARISTOTLE) trial with 1.8 years median follow-up. In the Randomized Evaluation of Long-Term Anticoagulation Therapy (RE-LY) trial, IL-6 was measured at study entry, 3, 6, and 12 months in 2559 patients with 2.0 years median follow-up. Associations between a second IL-6 measurement and outcomes, adjusted for baseline IL-6, clinical variables, and other cardiovascular biomarkers, were analyzed by Cox regression. RESULTS: Median IL-6 levels were 2.0 ng/L (interquartile range [IQR] 1.30-3.20) and 2.10 ng/L (IQR 1.40-3.40) at the two time-points in ARISTOTLE, and, in RE-LY, 2.5 ng/L (IQR 1.6-4.3), 2.5 ng/L (IQR 1.6-4.2), 2.4 ng/L (IQR 1.6, 3.9), and 2.4 ng/L (IQR 1.5, 3.9), respectively. IL-6 was associated with mortality; hazard ratios per 50% higher IL-6 at 2 or 3 months, respectively, were 1.32 (95% confidence interval, 1.23-1.41; P
Published: 2020
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41. Rate, Time Course, and Predictors of Implantable Cardioverter Defibrillator Infections: An Analysis From the SIMPLE Trial

Author: Fredrik Gadler, Stefan H. Hohnloser, Michael Glikson, Jeff S. Healey, Gilles O'Hara, Yan Y. Liu, Philippe Mabo, Josef Kautzner, Noa Lashevsky, Xavier Viñolas, Stuart J. Connolly, Jean Champagne, Jörg Neuzner, and François Philippon
Subjects: medicine.medical_specialty, Univariate analysis, lcsh:Diseases of the circulatory (Cardiovascular) system, business.industry, Defibrillation, medicine.medical_treatment, Risk of infection, Implantable cardioverter-defibrillator, lcsh:RC666-701, Internal medicine, Cohort, Time course, Medicine, Original Article, Implant, ddc:610, Cardiology and Cardiovascular Medicine, business, Complication
Abstract: Background: The number of implantable cardioverter defibrillator (ICD) infections is increasing due to an increased number of ICD implants, higher-risk patients, and more frequent replacement procedures, which carry a higher risk of infection. Reducing the morbidity, mortality, and cost of ICD-related infections requires an understanding of the current rate of this complication and its predictors. Methods: The Shock Implant Evaluation Trial (SIMPLE) trial randomized 2500 ICD recipients to defibrillation testing or not. Over an average of 3.1 years, patients were seen every 6 months and examined for evidence of ICD infection, which was defined as requiring device removal and/or intravenous antibiotics. Results: Within 24 months, 21 patients (0.8%) developed infection. Fourteen patients (67%) with infection presented within 30 days, 20 patients by 12 months, and only 1 patient beyond 12 months. Univariate analysis demonstrated that patients with primary electrical disorders (3 patients, P = 0.009) and those with a secondary prevention indication (13 patients, P = 0.0009) were more likely to develop infection. Among the 2.2% of patients who developed an ICD wound hematoma, 10.4% developed an infection. Among the 8.3% of patients requiring an ICD reintervention, 1.9% developed an infection. Conclusions: This cohort of ICD recipients at high-volume centres have a low risk of device-related infection. However; strategies to reduce wound hematoma and the need for ICD reintervention could further reduce the rate of infection. Résumé: Contexte: L’incidence des cas d’infection du défibrillateur cardioverteur implantable (DCI) augmente en raison du nombre accru d’implantations, de l’emploi de ces dispositifs chez des patients exposés à un risque très élevé et de l’augmentation de la fréquence des interventions de remplacement, qui sont associées à un plus grand risque d’infections. Pour parvenir à réduire la morbidité, la mortalité et les coûts associés aux infections liées à un DCI, il faut connaître la fréquence de cette complication et les facteurs qui permettent de la prédire. Méthodologie: Lors de l’essai Shock Implant Evaluation Trial (SIMPLE), 2 500 patients ayant reçu un DCI ont été répartis aléatoirement en deux groupes, l’un subissant des tests de défibrillation et l’autre, non. Sur une période de 3,1 ans en moyenne, les patients ont été vus en consultation tous les 6 mois et examinés à la recherche de signes d’infection du DCI, définie comme étant une infection exigeant le retrait du dispositif et/ou l’administration d’antibiotiques par voie intraveineuse. Résultats: Au total, 21 patients (0,8 %) ont présenté une infection dans les 24 mois suivant l’implantation. Quatorze patients (67 %) ont présenté une infection dans les 30 jours suivant l’intervention; à 12 mois, 20 patients avaient présenté une infection. Un seul patient a présenté une infection plus de 12 mois après l’intervention. Les résultats d’une analyse univariée ont démontré qu’une infection était plus probable chez les patients qui présentaient un trouble électrique primaire (3 patients, p = 0,009) et chez ceux qui avaient reçu un dispositif en prévention secondaire (13 patients, p = 0,0009). Parmi les patients qui présentaient un hématome après l’implantation du DCI (2,2 %), 10,4 % ont présenté une infection. Parmi les patients qui ont eu besoin d’une nouvelle intervention relative au DCI (8,3 %), 1,9 % ont présenté une infection. Conclusions: Les patients de cette cohorte ayant reçu un DCI dans des établissements à haut volume étaient exposés à un faible risque d’infection du défibrillateur. Des stratégies visant à réduire les hématomes et la nécessité d’une nouvelle intervention sur les DCI pourraient toutefois contribuer à réduire encore plus la fréquence des infections.
