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29 results on '"Pierluigi Tricoci"'

1. Stroke Outcomes With Vorapaxar Versus Placebo in Patients With Acute Coronary Syndromes: Insights From the TRACER Trial

Author: Leo Ungar, Robert M. Clare, Fatima Rodriguez, Bradley J. Kolls, Paul W. Armstrong, Philip Aylward, Claes Held, David J. Moliterno, John Strony, Frans Van de Werf, Lars Wallentin, Harvey D. White, Pierluigi Tricoci, Robert A. Harrington, Kenneth W. Mahaffey, and Chiara Melloni
Subjects: acute coronary syndrome, stroke, vorapaxar, Diseases of the circulatory (Cardiovascular) system, RC666-701
Abstract: Background Vorapaxar, a protease‐activated receptor‐1 antagonist, is approved for secondary prevention of cardiovascular events but is associated with increased intracranial hemorrhage. Methods and Results TRACER (Thrombin Receptor Antagonist for Clinical Event Reduction in Acute Coronary Syndrome) was a trial of vorapaxar versus placebo among patients with acute coronary syndrome. Strokes were adjudicated by a central events committee. Of 12 944 patients, 199 (1.5%) had ≥1 stroke during the study period (median follow‐up, 477 days). Four patients had a single stroke of unknown type; 195 patients had ≥1 stroke classified as hemorrhagic or nonhemorrhagic (165 nonhemorrhagic, 28 hemorrhagic, and 2 both). Strokes occurred in 96 of 6473 patients (1.5%) assigned vorapaxar and 103 of 6471 patients (1.6%) assigned placebo. Kaplan‐Meier incidence of stroke for vorapaxar versus placebo was higher for hemorrhagic stroke (0.45% versus 0.14% [hazard ratio, 2.74; 95% confidence interval, 1.22–6.15]), lower but not significantly different for nonhemorrhagic stroke (1.53% versus 1.98% at 2 years [hazard ratio, 0.79; 95% confidence interval, 0.58–1.07]), and similar for stroke overall (1.93% versus 2.13% at 2 years [hazard ratio, 0.94; 95% confidence interval, 0.71–1.24]). Conclusions Stroke occurred in
Published: 2018
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2. Efficacy and Safety of Vorapaxar in Non–ST‐Segment Elevation Acute Coronary Syndrome Patients Undergoing Noncardiac Surgery

Author: Sean vanDiepen, Pierluigi Tricoci, Mohua Podder, Cynthia M. Westerhout, Philip E. Aylward, Claes Held, Frans Van de Werf, John Strony, Lars Wallentin, David J. Moliterno, Harvey D. White, Kenneth W. Mahaffey, Robert A. Harrington, and Paul W. Armstrong
Subjects: coronary disease, hemorrhage, noncardiac surgery, non–ST‐segment elevation acute coronary syndromes, surgery, vorapaxar, Diseases of the circulatory (Cardiovascular) system, RC666-701
Abstract: Background Perioperative antiplatelet agents potentially increase bleeding after non–ST‐segment elevation (NSTE) acute coronary syndromes (ACS). The protease‐activated receptor 1 antagonist vorapaxar reduced cardiovascular events and was associated with increased bleeding versus placebo in NSTE ACS, but its efficacy and safety in noncardiac surgery (NCS) remain unknown. We aimed to evaluate ischemic, bleeding, and long‐term outcomes of vorapaxar in NCS after NSTE ACS. Methods and Results In the TRACER trial, 2202 (17.0%) patients underwent major or minor NCS after NSTE ACS over 1.5 years (median); continuing study treatment perioperatively was recommended. The primary ischemic end point for this analysis was cardiovascular death, myocardial infarction, stent thrombosis, or urgent revascularization within 30 days of NCS. Safety outcomes included 30‐day NCS bleeding and GUSTO moderate/severe bleeding. Overall, 1171 vorapaxar and 1031 placebo patients underwent NCS. Preoperative aspirin and thienopyridine use was 96.8% versus 97.7% (P=0.235) and 89.1% versus 86.1% (P=0.036) for vorapaxar versus placebo, respectively. Within 30 days of NCS, no differences were observed in the primary ischemic end point between vorapaxar and placebo groups (3.4% versus 3.9%; adjusted odds ratio 0.81, 95% CI 0.50 to 1.33, P=0.41). Similarly, no differences in NCS bleeding (3.9% versus 3.4%; adjusted odds ratio 1.41, 95% CI 0.87 to 2.31, P=0.17) or GUSTO moderate/severe bleeding (4.2% versus 3.7%; adjusted odds ratio 1.15, 95% CI, 0.72 to 1.83, P=0.55) were observed. In a 30‐day landmarked analysis, NCS patients had a higher long‐term risk of the ischemic end point (adjusted hazard ratio 1.62, 95% CI 1.33 to 1.97, P
Published: 2015
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3. Safety and efficacy of abciximab as an adjunct to percutaneous coronary intervention

Author: Jennifer Vergara-Jimenez and Pierluigi Tricoci
Subjects: Diseases of the circulatory (Cardiovascular) system, RC666-701
Abstract: Jennifer Vergara-Jimenez, Pierluigi TricociDepartment of Medicine-Cardiology, Duke Clinical Research Institute, Durham, North Carolina, USAAbstract: Abciximab is a widely studied glycoprotein IIb/IIIa inhibitor, specifically in the setting of patients undergoing percutaneous coronary intervention (PCI). The populations studied have included patients with non-ST-segment acute coronary syndromes, ST-segment elevation myocardial infarction, and elective PCI. This large amount of information provides a clear efficacy and safety profile of the drug, although a few questions on the use of abciximab still exist, particularly on its use and preference in the setting of newer antiplatelet and antithrombotic medications. In this article we review the most relevant data from randomized clinical trials with abciximab in patients undergoing PCI and discuss the recent guideline recommendation on use during PCI.Keywords: abciximab, percutaneous coronary intervention, glycoprotein inhibitor
Published: 2010

