Author: "John Eikelboom" / Topic: humans - Searchworks@Jio Institute Digital Library Search Results

36 results on '"John Eikelboom"'

1. A Multicenter, Phase 2, Randomized, Placebo-Controlled, Double-Blind, Parallel-Group, Dose-Finding Trial of the Oral Factor XIa Inhibitor Asundexian to Prevent Adverse Cardiovascular Outcomes After Acute Myocardial Infarction

Author: Sunil V. Rao, Bodo Kirsch, Deepak L. Bhatt, Andrzej Budaj, Rosa Coppolecchia, John Eikelboom, Stefan K. James, W. Schuyler Jones, Bela Merkely, Lars Keller, Renicus S. Hermanides, Gianluca Campo, José Luis Ferreiro, Taro Shibasaki, Hardi Mundl, John H. Alexander, Christian Hengstenberg, Clemens Steinwender, Hannes Alber, Regina Steringer-Mascherbauer, Andreas Schober, Johann Auer, Franz Xaver Roithinger, Dirk von Lewinski, Deddo Moertl, Kurt Huber, Patrick Coussement, Etienne Hoffer, Christophe Beauloye, Luc Janssens, Pascal Vranckx, Herbert De Raedt, Thomas Vanassche, Matthias Vrolix, Richard Rokyta, Jiri Parenica, Radek Pelouch, Zuzanna Motovska, David Alan, Jiri Kettner, Rostislav Polasek, Ondrej Cermak, Pavel Sedlon, Jiri Hanis, Martin Novak, Jan Belohlavek, Thomas Horacek, Stefan Leggewie, Philip Wenzel, Juergen vom Dahl, Burkhard Sievers, Jan Pulz, Sebastian Schellong, Peter Clemmensen, Matthias Muller-Hennessen, Tienush Rassaf, Jozsef Falukozi, Zoltan Ruzsa, Janos Tomcsanyi, Zoltan Csanadi, Bela Herczeg, Zsolt Koszegi, Andras Vorobcsuk, Robert Kiss, Csaba Baranyai, Csaba Dezsi, Geza Lupkovics, Roberta Rossini, Marino Scherillo, Pier Sergio Saba, Gianluca Calogero Campo, Leonardo Calo, Daniele Nassiacos, Giorgio Quadri, Alessandro Sciahbasi, Gian Carlo Silvio Marenzi, Bernhard Reimers, Gian Piero Perna, Salvatore Sacca, Luciano Fattore, Claudio Brunelli, Andrea Picchi, Takehiko Kuramochi, Kazuhisa Kondo, Takahiko Aoyama, Takashi Kudoh, Tadashi Yamamoto, Tomofumi Takaya, Yasushi Mukai, Kazuki Fukui, Nobuyuki Morioka, Kenji Ando, Atsushi Yamamuro, Yasuhiro Morita, Yasuaki Koga, Tetsuya Watanabe, Tomohiro Sakamoto, Daisuke Maebuchi, Akihiko Takahashi, Taishi Yonetsu, Tsunekazu Kakuta, Hidetaka Nishina, Rohit Oemrawsingh, Reinhart Dorman, Ton Oude Ophius, Paco Prins, N.Y.Y. al Windy, S.K. Zoet-Nugteren, Rik Hermanides, Martijn van Eck, Roderick Scherptong, J.H. Cornel, Peter Damman, Gerhard Bech, R. Torquay, Bas Kietselaer, Pawel Grzelakowski, Dyrbus Krzysztof, Pawel Miekus, Andrzej Przybylski, Maciej Zarebinski, Pawel Balsam, Joanna Szachniewicz, Marek Gierlotka, Agnieszka Tycinska, Andres Iniguez Romo, Antonio Fernandez Ortiz, Anna Carrasquer Cucarella, Marcelo Sanmartin Fernandez, Alessandro Sionis, Hector Bueno Zamora, Jose Luis Ferreiro Gutierrez, Luis Almenar, Ignacio Ferreira Gonzalez, Domingo A. Pascual Figal, Manuel Almendro Delia, Miriam Jimenez Fernandez, Mika Skeppholm, Crister Zedigh, Oskar Angeras, Jorg Lauermann, David Erlinge, Robin Gustafsson, Thomas Mooe, Alejandro Utreras, Stefan James, Per Grimfjard, Giovanni Pedrazzini, Francois Mach, Stephane Fournier, Laurent Haegeli, Jurg H. Beer, Gregor Leibundgut, Richard Kobza, Christoph Kaiser, Vijay Kunadian, Rasha Al-Lamee, Diana Gorog, Sohail Khan, Jasper Trevelyan, Iqbal Toor, James Smith, Bhaskar Purushottam, Charles Treasure, Frank Arena, Amarnath Vedere, David Henderson, Syed Gilani, Alonzo Jones, Rodolfo Carrillo-Jimenez, Eve Gillespie, Gregary Marhefka, David Wang, Charles Olson, Stephen Bloom, Faizan Iftikhar, David Brabham, John McGinty, Charles Thompson, James Talano, Wilson Ginete, Marcus Williams, Ali Masud, Mehrdad Ariani, Fahed Bitar, Thomas Wang, and Bradley Samuelson