Published: 2020

42. Impact of electrical cardioversion on quality of life for patients with symptomatic persistent atrial fibrillation: Is there a treatment expectation effect?

Author: Andrew C.T. Ha, Andrew Koren, John D. Stewart, Denis Roy, Paul Dorian, George J. Klein, and Stuart J. Connolly
Subjects: Male, medicine.medical_specialty, Time Factors, medicine.medical_treatment, Electric Countershock, 030204 cardiovascular system & hematology, Cardioversion, law.invention, 03 medical and health sciences, 0302 clinical medicine, Quality of life, Randomized controlled trial, law, Internal medicine, Atrial Fibrillation, Humans, Medicine, Sinus rhythm, 030212 general & internal medicine, Aged, Motivation, business.industry, Minimal clinically important difference, Atrial fibrillation, Middle Aged, medicine.disease, Dronedarone, Electrical cardioversion, Treatment Outcome, Quality of Life, Cardiology, Female, Cardiology and Cardiovascular Medicine, business, medicine.drug
Abstract: It is assumed that electrical cardioversion (ECV) improves the quality of life (QoL) of patients with atrial fibrillation (AF) by restoring sinus rhythm (SR).We examined the effect of ECV and rhythm status on QoL of patients with symptomatic persistent AF in a randomized controlled trial.The elective cardioversion for prevention of symptomatic atrial fibrillation trial examined the efficacy of dronedarone around the time of ECV in maintaining SR. Quality of life was measured with the University of Toronto Atrial Fibrillation Severity Scale. The primary outcome was the change in AF symptom severity (∆AFSS) score over 6 months (0-35 points, with higher scores reflecting worse QoL and a minimal clinically important difference defined as ∆AFSS ≥3 points). Multivariable linear regression was performed to identify factors associated with changes in QoL.We included 148 patients with complete AFSS scores at baseline and 6 months. Over 6 months, QoL improved irrespective of rhythm status (ΔAFSS scores for patients who (i) maintained SR; (ii) had AF relapse after successful ECV; and (iii) had unsuccessful ECV were -6.8 ± 6.4 points, -4.1 ± 6.2 points, and -4.0 ± 5.8 points respectively, P .01 for all subgroups). After adjustment of baseline covariates, maintenance of SR was associated with QoL improvement (ΔAFSS: -3.8 points, 95% CI: -6.0 to -1.6 points, P .01).Maintenance of SR was associated with clinically relevant improvement in patients' QoL at 6 months. Patients with AF recurrence had a small but still relevant improvement in their QoL, potentially due to factors other than sinus rhythm.