4. Lipoprotein(a) and Benefit of PCSK9 Inhibition in Patients With Nominally Controlled LDL Cholesterol

Author: Gregory G. Schwartz, Michael Szarek, Vera A. Bittner, Rafael Diaz, Shaun G. Goodman, J. Wouter Jukema, Ulf Landmesser, Patricio López-Jaramillo, Garen Manvelian, Robert Pordy, Michel Scemama, Peter R. Sinnaeve, Harvey D. White, Ph Gabriel Steg, P.h. Gabriel Steg, Deepak L. Bhatt, Robert A. Harrington, Andreas M. Zeiher, Pierluigi Tricoci, Matthew T. Roe, Kenneth W. Mahaffey, Jay M. Edelberg, Corinne Hanotin, Guillaume Lecorps, Angèle Moryusef, William J. Sasiela, Jean-François Tamby, Philip E. Aylward, Heinz Drexel, Peter Sinnaeve, Mirza Dilic, Renato D. Lopes, Nina N. Gotcheva, Juan-Carlos Prieto, Huo Yong, Ivan Pećin, Zeljko Reiner, Petr Ostadal, Steen Hvitfeldt Poulsen, Margus Viigimaa, Markku S. Nieminen, Nicolas Danchin, Vakhtang Chumburidze, Nikolaus Marx, Evangelos Liberopoulos, Pablo Carlos Montenegro Valdovinos, Hung-Fat Tse, Robert Gabor Kiss, Denis Xavier, Doron Zahger, Marco Valgimigli, Takeshi Kimura, Hyo Soo Kim, Sang-Hyun Kim, Andrejs Erglis, Aleksandras Laucevicius, Sasko Kedev, Khalid Yusoff, Gabriel Arturo Ramos López, Marco Alings, Sigrun Halvorsen, Roger M. Correa Flores, Rody G. Sy, Andrzej Budaj, Joao Morais, Maria Dorobantu, Yuri Karpov, Arsen D. Ristic, Terrance Chua, Jan Murin, Zlatko Fras, Anthony J. Dalby, José Tuñón, H. Asita de Silva, Emil Hagström, Christian Müller, Chern-En Chiang, Piyamitr Sritara, Sema Guneri, Alexander Parkhomenko, Kausik K. Ray, Patrick M. Moriarty, Robert Vogel, Bernard Chaitman, Sheryl F. Kelsey, Anders G. Olsson, Jean-Lucien Rouleau, Maarten L. Simoons, Karen Alexander, Chiara Meloni, Robert Rosenson, Eric J.G. Sijbrands, John H. Alexander, Luciana Armaganijan, Akshay Bagai, Maria Cecilia Bahit, J. Matthew Brennan, Shaun Clifton, Adam D. DeVore, Shalonda Deloatch, Sheila Dickey, Keith Dombrowski, Grégory Ducrocq, Zubin Eapen, Patricia Endsley, Arleen Eppinger, Robert W. Harrison, Connie Ng Hess, Mark A. Hlatky, Joseph Dedrick Jordan, Joshua W. Knowles, Bradley J. Kolls, David F. Kong, Sergio Leonardi, Linda Lillis, David J. Maron, Jill Marcus, Robin Mathews, Rajendra H. Mehta, Robert J. Mentz, Humberto Graner Moreira, Chetan B. Patel, Sabrina Bernardez Pereira, Lynn Perkins, Thomas J. Povsic, Etienne Puymirat, William Schuyler Jones, Bimal R. Shah, Matthew W. Sherwood, Kenya Stringfellow, Darin Sujjavanich, Mustafa Toma, Charlene Trotter, Sean F.P. van Diepen, Matthew D. Wilson, Andrew Tze-Kay Yan, Lilia B. Schiavi, Marcelo Garrido, Andrés F. Alvarisqueta, Sonia A. Sassone, Anselmo P. Bordonava, Alberto E. Alves De Lima, Jorge M. Schmidberg, Ernesto A. Duronto, Orlando C. Caruso, Leonardo P. Novaretto, Miguel Angel Hominal, Oscar R. Montaña, Alberto Caccavo, Oscar A. Gomez Vilamajo, Alberto J. Lorenzatti, Luis R. Cartasegna, Gustavo A. Paterlini, Ignacio J. Mackinnon, Guillermo D. Caime, Marcos Amuchastegui, Oscar Salomone, Oscar R. Codutti, Horacio O. Jure, Julio O.E. Bono, Adrian D. Hrabar, Julio A. Vallejos, Rodolfo A. Ahuad Guerrero, Federico Novoa, Cristian A. Patocchi, Cesar J. Zaidman, Maria E. Giuliano, Ricardo D. Dran, Marisa L. Vico, Gabriela S. Carnero, Pablo N. Guzman, Juan C. Medrano Allende, Daniela F. Garcia Brasca, Miguel H. Bustamante Labarta, Sebastian Nani, Eduardo D.S. Blumberg, Hugo R. Colombo, Alberto Liberman, Victorino Fuentealba, Hector L. Luciardi, Gabriel D. Waisman, Mario A. Berli, Ruben O. Garcia Duran, Horacio G. Cestari, Hugo A. Luquez, Jorge A. Giordano, Silvia S. Saavedra, Gerardo Zapata, Osvaldo Costamagna, Susana Llois, Jonathon H. Waites, Nicholas Collins, Allan Soward, Chris L.S. Hii, James Shaw, Margaret A. Arstall, John Horowitz, Daniel Ninio, James F. Rogers, David Colquhoun, Romulo E. Oqueli Flores, Philip Roberts-Thomson, Owen Raffel, Sam J. Lehman, Constantine Aroney, Steven G.M. Coverdale, Paul J. Garrahy, Gregory Starmer, Mark Sader, Patrick A. Carroll, Ronald Dick, Robert Zweiker, Uta Hoppe, Kurt Huber, Rudolf Berger, Georg Delle-Karth, Bernhard Frey, Dirk Faes, Kurt Hermans, Bruno Pirenne, Attilio Leone, Etienne Hoffer, Mathias C.M. Vrolix, Luc De Wolf, Bart Wollaert, Marc Castadot, Karl Dujardin, Christophe Beauloye, Geert Vervoort, Harry Striekwold, Carl Convens, John Roosen, Emanuele Barbato, Marc Claeys, Frank Cools, Ibrahim Terzic, Fahir Barakovic, Zlatko Midzic, Belma Pojskic, Emir Fazlibegovic, Azra Durak-Nalbantic, Mehmed Kulić, Dusko Vulic, Adis Muslibegovic, Boris Goronja, Gilmar Reis, Luciano Sousa, Jose C. Nicolau, Flavio E. Giorgeto, Ricardo P. Silva, Lilia Nigro Maia, Rafael Rech, Paulo R.F. Rossi, Maria José A.G. Cerqueira, Norberto Duda, Renato Kalil, Adrian Kormann, José Antonio M. Abrantes, Pedro Pimentel Filho, Ana Priscila Soggia, Mayler O.N. de Santos, Fernando Neuenschwander, Luiz C. Bodanese, Yorghos L. Michalaros, Freddy G. Eliaschewitz, Maria H. Vidotti, Paulo E. Leaes, Roberto V. Botelho, Sergio Kaiser, Euler Roberto F. Fernandes Manenti, Dalton B. Precoma, Jose C. Moura Jorge, Pedro Silva, Jose A. Silveira, Wladmir Saporito, Jose A. Marin Neto, Gilson S. Feitosa, Luiz Eduardo F. Ritt, Juliana A. de Souza, Fernando Costa, Weimar K.S.B. Souza, Helder J.L. Reis, Leandro Machado, José Carlos Aidar Ayoub, Georgi V. Todorov, Fedya P. Nikolov, Elena S. Velcheva, Maria L. Tzekova, Haralambi O. Benov, Stanislav L. Petranov, Haralin S. Tumbev, Nina S. Shehova-Yankova, Dimitar T. Markov, Dimitar H. Raev, Mihail N. Mollov, Kostadin N. Kichukov, Katya A. Ilieva-Pandeva, Raya Ivanova, Maryana Gospodinov, Valentina M. Mincheva, Petar V. Lazov, Bojidar I. Dimov, Manohara Senaratne, James Stone, Jan Kornder, Stephen Pearce, Danielle Dion, Daniel Savard, Yves Pesant, Amritanshu Pandey, Simon Robinson, Gilbert Gosselin, Saul Vizel, Gordon Hoag, Ronald Bourgeois, Anne Morisset, Eric Sabbah, Bruce Sussex, Simon Kouz, Paul MacDonald, Ariel Diaz, Nicolas Michaud, David Fell, Raymond Leung, Tycho Vuurmans, Christopher Lai, Frank Nigro, Richard Davies, Gustavo Nogareda, Ram Vijayaraghavan, John Ducas, Serge Lepage, Shamir Mehta, James Cha, Robert Dupuis, Peter Fong, Sohrab Lutchmedial, Josep Rodes-Cabau, Hussein Fadlallah, David Cleveland, Thao Huynh, Iqbal Bata, Adnan Hameed, Cristian Pincetti, Sergio Potthoff, Juan C. Prieto, Monica Acevedo, Arnoldo Aguirre, Margarita Vejar, Mario Yañez, Guillermo Araneda, Mauricio Fernandez, Luis Perez, Paola Varleta, Fernando Florenzano, Laura Huidobro, Carlos A. Raffo, Claudia Olivares, Leonardo Nahuelpan, Humberto Montecinos, Jiyan Chen, Yugang Dong, Weijian Huang, Jianzhong Wang, Shi'An Huang, Zhuhua Yao, Xiang Li, Lan Cui, Wenhua Lin, Yuemin Sun, Jingfeng Wang, Jianping Li, Xuelian Zhang, Hong Zhu, Dandan Chen, Lan Huang, Shaohong Dong, Guohai Su, Biao Xu, Xi Su, Xiaoshu Cheng, Jinxiu Lin, Wenxia Zong, Huanming Li, Yi Feng, Dingli Xu, Xinchun Yang, Yuannan Ke, Xuefeng Lin, Zheng Zhang, Zeqi Zheng, Zhurong Luo, Yundai Chen, Chunhua Ding, Yi Zhong, Yang Zheng, Xiaodong Li, Daoquan Peng, Shuiping Zhao, Ying Li, Xuebo Liu, Meng Wei, Shaowen Liu, Yihua Yu, Baiming Qu, Weihong Jiang, Yujie Zhou, Xingsheng Zhao, Zuyi Yuan, Ying Guo, Xiping Xu, Xubo Shi, Junbo Ge, Guosheng Fu, Feng Bai, Weiyi Fang, Xiling Shou, Xiangjun Yang, Jian'An Wang, Meixiang Xiang, Yingxian Sun, Qinghua Lu, Ruiyan Zhang, Jianhua Zhu, Yizhou Xu, Zhongcai Fan, Tianchang Li, Chun Wu, Nicolas Jaramillo, Gregorio Sanchez Vallejo, Diana C. Luna Botia, Rodrigo Botero Lopez, Dora I. Molina De Salazar, Alberto J. Cadena Bonfanti, Carlos Cotes Aroca, Juan Diego Higuera, Marco Blanquicett, Sandra I. Barrera Silva, Henry J. Garcia Lozada, Julian A. Coronel Arroyo, Jose L. Accini Mendoza, Ricardo L. Fernandez Ruiz, Alvaro M. Quintero Ossa, Fernando G. Manzur Jatin, Aristides Sotomayor Herazo, Jeffrey Castellanos Parada, Rafael Suarez Arambula, Miguel A. Urina Triana, Angela M. Fernandez Trujillo, Maja Strozzi, Siniša Car, Melita Jerić, Davor Miličić, Martina Lovrić Benčić, Hrvoje Pintarić, Đeiti Prvulović, Jozica Šikić, Viktor Peršić, Dean Mileta, Kresimir Štambuk, Zdravko Babić, Vjekoslav Tomulic, Josip Lukenda, Stanka Mejic-Krstulovic, Boris Starcevic, Jindrich Spinar, David Horak, Zdenek Velicka, Josef Stasek, David Alan, Vilma Machova, Ales Linhart, Vojtech Novotny, Vladimir Kaucak, Richard Rokyta, Robert Naplava, Zdenek Coufal, Vera Adamkova, Ivo Podpera, Jiri Zizka, Zuzana Motovska, Ivana Marusincova, Premysl Svab, Petr Heinc, Jiri Kuchar, Petr Povolny, Jiri Matuska, Steen H. Poulsen, Bent Raungaard, Peter Clemmensen, Lia E. Bang, Ole May, Morten Bøttcher, Jens D. Hove, Lars Frost, Gunnar Gislason, John Larsen, Peter Betton Johansen, Flemming Hald, Peter Johansen, Jørgen Jeppesen, Tonny Nielsen, Kjeld S. Kristensen, Piotr Maria Walichiewicz, Jens D. Lomholdt, Ib C. Klausen, Peter Kaiser Nielsen, Flemming Davidsen, Lars Videbaek, Mai Soots, Veiko Vahula, Anu Hedman, Üllar Soopõld, Kaja Märtsin, Tiina Jurgenson, Arved Kristjan, Heikki Huikuri, Juhani Airaksinen Pierre Coste, Emile Ferrari, Olivier Morel, Gilles Montalescot, Jacques Machecourt, Gilles Barone-Rochette, Jacques Mansourati, Yves Cottin, Florence Leclercq, Abdelkader Belhassane, Nicolas Delarche, Franck Boccara, Franck Paganelli, Jérôme Clerc, Francois Schiele, Victor Aboyans, Vincent Probst, Jacques Berland, Thierry Lefèvre, Bernard Citron, Irakli Khintibidze, Tamaz Shaburishvili, Zurab Pagava, Ramaz Ghlonti, Zaza Lominadze, George Khabeishvili, Rayyan Hemetsberger, Kemala Edward, Ursula Rauch-Kröhnert, Matthias Stratmann, Karl-Friedrich Appel, Ekkehard Schmidt, Heyder Omran, Christoph Stellbrink, Thomas Dorsel, Emmanouil Lianopoulos, Hans Friedrich Vöhringer, Roger Marx, Andreas Zirlik, Detlev Schellenberg, Thomas Heitzer, Ulrich Laufs, Christian Werner, Stephan Gielen, Sebastian Nuding, Bernhard Winkelmann, Steffen Behrens, Karsten Sydow, Mahir Karakas, Gregor Simonis, Thomas Muenzel, Nikos Werner, Stefan Leggewie, Dirk Böcker, Rüdiger Braun-Dullaeus, Nicole Toursarkissian, Michael Jeserich, Matthias Weißbrodt, Tim Schaeufele, Joachim Weil, Heinz Völler, Johannes Waltenberger, Mohammed Natour, Susanne Schmitt, Dirk Müller-Wieland, Stephan Steiner, Lothar Heidenreich, Elmar Offers, Uwe Gremmler, Holger Killat, Werner Rieker, Sotiris Patsilinakos, Athanasios Kartalis, Athanassios Manolis, Dimitrios Sionis, Geargios Chachalis, Ioannis Skoumas, Vasilios Athyros, Panagiotis Vardas, Frangkiskos Parthenakis, John Lekakis, Apostolos Hatzitolios, Sergio R. Fausto Ovando, Juan L. Arango Benecke, Edgar R. Rodriguez De Leon, Bryan P.Y. Yan, David C.W. Siu, Tibor Turi, Bela Merkely, Imre Ungi, Geza Lupkovics, Lajos Nagy, András Katona, István Édes, Gábor Müller, Iván Horvath, Tibor Kapin, Zsolt Szigeti, József Faluközy, Mukund Kumbla, Manjinder Sandhu, Sharath Annam, Naveen Reddy Proddutur, Reddy Regella, Rajendra K. Premchand, Ajaykumar Mahajan, Sudhir Pawar, Atul D. Abhyanakar, Prafulla Kerkar, Ravishankar A. Govinda, Abraham Oomman, Dhurjati Sinha, Sachin N. Patil, Dhiman Kahali, Jitendra Sawhney, Abhijeet B. Joshi, Sanjeev Chaudhary, Pankaj Harkut, Santanu Guha, Sanjay Porwal, Srimannarayana Jujjuru, Ramesh B. Pothineni, Minguel R. Monteiro, Aziz Khan, Shamanna S. Iyengar, Jasprakash Singh Grewal, Manoj Chopda, Mahesh C. Fulwani, Aparna Patange, Patil Sachin, Vijay K. Chopra, Naresh K. Goyal, Rituparna Shinde, Gajendra V. Manakshe, Nitin Patki, Sumeet Sethi, Vengatesh Munusamy, Sunil Karnaand Sunil Thanvi, Srilakshmi Adhyapak, Chandrakant Patil, Ulhas Pandurangi, Rishabh Mathur, Jugal Gupta, Suhas Kalashetti, Ajit Bhagwat, Bagirath Raghuraman, Shiv Kumar Yerra, Prasant Bhansali, Rohidas Borse, Patil Rahul, Srihari Das, Vinay Kumar, Jabir Abdullakutty, Shireesh Saathe, Priya Palimkar, Jabir Abdullkutty, Shireesh Sathe, Shaul Atar, Michael Shechter, Morris Mosseri, Yaron Arbel, Chorin Ehud, Havakuk Ofer, Chaim Lotan, Uri Rosenschein, Amos Katz, Yaakov Henkin, Adi Francis, Marc Klutstein, Eugenia Nikolsky, Robert Zukermann, Yoav Turgeman, Majdi Halabi, Alon Marmor, Ran Kornowski, Michael Jonas, Offer Amir, Yonathan Hasin, Yoseph Rozenman, Shmuel Fuchs, Vered Zvi, Osamah Hussein, Dov Gavish, Zvi Vered, Yoseph Caraco, Mazen Elias, Naveh Tov, Efrat Wolfovitz, Michael Lishner, Nizar Elias, Giancarlo Piovaccari, Annamaria De Pellegrin, Raffaella Garbelotto, Gabriele Guardigli, Valgimigli Marco, Giovanni Licciardello, Carla Auguadro, Filippo Scalise, Claudio Cuccia, Alessandro Salvioni, Giuseppe Musumeci, Michelle Senni, Paolo Calabrò, Salvatore Novo, Pompilio Faggiano, Marco Metra, Nicoletta B. De Cesare, Sergio Berti, Claudio Cavallini, Enrico Puccioni, Marcello Galvani, Maurizio Tespili, Piermarco Piatti, Michela Palvarini, Giuseppe De Luca, Roberto Violini, Alessandro De Leo, Zoran Olivari, Pasquale Perrone Filardi, Maurizio Ferratini, Vittorio Racca, Kazuoki Dai, Yuji Shimatani, Haruo Kamiya, Kenji Ando, Yoshihiro Takeda, Yoshihiro Morino, Yoshiki Hata, Kazuo Kimura, Koichi Kishi, Ichiro Michishita, Hiroki Uehara, Toshinori Higashikata, Atsushi Hirayama, Keiji Hirooka, Yasuji Doi, Satoru Sakagami, Shuichi Taguchi, Akihiro Koike, Hiroyuki Fujinaga, Shinji Koba, Ken Kozuma, Tomohiro Kawasaki, Yujiro Ono, Masatoshi Shimizu, Yousuke Katsuda, Atsuyuki Wada, Toshiro Shinke, Junya Ako, Kenshi Fujii, Toshiyuki Takahashi, Tomohiro Sakamoto, Koichi Nakao, Yutaka Furukawa, Hiroshi Sugino, Ritsu Tamura, Toshiaki Mano, Masaaki Uematsu, Noriaki Utsu, Kashima Ito, Takuya Haraguchi, Katsuhiko Sato, Yasunori Ueda, Akira Nishibe, Kazuteru Fujimoto, Motomaru Masutani, Jung Han Yoon, Hack-Lyoung Kim, Hun Sik Park, In-Ho Chae, Moo Hyun Kim, Myung Ho Jeong, Seungwoon Rha, Chongjin Kim, Hae Young Kim, Taekjong Hong, Seung-Jea Tahk, Youngkwon Kim, Arija Busmane, Natalija Pontaga, Aldis Strelnieks, Iveta Mintale, Iveta Sime, Zaneta Petrulioniene, Roma Kavaliauskiene, Ruta Jurgaitiene, Gintare Sakalyte, Rimvydas Slapikas, Sigute Norkiene, Nerijus Misonis, Aleksandras Kibarskis, Raimondas Kubilius, Stojko Bojovski, Nensi Lozance, Aleksandar Kjovkaroski, Snezana Doncovska, Tiong Kiam Ong, Sazzli Kasim, Oteh Maskon, Balachandran Kandasamy, Houng B. Liew, Wan Mohd Izani Wan Mohamed, Armando García Castillo, Jorge Carrillo Calvillo, Pedro Fajardo Campos, Juan Carlos Núñez Fragoso, Edmundo Alfredo Bayram Llamas, Marco Antonio Alcocer Gamba, Jaime Carranza Madrigal, Luis Gerardo González Salas, Enrique López Rosas, Belinda González Díaz, Eduardo Salcido Vázquez, Alfredo Nacoud Ackar, Guillermo Antonio Llamas Esperón, Carlos Rodolfo Martínez Sánchez, María Guerrero De Leon, Rodrigo Suarez Otero, Guillermo Fanghänel Salmón, Jesús Antonio Pérez Ríos, José Angel Garza Ruíz, Robert W. Breedveld, Margriet Feenema-Aardema, Alida Borger-Van Der Burg, Pieter A.M. Hoogslag, Harry Suryapranata, Antonius Oomen, Paulus Van Haelst, Margriet Feenema-Aradema, Jacobijne J. Wiersma, Dirk Basart, Ruud M.A. Van Der Wal, Peter Zwart, Pascalle Monraats, Henricus Van Kesteren, Ioannis Karalis, Johan Jukema, Gerardus J.E. Verdel, Bart R.G. Brueren, Roland PTh Troquay, Eric P. Viergever, Nadea Y.Y. Al-Windy, Gerard L. Bartels, Jan H. Cornel, Walter R.M. Hermans, Johannes P.R. Herrman, Robert J. Bos, Reginald G.E.J. Groutars, Coenraad C. Van Der Zwaan, Refik Kaplan, Raymond Lionarons, Eelko Ronner, Bjorn E. Groenemeijer, Patrick N.A. Bronzwaer, Anho A.H. Liem, Bernard J.W.M. Rensing, Marcel J.J.A. Bokern, Remco Nijmeijer, Ferry M.R.J. Hersbach, Frank F. Willems, Antonius T.M. Gosselink, Saman Rasoul, John Elliott, Gerard Wilkins, Raewyn Fisher, Douglas Scott, Hamish Hart, Ralph Stewart, Scott Harding, Ian Ternouth, Nicholas Fisher, Samuel Wilson, Denise Aitken, Russell Anscombe, Laura Davidson, Tadeusz Tomala, Ottar Nygård, Jon Arne Sparby, Kjell Andersen, Lars Gullestad, Jarle Jortveit, Peter S. Munk, Erlend gyllensten Singsaas, Ulf Hurtig, Jorge R. Calderon Ticona, Julio R. Durand Velasquez, Sandra A. Negron Miguel, Enrique S. Sanabria Perez, Jesus M. Carrion Chambilla, Carlos A. Chavez Ayala, Reynaldo P. Castillo Leon, Rolando J. Vargas Gonzales, Jose D. Hernandez Zuniga, Luis A. Camacho Cosavalente, Jorge E. Bravo Mannucci, Javier Heredia Landeo, Nassip C. Llerena Navarro, Yudy M. Roldan Concha, Víctor E. Rodriguez Chavez, Henry A. Anchante Hernandez, Carlos A. Zea Nunez, Walter Mogrovejo Ramos, Arthur Ferrolino, Rosa Allyn G. Sy, Louie Tirador, Generoso Matiga, Raul Martin Coching, Alisa Bernan, Gregorio Rogelio, Dante D. Morales, Edgar Tan, Dennis Jose Sulit, Adrian Wlodarczak, Krystyna Jaworska, Grzegorz Skonieczny, Lidia Pawlowicz, Pawel Wojewoda, Benita Busz-Papiez, Janusz Bednarski, Aleksander Goch, Pawel Staneta, Elzbieta Dulak, Krzysztof Saminski, Wlodzimierz Krasowski, Wanda Sudnik, Aleksander Zurakowski, Marcin Skorski, Roman Lysek, Beata Miklaszewicz, Jacek Kubica, Jan Andrzej Lipko, Edyta Kostarska-Srokosz, Marek Piepiorka, Anna Drzewiecka, Ryszard Sciborski, Arkadiusz Stasiewski, Tomasz Blicharski, Leszek Bystryk, Michal Szpajer, Marek Korol, Tomasz Czerski, Ewa Mirek-Bryniarska, Jacek Gniot, Andrzej Lubinski, Jerzy Gorny, Edward Franek, Grzegorz Raczak, Hanna Szwed, Pedro Monteiro, Jose Mesquita Bastos, Helder H. Pereira, Dinis Martins, Filipe Seixo, Carlos Mendonça, Ana Botelho, Francisca Caetano, Bogdan Minescu, Octavian Istratoaie, Dan N. Tesloianu, Gabriel Cristian, Silviu Dumitrescu, Cristian G.C. Podoleanu, Mircea C.A. Constantinescu, Cristina M. Bengus, Constantin Militaru, Doina Rosu, Irinel R. Parepa, Adrian V. Matei, Tom M. Alexandru, Mihaela Malis, Ioan Coman, Rodica Stanescu-Cioranu, Doina Dimulescu, Yury Shvarts, Olga Orlikova, Zhanna Kobalava, Olga L. Barbarash, Valentin Markov, Nadezhda Lyamina, Alexander Gordienko, Konstantin Zrazhevsky, Alexander Y. Vishnevsky, Victor Gurevich, Raisa Stryuk, Nikita V. Lomakin, Igor Bokarev, Tatiana Khlevchuk, Sergey Shalaev, Larisa Khaisheva, Petr Chizhov, Inna Viktorova, Natalya Osokina, Vladimir Shchekotov, Evgenia Akatova, Galina Chumakova, Igor Libov, Mikhail I. Voevoda, Tatyana V. Tretyakova, Evgeny Baranov, Sergey Shustov, Sergey Yakushin, Ivan Gordeev, Niiaz Khasanov, Olga Reshetko, Tatiana Sotnikova, Olga Molchanova, Konstantin Nikolaev, Liudmila Gapon, Elena Baranova, Zaur Shogenov, Elena Kosmachova, Yuriy Karpov, Anton Povzun, Liudmila Egorova, Vadim V. Tyrenko, Igor G. Ivanov, Masterov Ilya, Sergey Kanorsky, Dragan Simic, Nikola Ivanovic, Goran Davidovic, Nebojsa Tasic, Milika R. Asanin, Stevo Stojic, Svetlana R. Apostolovic, Stevan Ilic, Biljana Putnikovic Tosic, Aleksandar Stankovic, Aleksandra Arandjelovic, Slavica Radovanovic, Branislava Todic, Jovan Balinovac, Dragan V. Dincic, Petar Seferovic, Ana Karadzic, Slobodan Dodic, Sinisa Dimkovic, Tamara Jakimov, Kian-Keong Poh, Hean Yee Ong, Justin Tang I-Shing, Karol Micko, Jan Nociar, Daniel Pella, Peter Fulop, Marian Hranai, Juraj Palka, Juraj Mazur, Ivan Majercák, Andrej Dzupina, František Fazekas, Jozef Gonsorcik, Viliam Bugan, Juraj Selecky, Gabriel Kamensky, Jaroslava Strbova, Rudolf Smik, Andrej Dukat, Peter Olexa, Ivan Žuran, Janez Poklukar, Nataša Černič Šuligoj, Matija Cevc, Henry P. Cyster, Naresh Ranjith, Clive Corbett, Junaid Bayat, Ellen Makoali Makotoko, Hendrik du Toit Theron, Ilse E. Kapp, Matthys M. de V Basson, Hanlie Lottering, Dina Van Aswegen, Louis J. Van Zyl, Peter J. Sebastian, Thayabran Pillay, Jan A. Saaiman, Patrick J. Commerford, Soraya Cassimjee, Garda Riaz, Iftikhar O. Ebrahim, Mahomed Sarvan, Joseph H. Mynhardt, Helmuth Reuter, Rajendran Moodley, Manuel Vida, Angel R. Cequier Fillat, Vicente Bodí Peris, Francisco Fuentes Jimenez, Francisco Marín, Jose M. Cruz Fernández, Rafael Jesus Hidalgo Urbano, Blas Gil-Extremera, Pablo Toledo, Fernando Worner Diz, David Garcia-Dorado, Andres Iñiguez, José Tuñón Fernández, Jose R. Gonzalez-Juanatey, Javier Fernandez Portales, Fernando Civeira Murillo, Laia Matas Pericas, Jose Luis Zamorano, Manuel De Mora Martin, Jordi Bruguera Cortada, Joaquin J. Alonso Martin, Jose Maria Serrano Antolin, José R. De Berrazueta Fernández, José Antonio Vázquez de Prada, Jose Francisco Díaz Fernández, José Alberto García Lledó, Juan Cosín Sales, Javier Botas Rodriguez, Gabriel Gusi Tragant, Amparo Benedicto, Carlos Gonzalez-Juanatey, Mercedes Camprubí Potau, Ignacio Plaza Perez, César Morís De La Tassa, Pablo Loma-Osorio Rincon, Javier Balaguer Recena, Juan M. Escudier, Antonio Coca Payeras, Norberto Alonso Orcajo, Pedro Valdivielso, Godwin Constantine, Ruvaiz Haniffa, Nirmali Tissera, Stanley Amarasekera, Chandrike Ponnamperuma, Nimali Fernando, Kaputella Fernando, Jayanthimala Jayawardena, Santharaj Wijeyasingam, Gotabhaya Ranasinghe, Ruvan Ekanayaka, Sepalika Mendis, Vajira Senaratne, Gnanamoorthy Mayurathan, Ajantha Rajapaksha, Thilak Sirisena, Jagath I. Herath, Naomali Amarasena, Stefan Berglund, Gundars Rasmanis, Ola Vedin, Nils Witt, Georgios Mourtzinis, Peter Nicol, Ole Hansen, Stefano Romeo, Steen Agergaard Jensen, Ingemar Torstensson, Ulf Ahremark, Torbjörn Sundelin, Tiziano Moccetti, Francois Mach, Ronald Binde, Oliver Gämperli, Wei-Chuan Tsai, Kwo-Chang Ueng, Wen-Ter Lai, Ming-En Liu, Juey-Jen Hwang, Wei-Hsian Yin, I-Chang Hsieh, Ming-Jer Hsieh, Wei Hsiang Lin, Jen-Yuan Kuo, Tsuei-Yuan Huang, Chih-Yuan Fang, Pinij Kaewsuwanna, Wasant Soonfuang, Woravut Jintapakorn, Apichard Sukonthasarn, Nattawut Wongpraparut, Krisada Sastravaha, Nakarin Sansanayudh, Wirash Kehasukcharoen, Dilok Piyayotai, Paiboon Chotnoparatpat, Ahmet Camsari, Hakan Kultursay, Bulent Mutlu, Murat Ersanli, Mustafa Demirtas, Cevat Kirma, Ertan Ural, Lale Koldas, Oleksandr Karpenko, Alexander Prokhorov, Ihor Vakaluyk, Halyna Myshanych, Dmytro Reshotko, Valeriy Batushkin, Leonid Rudenko, Ihor Kovalskyi, Mykola Kushnir, Vira Tseluyko, Yuriy Mostovoy, Mykola Stanislavchuk, Yulian Kyiak, Yuriy Karpenko, Yaroslav Malynovsky, Andriy Klantsa, Oles Kutniy, Ekaterina Amosova, Viktor Tashchuk, Oleh Leshchuk, Mykola Rishko, Mykola Kopytsya, Andriy Yagensky, Mykola Vatutin, Andriy Bagriy, Olga M. Barna, Olexiy Ushakov, Georgiy Dzyak, Borys Goloborodko, Anatolii Rudenko, Volodymyr Zheleznyy, Jasper Trevelyan, Azfar Zaman, Kaeng Lee, Andrew Moriarty, Rajesh K. Aggarwal, Piers Clifford, Yuk-Ki Wong, Syed M.R. Iqbal, Eduardas Subkovas, Denise Braganza, David Sarkar, Robert Storey, Huw Griffiths, Sam Mcclure, Rangasamy Muthusamy, Simon Smith, John Kurian, Terry Levy, Craig Barr, Honer Kadr, Robert Gerber, Audrius Simaitis, Handrean Soran, Anthony Mathur, Adrian Brodison, Mohammad Ayaz, Muhammad Cheema, Richard Oliver, Simon Thackray, Telal Mudawi, Gohar Rahman, Ayyaz Sultan, Timothy Reynolds, David Sharman, null david Sprigings, Rob Butler, Peter Wilkinson, Gregory Y.H. Lip, Julian Halcox, Sean Gallagher, Nicholas Ossei-Gerning, Gil Vardi, Duccio Baldari, David Brabham, Charles Treasure, Charles Dahl, Bruce Palmer, Alan Wiseman, Abul Khan, Sanjeev Puri, Ann Elizabeth Mohart, Carlos Ince, Enrique Flores, Scott Wright, Shi-Chi Cheng, Michael Rosenberg, William Rogers, Edward Kosinski, Les Forgosh, Jonathan Waltman, Misal Khan, Mohammad Shoukfeh, Georges Dagher, Patrick Cambier, Ira Lieber, Priya Kumar, Cara East, Perry Krichmar, Mian Hasan, Lindsey White, Thomas Knickelbine, Thomas Haldis, Eve Gillespie, Thomas Amidon, David Suh, Imran Arif, Mouhamad Abdallah, Faiq Akhter, Eric Carlson, Michael D'Urso, Fadi El-Ahdab, William Nelson, Katie Moriarty, Barry Harris, Steven Cohen, Luther Carter, Daniel Doty, Kenneth Sabatino, Tariq Haddad, Amir Malik, Sunder Rao, Angel Mulkay, Ion Jovin, Kim Klancke, Vinay Malhotra, Sai K. Devarapalli, Michael Koren, Harish Chandna, George Dodds, Tauqir Goraya, James Bengston, Matthew Janik, Joseph Moran, Andrew Sumner, John Kobayashi, William Davis, Shahram Yazdani, John Pasquini, Maitreya Thakkar, Amarnath Vedere, Wayne Leimbach, James Rider, Sarah fenton, Narendra Singh, Anil V. Shah, Denise Janosik, Carl Pepine, Brett Berman, Joseph Gelormini, Christopher Daniels, Kerensky Richard, Friederike Keating, Nicholas I. Kondo, Sanjay Shetty, Howard Levite, Winfried Waider, Theodore Takata, Mazen Abu-Fadel, Vipul Shah, Rahul Aggarwal, Mark Izzo, Anil Kumar, Brack Hattler, Rose Do, Chad Link, Anna Bortnick, George Kinzfogl, Arnold Ghitis, John Larry, Edward Teufel, Peter Kuhlman, Brent Mclaurin, Wenwu Zhang, Stephen Thew, Jalal Abbas, Matthew White, Othman Islam, Sumeet Subherwal, Nandkishore Ranadive, Babak Vakili, Christian Gring, David Henderson, Timothy Schuchard, Naim Farhat, Geoffrey Kline, Sharan Mahal, Jack Whitaker, Shawn Speirs, Rolf Andersen, Nizar Daboul, Phillip Horwitz, Firas Zahr, George Ponce, Zubair Jafar, Joseph Mcgarvey, Vipul Panchal, Stephen Voyce, Thomas Blok, William Sheldon, Masoud M. Azizad, Carsten Schmalfuss, Mark Picone, Robert Pederson, William Herzog, Keith Friedman, Jason Lindsey, Rosemary Nowins, Eichenlaub Timothy, Parilak Leonard, Norman Lepor, Mahfouz El Shahawy, Howard Weintraub, Anand Irimpen, Alvaro Alonso, Wade May, Daniels Christopher, Thomas Galski, Alan Chu, Freny Mody, Ebrahimi Ramin, Zachary Hodes, Joseph Rossi, Gregory Rose, James Fairlamb, Charles Lambert, Ajit Raisinghani, Antonio Abbate, George Vetrovec, Marilyn King, Charles Carey, Jaime Gerber, Liwa Younis, Hyeun Park, Mladen Vidovich, Thomas Knutson, Dennis Friedman, Fred Chaleff, Arthur Loussararian, Phillip Rozeman, Carey Kimmelstiel, Jeffrey Kuvin, Kevin Silver, Malcolm Foster, Glen Tonnessen, Andrey Espinoza, Mohamadali Amlani, Andreas Wali, Christopher Malozzi, Geert T. Jong, Clara Massey, Keattiyoat Wattanakit, Philip J. O'Donnell, Dinesh Singal, Naseem Jaffrani, Sridhar Banuru, Daniel Fisher, Mark Xenakis, Neal Perlmutter, Ravi Bhagwat, James Strader, Ronald Blonder, Ayim Akyea-Djamson, Ajay Labroo, Kwan Lee, H. John Marais, Edmund Claxton, Robert Weiss, Rohr Kathryn, Martin Berk, Peter Rossi, Parag Joshi, Amit Khera, Ajit S. Khaira, Greg Kumkumian, Steven Lupovitch, Joshua Purow, Stephen Welka, David Hoffman, Stuart Fischer, Eugene Soroka, Donald Eagerton, Samir Pancholy, Michael Ray, Norman Erenrich, Michael Farrar, Stewart Pollock, William J. French, Steve Diamantis, Douglas Guy, Lawrence Gimple, Mark Neustel, Steven Schwartz, Edward Pereira, Seals Albert, Douglas Spriggs, Janet Strain, Suneet Mittal, Anthony Vo, Majed Chane, Jason Hall, Nampalli Vijay, Kapildeo Lotun, F. Martin Lester, Ahed Nahhas, Theodore Pope, Paul Nager, Rakesh Vohra, Mukesh Sharma, Riyaz Bashir, Hinan Ahmed, Michael Berlowitz, Robert Fishberg, Robert Barrucco, Eric Yang, Michael Radin, Daniel Sporn, Dwight Stapleton, Steven Eisenberg, Joel Landzberg, Martin Mcgough, Samir Turk, Michael Schwartz, P. Sandy Sundram, Diwakar Jain, Mark Zainea, Carlos Bayron, Ronald Karlsberg, Suhail Dohad, Henry Lui, William Keen, Donald Westerhausen, Sandeep Khurana, Himanshu Agarwal, Jessica Birchem, William Penny, Mark Chang, Sherrill Murphy, John Henry, Branislav Schifferdecker, John M Gilbert, Gopal Chalavarya, Charles Eaton, John F. Schmedtje, Stuart Christenson, Imran Dotani, Douglas Denham, Alexander Macdonell, Paul Gibson, Aref Rahman, Tammam Al Joundi, Nizar Assi, Gary Conrad, Purushotham Kotha, Michael Love, Gregory Giesler, Howard Rubenstein, Dawood Gamil, Laura Akright, Justine Krawczyk, Joanne Cobler, Terry Wells, James Welker, Robert Foster, Richard Gilmore, Jay Anderson, Douglas Jacoby, Bill Harris, Geraldine Gardner, Ramprasad Dandillaya, Kishor Vora, John Kostis, John Hunter, David Laxson, Eric Ball, Flavia Egydio, Anelise Kawakami, Janaina Oliveira, Julianna Wozniak, Alexander Matthews, Caroline Ratky, Janine Valiris, Lisa Berdan, Anita Hepditch, Kirby Quintero, Tyrus Rorick, Melissa Westbrook, Andrea Pascual, Carla Rovito, Madeleine Bezault, Elodie Drouet, Tabassome Simon, Caroline Alsweiler, Anne Luyten, Julie Butters, Liddy Griffith, Michelle Shaw, Lena Grunberg, Shahidul Islam, Marie-France Brégeault, Nathalie Bougon, Douglas Faustino, Sylvie Fontecave, Judith Murphy, Melanie Verrier, null Veronique Agnetti, Dorthe Andersen, Emmy Badreddine, Mhamed Bekkouche, Cecile Bouancheau, Imane Brigui, Maddy Brocklehurst, Joseph Cianciarulo, Dawn Devaul, Szilvia Domokos, Cecile Gache, Caroline Gobillot, Severine Guillou, Jan Healy, Megan Heath, Gayatri Jaiwal, Carine Javierre, Julien Labeirie, Myriam Monier, Ulises Morales, Asmaa Mrabti, Bicky Mthombeni, Betim Okan, Lucile Smith, Jennifer Sheller, Sebastien Sopena, Valerie Pellan, Fadela Benbernou, Nafissa Bengrait, Maud Lamoureux, Katarina Kralova, Raphael Bejuit, Anthony Coulange, Christelle Berthou, Jérôme Repincay, Christelle Lorenzato, Alexis Etienne, Valerie Gouet, Virginie Loizeau, Mickael Normand, Anne Ourliac, Christelle Rondel, Antony Adamo, Pascale Beltran, Pauline Barraud, Helene Dubois-Gache, Benjamin Halle, Lamia Metwally, Maxime Mourgues, Marc Sotty, Marion Vincendet, Raluca Cotruta, Zhu Chengyue, Dominique Fournie-Lloret, Christine Morrello, Aurelie Perthuis, Patrick Picault, Isabelle Zobouyan, Helen M. Colhoun, Michael A. Dempsey, Mark A. McClanahan, Masira, and Laucevičius, Aleksandras
Subjects: Male, Acute coronary syndrome, medicine.medical_specialty, Cardiac & Cardiovascular Systems, Randomization, PCSK9 inhibitor, LOW-DENSITY-LIPOPROTEIN, Antibodies, Monoclonal, Humanized, acute coronary syndrom, Placebo, Gastroenterology, lipoprotein(a), Internal medicine, medicine, Humans, Low-density lipoprotein cholesterol, Aged, Alirocumab, RISK, low-density lipoprotein cholesterol, Science & Technology, biology, business.industry, PCSK9, PCSK9 Inhibitors, Hazard ratio, ALIROCUMAB, acute coronary syndrome, Cholesterol, LDL, Lipoprotein(a), Middle Aged, EFFICACY, medicine.disease, Cardiovascular Diseases, CARDIOVASCULAR-DISEASE, SAFETY, Cardiovascular System & Cardiology, biology.protein, Female, lipids (amino acids, peptides, and proteins), STATIN, low-density lipoprotein, cholesterol PCSK9 inhibitor, CORONARY, Cardiology and Cardiovascular Medicine, business, Life Sciences & Biomedicine, Mace
Abstract: Digital, Background Guidelines recommend nonstatin lipid-lowering agents in patients at very high risk for major adverse cardiovascular events (MACE) if low-density lipoprotein cholesterol (LDL-C) remains ≥70 mg/dL on maximum tolerated statin treatment. It is uncertain if this approach benefits patients with LDL-C near 70 mg/dL. Lipoprotein(a) levels may influence residual risk. Objectives In a post hoc analysis of the ODYSSEY Outcomes (Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab) trial, the authors evaluated the benefit of adding the proprotein subtilisin/kexin type 9 inhibitor alirocumab to optimized statin treatment in patients with LDL-C levels near 70 mg/dL. Effects were evaluated according to concurrent lipoprotein(a) levels. Methods ODYSSEY Outcomes compared alirocumab with placebo in 18,924 patients with recent acute coronary syndromes receiving optimized statin treatment. In 4,351 patients (23.0%), screening or randomization LDL-C was 13.7 mg/dL or ≤13.7 mg/dL; corresponding adjusted treatment hazard ratios were 0.82 (95% CI: 0.72-0.92) and 0.89 (95% CI: 0.75-1.06), with Pinteraction = 0.43. Conclusions In patients with recent acute coronary syndromes and LDL-C near 70 mg/dL on optimized statin therapy, proprotein subtilisin/kexin type 9 inhibition provides incremental clinical benefit only when lipoprotein(a) concentration is at least mildly elevated. (ODYSSEY Outcomes: Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab; NCT01663402), Ciencias Médicas y de la Salud
Published: 2021