Subjects: Male, Ticagrelor, Aspirin, Myocardial Infarction, Anticoagulants, Hemorrhage, Factor XIa, Percutaneous Coronary Intervention, Treatment Outcome, Double-Blind Method, Physiology (medical), Humans, Female, 03.02. Klinikai orvostan, Acute Coronary Syndrome, Cardiology and Cardiovascular Medicine, Prasugrel Hydrochloride, Platelet Aggregation Inhibitors, Aged
Abstract: Background: Oral activated factor XI (FXIa) inhibitors may modulate coagulation to prevent thromboembolic events without substantially increasing bleeding. We explored the pharmacodynamics, safety, and efficacy of the oral FXIa inhibitor asundexian for secondary prevention after acute myocardial infarction (MI). Methods: We randomized 1601 patients with recent acute MI to oral asundexian 10, 20, or 50 mg or placebo once daily for 6 to 12 months in a double-blind, placebo-controlled, phase 2, dose-ranging trial. Patients were randomized within 5 days of their qualifying MI and received dual antiplatelet therapy with aspirin plus a P2Y12 inhibitor. The effect of asundexian on FXIa inhibition was assessed at 4 weeks. The prespecified main safety outcome was Bleeding Academic Research Consortium type 2, 3, or 5 bleeding comparing all pooled asundexian doses with placebo. The prespecified efficacy outcome was a composite of cardiovascular death, MI, stroke, or stent thrombosis comparing pooled asundexian 20 and 50 mg doses with placebo. Results: The median age was 68 years, 23% of participants were women, 51% had ST-segment–elevation MI, 80% were treated with aspirin plus ticagrelor or prasugrel, and 99% underwent percutaneous coronary intervention before randomization. Asundexian caused dose-related inhibition of FXIa activity, with 50 mg resulting in >90% inhibition. Over a median follow-up of 368 days, the main safety outcome occurred in 30 (7.6%), 32 (8.1%), 42 (10.5%), and 36 (9.0%) patients receiving asundexian 10 mg, 20 mg, or 50 mg, or placebo, respectively (pooled asundexian versus placebo: hazard ratio, 0.98 [90% CI, 0.71–1.35]). The efficacy outcome occurred in 27 (6.8%), 24 (6.0%), 22 (5.5%), and 22 (5.5%) patients assigned asundexian 10 mg, 20 mg, or 50 mg, or placebo, respectively (pooled asundexian 20 and 50 mg versus placebo: hazard ratio, 1.05 [90% CI, 0.69–1.61]). Conclusions: In patients with recent acute MI, 3 doses of asundexian, when added to aspirin plus a P2Y12 inhibitor, resulted in dose-dependent, near-complete inhibition of FXIa activity without a significant increase in bleeding and a low rate of ischemic events. These data support the investigation of asundexian at a dose of 50 mg daily in an adequately powered clinical trial of patients who experienced acute MI. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT04304534; URL: https://www.clinicaltrialsregister.eu/ctr-search/search ; Unique identifier: 2019-003244-79.
Published: 2022
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2. Great Debate: Triple antithrombotic therapy in patients with atrial fibrillation undergoing coronary stenting should be limited to 1 week