Published: 2020
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43. Frequency and Predictors of Major Bleeding in Patients With Embolic Strokes of Undetermined Source

Author: Ashkan Shoamanesh, Robert G. Hart, Verónica V. Olavarría, Scott D. Berkowitz, Ángel Chamorro, Roland Veltkamp, Stuart J. Connolly, Joan Martí-Fàbregas, Jens Eckstein, Robert Mikulik, W. Frank Peacock, Şerefnur Öztürk, Lesly A. Pearce, Salvatore Rudilosso, Hardi Mundl, and Turgut Tatlisumak
Subjects: Adult, Male, medicine.medical_specialty, Infarction, Renal function, Hemorrhage, 030204 cardiovascular system & hematology, 03 medical and health sciences, 0302 clinical medicine, Asian People, Double-Blind Method, Rivaroxaban, Risk Factors, Internal medicine, Antithrombotic, medicine, Humans, In patient, Aged, Cerebral Hemorrhage, Advanced and Specialized Nursing, Asia, Eastern, business.industry, Middle Aged, 16. Peace & justice, medicine.disease, 3. Good health, Stroke, Blood pressure, Intracranial Embolism, Embolism, Cardiology, Female, Neurology (clinical), Cardiology and Cardiovascular Medicine, business, 030217 neurology & neurosurgery, Major bleeding, Factor Xa Inhibitors, Glomerular Filtration Rate, medicine.drug
Abstract: Background and Purpose: Risks, sites, and predictors of major bleeding during antithrombotic therapies have not been well defined for patients with recent embolic stroke of undetermined source. Methods: Exploratory analysis of major bleeds defined by International Society of Thrombosis and Hemostasis criteria occurring among 7213 participants in international NAVIGATE (New Approach Rivaroxaban Inhibition of Factor Xa in a Global Trial) embolic stroke of undetermined source randomized trial comparing rivaroxaban 15 mg daily with aspirin 100 mg daily. Results: During a median follow-up of 11 months, 85 major bleeds occurred. The most frequent site was gastrointestinal (38%), followed by intracranial (29%). Assignment to rivaroxaban (hazard ratio [HR], 2.7 [95% CI, 1.7–4.3]), East Asia region (HR, 2.5 [95% CI, 1.6–3.9]), systolic blood pressure ≥160 mm Hg (HR, 2.2 [95% CI, 1.2–3.8]), and reduced estimated glomerular filtration rate (HR, 1.2 per 10 mL/min per 1.73 m 2 decrease, [95% CI, 1.0–1.3]) were independently associated with presence of major bleeds. Five (6%) were fatal. Among 15 patients with intracerebral hemorrhage, 2 (13%) were fatal. There was no evidence of an early high-risk period following initiation of rivaroxaban. The annualized rate of intracerebral hemorrhage was 6-fold higher among East Asian participants (0.67%) versus all other regions (0.11%; HR, 6.3 [95% CI, 2.2–18.0]). Distribution of bleeding sites was similar for rivaroxaban and aspirin. Conclusions: Among embolic stroke of undetermined source patients participating in an international randomized trial, independent predictors of major bleeding were assignment to rivaroxaban, East Asia region, increased systolic blood pressure, and impaired renal function. East Asia as a region was strongly associated with risk of intracerebral hemorrhage. Estimated glomerular filtration rate should be a consideration for stratifying bleeding risk. Registration: URL: https://www.clinicaltrials.gov . Unique identifier: NCT02313909.
Published: 2020
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44. The INVICTUS rheumatic heart disease research program: Rationale, design and baseline characteristics of a randomized trial of rivaroxaban compared to vitamin K antagonists in rheumatic valvular disease and atrial fibrillation

Author: Tantchou T J Cabral, Katherine Connolly, Jesus A Gonzalez-Hermosillo, Hu Dayi, Ahmed Elsayed, Lillian Gondwe-Chunda, Antonio L. Dans, Albertino Damasceno, Okechukwu S Ogah, Salim Yusuf, Peter Lwabi, John Musuku, Onkabetse Julia Molefe-Baikai, Alaa Eldin Elghamrawy, Bernard Gitura, Abraham Haileamlak, Liesl Zühlke, Gayle Lewis, James Hakim, Sumathy Rangarajan, Sanjib Sharma, Yan Yun, Ma Changsheng, Pilly Chillo, Alvaro Avezum, Khawar Kazmi, Kairat Davletov, Ganesan Karthikeyan, Maria Paniagua, Emmanuel R Kamanzi, Stuart J. Connolly, Alexander P. Benz, Bongani M. Mayosi, Invictus Investigators, Mpiko Ntsekhe, and Fathi A. Maklady
Subjects: Adult, Male, medicine.medical_specialty, Vitamin K, Heart disease, Embolism, Pregnancy Complications, Cardiovascular, Population, Hemorrhage, 030204 cardiovascular system & hematology, law.invention, 03 medical and health sciences, 0302 clinical medicine, Rivaroxaban, Randomized controlled trial, Pregnancy, law, Internal medicine, Atrial Fibrillation, medicine, Humans, 030212 general & internal medicine, education, Stroke, Aged, Aspirin, education.field_of_study, business.industry, Rheumatic Heart Disease, Atrial fibrillation, Middle Aged, medicine.disease, Clinical research, Female, Cardiology and Cardiovascular Medicine, business, Factor Xa Inhibitors, medicine.drug