5. Effect of Alirocumab on Mortality After Acute Coronary Syndromes

Author: Philippe Gabriel, Steg, Michael, Szarek, Deepak L, Bhatt, Vera A, Bittner, Marie-France, Brégeault, Anthony J, Dalby, Rafael, Diaz, Jay M, Edelberg, Shaun G, Goodman, Corinne, Hanotin, Robert A, Harrington, J Wouter, Jukema, Guillaume, Lecorps, Kenneth W, Mahaffey, Angèle, Moryusef, Petr, Ostadal, Alexander, Parkhomenko, Robert, Pordy, Matthew T, Roe, Pierluigi, Tricoci, Robert, Vogel, Harvey D, White, Andreas M, Zeiher, and Gregory G, Schwartz
Subjects: Male, Injections, Subcutaneous, Hypercholesterolemia, alirocumab, Antibodies, Monoclonal, Humanized, Corrections, acute coronary syndrome, Double-Blind Method, Original Research Articles, Humans, PCSK9 protein, Aged, cholesterol, Cholesterol, LDL, Middle Aged, mortality, Treatment Outcome, ComputingMethodologies_DOCUMENTANDTEXTPROCESSING, Drug Therapy, Combination, Female, Hydroxymethylglutaryl-CoA Reductase Inhibitors, Follow-Up Studies
Abstract: Supplemental Digital Content is available in the text., Background: Previous trials of PCSK9 (proprotein convertase subtilisin-kexin type 9) inhibitors demonstrated reductions in major adverse cardiovascular events, but not death. We assessed the effects of alirocumab on death after index acute coronary syndrome. Methods: ODYSSEY OUTCOMES (Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab) was a double-blind, randomized comparison of alirocumab or placebo in 18 924 patients who had an ACS 1 to 12 months previously and elevated atherogenic lipoproteins despite intensive statin therapy. Alirocumab dose was blindly titrated to target achieved low-density lipoprotein cholesterol (LDL-C) between 25 and 50 mg/dL. We examined the effects of treatment on all-cause death and its components, cardiovascular and noncardiovascular death, with log-rank testing. Joint semiparametric models tested associations between nonfatal cardiovascular events and cardiovascular or noncardiovascular death. Results: Median follow-up was 2.8 years. Death occurred in 334 (3.5%) and 392 (4.1%) patients, respectively, in the alirocumab and placebo groups (hazard ratio [HR], 0.85; 95% CI, 0.73 to 0.98; P=0.03, nominal P value). This resulted from nonsignificantly fewer cardiovascular (240 [2.5%] vs 271 [2.9%]; HR, 0.88; 95% CI, 0.74 to 1.05; P=0.15) and noncardiovascular (94 [1.0%] vs 121 [1.3%]; HR, 0.77; 95% CI, 0.59 to 1.01; P=0.06) deaths with alirocumab. In a prespecified analysis of 8242 patients eligible for ≥3 years follow-up, alirocumab reduced death (HR, 0.78; 95% CI, 0.65 to 0.94; P=0.01). Patients with nonfatal cardiovascular events were at increased risk for cardiovascular and noncardiovascular deaths (P
Published: 2019

6. Alirocumab Reduces Total Nonfatal Cardiovascular and Fatal Events: The ODYSSEY OUTCOMES Trial

Author: Michael, Szarek, Harvey D, White, Gregory G, Schwartz, Marco, Alings, Deepak L, Bhatt, Vera A, Bittner, Chern-En, Chiang, Rafael, Diaz, Jay M, Edelberg, Shaun G, Goodman, Corinne, Hanotin, Robert A, Harrington, J Wouter, Jukema, Takeshi, Kimura, Robert Gabor, Kiss, Guillaume, Lecorps, Kenneth W, Mahaffey, Angèle, Moryusef, Robert, Pordy, Matthew T, Roe, Pierluigi, Tricoci, Denis, Xavier, Andreas M, Zeiher, Ph Gabriel, Steg, and Rushton-Smith, Sophie
Subjects: Male, total events, Antibodies, Monoclonal, food and beverages, alirocumab, Middle Aged, Antibodies, Monoclonal, Humanized, acute coronary syndrome, Humans, Drug Therapy, Combination, Female, ddc:610, Hydroxymethylglutaryl-CoA Reductase Inhibitors, Aged, Follow-Up Studies
Abstract: Background: The ODYSSEY OUTCOMES (Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab) trial compared alirocumab with placebo, added to high-intensity or maximum-tolerated statin treatment, after acute coronary syndrome (ACS) in 18, 924 patients. Alirocumab reduced the first occurrence of the primary composite endpoint and was associated with fewer all-cause deaths. Objectives: This pre-specified analysis determined the extent to which alirocumab reduced total (first and subsequent) nonfatal cardiovascular events and all-cause deaths in ODYSSEY OUTCOMES. Methods: Hazard functions for total nonfatal cardiovascular events (myocardial infarction, stroke, ischemia-driven coronary revascularization, and hospitalization for unstable angina or heart failure) and death were jointly estimated, linked by a shared frailty accounting for patient risk heterogeneity and correlated within-patient nonfatal events. An association parameter also quantified the strength of the linkage between risk of nonfatal events and death. The model provides accurate relative estimates of nonfatal event risk if nonfatal events are associated with increased risk for death. Results: With 3, 064 first and 5, 425 total events, 190 fewer first and 385 fewer total nonfatal cardiovascular events or deaths were observed with alirocumab compared with placebo. Alirocumab reduced total nonfatal cardiovascular events (hazard ratio: 0.87; 95% confidence interval: 0.82 to 0.93) and death (hazard ratio: 0.83; 95% confidence interval: 0.71 to 0.97) in the presence of a strong association between nonfatal and fatal event risk. Conclusions: In patients with ACS, the total number of nonfatal cardiovascular events and deaths prevented with alirocumab was twice the number of first events prevented. Consequently, total event reduction is a more comprehensive metric to capture the totality of alirocumab clinical efficacy after ACS.
Published: 2019

7. Standardized classification and framework for reporting, interpreting, and analysing medication non-adherence in cardiovascular clinical trials: a consensus report from the Non-adherence Academic Research Consortium (NARC)

Author: Bernard Vrijens, Stephan Windecker, Antonio Colombo, Karen S. Pieper, Gerrit Anne van Es, Dominick J. Angiolillo, Gregg W. Stone, Pascal Vranckx, Pierluigi Tricoci, Gabriel Steg, Fausto Feres, Min Zhang, Patrick W. Serruys, Usman Baber, Deepak L. Bhatt, Adnan Kastrati, Hector M. Garcia-Garcia, Gilles Montalescot, Andrew Farb, Peter Jüni, Marco Valgimigli, Roxana Mehran, Francesco Costa, David M. Vock, Eugene P. McFadden, Jan G.P. Tijssen, Academic Medical Center, Cardiology, and ACS - Heart failure & arrhythmias
Subjects: Societies, Scientific, medicine.medical_specialty, Quality management, Consensus, Decision Making, 610 Medicine & health, 030204 cardiovascular system & hematology, Cardiovascular System, Risk Assessment, law.invention, Medication Adherence, Placebos, 03 medical and health sciences, Special Article, 0302 clinical medicine, Consistency (negotiation), Randomized controlled trial, law, Physicians, Health care, Clinical endpoint, Medicine, Humans, business.industry, Surrogate endpoint, United States Food and Drug Administration, Cardiovascular Agents, 030229 sport sciences, Health Care Costs, United States, Test (assessment), Intention to Treat Analysis, Clinical trial, Treatment Outcome, Cardiovascular Diseases, Spain, Family medicine, Case-Control Studies, Safety, Cardiology and Cardiovascular Medicine, business
Abstract: Non-adherence has been well recognized for years to be a common issue that significantly impacts clinical outcomes and health care costs. Medication adherence is remarkably low even in the controlled environment of clinical trials where it has potentially complex major implications. Collection of non-adherence data diverge markedly among cardiovascular randomized trials and, even where collected, is rarely incorporated in the statistical analysis to test the consistency of the primary endpoint(s). The imprecision introduced by the inconsistent assessment of non-adherence in clinical trials might confound the estimate of the calculated efficacy of the study drug. Hence, clinical trials may not accurately answer the scientific question posed by regulators, who seek an accurate estimate of the true efficacy and safety of treatment, or the question posed by payers, who want a reliable estimate of the effectiveness of treatment in the marketplace after approval. The Non-adherence Academic Research Consortium is a collaboration among leading academic research organizations, representatives from the U.S. Food and Drug Administration and physician-scientists from the USA and Europe. One in-person meeting was held in Madrid, Spain, culminating in a document describing consensus recommendations for reporting, collecting, and analysing adherence endpoints across clinical trials. The adoption of these recommendations will afford robustness and consistency in the comparative safety and effectiveness evaluation of investigational drugs from early development to post-marketing approval studies. These principles may be useful for regulatory assessment, as well as for monitoring local and regional outcomes to guide quality improvement initiatives.
Published: 2019

8. Rationale and design of ApoA-I Event Reducing in Ischemic Syndromes II (AEGIS-II): A phase 3, multicenter, double-blind, randomized, placebo-controlled, parallel-group study to investigate the efficacy and safety of CSL112 in subjects after acute myocardial infarction

Author: Lawrence I. Deckelbaum, Adam T. Phillips, Megan K. Yee, Christoph Bode, A. Michael Lincoff, Danielle Duffy, Pierluigi Tricoci, Paul M. Ridker, Philip E. Aylward, Stuart J. Pocock, John J.P. Kastelein, Sojaita Jenny Mears, Roxana Mehran, John H. Alexander, P. Gabriel Steg, Michal Tendera, C. Michael Gibson, Gail Berman, Shaun G. Goodman, Stephen J. Nicholls, and Mark Heise
Subjects: medicine.medical_specialty, Time Factors, Myocardial Infarction, Myocardial Ischemia, Coronary Artery Disease, 030204 cardiovascular system & hematology, Placebo, Drug Administration Schedule, law.invention, Brain Ischemia, Coronary artery disease, Placebos, 03 medical and health sciences, chemistry.chemical_compound, 0302 clinical medicine, Randomized controlled trial, Double-Blind Method, law, Ischemia, Internal medicine, Diabetes mellitus, Diabetes Mellitus, Medicine, Humans, 030212 general & internal medicine, Myocardial infarction, Stroke, Aged, Peripheral Vascular Diseases, business.industry, Cholesterol, medicine.disease, Plaque, Atherosclerotic, Clinical trial, Hospitalization, chemistry, Liver, Cardiology, Cardiology and Cardiovascular Medicine, business, Lipoproteins, HDL
Abstract: Acute myocardial infarction (MI) patients remain at high risk for recurrent events. Cholesterol efflux, mediated by apolipoprotein A-I, removes excess cholesterol from atherosclerotic plaque and transports it to the liver for excretion. Impaired cholesterol efflux is associated with higher cardiovascular (CV) event rates among both patients with stable coronary artery disease and recent MI. CSL112, a novel intravenous formulation of apolipoprotein A-I (human) derived from human plasma, increases cholesterol efflux capacity. AEGIS-II is a phase 3, multicenter, double-blind, randomized, placebo-controlled, parallel-group trial investigating the efficacy and safety of CSL112 compared to placebo among high-risk acute MI participants. Eligibility criteria include age ≥ 18 years with type 1 (spontaneous) MI, evidence of multivessel stable coronary artery disease, and presence of diabetes requiring pharmacotherapy, or ≥2 of the following: age ≥ 65 years, prior MI, or peripheral artery disease. A target sample of 17,400 participants will be randomized 1:1 to receive 4 weekly infusions of CSL112 6 g or placebo, initiated prior to or on the day of discharge and within 5 days of first medical contact. The primary outcome is the time to first occurrence of the composite of CV death, MI, or stroke through 90 days. Key secondary outcomes include the total number of hospitalizations for coronary, cerebral, or peripheral ischemia through 90 days and time to first occurrence of the composite primary outcome through 180 and 365 days. AEGIS-II will be the first trial to formally test whether enhancing cholesterol efflux can reduce the rate of recurrent major adverse CV events.
Published: 2021

9. Evaluation of potential antiplatelet effects of CSL112 (Apolipoprotein A-I [Human]) in patients with atherosclerosis: results from a phase 2a study

Author: Pierluigi Tricoci, Denise D'Andrea, Udaya S. Tantry, Kevin P. Bliden, John H. Alexander, Samuel D. Wright, Thomas Chung, and Paul A. Gurbel
Subjects: Platelets, Adult, Male, medicine.medical_specialty, Prasugrel, Apolipoprotein B, Platelet Aggregation, Platelet Function Tests, Myocardial Infarction, Hemorrhage, 030204 cardiovascular system & hematology, Placebo, Gastroenterology, Article, 03 medical and health sciences, 0302 clinical medicine, Clinical trials, Internal medicine, medicine, Humans, Platelet, 030212 general & internal medicine, Myocardial infarction, Aged, Aspirin, biology, Apolipoprotein A-I, business.industry, Hematology, Middle Aged, medicine.disease, Clopidogrel, Atherosclerosis, Dual antiplatelet therapy, biology.protein, Platelet aggregation inhibitor, High-density lipoprotein, Drug Therapy, Combination, Female, Cardiology and Cardiovascular Medicine, business, Lipoproteins, HDL, Platelet Aggregation Inhibitors, medicine.drug
Abstract: CSL112 (Apolipoprotein A-I [Human]), an infusible, plasma-derived apolipoprotein A-I, is being developed to reduce cardiovascular events following acute myocardial infarction (AMI). A predecessor compound (CSL111) demonstrated a potential antiplatelet effect. A phase 2a multicentre, randomised, single-ascending dose study in patients with stable atherosclerotic disease receiving dual antiplatelet therapy (DAPT) assessed the potential additive effects of CSL112 administration on platelet function and increase bleeding risk in the subacute period after AMI. Patients (n = 44) on aspirin (75–325 mg/day) and either clopidogrel (75 mg/day, n = 37) or prasugrel (10 mg/day, n = 7) for > 30 days alongside standard-of-care therapy were randomised to a single dose of placebo or CSL112: 1.7, 3.4, or 6.8 g. Light transmission aggregometry was used to assess platelet aggregation in response to 2 mM arachidonic acid, 5 and 20 µM adenosine diphosphate, and 4 µg/mL collagen, pre-dose (baseline) and up to 48 h post-dosing. Compared to placebo, CSL112 had no clinically meaningful time- or dose-dependent effects on maximum platelet aggregation in response to any agonist, by either dose or renal function subgroup (p > 0.05). Coagulation parameters showed little variation over time or between treatment groups (p > 0.05). CSL112, when co-administered with standard DAPT, did not significantly influence platelet aggregation in response to agonists and is, therefore, not expected to significantly increase bleeding risk when administered with antiplatelet therapies. Electronic supplementary material The online version of this article (10.1007/s11239-018-1644-z) contains supplementary material, which is available to authorized users.
Published: 2018

10. Ischemic Events Occur Early in Patients Undergoing Percutaneous Coronary Intervention and Are Reduced With Cangrelor: Findings From CHAMPION PHOENIX

Author: Matthew A. Cavender, Robert A. Harrington, Gregg W. Stone, Ph. Gabriel Steg, C. Michael Gibson, Christian W. Hamm, Matthew J. Price, Renato D. Lopes, Sergio Leonardi, Efthymios N. Deliargyris, Jayne Prats, Kenneth W. Mahaffey, Harvey D. White, Deepak L. Bhatt, Kurt Huber, Valter C. Lima, Julia B. Jorgova-Makedonska, Petr Widimský, Bondo Kobulia, Peter W. Radke, Ezio Bramucci, Adam Witkowski, Evgeny Shlyakhto, Frans Van de Werf, David P. Faxon, E. Magnus Ohman, Freek W.A. Verheugt, W. Douglas Weaver, Jan G.P. Tijssen, Matthew Wilson, Stacey Mangum, Chiara Melloni, Matthew J. Brennan, Pierluigi Tricoci, Robert Harrison, Pedro Barros, Luciana Armaganijan, Monique Anderson, Akshay Bagai, Philippe Généreux, Sorin J. Brener, Laura LaSalle, Werner Benzer, Georg Delle-Karth, Franz Leisch, Jamil Abdalla Saad, Alexandre Abizaid, Carlos Augusto Formiga Areas, Expedito E. Ribeiro, Fabio Rossi Dos Santos, Rogerio Tadeu Tumelero, Roberto Vieira Botelho, Borislav Atzev, Boicho Boichev, Georgi Grigorov, Nikolay Penkov, Ivo Petrov, Boris Zehirov, Pavel Cervinka, Zdenek Coufal, Petr Hajek, David Horak, Petr Kala, Petr Kmonicek, Viktor Kocka, Jan Mrozek, Stanislav Simek, Jan Sitar, Josef Stasek, Frantisek Tousek, Gulnara Chapidze, Nodar Emukhvari, George Khabeishvili, Merab Mamatsashvili, Tamaz Shaburishvili, Steffen Behrens, Harald Darius, Martin Dissmann, Stephan Fichtlscherer, Wolfgang Franz, Tobias Geisler, Sabine Genth-Zotz, Britta Goldmann, Hubertus Heuer, Stefan Hoffmann, Andreas Mugge, Tudor Poerner, Peter Radke, Gert Richardt, Christoph Stellbrink, Nikos Werner, Stefano De Servi, Gennaro Galasso, Alberto Menozzi, Giuseppe Musumeci, Andrea Picchi, Patrizia Presbitero, Gerard Devlin, Alexander Sasse, Douglas Scott, Ralph Stewart, Szyszka Andrzej, Witold Dubaniewicz, Zbigniew Gasior, Jaroslaw Kasprzak, Andrzej Kleinrok, Zdzislawa Kornacewicz-Jach, Andrzej Rynkiewicz, Cezary Sosnowski, Radoslaw Targonski, Jaroslaw Trebacz, Elzbieta Zinka, Olga Barbarash, Yakov Dovgalevsky, Ivan Gordeev, Svetlana Kalinina, Elena Kosmachova, Valentin Markov, Prokhor Pavlov, Sergey Shalaev, Zaur Shogenov, Irina Sukmanova, Elena Vasilieva, Alexey Yakovlev, Sarana Boonbaichaiyapruck, Noppadol Chamnarnphol, Pinij Kaewsuwanna, Srun Kuanprasert, Dilok Piyayotai, Maged Amine, Dominick Angiolillo, Imran Arif, James Blankenship, Emmanouil Brilakis, Michael Chan, Joseph Cinderella, Brent Davis, Chandanreddy Devireddy, Mark Dorogy, John Douglas, Norman Ferrier, Daniel Fisher, Robert Foster, William French, John Galla, Lawrence Gimple, Harinder Gogia, Prospero Gogo, Raghava Gollapudi, Luis Gruberg, James Hermiller, Richard Heuser, Robert Iwaoka, Zubair Jafar, Carey Kimmelstiel, Scott Kinlay, James Leggett, Pierre Leimgruber, Dustin Letts, Michael Lipsitt, Reginald Low, Joaquin Martinez-Arraras, Marc Mayhew, Brent McLaurin, Paul McWhirter, Ayoub Mirza, Brian Negus, Thomas Nygaard, William O’Riordan, Richard Paulus, John Petersen, Hector Picon, Mark Picone, Ernesto Rivera, David Rizik, Arsenio Rodriguez, Jorge Saucedo, J. Christopher Scott, Virender Sethi, Adhir Shroff, Craig Siegel, Douglas Spriggs, Daniel Steinberg, Michael Stillabower, Thomas Stuckey, Jose Suarez, Jeffrey Tauth, Dogan Temizer, Mladen Vidovich, Michele Voeltz, Jonathan Waltman, Michael Wilensky, ACS - Heart failure & arrhythmias, and Cardiology
Subjects: percutaneous coronary intervention, P2Y12 receptor antagonist, Original Articles, Adenosine Monophosphate, Clopidogrel, Coronary Interventions, Treatment Outcome, myocardial infarction, Purinergic P2Y Receptor Antagonists, ComputingMethodologies_DOCUMENTANDTEXTPROCESSING, Humans, Cardiology and Cardiovascular Medicine, Platelet Aggregation Inhibitors, coronary artery disease, thrombosis
Abstract: Supplemental Digital Content is available in the text., Background: Thrombotic events are reduced with cangrelor, an intravenous P2Y12 inhibitor. We sought to characterize the timing, number, and type of early events (within 2 hours of randomization) in CHAMPION PHOENIX (A Clinical Trial Comparing Cangrelor to Clopidogrel Standard of Care Therapy in Subjects Who Require Percutaneous Coronary Intervention). Methods: CHAMPION PHOENIX was a double-blind, placebo-controlled trial that randomized patients undergoing percutaneous coronary intervention to cangrelor or clopidogrel. For this analysis, we evaluated the efficacy of cangrelor in the first 2 hours postrandomization with regards to the primary end point (death, myocardial infarction, ischemia-driven revascularization, or stent thrombosis). Sensitivity analyses were performed evaluating a secondary, post hoc end point (death, Society of Coronary Angiography and Intervention myocardial infarction, ischemia-driven revascularization, or Academic Research Consortium definite stent thrombosis). Results: The majority of events (63%) that occurred in the trial occurred within 2 hours of randomization. The most common early event was myocardial infarction; next were stent thrombosis, ischemia driven revascularization, and death. In the first 2 hours after randomization, cangrelor significantly decreased the primary composite end point compared with clopidogrel (4.1% versus 5.4%; hazard ratio, 0.76 [95% CI, 0.64–0.90], P=0.002). Similar findings were seen for the composite end point of death, Society of Coronary Angiography and Intervention myocardial infarction, ischemia-driven revascularization, or Academic Research Consortium stent thrombosis at 2 hours (0.9% versus 1.6%; hazard ratio, 0.57 [95% CI, 0.40–0.80], P=0.001). Between 2 and 48 hours, there was no difference in the primary composite end point (0.6% versus 0.5%; odds ratio, 1.17 [95% CI, 0.71–1.93]; P=0.53). Early (≤2 hours of randomization) GUSTO (Global Use of Strategies to Open Occluded Coronary Arteries) moderate or severe bleeding events were infrequent, and there was no significant difference with cangrelor compared with clopidogrel (0.2% [n=10] versus 0.1% [n=4]; adjusted odds ratio, 1.41 [95% CI, 0.37–5.40]; P=0.62). Conclusions: The reductions in ischemic events and overall efficacy seen with cangrelor in CHAMPION PHOENIX occurred early and during the period of time in which patients were being actively treated with cangrelor. These findings provide evidence that supports the importance of potent platelet inhibition during percutaneous coronary intervention. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01156571.
Published: 2021

11. Alirocumab Reduces Total Nonfatal Cardiovascular and Fatal Events

Author: Investigators, Rafael Diaz, Vera Bittner, Takeshi Kimura, Pierluigi Tricoci, Gregory G. Schwartz, Michael Szarek, J. Wouter Jukema, Denis Xavier, Robert A. Harrington, Kenneth W. Mahaffey, Matthew T. Roe, Deepak L. Bhatt, Andreas M. Zeiher, Corinne Hanotin, Shaun G. Goodman, Róbert Gábor Kiss, Odyssey Outcomes Committees, Chern-En Chiang, Marco Alings, Harvey D. White, Jay M. Edelberg, Angele Moryusef, Guillaume Lecorps, Ph. Gabriel Steg, and Robert Pordy
Subjects: medicine.medical_specialty, Acute coronary syndrome, business.industry, Unstable angina, Hazard ratio, food and beverages, 030204 cardiovascular system & hematology, medicine.disease, Placebo, Confidence interval, 03 medical and health sciences, 0302 clinical medicine, Internal medicine, Cardiology, Medicine, acute coronary syndrome, alirocumab, total events, 030212 general & internal medicine, Myocardial infarction, Cardiology and Cardiovascular Medicine, business, Stroke, Alirocumab
Abstract: BACKGROUND The ODYSSEY OUTCOMES (Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab) trial compared alirocumab with placebo, added to high- intensity or maximum-tolerated statin treatment, after acute coronary syndrome (ACS) in 18, 924 patients. Alirocumab reduced the first occurrence of the primary composite endpoint and was associated with fewer all-cause deaths. OBJECTIVES This pre-specified analysis determined the extent to which alirocumab reduced total (first and subsequent) nonfatal cardiovascular events and all-cause deaths in ODYSSEY OUTCOMES. METHODS Hazard functions for total nonfatal cardiovascular events (myocardial infarction, stroke, ischemia-driven coronary revascularization, and hospitalization for unstable angina or heart failure) and death were jointly estimated, linked by a shared frailty accounting for patient risk heterogeneity and correlated within-patient nonfatal events. An association parameter also quantified the strength of the linkage between risk of nonfatal events and death. The model provides accurate relative estimates of nonfatal event risk if nonfatal events are associated with increased risk for death. RESULTS With 3, 064 first and 5, 425 total events, 190 fewer first and 385 fewer total nonfatal cardiovascular events or deaths were observed with alirocumab compared with placebo. Alirocumab reduced total nonfatal cardiovascular events (hazard ratio: 0.87 ; 95% confidence interval: 0.82 to 0.93) and death (hazard ratio: 0.83 ; 95% confidence interval: 0.71 to 0.97) in the presence of a strong association between nonfatal and fatal event risk. CONCLUSIONS In patients with ACS, the total number of nonfatal cardiovascular events and deaths prevented with alirocumab was twice the number of first events prevented. Consequently, total event reduction is a more comprehensive metric to capture the totality of alirocumab clinical efficacy after ACS. (c) 2019 The Authors. Published by Elsevier on behalf of the American College of Cardiology Foundation.
Published: 2019

12. Albiglutide and cardiovascular outcomes in patients with type 2 diabetes and cardiovascular disease (Harmony Outcomes): a double-blind, randomised placebo-controlled trial