Abstract: Background Rheumatic heart disease (RHD) is a neglected disease affecting 33 million people, mainly in low and middle income countries. Yet very few large trials or registries have been conducted in this population. The INVICTUS program of research in RHD consists of a randomized-controlled trial (RCT) of 4500 patients comparing rivaroxaban with vitamin K antagonists (VKA) in patients with RHD and atrial fibrillation (AF), a registry of 17,000 patients to document the contemporary clinical course of patients with RHD, including a focused sub-study on pregnant women with RHD within the registry. This paper describes the rationale, design, organization and baseline characteristics of the RCT and a summary of the design of the registry and its sub-study. Patients with RHD and AF are considered to be at high risk of embolic strokes, and oral anticoagulation with VKAs is recommended for stroke prevention. But the quality of anticoagulation with VKA is poor in developing countries. A drug which does not require monitoring, and which is safe and effective for preventing stroke in patients with valvular AF, would fulfill a major unmet need. Methods The INVestIgation of rheumatiC AF Treatment Using VKAs, rivaroxaban or aspirin Studies (INVICTUS-VKA) trial is an international, multicentre, randomized, open-label, parallel group trial, testing whether rivaroxaban 20 mg given once daily is non-inferior (or superior) to VKA in patients with RHD, AF, and an elevated risk of stroke (mitral stenosis with valve area ≤2 cm2, left atrial spontaneous echo-contrast or thrombus, or a CHA2DS2VASc score ≥2). The primary efficacy outcome is a composite of stroke or systemic embolism and the primary safety outcome is the occurrence of major bleeding. The trial has enrolled 4565 patients from 138 sites in 23 countries from Africa, Asia and South America. The Registry plans to enroll an additional 17,000 patients with RHD and document their treatments, and their clinical course for at least 2 years. The pregnancy sub-study will document the clinical course of pregnant women with RHD. Conclusion INVICTUS is the largest program of clinical research focused on a neglected cardiovascular disease and will provide new information on the clinical course of patients with RHD, and approaches to anticoagulation in those with concomitant AF.
Published: 2020
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45. Restricted versus liberal intraoperative benzodiazepine use in cardiac anaesthesia for reducing delirium (B-Free Pilot): a pilot, multicentre, randomised, cluster crossover trial

Author: Stuart J. Connolly, Richard P. Whitlock, Summer Syed, Ian Fast, Jessica Spence, Eric Jacobsohn, Rakesh C. Arora, Sarah MacIsaac, Philip J. Devereaux, Shun Fu Lee, Shrikant I. Bangdiwala, Steven Long, Emilie P. Belley-Côté, Kevin J. Um, Andre Lamy, Anisha Sarkaria, William F. McIntyre, A. Lengyel, and Morvarid S. Kavosh
Subjects: Male, Canada, medicine.medical_specialty, medicine.drug_class, Pilot Projects, Intraoperative Awareness, Benzodiazepines, 03 medical and health sciences, Postoperative Complications, 0302 clinical medicine, 030202 anesthesiology, Anesthesia, Cardiac Procedures, medicine, Cluster Analysis, Humans, Aged, Benzodiazepine, Cross-Over Studies, Dose-Response Relationship, Drug, business.industry, Incidence (epidemiology), Delirium, Perioperative, Crossover study, Cardiac surgery, Clinical trial, Anesthesiology and Pain Medicine, Emergency medicine, Female, medicine.symptom, business
Abstract: Background Delirium is common after cardiac surgery and is associated with adverse outcomes. Perioperative benzodiazepine use is associated with delirium and is common during cardiac surgery, which may increase the risk of postoperative delirium. We undertook a pilot study to inform the feasibility of a large randomised cluster crossover trial examining whether an institutional policy of restricted benzodiazepine administration during cardiac surgery (compared with liberal administration) would reduce delirium. Methods We conducted a two-centre, pilot, randomised cluster crossover trial with four 4 week crossover periods. Each centre was randomised to a policy of restricted or liberal use, and then alternated between the two policies during the remaining three periods. Our feasibility outcomes were adherence to each policy (goal ≥80%) and outcome assessment (one delirium assessment per day in the ICU in ≥90% of participants). We also evaluated the incidence of intraoperative awareness in one site using serial Brice questionnaires. Results Of 800 patients undergoing cardiac surgery during the trial period, 127/800 (15.9%) had delirium. Of these, 355/389 (91.3%) received benzodiazepines during the liberal benzodiazepine periods and 363/411 (88.3%) did not receive benzodiazepines during the restricted benzodiazepine periods. Amongst the 800 patients, 740 (92.5%) had ≥1 postoperative delirium assessment per day in the ICU. Of 521 patients screened for intraoperative awareness, one patient (0.2%), managed during the restricted benzodiazepine period (but who received benzodiazepine), experienced intraoperative awareness. Conclusions This pilot study demonstrates the feasibility of a large, multicentre, randomised, cluster crossover trial examining whether an institutional policy of restricted vs liberal benzodiazepine use during cardiac surgery will reduce postoperative delirium. Clinical trial registration NCT03053869.