Author: Adrian F Hernandez, Jennifer B Green, Salim Janmohamed, Ralph B D'Agostino, Christopher B Granger, Nigel P Jones, Lawrence A Leiter, Anne E Rosenberg, Kristina N Sigmon, Matthew C Somerville, Karl M Thorpe, John J V McMurray, Stefano Del Prato, John J.V. McMurray, Ralph B. D'Agostino, Christopher B. Granger, Adrian F. Hernandez, Lawrence A. Leiter, Robert M Califf, Rury Holman, David DeMets, Matthew Riddle, Shaun Goodman, Darren McGuire, Karen Alexander, Adam Devore, Chiara Melloni, Chetan Patel, David Kong, Gerald Bloomfield, Matthew Roe, Pierluigi Tricoci, Rob Harrison, Renato Lopes, Robin Mathews, Rajendra Mehta, William Schuyler Jones, Sreekanth Vemulapalli, Thomas Povsic, Zubin Eapen, Keith Dombrowski, Brad Kolls, Dedrick Jordan, Andrew Ambrosy, Stephen Greene, Aditya Mandawat, Jay Shavadia, Lauren Cooper, Abhinav Sharma, Patricia Guimaraes, Daniel Friedman, Matt Wilson, Patricia Endsley, Tracy Gentry, Jeannie Collier, Kathleen Perez, Kourtnei James, Jennifer Roush, Connie Pope, Christina Howell, Megan Johnson, Matt Bailey, Joanna Cole, Teresa Akers, Beth Vandyne, Betsy Thomas, Jenny Rich, Susan Bartone, Gail Beaulieu, Kim Brown, Tuan Chau, Tamra Christian, Rebecca Coker, Deb Greene, Trevorlyn Haddock, Wendy Jenkins, Ghazala Haque, Marsha Marquess, Jean Pesarchick, Renee Rethaford, Allegra Stone, Firas Al Kawas, Michelle Anderson, Robert Enns, Isaac Sinay, Chantal Mathieu, Victor Yordanov, Irene Hramiak, Martin Haluzik, Søren Galatius, Bruno Guerci, Michael Nauck, Ilias Migdalis, Choon Beng Kathryn Tan, Gyozo Kocsis, Andrea Giaccari, Moon Kyu Lee, Ernesto German Cardona Muñoz, Jan Cornel, Kare Birkeland, Miguel Pinto, Louie Tirador, Martyna Olesinska-Mader, Marina Shestakova, Larry Distiller, Jose Lopez-Sendon, Bjorn Eliasson, Chern-En Chiang, Suphot Srimahachota, Boris Mankovsky, M Angelyn Bethel, Kathleen Dungan, Mikhail Kosiborod, Andres Alvarisqueta, Jorge Baldovino, Diego Besada, Pedro Calella, Maria Cecilia Cantero, Patricia Castaño, Alejandro Chertkoff, Jesus Cuadrado, Luis De Loredo, Andrea Dominguez, Maria Vanesa Español, Hernan Finkelstein, Gustavo Frechtel, Jose Fretes, Natalia Garrido Santos, Joaquin Gonzalez, Marcos Litvak, Juan Loureyro, Laura Maffei, Natacha Maldonado, Diego Mohr Gasparini, Silvia Orio, Federico Perez Manghi, Nelson Rodriguez Papini, Jorgelina Sala, Pablo Schygiel, Georgina Sposetti, Maria Ulla, Fernando Verra, Silvina Zabalua, Cesar Zaidman, Laurent Crenier, Corinne Debroye, Francis Duyck, André Scheen, Luc Van Gaal, Chris Vercammen, Velichka Damyanova, Stefan Dimitrov, Snezhina Kovacheva, Lachezar Lozanov, Viktor Margaritov, Rositsa Mihaylova-Shumkova, Antoaneta Nikolaeva, Zhasmina Stoyanova, Ronald Akhras, Yves Beaudry, Jacques Bedard, Joseph Berlingieri, Raja Chehayeb, Stephen Cheung, James Conway, Jean Cusson, Anthony Della Siega, Richard Dumas, Peter Dzongowski, Murdo Ferguson, Daniel Gaudet, Francois Grondin, Anil Gupta, Milan Gupta, Frank Halperin, Pierre-Alain Houle, Michael Jones, Simon Kouz, Christopher Kovacs, Daniel Landry, Eva Lonn, William O'Mahony, Sean Peterson, Dennis Reich, Alan Rosenbloom, Francois St-Maurice, Barna Tugwell, Saul Vizel, Vincent Woo, Tomas Brychta, Vladimir Cech, Eva Dvorakova, Tomas Edelsberger, Katarina Halciakova, Jarmila Krizova, Jiri Lastuvka, Martin Piperek, Vera Prymkova, Lea Raclavska, Elena Silhova, Robin Urbanek, Jan Vrkoc, Ulla Andersen, Jens Brønnum-Schou, Jens Hove, Jan Skov Jensen, Lars Kober, Ole Peter Kristiansen, Per Lund, Thomas Melchior, Ole Nyvad, Morten Schou, Alain Boye, Didier Cadinot, Didier Gouet, Patrick Henry, Laurence Kessler, Jean-Daniel Lalau, Catherine Petit, Jean-Francois Thuan, Christel Voinot, Julien Vouillarmet, Christoph Axthelm, Dirk Berger, Tasso Bieler, Andreas Birkenfeld, Jochen Bott, Klaus Busch, Karel Caca, Julia Chevts, Torsten Donaubauer, Rudolf Erlinger, Klaus Funke, Josef Grosskopf, Andreas Hagenow, Monika Hamann, Manfred Hartard, Peter Heymer, Wolfgang Huppertz, Gabriele Illies, Stephan Jacob, Thomas Jung, Gerd Kahrmann, Petra Kast, Monika Kellerer, Hans-Peter Kempe, Andrei Khariouzov, Gerhard Klausmann, Christiane Klein, Uwe Kleinecke-Pohl, Klaus Kleinertz, Thorsten Koch, Christine Kosch, Babette Lorra, Joerg Luedemann, Matthias Luttermann, Stephan Maxeiner, Karsten Milek, Andrea Moelle, Gerhard Neumann, Ruth Nischik, Edith Oehrig-Pohl, Georg Plassmann, Lars Pohlmeier, Felix Proepper, Stefan Regner, Werner Rieker, Ludger Rose, Holger Samer, Joachim Sauter, Frank Schaper, Clemens Schiffer, Juergen Schmidt, Bernd-M. Scholz, Joerg Schulze, Alexander Segner, Jochen Seufert, Helena Sigal, Joerg Steindorf, Juergen Stockhausen, Petra Stuebler, Heidrun Taeschner, Dietrich Tews, Diethelm Tschoepe, Karl Wilhelm, Helga Zeller-Stefan, Iakovos Avramidis, Stavros Bousboulas, Magdalini Bristianou, Georgios Dimitriadis, Moses Elisaf, Kalliopi Kotsa, Andreas Melidonis, Asimina Mitrakou, Emmanouil Pagkalos, Nikolaos Papanas, Angelos Pappas, Christos Sampanis, Nikolaos Tentolouris, Apostolos Tsapas, Glykeria Tzatzagou, Risa Ozaki, Csaba Hajdú, Eleonóra Harcsa, Laszlo Konyves, János Mucsi, Zsolt Pauker, Gizella Petró, Zsolt Plés, Katalin Revesz, Vangel Sándor, Viktor Vass, Angelo Avogaro, Massimo Boemi, Riccardo Bonadonna, Agostino Consoli, Salvatore De Cosmo, Paolo Di Bartolo, Francesco Dotta, Simona Frontoni, Marianna Galetta, Alessandra Gambineri, Carmine Gazzaruso, Francesco Giorgino, Davide Lauro, Emanuela Orsi, Giuseppe Paolisso, Gabriele Perriello, Piermarco Piatti, Antonio Pontiroli, Paola Ponzani, Angela Albarosa Rivellese, Giorgio Sesti, Giancarlo Tonolo, Roberto Trevisan, Chul Woo Ahn, Sei-Hyun Baik, Bong-Soo Cha, Choon-Hee Chung, Hak Chul Jang, Chong-Jin Kim, Hye Soon Kim, In Joo Kim, Eun Young Lee, Hyoung Woo Lee, Kwan-Woo Lee, Keon-Woong Moon, June Namgung, Kyong Soo Park, Soon Jib Yoo, Jaemyung Yu, Edmundo-Alfredo Bayram Llamas, Jose-Luis Cervantes-Escárcega, Luis Fernando Flota-Cervera, José Gerardo González-González, Sara Pascoe-Gonzalez, Emilia Susana Pelayo-Orozco, Santiago-Paulino Ramirez-Diaz, Arturo Saldana-Mendoza, Carlos Sánchez Jerjes-Díaz, Jose Juan Torres-Colores, Maricela Vidrio-Velázquez, Juan Villagordoa-Mesa, Hugo Peter Beijerbacht, Reginald G.E.J. Groutars, Boudewijn A Hoek, Pieter A.M. Hoogslag, Adriaan Kooy, Johannes A. Kragten, Aloysius G. Lieverse, Hendrik P. Swart, Eric P. Viergever, Jørn Ahlqvist, John Cooper, Hanne Gulseth, Gaute Guttormsen, Cecilie Wium, Hugo Arbañil, Jorge Calderon, Luis Camacho, Augusto Dextre Espinoza, Elizabeth Garrido, Alejandro Luna, Helard Manrique, Frederick Massucco Revoredo, Rolando Vargas Gonzales, Luis Zapata Rincon, Carlos Zubiate, Geraldine Ebo, Ellen Morales-Palomares, Malgorzata Arciszewska, Marek Banach, Renata Bijata-Bronisz, Tadeusz Derezinski, Waldemar Gadzinski, Jacek Gajek, Katarzyna Klodawska, Ewa Krzyzagorska, Andrzej Madej, Pawel Miekus, Jaroslaw Opiela, Piotr Romanczuk, Anna Siegel, Ewa Skokowska, Andrzej Stankiewicz, Teresa Stasinska, Iwona Trznadel-Morawska, Robert Witek, Sergey Aksentyev, Irina Bondar, Irina Demidova, Alexander Dreval, Olga Ershova, Gagik Galstyan, Alla Garganeeva, Nadezhda Izmozherova, Victoria Karetnikova, Marina Kharakhulakh, Aleksandr Khokhlov, Zhanna Kobalava, Olga Koshelskaya, Elena Kosmacheva, Vladimir Kostin, Natalia Koziolova, Anatoly Kuzin, Victor Lesnov, Tatyana Lysenko, Valentin Markov, Alexander Mayorov, Sergey Moiseev, Svetlana Myasoedova, Nina Petunina, Andrey Rebrov, Ludmila Ruyatkina, Julia Samoylova, Olga Sazonova, Natalia Shilkina, Nadezhda Sokolova, Olga Vasilevskaya, Nelli Verbovaya, Elena Vishneva, Sergey Vorobyev, Natalya Vorokhobina, Olga Zanozina, Elena Zhdanova, Tatyana Zykova, Lesley Burgess, Kathleen Coetzee, Saleem Dawood, Landman Lombard, Ellen Makotoko, Rajendran Moodley, Wessels Oosthuysen, Mohamed Sarvan, Carlos Calvo Gómez, Isidoro Cano Rodríguez, Almudena Castro Conde, Angel Cequier Fillat, Guillem Cuatrecasas Cambra, Fernando de Álvaro Moreno, Luis De Teresa Parreño, Javier Delgado Lista, José Ramón Domínguez Escribano, Santiago Durán García, Javier Elvira González, José María Fernández Rodríguez, Alberto Goday Arno, Ricardo Gomez Huelgas, José Ramón González Juanatey, Antonio Hernandez Mijares, Víctor Alfonso Jiménez Díaz, Esteban Jodar Gimeno, Tomás Lucas Morante, Monica Marazuela, Nieves Martell Claros, Didac Mauricio Puente, Elena Mena Ribas, Juan Francisco Merino Torres, Pedro Mezquita Raya, Andreu Nubiola Calonge, Xavier Ordoñez Sánchez, Jose Maria Pascual Izuel, Verónica Perea Castilla, Antonio Pérez Pérez, Isabel Perez Soto, Miguel Quesada Charneco, Angustias Quesada Simón, Josep Redón Mas, Antonia Rego Iraeta, Maria Rodriguez Alvarez, Irene Rodríguez Rodríguez, José Sabán Ruiz, Alfonso Soto González, Francisco Tinahones Madueno, Carlos Trescoli Serrano, Angels Ulied Armiñana, Erasmus Bachus, Katarina Berndtsson Blom, Ken Eliasson, Pekka Koskinen, Hans Larnefeldt, Cornelia Lif-Tiberg, Carina Linderfalk, Gustav Lund, Pia Lundman, Linda Moris, Åke Olsson, Staffan Salmonsson, Johan Sanmartin Berglund, Folke Sjöberg, Stefan Söderberg, Ingemar Torstensson, Jung-Fu Chen, Kai Jen Tien, Shih-Ting Tseng, Shih-Te Tu, Chih-Yuan Wang, Ji-Hung Wang, Arintaya Phrommintikul, Sukit Yamwong, Woravut Jintapakorn, Pisit Hutayanon, Nakarin Sansanayudh, Larysa Bazhan, Ivan Fushtey, Mariya Grachova, Vitaliy Katerenchuk, Vadym Korpachev, Nonna Kravchun, Oleksandr Larin, Galyna Mykhalchyshyn, Halyna Myshanych, Olga Oleksyk, Valeriia Orlenko, Nataliia Pashkovska, Nataliia Pertseva, Olena Petrosyan, Ivan Smirnov, Maryna Vlasenko, Tetiana Zlova, Myint Aye, Arun Baksi, Mathangi Balasubramani, Ronnie Beboso, Mark Blagden, Charles Bundy, Tobias Cookson, Allan Copland, Alistair Emslie-Smith, Fiona Green, Anthony Gunstone, Basil Issa, Ewart Jackson-Voyzey, Andrew Johnson, Malcolm Maclean, John McKnight, Solomon Muzulu, Ian O'Connell, Babatunde Oyesile, Catherine Patterson, Ewan Pearson, Sam Philip, Paul Smith, Usha Sukumaran, Jalal Abbas, Gaurav Aggarwala, Faiq Akhter, James Andersen, Moise Anglade, Georges Argoud, Mehrdad Ariani, Reswan Ashdji, Ladan Bakhtari, Subhash Banerjee, Andrew Bartlett, Howard Baum, Harold Bays, Richard Beasley, Renata Belfort de Aguiar, Sabrina Benjamin, Ravi Bhagwat, Anuj Bhargava, Bruce Bode, Christina Bratcher, Toby Briskin, Andrew Brockmyre, Raymond Broughton, Judith Brown, Madhusudan Budhraja, Kevin Cannon, Jewell Carr, Harold Cathcart, Arvind Cavale, Louis Chaykin, Deanna Cheung, Richard Childress, Allan Cohen, Jonathan Condit, Erin Cooksey, George Mitchell Cornett, Ira Dauber, William Davila, Luis De Armas, Julius Dean, Robert Detweiler, Ernesto Diaz, Michael Di Giovanna, Isaac Dor, Waymon Drummond, Donald Eagerton, John Earl, Charles Eaton, Howard Ellison, Neil Farris, Thomas Fiel, Anthony Firek, Brian First, Les Forgosh, William French, Winston Gandy, Ronald Garcia, Santosh Gill, Murray Gordon, Michael Guice, Siva Gummadi, Jonathan Hackenyos, Kristen Hairston, Lenita Hanson, Lindsay Harrison, Israel Hartman, John Heitner, Srini Hejeebu, Paul Hermany, Carlos Hernandez-Cassis, Horacio Hidalgo, Alexander Higgins, Hassan Ibrahim, Shahram Jacobs, David Johnson, Parag Joshi, Steven Kaster, Daniel Kellum, Christopher Kim, Ellen Kim, William Kirby, Albert Knouse, Steven Kulback, Mariananda Kumar, Tulsidas Kuruvanka, Ajay Labroo, William Lasswell, John Lentz, Thomas Lenzmeier, David Lewis, Zhaoping Li, Michael Lillestol, Raymond Little, Richard Lorraine, Cecilia McKeown-Biagas, Robert McNeill, Anand Mehta, Alan Miller, Joseph Moran, Emily Morawski, Venkatesh Nadar, Thomas O'Connor, Alberto Odio, Reginald Parker, Rajesh Patel, Lawrence Phillips, George Raad, Aref Rahman, Marina Raikhel, Ajit Raisinghani, Raj Rajan, Neda Rasouli, Frank Rauzi, Kathryn Rohr, Hal Roseman, Sergio Rovner, Fadi Saba, Richard Sachson, Alex Schabauer, Ricky Schneider, Timothy Schuchard, John Sensenbrenner, Yshay Shlesinger, Narendra Singh, Kanagaratnam Sivalingam, Larry Stonesifer, Daniel Storey, David Suh, Mohammed Tahir, Anjanette Tan, Marilyn Tan, Alain Taylon, Maitreya Thakkar, Devjit Tripathy, Gabriel Uwaifo, Amarnath Vedere, Chandra Venugopal, Anthony Vo, Michelle Welch, James Welker, Alexander White, John Willis, Alan Wynne, Shahram Yazdani, Anne Rosenberg, Lauren Price, Kristina Sigmon, Yuliya Lokhngina, Weibing Xing, Robert Overton, Murray Stewart, Janet Stead, Alistair Lindsay, Vickas Patel, Jorge Ross, Joseph Soffer, Shruti Daga, Margaret Sowell, Prashant Patel, Louisa Garvey, Jessica Ackert, Sybil Abraham, Mary Beth Sabol, Desma Altobelli, JuYoung Ha, Mangesh Kulkarni, Matthew Somerville, Drusilla Noronha, Ed Casson, Eddie Zang, Chamandeep Sandhu, Rakesh Kumar, David Chen, Lin Taft, Rajivkumar Patel, June Ye, Jennifer Shannon, Tim Wilson, Charleen Babi, Diane Miller, Karl Thorpe, Rachael Russell, Georgina Bull, Belinda Hereghty, Eva Fernandez-Salazar, Troy Longley, Jill Donaldson, Marie Jarosz, Karen Murphy, Patricia Adams, Peter Smith, Rachel James, Jackie Richards, Sangeeta Sedani, Denise Althouse, David Watson, Jamie Lorimer, Steven Lauder, Ron Schultheis, Terese Womer, Ella Wraight, Wenyan Li, Emma Price-Olsen, Anthony Watson, Aoife Kelly, Patricia McLaughlin, John Fleming, Jessica Schubert, Debra Schleiden, Tara Harris, Rahul Prakash, Jody Breneman, Sameer Deshpande, Aarti Saswadkar, Aditi Kumari, Aditi Shitut, Amruta Raorane, Anisha Karmalkar, Ankita Mhambrey, Archana Bhosale, Ashok Vaphare, Ashwini P Patil, Chaitali Khandelwal, Fayaz Shaik, Madhumitha Nadar, Mounika Karka, Neha Kadgaonkar, Nikita Gupta, Nutan Aher, Omkar Potnis, Pallavi Naicker, Rakesh Shinde, Richa Sharma, Rupali Godse, Sheetal Solanki, Shruti Sahu, Snehal Dumbre, Somesh Kumar, Suradnya Patil, Trisha Mandal, Hernandez, Adrian F, Green, Jennifer B, Janmohamed, Salim, D'Agostino, Ralph B, Granger, Christopher B, Jones, Nigel P, Leiter, Lawrence A, Rosenberg, Anne E, Sigmon, Kristina N, Somerville, Matthew C, Thorpe, Karl M, Mcmurray, John J V, Del Prato, Stefano, Mcmurray, John J. V., D'Agostino, Ralph B., Granger, Christopher B., Hernandez, Adrian F., Leiter, Lawrence A., Califf, Robert M, Holman, Rury, Demets, David, Riddle, Matthew, Goodman, Shaun, Mcguire, Darren, Alexander, Karen, Devore, Adam, Melloni, Chiara, Patel, Chetan, Kong, David, Bloomfield, Gerald, Roe, Matthew, Tricoci, Pierluigi, Harrison, Rob, Lopes, Renato, Mathews, Robin, Mehta, Rajendra, Schuyler Jones, William, Vemulapalli, Sreekanth, Povsic, Thoma, Eapen, Zubin, Dombrowski, Keith, Kolls, Brad, Jordan, Dedrick, Ambrosy, Andrew, Greene, Stephen, Mandawat, Aditya, Shavadia, Jay, Cooper, Lauren, Sharma, Abhinav, Guimaraes, Patricia, Friedman, Daniel, Wilson, Matt, Endsley, Patricia, Gentry, Tracy, Collier, Jeannie, Perez, Kathleen, James, Kourtnei, Roush, Jennifer, Pope, Connie, Howell, Christina, Johnson, Megan, Bailey, Matt, Cole, Joanna, Akers, Teresa, Vandyne, Beth, Thomas, Betsy, Rich, Jenny, Bartone, Susan, Beaulieu, Gail, Brown, Kim, Chau, Tuan, Christian, Tamra, Coker, Rebecca, Greene, Deb, Haddock, Trevorlyn, Jenkins, Wendy, Haque, Ghazala, Marquess, Marsha, Pesarchick, Jean, Rethaford, Renee, Stone, Allegra, Al Kawas, Fira, Anderson, Michelle, Enns, Robert, Sinay, Isaac, Mathieu, Chantal, Yordanov, Victor, Hramiak, Irene, Haluzik, Martin, Galatius, Søren, Guerci, Bruno, Nauck, Michael, Migdalis, Ilia, Tan, Choon Beng Kathryn, Kocsis, Gyozo, Giaccari, Andrea, Lee, Moon Kyu, Muñoz, Ernesto German Cardona, Cornel, Jan, Birkeland, Kare, Pinto, Miguel, Tirador, Louie, Olesinska-Mader, Martyna, Shestakova, Marina, Distiller, Larry, Lopez-Sendon, Jose, Eliasson, Bjorn, Chiang, Chern-En, Srimahachota, Suphot, Mankovsky, Bori, Bethel, M Angelyn, Dungan, Kathleen, Kosiborod, Mikhail, Alvarisqueta, Andre, Baldovino, Jorge, Besada, Diego, Calella, Pedro, Cantero, Maria Cecilia, Castaño, Patricia, Chertkoff, Alejandro, Cuadrado, Jesu, De Loredo, Lui, Dominguez, Andrea, Español, Maria Vanesa, Finkelstein, Hernan, Frechtel, Gustavo, Fretes, Jose, Garrido Santos, Natalia, Gonzalez, Joaquin, Litvak, Marco, Loureyro, Juan, Maffei, Laura, Maldonado, Natacha, Mohr Gasparini, Diego, Orio, Silvia, Perez Manghi, Federico, Rodriguez Papini, Nelson, Sala, Jorgelina, Schygiel, Pablo, Sposetti, Georgina, Ulla, Maria, Verra, Fernando, Zabalua, Silvina, Zaidman, Cesar, Crenier, Laurent, Debroye, Corinne, Duyck, Franci, Scheen, André, Van Gaal, Luc, Vercammen, Chri, Damyanova, Velichka, Dimitrov, Stefan, Kovacheva, Snezhina, Lozanov, Lachezar, Margaritov, Viktor, Mihaylova-Shumkova, Rositsa, Nikolaeva, Antoaneta, Stoyanova, Zhasmina, Akhras, Ronald, Beaudry, Yve, Bedard, Jacque, Berlingieri, Joseph, Chehayeb, Raja, Cheung, Stephen, Conway, Jame, Cusson, Jean, Della Siega, Anthony, Dumas, Richard, Dzongowski, Peter, Ferguson, Murdo, Gaudet, Daniel, Grondin, Francoi, Gupta, Anil, Gupta, Milan, Halperin, Frank, Houle, Pierre-Alain, Jones, Michael, Kouz, Simon, Kovacs, Christopher, Landry, Daniel, Lonn, Eva, O'Mahony, William, Peterson, Sean, Reich, Denni, Rosenbloom, Alan, St-Maurice, Francoi, Tugwell, Barna, Vizel, Saul, Woo, Vincent, Brychta, Toma, Cech, Vladimir, Dvorakova, Eva, Edelsberger, Toma, Halciakova, Katarina, Krizova, Jarmila, Lastuvka, Jiri, Piperek, Martin, Prymkova, Vera, Raclavska, Lea, Silhova, Elena, Urbanek, Robin, Vrkoc, Jan, Andersen, Ulla, Brønnum-Schou, Jen, Hove, Jen, Jensen, Jan Skov, Kober, Lar, Kristiansen, Ole Peter, Lund, Per, Melchior, Thoma, Nyvad, Ole, Schou, Morten, Boye, Alain, Cadinot, Didier, Gouet, Didier, Henry, Patrick, Kessler, Laurence, Lalau, Jean-Daniel, Petit, Catherine, Thuan, Jean-Francoi, Voinot, Christel, Vouillarmet, Julien, Axthelm, Christoph, Berger, Dirk, Bieler, Tasso, Birkenfeld, Andrea, Bott, Jochen, Busch, Klau, Caca, Karel, Chevts, Julia, Donaubauer, Torsten, Erlinger, Rudolf, Funke, Klau, Grosskopf, Josef, Hagenow, Andrea, Hamann, Monika, Hartard, Manfred, Heymer, Peter, Huppertz, Wolfgang, Illies, Gabriele, Jacob, Stephan, Jung, Thoma, Kahrmann, Gerd, Kast, Petra, Kellerer, Monika, Kempe, Hans-Peter, Khariouzov, Andrei, Klausmann, Gerhard, Klein, Christiane, Kleinecke-Pohl, Uwe, Kleinertz, Klau, Koch, Thorsten, Kosch, Christine, Lorra, Babette, Luedemann, Joerg, Luttermann, Matthia, Maxeiner, Stephan, Milek, Karsten, Moelle, Andrea, Neumann, Gerhard, Nischik, Ruth, Oehrig-Pohl, Edith, Plassmann, Georg, Pohlmeier, Lar, Proepper, Felix, Regner, Stefan, Rieker, Werner, Rose, Ludger, Samer, Holger, Sauter, Joachim, Schaper, Frank, Schiffer, Clemen, Schmidt, Juergen, Scholz, Bernd-M., Schulze, Joerg, Segner, Alexander, Seufert, Jochen, Sigal, Helena, Steindorf, Joerg, Stockhausen, Juergen, Stuebler, Petra, Taeschner, Heidrun, Tews, Dietrich, Tschoepe, Diethelm, Wilhelm, Karl, Zeller-Stefan, Helga, Avramidis, Iakovo, Bousboulas, Stavro, Bristianou, Magdalini, Dimitriadis, Georgio, Elisaf, Mose, Kotsa, Kalliopi, Melidonis, Andrea, Mitrakou, Asimina, Pagkalos, Emmanouil, Papanas, Nikolao, Pappas, Angelo, Sampanis, Christo, Tentolouris, Nikolao, Tsapas, Apostolo, Tzatzagou, Glykeria, Ozaki, Risa, Hajdú, Csaba, Harcsa, Eleonóra, Konyves, Laszlo, Mucsi, Jáno, Pauker, Zsolt, Petró, Gizella, Plés, Zsolt, Revesz, Katalin, Sándor, Vangel, Vass, Viktor, Avogaro, Angelo, Boemi, Massimo, Bonadonna, Riccardo, Consoli, Agostino, De Cosmo, Salvatore, Di Bartolo, Paolo, Dotta, Francesco, Frontoni, Simona, Galetta, Marianna, Gambineri, Alessandra, Gazzaruso, Carmine, Giorgino, Francesco, Lauro, Davide, Orsi, Emanuela, Paolisso, Giuseppe, Perriello, Gabriele, Piatti, Piermarco, Pontiroli, Antonio, Ponzani, Paola, Rivellese, Angela Albarosa, Sesti, Giorgio, Tonolo, Giancarlo, Trevisan, Roberto, Ahn, Chul Woo, Baik, Sei-Hyun, Cha, Bong-Soo, Chung, Choon-Hee, Jang, Hak Chul, Kim, Chong-Jin, Kim, Hye Soon, Kim, In Joo, Lee, Eun Young, Lee, Hyoung Woo, Lee, Kwan-Woo, Moon, Keon-Woong, Namgung, June, Park, Kyong Soo, Yoo, Soon Jib, Yu, Jaemyung, Llamas, Edmundo-Alfredo Bayram, Cervantes-Escárcega, Jose-Lui, Flota-Cervera, Luis Fernando, González-González, José Gerardo, Pascoe-Gonzalez, Sara, Pelayo-Orozco, Emilia Susana, Ramirez-Diaz, Santiago-Paulino, Saldana-Mendoza, Arturo, Jerjes-Díaz, Carlos Sánchez, Torres-Colores, Jose Juan, Vidrio-Velázquez, Maricela, Villagordoa-Mesa, Juan, Beijerbacht, Hugo Peter, Groutars, Reginald G. E. J., Hoek, Boudewijn A, Hoogslag, Pieter A. M., Kooy, Adriaan, Kragten, Johannes A., Lieverse, Aloysius G., Swart, Hendrik P., Viergever, Eric P., Ahlqvist, Jørn, Cooper, John, Gulseth, Hanne, Guttormsen, Gaute, Wium, Cecilie, Arbañil, Hugo, Calderon, Jorge, Camacho, Lui, Espinoza, Augusto Dextre, Garrido, Elizabeth, Luna, Alejandro, Manrique, Helard, Revoredo, Frederick Massucco, Gonzales, Rolando Varga, Rincon, Luis Zapata, Zubiate, Carlo, Ebo, Geraldine, Morales-Palomares, Ellen, Arciszewska, Malgorzata, Banach, Marek, Bijata-Bronisz, Renata, Derezinski, Tadeusz, Gadzinski, Waldemar, Gajek, Jacek, Klodawska, Katarzyna, Krzyzagorska, Ewa, Madej, Andrzej, Miekus, Pawel, Opiela, Jaroslaw, Romanczuk, Piotr, Siegel, Anna, Skokowska, Ewa, Stankiewicz, Andrzej, Stasinska, Teresa, Trznadel-Morawska, Iwona, Witek, Robert, Aksentyev, Sergey, Bondar, Irina, Demidova, Irina, Dreval, Alexander, Ershova, Olga, Galstyan, Gagik, Garganeeva, Alla, Izmozherova, Nadezhda, Karetnikova, Victoria, Kharakhulakh, Marina, Khokhlov, Aleksandr, Kobalava, Zhanna, Koshelskaya, Olga, Kosmacheva, Elena, Kostin, Vladimir, Koziolova, Natalia, Kuzin, Anatoly, Lesnov, Victor, Lysenko, Tatyana, Markov, Valentin, Mayorov, Alexander, Moiseev, Sergey, Myasoedova, Svetlana, Petunina, Nina, Rebrov, Andrey, Ruyatkina, Ludmila, Samoylova, Julia, Sazonova, Olga, Shilkina, Natalia, Sokolova, Nadezhda, Vasilevskaya, Olga, Verbovaya, Nelli, Vishneva, Elena, Vorobyev, Sergey, Vorokhobina, Natalya, Zanozina, Olga, Zhdanova, Elena, Zykova, Tatyana, Burgess, Lesley, Coetzee, Kathleen, Dawood, Saleem, Lombard, Landman, Makotoko, Ellen, Moodley, Rajendran, Oosthuysen, Wessel, Sarvan, Mohamed, Calvo Gómez, Carlo, Cano Rodríguez, Isidoro, Castro Conde, Almudena, Cequier Fillat, Angel, Cuatrecasas Cambra, Guillem, de Álvaro Moreno, Fernando, De Teresa Parreño, Lui, Delgado Lista, Javier, Domínguez Escribano, José Ramón, Durán García, Santiago, Elvira González, Javier, Fernández Rodríguez, José María, Goday Arno, Alberto, Gomez Huelgas, Ricardo, González Juanatey, José Ramón, Hernandez Mijares, Antonio, Jiménez Díaz, Víctor Alfonso, Jodar Gimeno, Esteban, Lucas Morante, Tomá, Marazuela, Monica, Martell Claros, Nieve, Mauricio Puente, Didac, Mena Ribas, Elena, Merino Torres, Juan Francisco, Mezquita Raya, Pedro, Nubiola Calonge, Andreu, Ordoñez Sánchez, Xavier, Pascual Izuel, Jose Maria, Perea Castilla, Verónica, Pérez Pérez, Antonio, Perez Soto, Isabel, Quesada Charneco, Miguel, Quesada Simón, Angustia, Redón Mas, Josep, Rego Iraeta, Antonia, Rodriguez Alvarez, Maria, Rodríguez Rodríguez, Irene, Sabán Ruiz, José, Soto González, Alfonso, Tinahones Madueno, Francisco, Trescoli Serrano, Carlo, Ulied Armiñana, Angel, Bachus, Erasmu, Berndtsson Blom, Katarina, Eliasson, Ken, Koskinen, Pekka, Larnefeldt, Han, Lif-Tiberg, Cornelia, Linderfalk, Carina, Lund, Gustav, Lundman, Pia, Moris, Linda, Olsson, Åke, Salmonsson, Staffan, Sanmartin Berglund, Johan, Sjöberg, Folke, Söderberg, Stefan, Torstensson, Ingemar, Chen, Jung-Fu, Tien, Kai Jen, Tseng, Shih-Ting, Tu, Shih-Te, Wang, Chih-Yuan, Wang, Ji-Hung, Phrommintikul, Arintaya, Yamwong, Sukit, Jintapakorn, Woravut, Hutayanon, Pisit, Sansanayudh, Nakarin, Bazhan, Larysa, Fushtey, Ivan, Grachova, Mariya, Katerenchuk, Vitaliy, Korpachev, Vadym, Kravchun, Nonna, Larin, Oleksandr, Mykhalchyshyn, Galyna, Myshanych, Halyna, Oleksyk, Olga, Orlenko, Valeriia, Pashkovska, Nataliia, Pertseva, Nataliia, Petrosyan, Olena, Smirnov, Ivan, Vlasenko, Maryna, Zlova, Tetiana, Aye, Myint, Baksi, Arun, Balasubramani, Mathangi, Beboso, Ronnie, Blagden, Mark, Bundy, Charle, Cookson, Tobia, Copland, Allan, Emslie-Smith, Alistair, Green, Fiona, Gunstone, Anthony, Issa, Basil, Jackson-Voyzey, Ewart, Johnson, Andrew, Maclean, Malcolm, Mcknight, John, Muzulu, Solomon, O'Connell, Ian, Oyesile, Babatunde, Patterson, Catherine, Pearson, Ewan, Philip, Sam, Smith, Paul, Sukumaran, Usha, Abbas, Jalal, Aggarwala, Gaurav, Akhter, Faiq, Andersen, Jame, Anglade, Moise, Argoud, George, Ariani, Mehrdad, Ashdji, Reswan, Bakhtari, Ladan, Banerjee, Subhash, Bartlett, Andrew, Baum, Howard, Bays, Harold, Beasley, Richard, Belfort de Aguiar, Renata, Benjamin, Sabrina, Bhagwat, Ravi, Bhargava, Anuj, Bode, Bruce, Bratcher, Christina, Briskin, Toby, Brockmyre, Andrew, Broughton, Raymond, Brown, Judith, Budhraja, Madhusudan, Cannon, Kevin, Carr, Jewell, Cathcart, Harold, Cavale, Arvind, Chaykin, Loui, Cheung, Deanna, Childress, Richard, Cohen, Allan, Condit, Jonathan, Cooksey, Erin, Cornett, George Mitchell, Dauber, Ira, Davila, William, De Armas, Lui, Dean, Juliu, Detweiler, Robert, Diaz, Ernesto, Di Giovanna, Michael, Dor, Isaac, Drummond, Waymon, Eagerton, Donald, Earl, John, Eaton, Charle, Ellison, Howard, Farris, Neil, Fiel, Thoma, Firek, Anthony, First, Brian, Forgosh, Le, French, William, Gandy, Winston, Garcia, Ronald, Gill, Santosh, Gordon, Murray, Guice, Michael, Gummadi, Siva, Hackenyos, Jonathan, Hairston, Kristen, Hanson, Lenita, Harrison, Lindsay, Hartman, Israel, Heitner, John, Hejeebu, Srini, Hermany, Paul, Hernandez-Cassis, Carlo, Hidalgo, Horacio, Higgins, Alexander, Ibrahim, Hassan, Jacobs, Shahram, Johnson, David, Joshi, Parag, Kaster, Steven, Kellum, Daniel, Kim, Christopher, Kim, Ellen, Kirby, William, Knouse, Albert, Kulback, Steven, Kumar, Mariananda, Kuruvanka, Tulsida, Labroo, Ajay, Lasswell, William, Lentz, John, Lenzmeier, Thoma, Lewis, David, Li, Zhaoping, Lillestol, Michael, Little, Raymond, Lorraine, Richard, McKeown-Biagas, Cecilia, Mcneill, Robert, Mehta, Anand, Miller, Alan, Moran, Joseph, Morawski, Emily, Nadar, Venkatesh, O'Connor, Thoma, Odio, Alberto, Parker, Reginald, Patel, Rajesh, Phillips, Lawrence, Raad, George, Rahman, Aref, Raikhel, Marina, Raisinghani, Ajit, Rajan, Raj, Rasouli, Neda, Rauzi, Frank, Rohr, Kathryn, Roseman, Hal, Rovner, Sergio, Saba, Fadi, Sachson, Richard, Schabauer, Alex, Schneider, Ricky, Schuchard, Timothy, Sensenbrenner, John, Shlesinger, Yshay, Singh, Narendra, Sivalingam, Kanagaratnam, Stonesifer, Larry, Storey, Daniel, Suh, David, Tahir, Mohammed, Tan, Anjanette, Tan, Marilyn, Taylon, Alain, Thakkar, Maitreya, Tripathy, Devjit, Uwaifo, Gabriel, Vedere, Amarnath, Venugopal, Chandra, Vo, Anthony, Welch, Michelle, Welker, Jame, White, Alexander, Willis, John, Wynne, Alan, Yazdani, Shahram, Rosenberg, Anne, Price, Lauren, Sigmon, Kristina, Lokhngina, Yuliya, Xing, Weibing, Overton, Robert, Stewart, Murray, Stead, Janet, Lindsay, Alistair, Patel, Vicka, Ross, Jorge, Soffer, Joseph, Daga, Shruti, Sowell, Margaret, Patel, Prashant, Garvey, Louisa, Ackert, Jessica, Abraham, Sybil, Sabol, Mary Beth, Altobelli, Desma, Ha, Juyoung, Kulkarni, Mangesh, Somerville, Matthew, Noronha, Drusilla, Casson, Ed, Zang, Eddie, Sandhu, Chamandeep, Kumar, Rakesh, Chen, David, Taft, Lin, Patel, Rajivkumar, Ye, June, Shannon, Jennifer, Wilson, Tim, Babi, Charleen, Miller, Diane, Thorpe, Karl, Russell, Rachael, Bull, Georgina, Hereghty, Belinda, Fernandez-Salazar, Eva, Longley, Troy, Donaldson, Jill, Jarosz, Marie, Murphy, Karen, Adams, Patricia, Smith, Peter, James, Rachel, Richards, Jackie, Sedani, Sangeeta, Althouse, Denise, Watson, David, Lorimer, Jamie, Lauder, Steven, Schultheis, Ron, Womer, Terese, Wraight, Ella, Li, Wenyan, Price-Olsen, Emma, Watson, Anthony, Kelly, Aoife, Mclaughlin, Patricia, Fleming, John, Schubert, Jessica, Schleiden, Debra, Harris, Tara, Prakash, Rahul, Breneman, Jody, Deshpande, Sameer, Saswadkar, Aarti, Kumari, Aditi, Shitut, Aditi, Raorane, Amruta, Karmalkar, Anisha, Mhambrey, Ankita, Bhosale, Archana, Vaphare, Ashok, Patil, Ashwini P, Khandelwal, Chaitali, Shaik, Fayaz, Nadar, Madhumitha, Karka, Mounika, Kadgaonkar, Neha, Gupta, Nikita, Aher, Nutan, Potnis, Omkar, Naicker, Pallavi, Shinde, Rakesh, Sharma, Richa, Godse, Rupali, Solanki, Sheetal, Sahu, Shruti, Dumbre, Snehal, Kumar, Somesh, Patil, Suradnya, Mandal, Trisha, McMurray, John J V, McMurray, John J.V., DeMets, David, McGuire, Darren, Groutars, Reginald G.E.J., Hoogslag, Pieter A.M., McKnight, John, McNeill, Robert, Ha, JuYoung, McLaughlin, Patricia, Hernandez, A. F., Green, J. B., Janmohamed, S., D'Agostino, R. B., Granger, C. B., Jones, N. P., Leiter, L. A., Rosenberg, A. E., Sigmon, K. N., Somerville, M. C., Thorpe, K. M., Mcmurray, J. J. V., Del Prato, S., Califf, R. M., Holman, R., Demets, D., Riddle, M., Goodman, S., Mcguire, D., Alexander, K., Devore, A., Melloni, C., Patel, C., Kong, D., Bloomfield, G., Roe, M., Tricoci, P., Harrison, R., Lopes, R., Mathews, R., Mehta, R., Schuyler Jones, W., Vemulapalli, S., Povsic, T., Eapen, Z., Dombrowski, K., Kolls, B., Jordan, D., Ambrosy, A., Greene, S., Mandawat, A., Shavadia, J., Cooper, L., Sharma, A., Guimaraes, P., Friedman, D., Wilson, M., Endsley, P., Gentry, T., Collier, J., Perez, K., James, K., Roush, J., Pope, C., Howell, C., Johnson, M., Bailey, M., Cole, J., Akers, T., Vandyne, B., Thomas, B., Rich, J., Bartone, S., Beaulieu, G., Brown, K., Chau, T., Christian, T., Coker, R., Greene, D., Haddock, T., Jenkins, W., Haque, G., Marquess, M., Pesarchick, J., Rethaford, R., Stone, A., Al Kawas, F., Anderson, M., Enns, R., Sinay, I., Mathieu, C., Yordanov, V., Hramiak, I., Haluzik, M., Galatius, S., Guerci, B., Nauck, M., Migdalis, I., Tan, C. B. K., Kocsis, G., Giaccari, A., Lee, M. K., Munoz, E. G. C., Cornel, J., Birkeland, K., Pinto, M., Tirador, L., Olesinska-Mader, M., Shestakova, M., Distiller, L., Lopez-Sendon, J., Eliasson, B., Chiang, C. -E., Srimahachota, S., Mankovsky, B., Bethel, M. A., Dungan, K., Kosiborod, M., Alvarisqueta, A., Baldovino, J., Besada, D., Calella, P., Cantero, M. C., Castano, P., Chertkoff, A., Cuadrado, J., De Loredo, L., Dominguez, A., Espanol, M. V., Finkelstein, H., Frechtel, G., Fretes, J., Garrido Santos, N., Gonzalez, J., Litvak, M., Loureyro, J., Maffei, L., Maldonado, N., Mohr Gasparini, D., Orio, S., Perez Manghi, F., Rodriguez Papini, N., Sala, J., Schygiel, P., Sposetti, G., Ulla, M., Verra, F., Zabalua, S., Zaidman, C., Crenier, L., Debroye, C., Duyck, F., Scheen, A., Van Gaal, L., Vercammen, C., Damyanova, V., Dimitrov, S., Kovacheva, S., Lozanov, L., Margaritov, V., Mihaylova-Shumkova, R., Nikolaeva, A., Stoyanova, Z., Akhras, R., Beaudry, Y., Bedard, J., Berlingieri, J., Chehayeb, R., Cheung, S., Conway, J., Cusson, J., Della Siega, A., Dumas, R., Dzongowski, P., Ferguson, M., Gaudet, D., Grondin, F., Gupta, A., Gupta, M., Halperin, F., Houle, P. -A., Jones, M., Kouz, S., Kovacs, C., Landry, D., Lonn, E., O'Mahony, W., Peterson, S., Reich, D., Rosenbloom, A., St-Maurice, F., Tugwell, B., Vizel, S., Woo, V., Brychta, T., Cech, V., Dvorakova, E., Edelsberger, T., Halciakova, K., Krizova, J., Lastuvka, J., Piperek, M., Prymkova, V., Raclavska, L., Silhova, E., Urbanek, R., Vrkoc, J., Andersen, U., Bronnum-Schou, J., Hove, J., Jensen, J. 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P., Lund, P., Melchior, T., Nyvad, O., Schou, M., Boye, A., Cadinot, D., Gouet, D., Henry, P., Kessler, L., Lalau, J. -D., Petit, C., Thuan, J. -F., Voinot, C., Vouillarmet, J., Axthelm, C., Berger, D., Bieler, T., Birkenfeld, A., Bott, J., Busch, K., Caca, K., Chevts, J., Donaubauer, T., Erlinger, R., Funke, K., Grosskopf, J., Hagenow, A., Hamann, M., Hartard, M., Heymer, P., Huppertz, W., Illies, G., Jacob, S., Jung, T., Kahrmann, G., Kast, P., Kellerer, M., Kempe, H. -P., Khariouzov, A., Klausmann, G., Klein, C., Kleinecke-Pohl, U., Kleinertz, K., Koch, T., Kosch, C., Lorra, B., Luedemann, J., Luttermann, M., Maxeiner, S., Milek, K., Moelle, A., Neumann, G., Nischik, R., Oehrig-Pohl, E., Plassmann, G., Pohlmeier, L., Proepper, F., Regner, S., Rieker, W., Rose, L., Samer, H., Sauter, J., Schaper, F., Schiffer, C., Schmidt, J., Scholz, B. -M., Schulze, J., Segner, A., Seufert, J., Sigal, H., Steindorf, J., Stockhausen, J., Stuebler, P., Taeschner, H., Tews, D., Tschoepe, D., Wilhelm, K., Zeller-Stefan, H., Avramidis, I., Bousboulas, S., Bristianou, M., Dimitriadis, G., Elisaf, M., Kotsa, K., Melidonis, A., Mitrakou, A., Pagkalos, E., Papanas, N., Pappas, A., Sampanis, C., Tentolouris, N., Tsapas, A., Tzatzagou, G., Ozaki, R., Hajdu, C., Harcsa, E., Konyves, L., Mucsi, J., Pauker, Z., Petro, G., Ples, Z., Revesz, K., Sandor, V., Vass, V., Avogaro, A., Boemi, M., Bonadonna, R., Consoli, A., De Cosmo, S., Di Bartolo, P., Dotta, F., Frontoni, S., Galetta, M., Gambineri, A., Gazzaruso, C., Giorgino, F., Lauro, D., Orsi, E., Paolisso, G., Perriello, G., Piatti, P., Pontiroli, A., Ponzani, P., Rivellese, A. 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Tan, A, Tan, M, Taylon, A, Thakkar, M, Tripathy, D, Uwaifo, G, Vedere, A, Venugopal, C, Vo, A, Welch, M, Welker, J, White, A, Willis, J, Wynne, A, Yazdani, S, Price, L, Lokhngina, Y, Xing, W, Overton, R, Stewart, M, Stead, J, Lindsay, A, Patel, V, Ross, J, Soffer, J, Daga, S, Sowell, M, Patel, P, Garvey, L, Ackert, J, Abraham, S, Sabol, M, Altobelli, D, Ha, J, Kulkarni, M, Noronha, D, Casson, E, Zang, E, Sandhu, C, Kumar, R, Chen, D, Taft, L, Ye, J, Shannon, J, Wilson, T, Babi, C, Miller, D, Russell, R, Bull, G, Hereghty, B, Fernandez-Salazar, E, Longley, T, Donaldson, J, Jarosz, M, Murphy, K, Adams, P, James, R, Richards, J, Sedani, S, Althouse, D, Watson, D, Lorimer, J, Lauder, S, Schultheis, R, Womer, T, Wraight, E, Li, W, Price-Olsen, E, Watson, A, Kelly, A, Mclaughlin, P, Fleming, J, Schubert, J, Schleiden, D, Harris, T, Prakash, R, Breneman, J, Deshpande, S, Saswadkar, A, Kumari, A, Shitut, A, Raorane, A, Karmalkar, A, Mhambrey, A, Bhosale, A, Vaphare, A, Patil, A, Khandelwal, C, Shaik, F, Nadar, M, Karka, M, Kadgaonkar, N, Gupta, N, Aher, N, Potnis, O, Naicker, P, Shinde, R, Sharma, R, Godse, R, Solanki, S, Sahu, S, Dumbre, S, Kumar, S, Patil, S, and Mandal, T
Subjects: Male, Placebo-controlled study, Myocardial Infarction, alanine aminotransferase, albiglutide, bilirubin, placebo, antidiabetic agent, glucagon like peptide 1, rGLP-1 protein, Kaplan-Meier Estimate, 030204 cardiovascular system & hematology, law.invention, 0302 clinical medicine, Randomized controlled trial, law, Glucagon-Like Peptide 1, Cardiovascular Disease, Medicine(all), education.field_of_study, Subcutaneous, Medicine (all), albigutide, Hazard ratio, General Medicine, Middle Aged, Albiglutide, Stroke, Treatment Outcome, Tolerability, Cardiovascular Diseases, Female, type 2 diabetes, Type 2, Human, Adult, medicine.medical_specialty, Injections, Subcutaneous, Population, 030209 endocrinology & metabolism, Placebo, Injections, Subcutaneou, Drug Administration Schedule, Injections, 03 medical and health sciences, Double-Blind Method, Internal medicine, Diabetes Mellitus, medicine, Humans, Hypoglycemic Agents, education, Aged, Diabetes Mellitus, Type 2, Hypoglycemic Agent, business.industry, Semaglutide, Settore MED/13 - ENDOCRINOLOGIA, Harmony, business
Abstract: Background: \ud Glucagon-like peptide 1 receptor agonists differ in chemical structure, duration of action, and in their effects on clinical outcomes. The cardiovascular effects of once-weekly albiglutide in type 2 diabetes are unknown. We aimed to determine the safety and efficacy of albiglutide in preventing cardiovascular death, myocardial infarction, or stroke.\ud \ud Methods: \ud We did a double-blind, randomised, placebo-controlled trial in 610 sites across 28 countries. We randomly assigned patients aged 40 years and older with type 2 diabetes and cardiovascular disease (at a 1:1 ratio) to groups that either received a subcutaneous injection of albiglutide (30–50 mg, based on glycaemic response and tolerability) or of a matched volume of placebo once a week, in addition to their standard care. Investigators used an interactive voice or web response system to obtain treatment assignment, and patients and all study investigators were masked to their treatment allocation. We hypothesised that albiglutide would be non-inferior to placebo for the primary outcome of the first occurrence of cardiovascular death, myocardial infarction, or stroke, which was assessed in the intention-to-treat population. If non-inferiority was confirmed by an upper limit of the 95% CI for a hazard ratio of less than 1·30, closed testing for superiority was prespecified. This study is registered with ClinicalTrials.gov, number NCT02465515.\ud \ud Findings: \ud Patients were screened between July 1, 2015, and Nov 24, 2016. 10 793 patients were screened and 9463 participants were enrolled and randomly assigned to groups: 4731 patients were assigned to receive albiglutide and 4732 patients to receive placebo. On Nov 8, 2017, it was determined that 611 primary endpoints and a median follow-up of at least 1·5 years had accrued, and participants returned for a final visit and discontinuation from study treatment; the last patient visit was on March 12, 2018. These 9463 patients, the intention-to-treat population, were evaluated for a median duration of 1·6 years and were assessed for the primary outcome. The primary composite outcome occurred in 338 (7%) of 4731 patients at an incidence rate of 4·6 events per 100 person-years in the albiglutide group and in 428 (9%) of 4732 patients at an incidence rate of 5·9 events per 100 person-years in the placebo group (hazard ratio 0·78, 95% CI 0·68–0·90), which indicated that albiglutide was superior to placebo (p
Published: 2018