Published: 2020
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46. Role of Combination Antiplatelet and Anticoagulation Therapy in Diabetes Mellitus and Cardiovascular Disease

Author: Deepak L. Bhatt, John W. Eikelboom, Stuart J. Connolly, P. Gabriel Steg, Sonia S. Anand, Subodh Verma, Kelley R.H. Branch, Jeffrey Probstfield, Jackie Bosch, Olga Shestakovska, Michael Szarek, Aldo Pietro Maggioni, Petr Widimský, Alvaro Avezum, Rafael Diaz, Basil S. Lewis, Scott D. Berkowitz, Keith A.A. Fox, Lars Ryden, Salim Yusuf, V. Aboyans, M. Alings, P. Commerford, N. Cook-Bruns, G. Dagenais, A. Dans, G. Ertl, C. Felix, T. Guzik, R. Hart, M. Hori, A. Kakkar, K. Keltai, M. Keltai, J. Kim, A. Lamy, F. Lanas, Y. Liang, L. Liu, E. Lonn, P. Lopez-Jaramillo, K. Metsarinne, P. Moayyedi, M. O’Donnell, A. Parkhomenko, L. Piegas, N. Pogosova, M. Sharma, S. Stoerk, A. Tonkin, C. Torp-Pedersen, J. Varigos, P. Verhamme, D. Vinereanu, K. Yusoff, and J. Zhu
Subjects: Male, medicine.medical_specialty, Arterial disease, MEDLINE, Disease, Coronary artery disease, Double-Blind Method, Rivaroxaban, Physiology (medical), Internal medicine, Diabetes mellitus, Diabetes Mellitus, medicine, Humans, Aged, Aspirin, business.industry, Anticoagulants, Middle Aged, medicine.disease, Cardiovascular Diseases, Cardiology, Platelet aggregation inhibitor, Drug Therapy, Combination, Female, Cardiology and Cardiovascular Medicine, business, Platelet Aggregation Inhibitors, Factor Xa Inhibitors
Abstract: Background: Patients with established coronary artery disease or peripheral artery disease often have diabetes mellitus. These patients are at high risk of future vascular events. Methods: In a prespecified analysis of the COMPASS trial (Cardiovascular Outcomes for People Using Anticoagulation Strategies), we compared the effects of rivaroxaban (2.5 mg twice daily) plus aspirin (100 mg daily) versus placebo plus aspirin in patients with diabetes mellitus versus without diabetes mellitus in preventing major vascular events. The primary efficacy end point was the composite of cardiovascular death, myocardial infarction, or stroke. Secondary end points included all-cause mortality and all major vascular events (cardiovascular death, myocardial infarction, stroke, or major adverse limb events, including amputation). The primary safety end point was a modification of the International Society on Thrombosis and Haemostasis criteria for major bleeding. Results: There were 10 341 patients with diabetes mellitus and 17 054 without diabetes mellitus in the overall trial. A consistent and similar relative risk reduction was seen for benefit of rivaroxaban plus aspirin (n=9152) versus placebo plus aspirin (n=9126) in patients both with (n=6922) and without (n=11 356) diabetes mellitus for the primary efficacy end point (hazard ratio, 0.74, P =0.002; and hazard ratio, 0.77, P =0.005, respectively, P interaction =0.77) and all-cause mortality (hazard ratio, 0.81, P =0.05; and hazard ratio, 0.84, P =0.09, respectively; P interaction =0.82). However, although the absolute risk reductions appeared numerically larger in patients with versus without diabetes mellitus, both subgroups derived similar benefit (2.3% versus 1.4% for the primary efficacy end point at 3 years, Gail-Simon qualitative P interaction P interaction =0.02; 2.7% versus 1.7% for major vascular events, P interaction P interaction =0.001). Conclusions: In stable atherosclerosis, the combination of aspirin plus rivaroxaban 2.5 mg twice daily provided a similar relative degree of benefit on coronary, cerebrovascular, and peripheral end points in patients with and without diabetes mellitus. Given their higher baseline risk, the absolute benefits appeared larger in those with diabetes mellitus, including a 3-fold greater reduction in all-cause mortality. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT01776424.