13. Stroke Outcomes With Vorapaxar Versus Placebo in Patients With Acute Coronary Syndromes : Insights From the TRACER Trial

Author: Chiara Melloni, Lars Wallentin, Frans Van de Werf, Paul W. Armstrong, Bradley J. Kolls, Leo Ungar, Pierluigi Tricoci, Kenneth W. Mahaffey, Philip E. Aylward, Harvey D. White, Claes Held, David J. Moliterno, Robert M. Clare, Fatima Rodriguez, John Strony, and Robert A. Harrington
Subjects: Male, Cardiac & Cardiovascular Systems, Pyridines, Myocardial Infarction, 030204 cardiovascular system & hematology, Lactones, 0302 clinical medicine, Recurrence, Risk Factors, Clinical Studies, Secondary Prevention, Multicenter Studies as Topic, Cardiac and Cardiovascular Systems, 030212 general & internal medicine, Stroke, Original Research, Randomized Controlled Trials as Topic, Vorapaxar, Secondary prevention, RISK, Kardiologi, Incidence, Middle Aged, stroke, Treatment Outcome, ISCHEMIC-STROKE, Cardiology, Female, Cardiology and Cardiovascular Medicine, Intracranial Hemorrhages, Life Sciences & Biomedicine, medicine.drug, Platelets, medicine.medical_specialty, Acute coronary syndrome, vorapaxar, Placebo, Risk Assessment, acute coronary syndrome, 03 medical and health sciences, Internal medicine, SCORE, medicine, Humans, In patient, Aged, Science & Technology, business.industry, Antagonist, medicine.disease, Clinical Trials, Phase III as Topic, ATRIAL-FIBRILLATION, Cardiovascular System & Cardiology, Cerebrovascular Disease/Stroke, business, Acute Coronary Syndromes, Platelet Aggregation Inhibitors
Abstract: Background Vorapaxar, a protease‐activated receptor‐1 antagonist, is approved for secondary prevention of cardiovascular events but is associated with increased intracranial hemorrhage. Methods and Results TRACER (Thrombin Receptor Antagonist for Clinical Event Reduction in Acute Coronary Syndrome) was a trial of vorapaxar versus placebo among patients with acute coronary syndrome. Strokes were adjudicated by a central events committee. Of 12 944 patients, 199 (1.5%) had ≥1 stroke during the study period (median follow‐up, 477 days). Four patients had a single stroke of unknown type; 195 patients had ≥1 stroke classified as hemorrhagic or nonhemorrhagic (165 nonhemorrhagic, 28 hemorrhagic, and 2 both). Strokes occurred in 96 of 6473 patients (1.5%) assigned vorapaxar and 103 of 6471 patients (1.6%) assigned placebo. Kaplan‐Meier incidence of stroke for vorapaxar versus placebo was higher for hemorrhagic stroke (0.45% versus 0.14% [hazard ratio, 2.74; 95% confidence interval, 1.22–6.15]), lower but not significantly different for nonhemorrhagic stroke (1.53% versus 1.98% at 2 years [hazard ratio, 0.79; 95% confidence interval, 0.58–1.07]), and similar for stroke overall (1.93% versus 2.13% at 2 years [hazard ratio, 0.94; 95% confidence interval, 0.71–1.24]). Conclusions Stroke occurred in
Published: 2018

14. Effects of genetic variation in protease activated receptor 4 after an acute coronary syndrome: Analysis from the TRACER trial

Author: Michael J. Whitley, Harvey D. White, Claes Held, Frans Van de Werf, Pierluigi Tricoci, Robert A. Harrington, Leonard C. Edelstein, Lars Wallentin, Lisa K. Jennings, Megan L. Neely, Kenneth W. Mahaffey, Paul F. Bray, Paul W. Armstrong, Philip E. Aylward, Chad A. Shaw, Lukas M. Simon, Paolo Fortina, and David J. Moliterno
Subjects: Male, 0301 basic medicine, Platelets, Acute coronary syndrome, medicine.medical_specialty, Genotype, Pyridines, Hemorrhage, Single-nucleotide polymorphism, 030204 cardiovascular system & hematology, Polymorphism, Single Nucleotide, Gastroenterology, Article, Lactones, 03 medical and health sciences, 0302 clinical medicine, Thrombin, Ischemia, Internal medicine, medicine, Humans, SNP, Receptor, PAR-1, Platelet, Acute Coronary Syndrome, Allele, Receptor, Molecular Biology, Aged, Randomized Controlled Trials as Topic, Vorapaxar, business.industry, Bleeding, Genetic Variation, Hematology, Cell Biology, Middle Aged, PAR4, medicine.disease, PAR1, 030104 developmental biology, Pharmacogenetics, Molecular Medicine, Female, Receptors, Thrombin, business, Platelet Aggregation Inhibitors, medicine.drug
Abstract: Variation in platelet response to thrombin may affect the safety and efficacy of PAR antagonism. The Thr120 variant of the common single nucleotide polymorphism (SNP) rs773902 in the protease-activated receptor (PAR) 4 gene is associated with higher platelet aggregation compared to the Ala120 variant. We investigated the relationship between the rs773902 SNP with major bleeding and ischemic events, safety, and efficacy of PAR1 inhibition in 6177 NSTE ACS patients in the TRACER trial. There was a lower rate of GUSTO moderate/severe bleeding in patients with the Thr120 variant. The difference was driven by a lower rate in the smaller homozygous group (recessive model, HR 0.13 [0.02–0.92] P = 0.042). No significant differences were observed in the ischemic outcomes. The excess in bleeding observed with PAR1 inhibition was attenuated in patients with the Thr120 variant, but the interactions were not statistically significant. In summary, lower major bleeding rates were observed in the overall TRACER cohort with the hyperreactive PAR4 Thr120 variant. The increase in bleeding with vorapaxar was attenuated with the Thr120 variant, but we could not demonstrate an interaction with PAR1 inhibition. These findings warrant further exploration, including those of African ancestry where the A allele (Thr120) frequency is ~65%.
Published: 2018

15. An examination of the relationship between serum uric acid level, a clinical history of gout, and cardiovascular outcomes among patients with acute coronary syndrome

Author: Kenneth W. Mahaffey, Matthew T. Roe, Alyssa B Klein, Stefan James, Robert M. Clare, Axel Åkerblom, Claes Held, Lars Wallentin, Robert T. Keenan, Daniel Wojdyla, Connie N. Hess, Pierluigi Tricoci, and Neha J. Pagidipati
Subjects: Male, medicine.medical_specialty, Acute coronary syndrome, Gout, 030204 cardiovascular system & hematology, Article, 03 medical and health sciences, 0302 clinical medicine, Risk Factors, Internal medicine, Diabetes mellitus, Cause of Death, medicine, Humans, 030212 general & internal medicine, Myocardial infarction, Acute Coronary Syndrome, Stroke, Cause of death, Aged, business.industry, Middle Aged, medicine.disease, Surgery, Uric Acid, Cardiovascular Diseases, Heart failure, Female, Cardiology and Cardiovascular Medicine, business, Cardiovascular outcomes
Abstract: BACKGROUND: Studies have suggested a relationship between higher baseline serum uric acid (sUA) levels and an elevated risk of subsequent ischemic cardiovascular outcomes among acute coronary syndrome (ACS) patients; this relationship may be modified by a clinical history of gout and has not been studied in large patient cohorts. We sought to understand the effect of sUA and gout on ACS outcomes. METHODS: Using PLATO and TRACER data on 27,959 ACS patients, we evaluated baseline sUA levels in relation to a composite of cardiovascular death, myocardial infarction (MI), or stroke. We assessed interaction terms to determine if a baseline clinical diagnosis of gout modified this putative relationship; 46% (n = 12,882) had sUA levels elevated >6.0 mg/dL. RESULTS: Patients with elevated levels were more often male with a history of prior MI, diabetes, and heart failure compared with those with sUA
Published: 2017

16. Use of thienopyridine prior to presentation with non-ST-segment elevation acute coronary syndrome and association with safety and efficacy of vorapaxar: insights from the TRACER trial

Author: Kenneth W. Mahaffey, Pierluigi Tricoci, David J. Moliterno, Giuseppe Ambrosio, Yuliya Lokhnygina, Robert M. Clare, Harvey D. White, Lars Wallentin, Philip E. Aylward, Paul W. Armstrong, Claes Held, Ralf E. Harskamp, John Strony, Frans Van de Werf, Robert A. Harrington, General practice, APH - Personalized Medicine, ACS - Heart failure & arrhythmias, and Cardiology
Subjects: Male, Acute coronary syndrome, medicine.medical_specialty, Thienopyridine, Pyridines, Hemorrhage, 030204 cardiovascular system & hematology, outcomes, Critical Care and Intensive Care Medicine, Vorapaxar, acute coronary syndrome, thienopyridine, Lactones, 03 medical and health sciences, 0302 clinical medicine, Internal medicine, Secondary Prevention, medicine, Humans, ST segment, 030212 general & internal medicine, Acute Coronary Syndrome, Aged, business.industry, General Medicine, Middle Aged, medicine.disease, Treatment Outcome, Ischemic stroke, Cardiology, Female, Medical emergency, Cardiology and Cardiovascular Medicine, business, Platelet Aggregation Inhibitors, medicine.drug
Abstract: Background: Vorapaxar is effective in the prevention of secondary atherothrombotic events, although the efficacy/safety balance appears less favorable in the treatment of patients with non-ST-segment elevation (NSTE) acute coronary syndrome (ACS). We hypothesized that patients with NSTE ACS already receiving thienopyridine prior to the ACS event may show differential efficacy/safety effects with vorapaxar vs. placebo added to their standard care. Methods: We studied 12,944 patients from the Thrombin Receptor Antagonist for Clinical Event Reduction in Acute Coronary Syndrome (TRACER) trial with respect to thienopyridine use before admission for the index NSTE ACS event. The primary endpoint was a composite of cardiovascular death, myocardial infarction, stroke, rehospitalization for ischemia, and urgent revascularization. The key secondary endpoint was a composite of cardiovascular death, myocardial infarction, and stroke. Safety endpoints were bleeding complications. Results: Only 1513 patients (11.7%) were receiving thienopyridine before admission for the index NSTE ACS event. In these patients, Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO) moderate/severe bleeding occurred in 5.7% treated with vorapaxar and 5.3% treated with a placebo (hazards ratio (HR) 1.10, 95% confidence interval (CI) 0.70-1.71); in thienopyridine-naive patients, the rates were 5.7% and 4.1%, respectively (HR 1.32, 95% CI 1.11-1.57; P-int=0.45). GUSTO severe bleeding in the prior thienopyridine group occurred in 0.5% of patients treated with vorapaxar and 1.3% of patients treated with placebo (HR 0.34, 95% CI 0.09-1.30); in thienopyridine-naive patients, the rates were 2.0% and 1.0%, respectively (HR 1.89, 95% CI 1.36-2.62; P-int=0.01). No interaction was observed between vorapaxar efficacy and prior thienopyridine use on the primary (adjusted P-int=0.53) or key secondary endpoints (P-int=0.61). Conclusions: TRACER was largely conducted in thienopyridine-naive patients with unknown tolerance to multiple antiplatelet treatments. Patients receiving thienopyridine before the index event may have had an attenuated increase in bleeding when adding vorapaxar, whereas concomitantly adding vorapaxar and thienopyridine in naive patients may have uncovered a latent susceptibility to bleeding
Published: 2017

17. Efficacy and Safety of Alirocumab 150 mg Every 4 Weeks in Patients With Hypercholesterolemia Not on Statin Therapy : The ODYSSEY CHOICE II Study

Author: Erik Stroes, John R. Guyton, Norman Lepor, Fernando Civeira, Daniel Gaudet, Gerald F. Watts, Marie T. Baccara‐Dinet, Guillaume Lecorps, Garen Manvelian, Michel Farnier, K. Kostner, S. Lehman, O. Descamps, L. Gheyle, C. Mathieu, J. Bergeron, T. Elliott, G. Girard, A. Gupta, G. Hoag, J. Hove, J. Jeppesen, J.H. Kjærulf, K. Klarlund, K.K. Thomsen, D.C.G. Basart, A. Kooy, A. Liem, H. Swart, R. Troquay, J Van Het Hof‐Wiersma, P. Viergever, F. Visseren, R.N. Doughty, R. Scott, C. Calvo, J.L. Díaz‐Díaz, F. Fuentes, B. Gil‐Extremera, C. Jericó, L. Matas Pericas, J.D. Mediavilla Garcia, D.E. Bolster, M. Koren, M. El Shahawy, G. Vardi, D. Weinstein, K. Zuzarte, Henry Ginsberg, Jennifer G. Robinson, Daniel J. Rader, Christopher P. Cannon, Helen Colhoun, John J.P. Kastelein, Yong Huo, Anders Olsson, David Waters, Dominique Larrey, Robert S. Rosenson, Peter A. Patriarca, Geert Molenberghs, Pierluigi Tricoci, Kenneth W. Mahaffey, Renato D. Lopes, Bimal R. Shah, Rajendra H. Mehta, Matthew T. Roe, Zubin Eapen, Luciana Armaganijan, Adriana Bertolami, Sergio Leonardi, Bradley J. Kolls, J. Dedrick Jordan, Grégory Ducrocq, Etienne Puymirat, Robin Mathews, ACS - Amsterdam Cardiovascular Sciences, and Vascular Medicine
Subjects: Male, lcsh:Diseases of the circulatory (Cardiovascular) system, alirocumab, 030204 cardiovascular system & hematology, 0302 clinical medicine, Fenofibrate, Clinical Studies, Coronary Heart Disease, 030212 general & internal medicine, Hypolipidemic Agents, Original Research, Lipids and Cholesterol, Anticholesteremic Agents, PCSK9 Inhibitors, low‐density lipoprotein cholesterol, Antibodies, Monoclonal, Middle Aged, Combined Modality Therapy, Treatment Outcome, Drug Therapy, Combination, Female, Cardiology and Cardiovascular Medicine, medicine.drug, cardiovascular risk, medicine.medical_specialty, Diet therapy, Hypercholesterolemia, Placebo, Antibodies, Monoclonal, Humanized, 03 medical and health sciences, proprotein convertase subtilisin/kexin type 9, Ezetimibe, Double-Blind Method, Internal medicine, Injection site reaction, medicine, Journal Article, Humans, Adverse effect, Alirocumab, Aged, Pharmacology, business.industry, PCSK9, Cholesterol, LDL, medicine.disease, Injection Site Reaction, Treatment, lcsh:RC666-701, Physical therapy, placebo‐controlled, business, Diet Therapy
Abstract: Background The PCSK 9 antibody alirocumab (75 mg every 2 weeks; Q2W) as monotherapy reduced low‐density lipoprotein‐cholesterol ( LDL ‐C) levels by 47%. Because the option of a monthly dosing regimen is convenient, ODYSSEY CHOICE II evaluated alirocumab 150 mg Q4W in patients with inadequately controlled hypercholesterolemia and not on statin (majority with statin‐associated muscle symptoms), receiving treatment with fenofibrate, ezetimibe, or diet alone. Methods and Results Patients were randomly assigned to placebo, alirocumab 150 mg Q4W or 75 mg Q2W (calibrator arm), with dose adjustment to 150 mg Q2W at week (W) 12 if W8 predefined LDL ‐C target levels were not met. The primary efficacy endpoint was LDL ‐C percentage change from baseline to W24. Mean baseline LDL ‐C levels were 163.9 mg/dL (alirocumab 150 mg Q4W, n=59), 154.5 mg/dL (alirocumab 75 mg Q2W, n=116), and 158.5 mg/dL (placebo, n=58). In the alirocumab 150 mg Q4W and 75 mg Q2W groups (49.1% and 36.0% of patients received dose adjustment, respectively), least‐squares mean LDL ‐C changes from baseline to W24 were −51.7% and −53.5%, respectively (placebo [+4.7%]; both groups P LDL ‐C targets at W24. Treatment‐emergent adverse events occurred in 77.6% (alirocumab 150 mg Q4W), 73.0% (alirocumab 75 mg Q2W), and 63.8% (placebo) of patients, with injection‐site reactions among the most common treatment‐emergent adverse events. Conclusions Alirocumab 150 mg Q4W can be considered in patients not on statin with inadequately controlled hypercholesterolemia as a convenient option for lowering LDL ‐C. Clinical Trial Registration URL : http://www.clinicaltrials.gov . Unique identifier: NCT 02023879.
Published: 2016

18. Infusion of Reconstituted High-Density Lipoprotein, CSL112, in Patients With Atherosclerosis: Safety and Pharmacokinetic Results From a Phase 2a Randomized Clinical Trial

Author: Charles L. Shear, John H. Alexander, Robert Schott, Andreas Gille, Louis Cannon, Robert M. Weiss, Zhenling Yao, Denise D'Andrea, Alison L. Bailey, Michael A. Blazing, Paul A. Gurbel, Pierluigi Tricoci, Marina Cuchel, Dominick J. Angiolillo, Brion Winston, and Samuel D. Wright
Subjects: Adult, Male, Acute coronary syndrome, medicine.medical_specialty, apolipoprotein, Coronary Artery Disease, Placebo, coronary disease, Gastroenterology, law.invention, plaque, chemistry.chemical_compound, High-density lipoprotein, Pharmacokinetics, Randomized controlled trial, Double-Blind Method, law, Internal medicine, high-density lipoprotein–raising therapies, medicine, Humans, Adverse effect, Infusions, Intravenous, Aged, Original Research, Hypolipidemic Agents, Peripheral Vascular Diseases, Apolipoprotein A-I, Cholesterol, business.industry, Editorials, clinical trial, Middle Aged, medicine.disease, Atherosclerosis, United States, Surgery, Treatment Outcome, chemistry, Pharmacodynamics, Female, ATP binding cassette transporter A1, Cardiology and Cardiovascular Medicine, business, Lipoproteins, HDL, Biomarkers
Abstract: Background CSL 112 is a new formulation of human apolipoprotein A‐I (apoA‐I) being developed to reduce cardiovascular events following acute coronary syndrome. This phase 2a, randomized, double‐blind, multicenter, dose‐ranging trial represents the first clinical investigation to assess the safety and pharmacokinetics/pharmacodynamics of a CSL 112 infusion among patients with stable atherosclerotic disease. Methods and Results Patients were randomized to single ascending doses of CSL 112 (1.7, 3.4, or 6.8 g) or placebo, administered over a 2‐hour period. Primary safety assessments consisted of alanine aminotransferase or aspartate aminotransferase elevations >3× upper limits of normal and study drug–related adverse events. Pharmacokinetic/pharmacodynamic assessments included apoA‐I plasma concentration and measures of the ability of serum to promote cholesterol efflux from cells ex vivo. Of 45 patients randomized, 7, 12, and 14 received 1.7‐, 3.4‐, and 6.8‐g CSL 112, respectively, and 11 received placebo. There were no clinically significant elevations (>3× upper limit of normal) in alanine aminotransferase or aspartate aminotransferase. Adverse events were nonserious and mild and occurred in 5 (71%), 5 (41%), and 6 (43%) patients in the CSL 112 1.7‐, 3.4‐, and 6.8‐g groups, respectively, compared with 3 (27%) placebo patients. The imbalance in adverse events was attributable to vessel puncture/infusion‐site bruising. CSL 112 resulted in rapid ( T max ≈2 hours) and dose‐dependent increases in apoA‐I (145% increase in the 6.8‐g group) and total cholesterol efflux (up to 3.1‐fold higher than placebo) ( P Conclusions CSL 112 infusion was well tolerated in patients with stable atherosclerotic disease. CSL 112 immediately raised apoA‐I levels and caused a rapid and marked increase in the capacity of serum to efflux cholesterol. This potential novel approach for the treatment of atherosclerosis warrants further investigation. Clinical Trial Registration URL : http://www.ClinicalTrials.gov . Unique identifier: NCT 01499420.
Published: 2015

19. Sex-Stratified Trends in Enrollment, Patient Characteristics, Treatment, and Outcomes Among Non–ST-Segment Elevation Acute Coronary Syndrome Patients: Insights from Clinical Trials Over 17 Years

Author: Robert P. Giugliano, Paul W. Armstrong, Kristian Kragholm, L. Kristin Newby, Kenneth W. Mahaffey, Pierluigi Tricoci, Qinghong Yang, Robert A. Harrington, Frans Van de Werf, E. Magnus Ohman, Sharif Halim, John H. Alexander, David J. Moliterno, Chiara Melloni, Phillip J. Schulte, Judith S. Hochman, and Harvey D. White
Subjects: Male, medicine.medical_specialty, Acute coronary syndrome, medicine.medical_treatment, Adrenergic beta-Antagonists, Angiotensin-Converting Enzyme Inhibitors, Revascularization, Coronary Angiography, Article, Electrocardiography, Percutaneous Coronary Intervention, Sex Factors, Interquartile range, Risk Factors, Internal medicine, Diabetes mellitus, medicine, ST segment, Humans, Myocardial infarction, Registries, Acute Coronary Syndrome, Sex Distribution, Aged, Hypolipidemic Agents, Retrospective Studies, Aged, 80 and over, business.industry, Middle Aged, medicine.disease, United States, Clinical trial, Survival Rate, Heart failure, Physical therapy, Female, Cardiology and Cardiovascular Medicine, business, Follow-Up Studies
Abstract: Background— Adequate representation by sex in trials allows generalizability of results. We examined representation of women in clinical trials during a 17-year period in which inclusion criteria were broadened and federal mandates for representativeness were launched. Methods and Results— Using mixed models, we studied sex-stratified temporal trends in enrollment, clinical characteristics, treatment, and outcomes among 76 148 non–ST-segment elevation acute coronary syndrome patients using patient-level data merged from 11 phase III trials conducted from 1994 to 2010. Overall, 33.3% of patients were women, which changed minimally over time. Women were consistently 4 to 5 years older than men (median age 68 [interquartile range 61–75] versus 64 [interquartile range 56–72] years) and more frequently had diabetes mellitus, hypertension, and heart failure; men more frequently had prior myocardial infarction and revascularization. GRACE risk scores increased over time for both sexes with the inclusion of older patients with more comorbidities. Use of percutaneous coronary intervention, in-hospital and discharge angiotensin-converting enzyme inhibitor/angiotensin II receptor blockers, β-blockers, and lipid-lowering drugs also increased among both sexes. Kaplan–Meier estimates of 6-month mortality declined from 7.0% [95% confidence interval 6.5%–7.6%] to 4.5% [95% confidence interval 4.0%–5.0%] among women and 6.3% [95% confidence interval 6.0%–6.7%] to 3.1% [95% confidence interval 2.9%–3.4%] among men during the 17-year period. Conclusions— The relative proportion of women in non–ST-segment elevation acute coronary syndrome trials changed minimally over time. Nevertheless, in parallel with men, use of evidence-based care and outcomes improved significantly over time among women.
Published: 2015

20. Efficacy and Safety of Vorapaxar in Non-ST-Segment Elevation Acute Coronary Syndrome Patients Undergoing Noncardiac Surgery

Author: Paul W. Armstrong, John Strony, Robert A. Harrington, Sean van Diepen, Mohua Podder, Frans Van de Werf, Lars Wallentin, Kenneth W. Mahaffey, Harvey D. White, Claes Held, Pierluigi Tricoci, Cynthia M. Westerhout, Philip E. Aylward, and David J. Moliterno
Subjects: Male, Acute coronary syndrome, medicine.medical_specialty, lcsh:Diseases of the circulatory (Cardiovascular) system, vorapaxar, Pyridines, medicine.medical_treatment, noncardiac surgery, Revascularization, coronary disease, surgery, Lactones, Double-Blind Method, Internal medicine, non-ST-segment elevation acute coronary syndromes, mental disorders, medicine, Coronary Heart Disease, Humans, Receptor, PAR-1, Cardiac and Cardiovascular Systems, Myocardial infarction, Acute Coronary Syndrome, Vorapaxar, Original Research, Aged, Aspirin, Kardiologi, business.industry, Hazard ratio, Odds ratio, Perioperative, Middle Aged, medicine.disease, non–ST‐segment elevation acute coronary syndromes, Treatment Outcome, lcsh:RC666-701, Surgical Procedures, Operative, Cardiology, Female, hemorrhage, Cardiology and Cardiovascular Medicine, business, Acute Coronary Syndromes, medicine.drug
Abstract: Background Perioperative antiplatelet agents potentially increase bleeding after non– ST ‐segment elevation ( NSTE ) acute coronary syndromes ( ACS ). The protease‐activated receptor 1 antagonist vorapaxar reduced cardiovascular events and was associated with increased bleeding versus placebo in NSTE ACS , but its efficacy and safety in noncardiac surgery ( NCS ) remain unknown. We aimed to evaluate ischemic, bleeding, and long‐term outcomes of vorapaxar in NCS after NSTE ACS . Methods and Results In the TRACER trial, 2202 (17.0%) patients underwent major or minor NCS after NSTE ACS over 1.5 years (median); continuing study treatment perioperatively was recommended. The primary ischemic end point for this analysis was cardiovascular death, myocardial infarction, stent thrombosis, or urgent revascularization within 30 days of NCS . Safety outcomes included 30‐day NCS bleeding and GUSTO moderate/severe bleeding. Overall, 1171 vorapaxar and 1031 placebo patients underwent NCS . Preoperative aspirin and thienopyridine use was 96.8% versus 97.7% ( P =0.235) and 89.1% versus 86.1% ( P =0.036) for vorapaxar versus placebo, respectively. Within 30 days of NCS , no differences were observed in the primary ischemic end point between vorapaxar and placebo groups (3.4% versus 3.9%; adjusted odds ratio 0.81, 95% CI 0.50 to 1.33, P =0.41). Similarly, no differences in NCS bleeding (3.9% versus 3.4%; adjusted odds ratio 1.41, 95% CI 0.87 to 2.31, P =0.17) or GUSTO moderate/severe bleeding (4.2% versus 3.7%; adjusted odds ratio 1.15, 95% CI , 0.72 to 1.83, P =0.55) were observed. In a 30‐day landmarked analysis, NCS patients had a higher long‐term risk of the ischemic end point (adjusted hazard ratio 1.62, 95% CI 1.33 to 1.97, P GUSTO moderate/severe bleeding (adjusted hazard ratio 5.63, 95% CI 3.98 to 7.97, P NCS , independent of study treatment. Conclusion NCS after NSTE ACS is common and associated with more ischemic outcomes and bleeding. Vorapaxar after NSTE ACS was not associated with increased perioperative ischemic or bleeding events in patients undergoing NCS .
Published: 2015

21. Long-term outcomes and causes of death after acute coronary syndrome in patients in the Bologna, Italy, area

Author: Samuele Nanni, Massimiliano Lorenzini, Rossana De Palma, Giulia Norscini, Anna Corsini, Franco Semprini, Pierluigi Tricoci, Massimiliano Marino, Paolo Ortolani, Maria Letizia Bacchi Reggiani, Claudio Rapezzi, Laura Cinti, Giulia Bugani, Fabio Vagnarelli, Nevio Taglieri, Giovanni Melandri, Vagnarelli, Fabio, Taglieri, Nevio, Ortolani, Paolo, Norscini, Giulia, Cinti, Laura, BACCHI REGGIANI, MARIA LETIZIA, Marino, Massimiliano, Lorenzini, Massimiliano, Bugani, Giulia, Corsini, Anna, Semprini, Franco, Nanni, Samuele, Tricoci, Pierluigi, De Palma, Rossana, Rapezzi, Claudio, and Melandri, Giovanni
Subjects: Male, endocrine system, Acute coronary syndrome, Pediatrics, medicine.medical_specialty, Time Factors, Time Factor, Prognosi, medicine.medical_treatment, Lower risk, Coronary Angiography, Follow-Up Studie, NO, Electrocardiography, Retrospective Studie, Cause of Death, Confidence Intervals, Medicine, Humans, Hospital Mortality, Acute Coronary Syndrome, Survival rate, Aged, Female, Follow-Up Studies, Hospitalization, Italy, Prognosis, Retrospective Studies, Survival Rate, Cardiology and Cardiovascular Medicine, Medicine (all), Cause of death, business.industry, Hazard ratio, Percutaneous coronary intervention, Retrospective cohort study, medicine.disease, Confidence interval, business, Confidence Interval, Human
Abstract: We sought to evaluate the rates, time course, and causes of death in the long-term follow-up of unselected patients with acute coronary syndromes (ACS). We enrolled 2046 consecutive patients hospitalized from January 2004 to December 2005 with an audited final diagnosis of ACS. The primary study end point was 5-year all-cause mortality. In our series, 896 patients had ST-segment elevation (STE) and 1,150 non-ST-segment elevation (NSTE). Mean age of the study population was 71.6 years. Primary percutaneous coronary intervention was performed in 86% of STE-ACS, and 70% of NSTE-ACS was managed invasively. The 5-year all-cause mortality was 36.4% for STE-ACS and 42.0% for NSTE-ACS, with patients with STE-ACS showing a trend boarding statistical significance toward a lower risk of mortality (hazard ratio [HR] = 0.88, 95% confidence interval [CI] 0.76 to 1.02, p = 0.08). Landmark analysis demonstrated that patients with STE-ACS had a higher risk of 30-day mortality (STE-ACS vs NSTE-ACS HR = 1.53, 95% CI 1.16 to 2.06, p = 0.003) whereas the risk of NSTE-ACS increased markedly after 1 year (STE-ACS vs NSTE-ACS HR = 0.67, 95% CI 0.53 to 0.84, p = 0.001). The contribution of noncardiovascular (CV) causes to overall mortality increased from 3% at 30 days to 34% at 5 years, with cancer and infections being the most common causes of non-CV death both in STE-ACS and NSTE-ACS. In conclusion, long-term mortality after ACS is still too high both for STE-ACS and NSTE-ACS. Although patients with STE-ACS have a higher mortality during the first year, the mortality of patients with NSTE-ACS increases later, when non-CV co-morbidities gain greater importance.
Published: 2015

22. Effect of alirocumab, a monoclonal antibody to PCSK9, on long-term cardiovascular outcomes following acute coronary syndromes : rationale and design of the ODYSSEY Outcomes trial

Author: Gregory G. Schwartz, Vera Bittner, Andreas M. Zeiher, Lisa G. Berdan, Tyrus Rorick, Rafael Diaz, Harvey D. White, Robert Pordy, Angele Moryusef, Shaun G. Goodman, Kenneth W. Mahaffey, Matthew T. Roe, Deepak L. Bhatt, Laurence Bessac, Robert A. Harrington, Cheerag Shirodaria, William J. Sasiela, Pierluigi Tricoci, Corinne Hanotin, Philippe Gabriel Steg, Jean-Francois Tamby, Michael Szarek, and J. Wouter Jukema
Subjects: medicine.medical_specialty, Acute coronary syndrome, Atorvastatin, Hypercholesterolemia, Myocardial Infarction, Antibodies, Monoclonal, Humanized, Angina, Double-Blind Method, Internal medicine, medicine, Humans, Rosuvastatin, Pyrroles, Myocardial infarction, Angina, Unstable, ddc:610, Acute Coronary Syndrome, Rosuvastatin Calcium, Alirocumab, Apolipoproteins B, Sulfonamides, Unstable angina, business.industry, PCSK9, Anticholesteremic Agents, Serine Endopeptidases, Antibodies, Monoclonal, Cholesterol, LDL, medicine.disease, Fluorobenzenes, Hospitalization, Stroke, Pyrimidines, Treatment Outcome, Heptanoic Acids, Physical therapy, Drug Therapy, Combination, Proprotein Convertases, Hydroxymethylglutaryl-CoA Reductase Inhibitors, Proprotein Convertase 9, Cardiology and Cardiovascular Medicine, business, medicine.drug
Abstract: Background Following acute coronary syndrome (ACS), the risk for future cardiovascular events is high and is related to levels of low-density lipoprotein cholesterol (LDL-C) even within the setting of intensive statin treatment. Proprotein convertase subtilisin/kexin type 9 (PCSK9) regulates LDL receptor expression and circulating levels of LDL-C. Antibodies to PCSK9 can produce substantial and sustained reductions of LDL-C. The ODYSSEY Outcomes trial tests the hypothesis that treatment with alirocumab, a fully human monoclonal antibody to PCSK9, improves cardiovascular outcomes after ACS. Design This Phase 3 study will randomize approximately 18,000 patients to receive biweekly injections of alirocumab (75-150 mg) or matching placebo beginning 1 to 12 months after an index hospitalization for acute myocardial infarction or unstable angina. Qualifying patients are treated with atorvastatin 40 or 80 mg daily, rosuvastatin 20 or 40 mg daily, or the maximum tolerated and approved dose of one of these agents and fulfill one of the following criteria: LDL-C ≥ 70 mg/dL, non–high-density lipoprotein cholesterol ≥ 100 mg/dL, or apolipoprotein B ≥ 80 mg/dL. The primary efficacy measure is time to first occurrence of coronary heart disease death, acute myocardial infarction, hospitalization for unstable angina, or ischemic stroke. The trial is expected to continue until 1613 primary end point events have occurred with minimum follow-up of at least 2 years, providing 90% power to detect a 15% hazard reduction. Adverse events of special interest include allergic events and injection site reactions. Interim analyses are planned when approximately 50% and 75% of the targeted number of primary end points have occurred. Summary ODYSSEY Outcomes will determine whether the addition of the PCSK9 antibody alirocumab to intensive statin therapy reduces cardiovascular morbidity and mortality after ACS.
Published: 2014

23. The management of acute myocardial infarction in the cardiological intensive care units in Italy: the ‘BLITZ 4 Qualità’ campaign for performance measurement and quality improvement

Author: Stefano Savonitto, Marino Scherillo, Aldo P. Maggioni, Pierluigi Tricoci, Salvatore Pirelli, Donata Lucci, Zoran Olivari, Alessandra Chinaglia, Giuseppe Steffenino, Francesco Chiarella, Stefano Urbinati, and Giampaolo Scorcu
Subjects: medicine.medical_specialty, Evidence-based practice, Quality management, business.industry, Acute Ischemic Heart Disease, General Medicine, Critical Care and Intensive Care Medicine, medicine.disease, Intensive care unit, law.invention, Reperfusion therapy, law, Intensive care, Antithrombotic, medicine, Myocardial infarction, Cardiology and Cardiovascular Medicine, Intensive care medicine, business, Fibrinolytic agent
Abstract: To assess and promote compliance of Italian cardiological intensive care units (CCUs) with evidence-based guidelines for the management of acute myocardial infarction (MI).The process of diagnosis and treatment of MI was prospectively evaluated in 163 CCUs by use of 30 indicators during two enrolment phases, each followed by a feedback of both local and general performance. Overall, 5854 patients with ST-segment elevation MI (STEMI) and 5852 with non-ST-segment elevation MI (NSTEMI) were consecutively enrolled. The target for each indicator was defined as compliance with the relevant recommendations in ≥90% of suitable patients and it was met for nine (30%) and 10 (33.3%) indicators in the first and second phases, respectively. Regardless of target, a significant improvement in compliance was observed in the second phase in 10 out of 30 indicators (33.3%). Use of pre-hospital ECG, expedite delivery of reperfusion therapy, dosage of antithrombotic drugs, and non-pharmacological implementation of secondary prevention were often off target. Similar in-hospital mortality was observed in phases I and II, both in patients with STEMI (4.0 vs. 4.2%, p=0.79) and NSTEMI (1.8 vs. 2.4%, p=0.11). Overall, 30-day mortality were 5.7% for patients with STEMI and 3.4% with NSTEMI.Performance indicators can accurately weigh the whole process of diagnosis and treatment of patients with MI and monitor the improvements in the quality of care. In our large population of consecutive patients, satisfactory 30-day outcomes were observed despite suboptimal adherence to guidelines for some indicators of recognised prognostic relevance.
Published: 2012

24. Prasugrel versus clopidogrel for acute coronary syndromes without revascularization

Author: L. Wang, T. Stys, William E. Boden, R. H. Urbano, D. M. Olinic, Karen S. Pieper, A. Kuijper, E. Soh, J. Nicolau, Jadwiga Nessler, William J. Rogers, Ernesto Rivera, R. Braam, H. Kadr, J. Csikasz, B. Boichev, Prafulla Kerkar, I. Kraiz, R. Babu, Ali Aydinlar, D. Safley, O. Nguyen-Khac, P. Chua, W. Buchanan, C. A. Morales, A. Abyankar, A. Srinivas, S. Genth-Zotz, J. Rocha Faria Neto, D. Drenning, L. Moretti, S. Varma, D. Roth, C. Matei, Jane E. Onken, H. Tumbev, P. Keeling, Xian Li, N. Ciglenecki, Shahyar M. Gharacholou, P. P. Goh, D. Sporn, M. Chang, Marcin Gruchała, R. Foreman, Bogdan Minescu, S. Nawaz, N. Alexeeva, Y. Shalev, C. Fastabend, L. van Zyl, J. F. Certic, J. Longo, J. Wang, K. Dave, Olivier Morel, F. Maatouk, Y. El Rakshy, J. Giacomini, P. Lazov, R. Marino, Dimitar Raev, M. Y. Chan, L. Z. Dextre, Y. Hao, P. Sepulveda, K. Ramshev, C. Bayron, Ameer Kabour, Alon Marmor, Luciano Moreira Baracioli, H. Marais, Rajendra H. Mehta, R. Breedveld, A. Ben Khalfallah, Kurtulus Ozdemir, I. Westendorp, J. A. Quion, Daniel J. George, D. F. Garcia, J.-P Bassand, G. Szalai, Huw Griffiths, O. Ushakov, M. Tzekova, E. Suprun, A. Mowafy, N. El Mansour, Gail V.W. Johnson, Tereshchenko Sn, W. T. Lai, Petr Widimsky, Hany Ragy, V. R. Castillo, M. Padour, Gilles Montalescot, Louie Tirador, Deepak L. Bhatt, M. Marrinan, S. Promisloff, A. Nambiar, Reginald G.E.J. Groutars, S. R. Lee, J. Cabrera, S. Zhang, András Jánosi, K. Wita, R. Sciborski, Annabelle Rodriguez, P. Sedlon, Jaroslaw D. Kasprzak, A. Faynyk, A. Romero Acuña, M. C. Ramirez, Rakesh Gupta, R. Saligrama, Jacek Gniot, Y. Ke, John H. Alexander, X. Liu, E. Baranov, R. Grzywna, Mukul Sharma, A. Linka, Jarosław Wójcik, Haroon Rashid, M. S. Sanchez, M. Gadkari, B. Rao, James S. Zebrack, Paul W. Armstrong, Francois Schiele, Gracita O. Topacio, Peter J. Casterella, A. Belhassane, P. Golino, F. Plat, P. Roberts-Thomson, K. S. Kim, Stephen D. Wiviott, Mathew T. Roe, Y. D. Chen, I. A. Khan, S. Thanvi, S. Isserman, G. Falck, R. M. Coching, S. C. Stamate, M. Ogorek, K. Danisa, Poul Anders Hansen, M. Medvegy, Amos Katz, R. K. Seerangachar, B. Farah, V. Kale, B. Kusnick, Maurice Pye, M. Mosseri, M. Vatutin, D. Weinstein, Norma Keller, A. Mihov, Ewa Mirek-Bryniarska, N. Adjei, S. Sethi, A. Irimpen, M. Broeders, T. Huynh, K. Niezgoda, P. Samardzic, D. Ziperman, Stuart J. Pocock, T. Arad, J. Lewczuk, M. Amuchastegui, R. Moscoso, B. Dimov, W. A. Ahmad, E. Dalli, P. Laothavorn, S. Shaikh, Helmut U. Klein, J. Menon, H. Colombo, L. Fattore, G. Zarrella, Dorairaj Prabhakaran, N. Viboolkitvarakul, Judith D. Goldberg, Neetika Garg, Y. Hasin, F. Rossi Dos Santos, S. J. Vigo, L. Horbach, O. Prokhorov, H. Moellmann, T. R. Vera, C. E. Botta, Domitilla Russo, M. Rossovskaya, David C. Henderson, Rebecca B. Costello, V. Shcherbak, C. J.P.J. Werter, W. Kus, I. Dobre, P. Marechal, T. Nair, H. Nielsen, J. Waites, J. B. Moraes Junior, T. Römer, J. Senior, P. Ionescu, S. Kalashetti, R. N. Ortega, Gail E. Hafley, G. A. Dan, Apur R. Kamdar, Ruth Ann Greenfield, David F. Kong, J. Bergallo, O. Barnum, Antonis S. Manolis, Sumeet Subherwal, S. Schaefer, A. Figueredo, Habib Gamra, S. Bandyopadhyay, V. Miloradovic, Imran Arif, Peter R. Carroll, M. Demirtas, S. Guidera, G. Rogelio, Naseem Jaffrani, N. Mulvihill, Marvin J. Slepian, Darren K. McGuire, Rohit Kalra, Luís A. Providência, F. Van de Werf, Andras Vertes, J. Xu, C. F. Gamio, R. G. Xuereb, R. F. Ramos, E. Kis, N. Bustros, M. De Luca, S. Zhurba, T. Connelly, S. Singhi, F. Gredler, Serdar Kucukoglu, Francesco Fedele, C. Chavez, Christoph Kadel, Antônio Carlos Sobral Sousa, S. Srimahachota, Igor Kaidashev, J. H. Garcia, I. Teodorescu, Birute Petrauskiene, O. Kracoff, Liwa T. Younis, Alain Bouchard, P. Osmancik, Y. Sun, C. Hammett, S. Sabri, William Wallace, Mehmet Yazici, L. Ermoshkina, Harish Chandna, G. Ramos-Lopez, M. Bronisz, Sergio Luiz Zimmermann, Giuseppe Ambrosio, V. Hergeldjieva, César A. Jardim, A. Rifai, H. Lui, A. Lee, J. Scholz Issa, A. Blenkhorn, P. Micale, V. Barbarich, C. Maccallum, Peter J. Grant, G. Topacio, N. Budassi, J. Yan, Keith A.A. Fox, Y. Xia, Jan H. Cornel, A. Rafael, Paul Hermany, S. Potthoff, Mohsin A.F. Khan, Pierre Coste, Neal Ready, N. T. Duda, M. Reyes, A. Chandran, I. G. Gordeev, Anne W. Beaven, B. J.B. Hamer, C. Treasure, Pravin Manga, M. R. Babarskiene, T. Devedzhiev, Alberto Menozzi, L. Lenarz, N. Llerena, Thomas F. Lüscher, Giovânio Vieira da Silva, Y. Malynovsky, L. Ramanathan, M. Belicova, M. O. Ibarra, D. Chew, R. Castillo, M. Kesselbrenner, A. H. Li, E. Baldjiev, M. El-Harari, S. H. Hur, S. Chiaramida, C. E. Chiang, Viliam Fridrich, L. R. Cartasegna, A. Yagensky, Steven E. Hearne, Gregory Pavlides, Witold Rużyłło, Y. Chandrashekhar, S. Welka, H. Petijean, Jose L. Leiva-Pons, Shaul Atar, Andrzej Lubiński, S. Zhao, János Tomcsányi, Narinder Singh, D. Banker, T. Boyek, H. Ebinc, N. Calambur, A. Mouhaffel, M. Creteanu, H. Huang, J. O. Jeong, E. Goudreau, D. Alexopoulos, E. Duronto, S. Car, O. Bashkirtsev, J. Mandak, V. Papademetriou, David O. Williams, Oscar Pereira Dutra, R. Baman, T. J. Hong, J. O. Ibañez, D. L. Gomez, R. K. Jain, R. Jozwa, L. Di Lorenzo, Matthew Wilson, Christian W. Hamm, A. Buakhamsri, Nikitas Moschos, Ashok Kumar, A. Kadiiski, C. Y. Lee, M. Opazo, J. Tang, E. Ferrari, P. Colon-Hernandez, Jean-Pierre Déry, B. Goloborodko, L. Gimple, Diego Ardissino, M. Bergovec, S. Thew, Dariusz Dudek, K. Tang, P. A.G. Zwart, A. Deshpande, S. Sathe, Yves Cottin, V. Pai, O. Koval, J. Lesnik, Pavan S. Reddy, A. Espinoza, Rungroj Krittayaphong, Carisi Anne Polanczyk, E. Kukuy, L. Tejada, J. Nobel, Renato D. Lopes, J. Bagatin, A. Manolova, E. Boudriot, A. Godoy, N. Perepech, Christopher D. Olympios, A. E. Guimarães, James Harris, Aref Rahman, D. Foley, H. J. Kruik, J. Bruguera I Cortada, I. Fotiadis, A. Bharani, Petar Otasevic, Eileen Brown, N. Gratsiansky, J. E. Poulard, Vladimir Gašparović, Habib Haouala, A. de Belder, J. Schmedtje, Lilia Nigro Maia, J. Cobos, Werner Benzer, E. Korban, A. U. Quraishi, X. Hong, A. Bazzi, P. Kotha, L. Gubolino, H. Ingersoll, Debra Marshall, Udo Sechtem, Sandipan Dutta, G. Frago, Anthony Mathur, Shaun G. Goodman, William Bachinsky, A. Hamer, Jaime Gomez, Patrizio Lancellotti, Vance Wilson, L. White, P.P. Mohanan, Aleksandar Knezevic, Sorin J. Brener, Susanna R. Stevens, H. Luquez, S. K. Lee, P. E. Leaes, P. Benjarge, T. Tu, Z. Coufal, N. Koliopoulos, Mahmut Şahin, X. Huang, S. Boldueva, J. De Souza, N. Chidambaram, S. Zolyomi, K. G. Shyu, H. Montecinos, A. Piombo, Wladmir Faustino Saporito, R. L. Kulkarni, I. Szakal, G. Arminio, M. Elbaz, Samir Pancholy, Jang Ho Bae, Giuseppe Musumeci, S. B. Zouari, A. Chois, D. Wojciechowski, A. Bakbak, E. Bozkurt, Kenneth J. Winters, R. Raugaliene, D. Sarkar, J. M. Alegret, Hubertus Heuer, E. Bobescu, E. Roncallo, R. Carlsson, R. Craig McLendon, L K Newby, K. Zrazhevskiy, João Pedro Ferreira, A. Haidar, D. Tellez, Robert Olszewski, Shmuel Gottlieb, H. Jure, A. Garcia Escudero, S. Sengupta, V. Ochean, W. Kostuk, G. Range, F. Leroy, G. Parale, R. Fernandez, M. Fulwani, M. Padovan, Y. Dovgalevskiy, Kreton Mavromatis, H. Hart, Y. G. Ko, F. Seixo, V. Bisne, J. McGarvey, Kimberly L. Blackwell, John H. Strickler, Sanjay Kumar, A. Bordonava, L. Egorova, C. Patocchi, A. Karczmarczyk, Chiara Melloni, Piyamitr Sritara, M. Anastasiou-Nana, Roman Szełemej, K. Penchev, D. Morales, M. Tokmakova, Krzysztof Zmudka, Rakesh Yadav, E. Bressollette, D. Nul, A. L. Astesiano, M. Urban, Abdulhay Albirini, C. T. Chin, F. Moulin, I. M. Coman, R. Watkin, J. Abanilla, J. Brønnum-Schou, J. Anusauskiene, P. Andrade Lotufo, Joseph G. Rogers, M. Bessen, P. C. Sartori, Paulo Roberto Ferreira Rossi, K. Atassi, H. V. Anderson, B. Klugherz, Bateshwar Prasad Singh, Mirza S. Baig, Z. Yusof, J. H. Geertman, A. Labroo, P. Nash, Freek W.A. Verheugt, Nancy J. Brown, M. A. Alcocer, A. Neskovic, L. Francek, Judith S. Hochman, A. Hoffmann, R. Dran, A. Podczeck-Schweighofer, Jeffry Katz, Josh Roberts, Roger E. McLendon, Ronald Rodriguez, T. Downes, A. Roth, L. E. Mayorga, Armagan Altun, José-Luis López-Sendón, M. Krotin, N. van der Merwe, O. Gigliotti, C. Park, G. Brigden, M. Kumbla, D. C G Basart, D. Erdogan, R. van Kranen, J. Beloscar, Johny Joseph, Pierluigi Tricoci, J. Marino, N. Mahon, S. Dani, I. Kovalskyy, Ioannis Nanas, V. Volkov, M. I. Edmilao, J. Kruells-Muench, F. Alamgir, R. Rinaldi, W. E. Mogrovejo, J. Mirat, C. Staniloae, S. Borromeo, H. Kozman, H. Zhang, Y. Zhou, S. Shurmur, A. Manari, M. A. Barrera, A. Vasylenko, D. Keedy, Paul A. Gurbel, Ali Oto, Charles R. Lambert, V. G. Ribeiro, A. Quintero, H. Joshi, L. Tang, J. Allan, C. S. Díaz, F. Carvalho Neuenschwander, Mircea Cintezǎ, M. Kokles, G. Piovaccari, Z. Kovacs, W. Li, C. Beauloye, E. J. Ramos, D. Bertolim Precoma, J. Burstein, G. Covelli, E. C. Zambrano, Assen Goudev, A. Tang, F. Henriquez, S. Tangsuntornwiwat, C. Kirma, GR Aycock, Kenneth W. Mahaffey, M. Ardnt, Jose C. Nicolau, O. Barbarash, E. K. Shin, P. Potapenko, T. Supryadkina, Asok Venkataraman, W. Mogrovejo, M. Acikel, R. Bohorquez, M. Syvänne, M. Chan, H. Mardikar, H. Berlin, O. Quintana, K. Heintz, J. M. Bastos, Guillermo Llamas Esperon, G. Aroney, J. Chen, Nancy H. Collins, C. Ahsan, G. Heins, F. Baer, V. Kondle, Nicholas Danchin, G. Shetty, Sergio Berti, Philip E. Aylward, James Cotton, G. S. Vallejo, Massimo Volpe, Z. Vasiljevic-Pokrajcic, C. Bugueño, Seung Woon Rha, S. Ilic, G. E. Stanciulescu, Z. Li, D. Nassiacos, R. Sciberras, S. Kuanprasert, Denilson Campos de Albuquerque, M. Pavlovic, Craig S. Barr, Mohammed R. Essop, John G. Canto, David T. Roberts, M. Ozdemir, Jacquelyn Miller, T. K. Ong, Sian E. Harding, V. Bose, J. Yoon, R. Syan, M. A. Paz, O. Maskon, Dennis V. Cokkinos, L. Kraus, Z. Masud, K. Amosova, M. Boyarkin, L. Mos, Dmitry Zamoryakhin, Arif Anis Khan, Jeffrey A. Breall, A. Gallino, Ivo Petrov, F. A. Alves da Cost, Saul Vizel, Hugo Vargas Filho, P. Kaewsuwanna, G. Antonelli, Chuen Den Tseng, I. Vakaliuk, J. Miklin, A. El Hawary, Ashok Jacob, D. Gumm, Kurt Huber, G. Pajes, N. Jathappa, Stanislaw Bartus, P. V. Lavhe, C. Romero, J. Balkin, T. Gould, R. Durgaprasad, Felipe Martinez, Henning Ebelt, A. Puri, D. K. Agarwal, E. E. Buyukoner, R. Mora Junior, P. Poliacik, A. Dande, X. Zhao, J. Floro, A. Bagriy, Yuliya Lokhnygina, M. Atieh, V. Batushkin, Valentin Markov, O. Karpenko, Peter Clemmensen, P. Castro, L. Paloscia, F. Florenzano, J. L. Accini, Tony Schibler, J. Arneja, W. Wu, B. Andruszkiewicz, Michael A. Morse, P. Vojtisek, D. Sadler, S. Frischwasser, M. Cayli, W N Leimbach, E. Flores, B. Wang, A Sosa Liprandi, Y. Michalaros, H. C. Finimundi, Raul D. Santos, N. Vijay, E. Magnus Ohman, Y. Karpenko, J. Sirotiakova, Z. Shogenov, D A Zateyshchikov, Eric P. Viergever, R. Bach, Gary S. Niess, D. C. Acosta, G. Piegari, J. B. Gupta, J. Shanes, E. Ronner, J. Arter, Claudio Cavallini, M. A. Hominal, V. Bugan, S. D. Varini, K. Nyman, B. G. Castillo, Sinan Aydoğdu, N. Novikova, D. Wang, P. Simpson, Y. Huang, Taral Patel, Gabriel Tatu-Chitoiu, D. Silva Junior, H. Theron, C. Alvarez, Anikó Ilona Nagy, T. Chua, P. Georgiev, D. Rittoo, G. De Luca, R. Blonder, Alberto Caccavo, D. Koganti, E. Manenti, N. Ghaisas, G. Letcher, D. Platogiannis, Arshed A. Quyyumi, J. Dy, Z. Ples, W. Kunz Sebba Barroso de Souza, Hamid Taheri, S. Kammoun, A. Salvioni, B. Stockins, K. Sutalo, J. C. Post, Merih Kutlu, Vijay K. Chopra, C. Mathis, Stephen M. Schwartz, Manish Jain, D. Coisne, A. Goudev, A. Dalby, João Morais, P. van Kalmthout, Andrzej Budaj, I. Dotani, L. Mircoli, R. Vicari, J. P. Herrman, M. Moran, G. Lupkovics, Alexander Parkhomenko, J. Heath, Andrew Moriarty, C. Pop, J. Y. Hwang, S. Kassam, R. Martingano, I. Nikolskaya, Z. Zheng, Johann S. de Bono, M. Izzo, R. Labonte, E. H. Forte, W. Moleerergpoom, Piera Angelica Merlini, D. Lee, W. Macias, G. Syan, S. Zhou, S. W. Kim, T. Duris, E. Shaoulian, Andreas U. Wali, Marco Antonio Mota Gomes, Pritibha Singh, M. Ovize, M. Del Core, W. Bowden, B. Xu, Ravi Bhagwat, C. Wongvipaporn, J. Vojacek, Steven Lindsay, F. McGrew, J. Gorny, J. D. Pappas, R. Vuyyuru, J. Chahin, Ashraf Reda, T. Lau, E. Conn, J. Meisner, S. Meymandi, A. D. Hrabar, M. Slanina, D. Jarasuniene, C. Lang, A. Vo, Christian Hamm, H. Gogia, Z. Yuan, T. Mathew, A. Van Dorpe, J. Kettner, M. Barbiero, Harvey D. White, L. Rudenko, V. Jain, M. Carter, David Erlinge, G. Ma, V. Sierkova, D. K. Kim, Steven O. Smith, R. K. Premchand, P. Jetty, J. Y. Hou, V. Simanenkov, T. Kaelsch, David P. Foley, A. Francis, Piotr Ponikowski, Ramón Corbalán, D. Connolly, J. Tuma, R. Zambahari, Miodrag Ostojic, R. Lamich, A. Rabelo Alves, V. Tseluyko, G. Moises Azize, L. Khaisheva, G. Pencheva, C. Ingram, J. Cooke, A. Prado, M. De Tollenaere, M. Kim, Alan Rees, Melanie B. Turner, Mark B. Abelson, H. L. Luciardi, L. Illyes, R. Sarma, L. Manriquez, J. A. Marin Neto, D. Iordachescu-Petica, G. Hoedemaker, Victor S. Gurevich, F. Ridocci, J. Grman, F. Waxman, Jorge F. Saucedo, E. Boughzala, B. S. Jagadesa, Heba Abdullah, A. Weiss, N. Bichan, L. Tami, Y. Bouzid, N. I. Gomez, Zafar Sy, Béla Merkely, J. P. Albisu, L. Rodriguez-Ospina, John C. Chambers, L. L. Lobo Marquez, R. Guan, Steven Georgeson, M. K. Sarna, L. Nogueira Liberato de Sousa, Mika Laine, P. Pimentel Filho, Teresa Kawka-Urbanek, G P Arutyunov, S. Elhadad, A. Dambrauskaite, R. Leon de la Fuente, Audes D. M. Feitosa, P. Baetslé, Abraham Al Ahmad, José Francisco Kerr Saraiva, Roland P.T. Troquay, J. Berlingieri, Margaret Arstall, J. L. Coronado, K. Yang, S. V. Shalaev, Bernard J. Gersh, A. El-Etreby, Elżbieta Zinka, F. De Valais, John E.A. Blair, P. Fajardo, M. Rodriguez, R. Boujnah, H. Hammerman, Y. S. Chong, Stigi Joseph, M. H. Jeong, J. Ge, Q. He, Robert S Iwaoka, Bimal R. Shah, J. Sawhney, T. Sakulsaengprapha, G. Werner, Jill Anderson, M. Hondl, Meinrad Gawaz, Gilmar Reis, M. Dalkowski, Tomáš Janota, M. Damiao Gomes Seabra, A. Dharmadhikari, Aleš Linhart, John Elliott, Kodangudi B. Ramanathan, Doron Zahger, Dilek Ural, L. Regos, F. R. Bolohan, Marcello Galvani, B. Zakhary, N. Qureshi, D. Deac, Maria Emília Figueiredo Teixeira, T. Venter, Santosh Gupta, W. Wright, P. Telekes, A. Furber, V. Nykonov, Zhu Junren, M. Cinteza, I. Lang, S. Junejo, D. Martins, Mauro Esteves Hernandes, G. Ishmurzin, Anthony J. Dalby, R. Scioli, P. Babu, R. Habaluyas, V. Mendoza, G. B. Scaro, Matthew T. Roe, M. Senaratne, D. J. van der Heijden, T. Pillay, Yoav Turgeman, J. Moreira, C. Cuccia, C. Astarita, S. De Servi, Robert G. Wilcox, M. C. Constantinescu, Kardiyoloji, Roe Matthew, T., Armstrong Paul, W., Fox Keith, A. A., White Harvey, D., Prabhakaran, Dorairaj, Goodman Shaun, G., Cornel Jan, H., Bhatt Deepak, L., Clemmensen, Peter, Martinez, Felipe, Ardissino, Diego, Nicolau Jose, C., Boden William, E., Gurbel Paul, A., Ruzyllo, Witold, Dalby Anthony, J., McGuire Darren, K., Leiva Pons Jose, L., Parkhomenko, Alexander, Gottlieb, Shmuel, Topacio Gracita, O., Hamm, Christian, Pavlides, Gregory, Goudev Assen, R., Oto, Ali, Tseng Chuen, Den, Merkely, Bela, Gasparovic, Vladimir, Corbalan, Ramon, Cinteza, Mircea, McLendon R., Craig, Winters Kenneth, J., Brown Eileen, B., Lokhnygina, Yuliya, Aylward Philip, E., Huber, Kurt, Hochman Judith, S., Ohman E., Magnu, and Golino, Paolo
Subjects: Male, Prasugrel, Myocardial Infarction, Kaplan-Meier Estimate, Piperazines, Purinergic P2 Receptor Antagonists, Myocardial infarction, education.field_of_study, Cardiovascular diseases [NCEBP 14], Acute Coronary Syndrome, Aged, Angina, Unstable, Aspirin, Cardiovascular Diseases, Double-Blind Method, Drug Therapy, Combination, Female, Follow-Up Studies, Humans, Middle Aged, Platelet Aggregation Inhibitors, Prasugrel Hydrochloride, Stroke, Thiophenes, Ticlopidine, Medicine (all), Hazard ratio, Clopidogrel, Acute Coronary Syndromes, General Medicine, Angina, Combination, Cardiology, medicine.drug, medicine.medical_specialty, Acute coronary syndrome, Population, Unstable, Drug Therapy, General & Internal Medicine, Internal medicine, medicine, cardiovascular diseases, education, Acute coronary syndromes, Revascularisation, Unstable angina, business.industry, medicine.disease, REVASCULARIZAÇÃO MIOCÁRDICA, business
Abstract: Item does not contain fulltext BACKGROUND: The effect of intensified platelet inhibition for patients with unstable angina or myocardial infarction without ST-segment elevation who do not undergo revascularization has not been delineated. METHODS: In this double-blind, randomized trial, in a primary analysis involving 7243 patients under the age of 75 years receiving aspirin, we evaluated up to 30 months of treatment with prasugrel (10 mg daily) versus clopidogrel (75 mg daily). In a secondary analysis involving 2083 patients 75 years of age or older, we evaluated 5 mg of prasugrel versus 75 mg of clopidogrel. RESULTS: At a median follow-up of 17 months, the primary end point of death from cardiovascular causes, myocardial infarction, or stroke among patients under the age of 75 years occurred in 13.9% of the prasugrel group and 16.0% of the clopidogrel group (hazard ratio in the prasugrel group, 0.91; 95% confidence interval [CI], 0.79 to 1.05; P=0.21). Similar results were observed in the overall population. The prespecified analysis of multiple recurrent ischemic events (all components of the primary end point) suggested a lower risk for prasugrel among patients under the age of 75 years (hazard ratio, 0.85; 95% CI, 0.72 to 1.00; P=0.04). Rates of severe and intracranial bleeding were similar in the two groups in all age groups. There was no significant between-group difference in the frequency of nonhemorrhagic serious adverse events, except for a higher frequency of heart failure in the clopidogrel group. CONCLUSIONS: Among patients with unstable angina or myocardial infarction without ST-segment elevation, prasugrel did not significantly reduce the frequency of the primary end point, as compared with clopidogrel, and similar risks of bleeding were observed. (Funded by Eli Lilly and Daiichi Sankyo; TRILOGY ACS ClinicalTrials.gov number, NCT00699998.).
Published: 2012