Published: 2020
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47. Potential Embolic Sources and Outcomes in Embolic Stroke of Undetermined Source in the NAVIGATE-ESUS Trial

Author: Hardi Mundl, Robert G. Hart, Mukul Sharma, Scott D. Berkowitz, Lesly A. Pearce, George Ntaios, Stuart J. Connolly, Eleni Korompoki, Roland Veltkamp, Haralampos J. Milionis, and Scott E. Kasner
Subjects: Male, medicine.medical_specialty, Disease-Free Survival, Double-Blind Method, Rivaroxaban, Risk Factors, Internal medicine, Prevalence, Humans, Medicine, Myocardial infarction, Stroke, Aged, Aged, 80 and over, Advanced and Specialized Nursing, Aspirin, business.industry, Hazard ratio, Anticoagulants, Atrial fibrillation, Middle Aged, medicine.disease, Survival Rate, body regions, Intracranial Embolism, Embolism, Cardiology, Patent foramen ovale, Female, Neurology (clinical), Cardiology and Cardiovascular Medicine, business, human activities, Platelet Aggregation Inhibitors, medicine.drug
Abstract: Background and Purpose— Emboli in embolic stroke of undetermined source (ESUS) may originate from various potential embolic sources (PES), some of which may respond better to anticoagulation, whereas others to antiplatelets. We analyzed whether rivaroxaban is associated with reduction of recurrent stroke compared with aspirin in patients with ESUS across different PES and by number of PES. Methods— We assessed the presence/absence of each PES (atrial cardiopathy, atrial fibrillation, arterial atherosclerosis, left ventricular dysfunction, cardiac valvulopathy, patent foramen ovale, cancer) in NAVIGATE-ESUS (New Approach Rivaroxaban Inhibition of Factor Xa in a Global Trial Versus ASA to Prevent Embolism in Embolic Stroke of Undetermined Source) participants. Prevalence of each PES, as well as treatment effect and risk of event for each PES were determined. Results by number of PES were also determined. The outcomes were ischemic stroke, all-cause mortality, cardiovascular mortality, and myocardial infarction. Results— In 7213 patients (38% women, mean age 67years) followed for a median of 11 months, the 3 most prevalent PES were atrial cardiopathy (37%), left ventricular disease (36%), and arterial atherosclerosis (29%). Forty-one percent of all patients had multiple PES, with 15% having ≥3 PES. None or a single PES was present in 23% and 36%, respectively. Recurrent ischemic stroke risk was similar for rivaroxaban- and aspirin-assigned patients for each PES, except for those with cardiac valvular disease which was marginally higher in rivaroxaban-assigned patients (hazard ratio, 1.8 [95% CI, 1.0–3.0]). All-cause mortality risks were similar across treatment groups for each PES while too few myocardial infarctions and cardiovascular deaths occurred for meaningful assessment. Increasing number of PES was not associated with increased stroke recurrence nor all-cause mortality, and outcomes did not vary between rivaroxaban- and aspirin-assigned patients by number of PES. Conclusions— A large proportion of patients with ESUS had multiple PES which could explain the neutral results of NAVIGATE-ESUS. Recurrence rates between rivaroxaban- and aspirin-assigned patients were similar across the spectrum of PES. Registration— URL: https://www.clinicaltrials.gov ; Unique identifier: NCT02313909.