25. The Thrombin Receptor Antagonist for Clinical Event Reduction in Acute Coronary Syndrome (TRA*CER) trial: study design and rationale

Author: Park Seung-Jung, Christoph Bode, David J. Whellan, Jan Erik Nordrehaug, Robert F. Storey, A. Michael Lincoff, Robert A. Harrington, M. Pfisterer, Marco Valgimigli, Lars Wallentin, Edmond Chen, Peter Ofner, Gilles Montalescot, Witold Rużyłło, Kenneth W. Mahaffey, Huay-Cheem Tan, Anthony J. Dalby, J. Wouter Jukema, Basil S. Lewis, Petr Widimsky, Angel Cequier, Daniel Isaza, Frans Van de Werf, John Strony, Peer Grande, Chen Ming-Fong, Jan H. Cornel, Claes Held, Paul W. Armstrong, Enrico P. Veltri, Kurt Huber, David J. Moliterno, Giuseppe Ambrosio, Hisao Ogawa, Juan Carlos Prieto, Pierluigi Tricoci, Lawrence Wong, Markku S. Nieminen, Amadeo Betriu, Jun-ichi Yamaguchi, Luís A. Providência, Michael P. Hudson, Jose C. Nicolau, Timur Timurkaynak, David A. Morrow, Rafael Diaz, Harvey D. White, and Phil Aylward
Subjects: Adult, Blood Platelets, medicine.medical_specialty, Acute coronary syndrome, Pyridines, law.invention, Lactones, Randomized controlled trial, Double-Blind Method, law, Internal medicine, medicine, Humans, Receptor, PAR-1, Myocardial infarction, Prospective Studies, Acute Coronary Syndrome, Stroke, Vorapaxar, Aspirin, business.industry, medicine.disease, Clopidogrel, Surgery, carbohydrates (lipids), Research Design, Cardiology, Cardiology and Cardiovascular Medicine, business, TIMI, Platelet Aggregation Inhibitors, medicine.drug
Abstract: Background The protease-activated receptor 1 (PAR-1), the main platelet receptor for thrombin, represents a novel target for treatment of arterial thrombosis, and SCH 530348 is an orally active, selective, competitive PAR-1 antagonist. We designed TRA.CER to evaluate the efficacy and safety of SCH 530348 compared with placebo in addition to standard of care in patients with non-ST-segment elevation (NSTE) acute coronary syndromes (ACS) and high-risk features. Trial design TRA.CER is a prospective, randomized, double-blind, multicenter, phase III trial with an original estimated sample size of 10,000 subjects. Our primary objective is to demonstrate that SCH 530348 in addition to standard of care will reduce the incidence of the composite of cardiovascular death, myocardial infarction (MI), stroke, recurrent ischemia with rehospitalization, and urgent coronary revascularization compared with standard of care alone. Our key secondary objective is to determine whether SCH 530348 will reduce the composite of cardiovascular death, MI, or stroke compared with standard of care alone. Secondary objectives related to safety are the composite of moderate and severe GUSTO bleeding and clinically significant TIMI bleeding. The trial will continue until a predetermined minimum number of centrally adjudicated primary and key secondary end point events have occurred and all subjects have participated in the study for at least I year. The TRA.CER trial is part of the large phase III SCH 530348 development program that includes a concomitant evaluation in secondary prevention. Conclusion TRA.CER will define efficacy and safety of the novel platelet PAR-1 inhibitor SCH 530348 in the treatment of high-risk patients with NSTE ACS in the setting of current treatment strategies.
Published: 2009

26. Quantification of fatty tissue mass by magnetic resonance imaging in arrhythmogenic right ventricular dysplasia

Author: Vincenzo Russo, Angelo Branzi, Luigi Lovato, Rossella Fattori, Giampaolo Gavelli, Pierluigi Tricoci, Giuseppe Boriani, Letizia Bacchi-Reggiani, Fattori R, Tricoci P, Russo V, Lovato L, Bacchi-Reggiani L, Gavelli G, Branzi A, and Boriani G.
Subjects: Adult, Male, Pathology, medicine.medical_specialty, FATTY/ADIPOSE TISSUE, Adipose tissue, Heart muscle disorder, Physiology (medical), Internal medicine, MRI, ARVD, medicine, Humans, Pathological, Myocardial mass, Arrhythmogenic Right Ventricular Dysplasia, medicine.diagnostic_test, business.industry, Objective method, Magnetic resonance imaging, Middle Aged, medicine.disease, Magnetic Resonance Imaging, Arrhythmogenic right ventricular dysplasia, Adipose Tissue, Case-Control Studies, Ventricular Function, Right, Cardiology, Diagnostic assessment, Female, Cardiology and Cardiovascular Medicine, business
Abstract: Quantification of Fatty Tissue Mass. Introduction: Arrhythmogenic right ventricular dysplasia (ARVD) is a heart muscle disorder in which the pathological substrate is a fatty or fibro-fatty replacement of the right ventricular (RV) myocardium. Methods and Results: Magnetic resonance imaging (MRI) studies were performed in 10 patients with arrhythmogenic right ventricular dysplasia and in 24 matched controls in order to assess right ventricular epicardial/intramyocardial fatty tissue mass, RV myocardial mass, and RV functional parameters. Functional abnormalities were found in all ARVD cases. Patients with ARVD showed increased fatty tissue compared to controls (8.2 ′ 4 g vs. 2.0 ′ 1.0 g; P = 0.001), whereas no significant differences were found in RV myocardial mass (29.5 ′ 9.2 g vs. 23.2 ′ 6.7 g; P = NS). A correlation coefficient between 0.87 and 0.97 was found for repeated measurements. Conclusion: Quantification of fatty tissue with MRI is feasible and constitutes an objective method for differentiating normal from pathological conditions. This approach may lead to a complete diagnostic assessment of ARVD with the potential application for monitoring the evolution of the disease.
Published: 2005

27. Vorapaxar in Acute Coronary Syndrome Patients Undergoing Coronary Artery Bypass Graft Surgery Subgroup Analysis From the TRACER Trial (Thrombin Receptor Antagonist for Clinical Event Reduction in Acute Coronary Syndrome)

Author: David J, Whellan, Pierluigi, Tricoci, Edmond, Chen, Zhen, Huang, David, Leibowitz, Pascal, Vranckx, Gregary D, Marhefka, Claes, Held, Jose C, Nicolau, Robert F, Storey, Witold, Ruzyllo, Kurt, Huber, Peter, Sinnaeve, A Teddy, Weiss, Jean-Pierre, Dery, David J, Moliterno, Frans, Van de Werf, Philip E, Aylward, Harvey D, White, Paul W, Armstrong, Lars, Wallentin, John, Strony, Robert A, Harrington, and Kenneth W, Mahaffey
Subjects: Male, Pyridines, Myocardial Ischemia, Kaplan-Meier Estimate, Postoperative Hemorrhage, coronary disease, Risk Assessment, Severity of Illness Index, Electrocardiography, Lactones, Postoperative Complications, Reference Values, Confidence Intervals, Humans, Hospital Mortality, Prospective Studies, Acute Coronary Syndrome, Coronary Artery Bypass, bypass, Aged, Proportional Hazards Models, Middle Aged, Survival Analysis, thrombin, Stroke, Treatment Outcome, myocardial infarction, platelets, Female, Receptors, Thrombin, Follow-Up Studies
Abstract: ObjectivesThis study evaluated effects of protease-activated receptor-1 antagonist vorapaxar (Merck, Whitehouse Station, New Jersey) versus placebo among the TRACER (Thrombin Receptor Antagonist for Clinical Event Reduction in Acute Coronary Syndrome) study patients with non–ST-segment elevation acute coronary syndromes undergoing coronary artery bypass grafting (CABG).BackgroundPlatelet activation may play a key role in graft occlusion, and antiplatelet therapies may reduce ischemic events, but perioperative bleeding risk remains a major concern. Although the TRACER study did not meet the primary quintuple composite outcome in the overall population with increased bleeding, an efficacy signal with vorapaxar was noted on major ischemic outcomes, and preliminary data suggest an acceptable surgical bleeding profile. We aimed to assess efficacy and safety of vorapaxar among CABG patients.MethodsAssociations between treatment and ischemic and bleeding outcomes were assessed using time-to-event analysis. Hazard ratios (HRs) and 95% confidence intervals (CIs) were calculated using the Cox hazards model. Event rates were estimated using the Kaplan-Meier method.ResultsAmong 12,944 patients, 1,312 (10.1%) underwent CABG during index hospitalization, with 78% on the study drug at the time of surgery. Compared with placebo CABG patients, vorapaxar-treated patients had a 45% lower rate of the primary endpoint (i.e., a composite of death, myocardial infarction, stroke, recurrent ischemia with rehospitalization, or urgent coronary revascularization during index hospitalization) (HR: 0.55; 95% CI: 0.36 to 0.83; p = 0.005), with a significant interaction (p = 0.012). The CABG-related Thrombolysis In Myocardial Infarction major bleeding was numerically higher with vorapaxar, but not significantly different between vorapaxar and placebo (9.7% vs. 7.3%; HR: 1.36; 95% CI: 0.92 to 2.02; p = 0.12), with no excess in fatal bleeding (0% vs. 0.3%) or need for reoperation (4.7% vs. 4.6%).ConclusionsIn non–ST-segment elevation acute coronary syndrome patients undergoing CABG, vorapaxar was associated with a significant reduction in ischemic events and no significant increase in major CABG-related bleeding. These data show promise for protease-activated receptor 1 antagonism in patients undergoing CABG and warrant confirmatory evidence in randomized trials. (Trial to Assess the Effects of SCH 530348 in Preventing Heart Attack and Stroke in Patients With Acute Coronary Syndrome [TRA·CER] [Study P04736AM3]; NCT00527943)
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28. Matrix metalloproteinases and their inhibitors in premature coronary atherosclerosis: Relation with inflammation and metabolic markers

Author: Luciana Tomasi, Chiara Melloni, Angelo Branzi, Roeland Hanemaaijer, Samuele Nanni, Vittorio Cervi, Giovanni Melandri, and Pierluigi Tricoci
Subjects: business.industry, Immunology, Metabolic markers, Medicine, Inflammation, Matrix metalloproteinase, medicine.symptom, business, Cardiology and Cardiovascular Medicine, Coronary atherosclerosis
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29. PHARMACODYNAMICS OF VORAPAXAR, A PLATELET PAR-1 ANTAGONIST, AND ITS INTERACTION WITH P2Y12 RECEPTOR PATHWAY IN THE TRACER TRIAL

Author: Robert F. Storey, Kurt Huber, Edward Hord, Luís A. Providência, Kenneth Mahaffey, Gregory Thomas, Pierluigi Tricoci, J.H. Cornel, Edmond Chen, Susan Smyth, John Strony, Tyrus Rorick, Jean-Pierre Dery, Tiziano Moccetti, Lisa K. Jennings, Jayaprakash Kotha, Richard Becker, David Moliterno, and Marco Valgimigli
Subjects: Aspirin, business.industry, Antagonist, Pharmacology, Placebo, Clopidogrel, P2Y12, Pharmacodynamics, medicine, Platelet, business, Cardiology and Cardiovascular Medicine, medicine.drug, Vorapaxar
Abstract: The TRACER trial compared vorapaxar, a novel oral PAR-1 antagonist, with placebo, as add-on therapy to standard of care, among 12944 NSTE ACS patients who were predominantly treated with aspirin and clopidogrel. While vorapaxar was associated with a significant increase in major bleeding in the
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29 results on '"Pierluigi Tricoci"'

1. Stroke Outcomes With Vorapaxar Versus Placebo in Patients With Acute Coronary Syndromes: Insights From the TRACER Trial

2. Efficacy and Safety of Vorapaxar in Non–ST‐Segment Elevation Acute Coronary Syndrome Patients Undergoing Noncardiac Surgery

3. Safety and efficacy of abciximab as an adjunct to percutaneous coronary intervention

4. Lipoprotein(a) and Benefit of PCSK9 Inhibition in Patients With Nominally Controlled LDL Cholesterol

5. Effect of Alirocumab on Mortality After Acute Coronary Syndromes

6. Alirocumab Reduces Total Nonfatal Cardiovascular and Fatal Events: The ODYSSEY OUTCOMES Trial

7. Standardized classification and framework for reporting, interpreting, and analysing medication non-adherence in cardiovascular clinical trials: a consensus report from the Non-adherence Academic Research Consortium (NARC)

8. Rationale and design of ApoA-I Event Reducing in Ischemic Syndromes II (AEGIS-II): A phase 3, multicenter, double-blind, randomized, placebo-controlled, parallel-group study to investigate the efficacy and safety of CSL112 in subjects after acute myocardial infarction

9. Evaluation of potential antiplatelet effects of CSL112 (Apolipoprotein A-I [Human]) in patients with atherosclerosis: results from a phase 2a study

10. Ischemic Events Occur Early in Patients Undergoing Percutaneous Coronary Intervention and Are Reduced With Cangrelor: Findings From CHAMPION PHOENIX

11. Alirocumab Reduces Total Nonfatal Cardiovascular and Fatal Events

12. Albiglutide and cardiovascular outcomes in patients with type 2 diabetes and cardiovascular disease (Harmony Outcomes): a double-blind, randomised placebo-controlled trial

13. Stroke Outcomes With Vorapaxar Versus Placebo in Patients With Acute Coronary Syndromes : Insights From the TRACER Trial

14. Effects of genetic variation in protease activated receptor 4 after an acute coronary syndrome: Analysis from the TRACER trial

15. An examination of the relationship between serum uric acid level, a clinical history of gout, and cardiovascular outcomes among patients with acute coronary syndrome

16. Use of thienopyridine prior to presentation with non-ST-segment elevation acute coronary syndrome and association with safety and efficacy of vorapaxar: insights from the TRACER trial

17. Efficacy and Safety of Alirocumab 150 mg Every 4 Weeks in Patients With Hypercholesterolemia Not on Statin Therapy : The ODYSSEY CHOICE II Study

18. Infusion of Reconstituted High-Density Lipoprotein, CSL112, in Patients With Atherosclerosis: Safety and Pharmacokinetic Results From a Phase 2a Randomized Clinical Trial

19. Sex-Stratified Trends in Enrollment, Patient Characteristics, Treatment, and Outcomes Among Non–ST-Segment Elevation Acute Coronary Syndrome Patients: Insights from Clinical Trials Over 17 Years

20. Efficacy and Safety of Vorapaxar in Non-ST-Segment Elevation Acute Coronary Syndrome Patients Undergoing Noncardiac Surgery

21. Long-term outcomes and causes of death after acute coronary syndrome in patients in the Bologna, Italy, area

22. Effect of alirocumab, a monoclonal antibody to PCSK9, on long-term cardiovascular outcomes following acute coronary syndromes : rationale and design of the ODYSSEY Outcomes trial

23. The management of acute myocardial infarction in the cardiological intensive care units in Italy: the ‘BLITZ 4 Qualità’ campaign for performance measurement and quality improvement

24. Prasugrel versus clopidogrel for acute coronary syndromes without revascularization

25. The Thrombin Receptor Antagonist for Clinical Event Reduction in Acute Coronary Syndrome (TRA*CER) trial: study design and rationale

26. Quantification of fatty tissue mass by magnetic resonance imaging in arrhythmogenic right ventricular dysplasia

27. Vorapaxar in Acute Coronary Syndrome Patients Undergoing Coronary Artery Bypass Graft Surgery Subgroup Analysis From the TRACER Trial (Thrombin Receptor Antagonist for Clinical Event Reduction in Acute Coronary Syndrome)

28. Matrix metalloproteinases and their inhibitors in premature coronary atherosclerosis: Relation with inflammation and metabolic markers

29. PHARMACODYNAMICS OF VORAPAXAR, A PLATELET PAR-1 ANTAGONIST, AND ITS INTERACTION WITH P2Y12 RECEPTOR PATHWAY IN THE TRACER TRIAL

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