Published: 2020
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48. Characteristics and outcomes of atrial fibrillation in patients without traditional risk factors

Author: Marie Ntep-Gweth, Philip Joseph, Supachai Tanosmsup, Stuart J. Connolly, Mariëlle Kloosterman, Michael D. Ezekowitz, Guy Amit, Lars Wallentin, Alex Grinvalds, Alvaro Avezum, Shun Fu Lee, Salim Yusuf, Jonas Oldgren, David Conen, Tyler W. Barrett, Ratika Parkash, Isabelle C. Van Gelder, Jorge A. Wong, William F. McIntyre, Jeff S. Healey, and Cardiovascular Centre (CVC)
Subjects: Male, COUNTRIES, medicine.medical_specialty, Registry, PROGNOSIS, Heart disease, 030204 cardiovascular system & hematology, Left ventricular hypertrophy, Borderline risk factors, Coronary artery disease, 03 medical and health sciences, 0302 clinical medicine, Lone atrial fibrillation, Clinical Research, Risk Factors, Physiology (medical), Internal medicine, Atrial Fibrillation, medicine, Less-established risk factors, MANAGEMENT, Humans, 030212 general & internal medicine, Registries, Stroke, Atrial fibrillation hospitalization, Heart Failure, business.industry, MORTALITY, DEATH, Atrial fibrillation, Middle Aged, medicine.disease, Cardiac surgery, Heart failure, Cardiology and Cardiovascular Medicine, business, Substrate, 30-YEAR FOLLOW-UP, Kidney disease
Abstract: Aims Data on patient characteristics, prevalence, and outcomes of atrial fibrillation (AF) patients without traditional risk factors, often labelled ‘lone AF’, are sparse. Methods and results The RE-LY AF registry included 15 400 individuals who presented to emergency departments with AF in 47 countries. This analysis focused on patients without traditional risk factors, including age ≥60 years, hypertension, coronary artery disease, heart failure, left ventricular hypertrophy, congenital heart disease, pulmonary disease, valve heart disease, hyperthyroidism, and prior cardiac surgery. Patients without traditional risk factors were compared with age- and region-matched controls with traditional risk factors (1:3 fashion). In 796 (5%) patients, no traditional risk factors were present. However, 98% (779/796) had less-established or borderline risk factors, including borderline hypertension (130–140/80–90 mmHg; 47%), chronic kidney disease (eGFR 30; 19%), diabetes (5%), excessive alcohol intake (>14 units/week; 4%), and smoking (25%). Compared with patients with traditional risk factors (n = 2388), patients without traditional risk factors were more often men (74% vs. 59%, P Conclusion Almost all patients without traditionally defined AF risk factors have less-established or borderline risk factors. These patients have a favourable 1-year prognosis, but risk of AF-related re-hospitalization remains high. Greater emphasis should be placed on recognition and management of less-established or borderline risk factors.
Published: 2020

49. Rivaroxaban Plus Aspirin Versus Aspirin Alone in Patients With Prior Percutaneous Coronary Intervention (COMPASS-PCI)

Author: John W. Eikelboom, Deepak L. Bhatt, Scott D. Berkowitz, Jackie Bosch, Tamara Marsden, Derek L Connolly, Kelley R. Branch, Dragos Vinereanu, Keith A.A. Fox, Kevin R. Bainey, Jeffrey L. Probstfield, Petr Widimsky, Robert C. Welsh, Salim Yusuf, Basil S. Lewis, Rafael Diaz, Stuart J. Connolly, Eva Muehlhofer, P. Gabriel Steg, and JoAnne M. Foody
Subjects: Rivaroxaban, medicine.medical_specialty, Aspirin, business.industry, medicine.medical_treatment, Percutaneous coronary intervention, 030204 cardiovascular system & hematology, medicine.disease, Coronary artery disease, 03 medical and health sciences, 0302 clinical medicine, Physiology (medical), Internal medicine, Conventional PCI, medicine, Cardiology, In patient, cardiovascular diseases, 030212 general & internal medicine, Cardiology and Cardiovascular Medicine, business, Cardiovascular outcomes, Dual pathway, medicine.drug
Abstract: Background: The COMPASS trial (Cardiovascular Outcomes for People using Anticoagulation Strategies) demonstrated that dual pathway inhibition (DPI) with rivaroxaban 2.5 mg twice daily plus aspirin 100 mg once daily versus aspirin 100 mg once daily reduced the primary major adverse cardiovascular event (MACE) outcome of cardiovascular death, myocardial infarction, or stroke, as well as, mortality, in patients with chronic coronary syndromes or peripheral arterial disease. Whether this remains true in patients with a history of percutaneous coronary intervention (PCI) is unknown. Methods: In a prespecified subgroup analysis from COMPASS, we examined the outcomes of patients with a chronic coronary syndrome with or without a previous PCI treated with DPI versus aspirin alone. Among patients with a previous PCI, we studied the effects of treatment according to the timing of the previous PCI. Results: Of the 27 395 patients in COMPASS, 16 560 patients with a chronic coronary syndrome were randomly assigned to DPI or aspirin, and, of these, 9862 (59.6%) had previous PCI (mean age 68.2±7.8, female 19.4%, diabetes mellitus 35.7%, previous myocardial infarction 74.8%, multivessel PCI 38.0%). Average time from PCI to randomization was 5.4 years (SD, 4.4) and follow-up was 1.98 (SD, 0.72) years. Regardless of previous PCI, DPI versus aspirin produced consistent reductions in MACE (PCI: 4.0% versus 5.5%; hazard ratio [HR], 0.74 [95% CI, 0.61–0.88]; no PCI: 4.4% versus 5.7%; HR, 0.76 [95% CI, 0.61–0.94], P -interaction=0.85) and mortality (PCI: 2.5% versus 3.5%; HR, 0.73 [95% CI, 0.58–0.92]; no PCI: 4.1% versus 5.0%; HR, 0.80 [95% CI, 0.64–1.00], P -interaction=0.59), but increased major bleeding (PCI: 3.3% versus 2.0%; HR, 1.72 [95% CI, 1.34–2.21]; no PCI: 2.9% versus 1.8%; HR, 1.58 [95% CI, 1.15–2.17], P -interaction=0.68). In those with previous PCI, DPI compared with aspirin produced consistent (robust) reductions in MACE irrespective of time since previous PCI (as early as 1 year and as far as 10 years; P -interaction=0.65), irrespective of having a previous myocardial infarction ( P -interaction=0.64). Conclusions: DPI compared with aspirin produced consistent reductions in MACE and mortality but with increased major bleeding with or without previous PCI. Among those with previous PCI 1 year and beyond, the effects on MACE and mortality were consistent irrespective of time since last PCI. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT01776424.
Published: 2020
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50. Variations in stepped-wedge cluster randomized trial design: Insights from the Patient-Centered Care Transitions in Heart Failure trial

Author: Stuart J. Connolly, Harriette G.C. Van Spall, Lehana Thabane, Shun Fu Lee, and Rudy R Unni
Subjects: Research design, media_common.quotation_subject, Fidelity, 030204 cardiovascular system & hematology, Statistical power, law.invention, 03 medical and health sciences, 0302 clinical medicine, Randomized controlled trial, law, Patient-Centered Care, Outcome Assessment, Health Care, Humans, Medicine, Patient Reported Outcome Measures, 030212 general & internal medicine, Cluster randomised controlled trial, Cluster analysis, media_common, Heart Failure, Cross-Over Studies, business.industry, Transitional Care, Crossover study, Reliability engineering, Cross-Sectional Studies, Research Design, Sample size determination, Sample Size, Cardiology and Cardiovascular Medicine, business
Abstract: The stepped-wedge (SW) cluster randomized controlled trial, in which clusters cross over in a randomized sequence from control to intervention, is ideal for the implementation and testing of complex health service interventions. In certain cases however, implementation of the intervention may pose logistical challenges, and variations in SW design may be required. We examine the logistical and statistical implications of variations in SW design using the optimization of the Patient-Centered Care Transitions in Heart Failure trial for illustration. We review the following complete SW design variations: a typical SW design; an SW design with multiple clusters crossing over per period to achieve balanced cluster sizes at each step; hierarchical randomization to account for higher-level clustering effects; nested substudies to measure outcomes requiring a smaller sample size than the primary outcomes; and hybrid SW design, which combines parallel cluster with SW design to improve efficiency. We also reviewed 3 incomplete SW design variations in which data are collected in some but not all steps to ease measurement burden. These include designs with a learning period that improve fidelity to the intervention, designs with reduced measurements to minimize collection burden, and designs with early and late blocks to accommodate cluster readiness. Variations in SW design offer pragmatic solutions to logistical challenges but have implications to statistical power. Advantages and disadvantages of each variation should be considered before finalizing the design of an SW randomized controlled trial.
Published: 2020
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