Author: Raffaele De Caterina, Stefan Agewall, Felicita Andreotti, Dominick J Angiolillo, Deepak L Bhatt, Robert A Byrne, Jean-Philippe Collet, John Eikelboom, Alexander C Fanaroff, C Michael Gibson, Andreas Goette, Gerhard Hindricks, Gregory Y H Lip, Tatjana Potpara, Holger Thiele, Renato D Lopes, and Mattia Galli
Subjects: Fibrinolytic Agents, Atrial Fibrillation, Humans, Stents, Cardiology and Cardiovascular Medicine, Platelet Aggregation Inhibitors
Published: 2022
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3. Advances in anticoagulation: patients with bioprosthetic heart valves

Author: Stephanie Carlin and John Eikelboom
Subjects: Bioprosthesis, Treatment Outcome, Physiology, Aortic Valve, Heart Valve Prosthesis, Physiology (medical), Anticoagulants, Humans, Prosthesis Design, Cardiology and Cardiovascular Medicine, Heart Valves
Published: 2022
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4. Efficacy and safety of low-dose colchicine in patients with coronary disease: a systematic review and meta-analysis of randomized trials

Author: A. Mosterd, Anthony C Keech, David C Tong, Charley A. Budgeon, Jan H. Cornel, Jaimie Layland, Jan G.P. Tijssen, Peter J. Kelly, Aernoud T L Fiolet, Peter L. Thompson, Stefan M. Nidorf, Sanjit S. Jolly, John Eikelboom, Tjerk S.J. Opstal, Cardiology, and ACS - Heart failure & arrhythmias
Subjects: medicine.medical_specialty, Vascular damage Radboud Institute for Health Sciences [Radboudumc 16], Myocardial Infarction, Coronary Artery Disease, 030204 cardiovascular system & hematology, law.invention, 03 medical and health sciences, 0302 clinical medicine, Randomized controlled trial, law, Internal medicine, medicine, Clinical endpoint, Humans, 030212 general & internal medicine, Myocardial infarction, Stroke, Randomized Controlled Trials as Topic, Coronary disease, business.industry, Incidence (epidemiology), Atherosclerosis, medicine.disease, Confidence interval, Treatment Outcome, Major adverse cardiovascular events, Relative risk, Colchicine, Cardiology and Cardiovascular Medicine, business, Mace
Abstract: Aims Recent randomized trials demonstrated a benefit of low-dose colchicine added to guideline-based treatment in patients with recent myocardial infarction or chronic coronary disease. We performed a systematic review and meta-analysis to obtain best estimates of the effects of colchicine on major adverse cardiovascular events (MACE). Methods and results We searched the literature for randomized clinical trials of long-term colchicine in patients with atherosclerosis published up to 1 September 2020. The primary efficacy endpoint was MACE, the composite of myocardial infarction, stroke, or cardiovascular death. We combined the results of five trials that included 11 816 patients. The primary endpoint occurred in 578 patients. Colchicine reduced the risk for the primary endpoint by 25% [relative risk (RR) 0.75, 95% confidence interval (CI) 0.61–0.92; P = 0.005], myocardial infarction by 22% (RR 0.78, 95% CI 0.64–0.94; P = 0.010), stroke by 46% (RR 0.54, 95% CI 0.34–0.86; P = 0.009), and coronary revascularization by 23% (RR 0.77, 95% CI 0.66–0.90; P Conclusion Our meta-analysis indicates that low-dose colchicine reduced the risk of MACE as well as that of myocardial infarction, stroke, and the need for coronary revascularization in a broad spectrum of patients with coronary disease. There was no difference in all-cause mortality and fewer cardiovascular deaths were counterbalanced by more non-cardiovascular deaths.
Published: 2021
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5. Tranexamic Acid in Patients Undergoing Noncardiac Surgery

Author: P J, Devereaux, Maura, Marcucci, Thomas W, Painter, David, Conen, Vladimir, Lomivorotov, Daniel I, Sessler, Matthew T V, Chan, Flavia K, Borges, María J, Martínez-Zapata, Chew Yin, Wang, Denis, Xavier, Sandra N, Ofori, Michael K, Wang, Sergey, Efremov, Giovanni, Landoni, Ydo V, Kleinlugtenbelt, Wojciech, Szczeklik, Denis, Schmartz, Amit X, Garg, Timothy G, Short, Maria, Wittmann, Christian S, Meyhoff, Mohammed, Amir, David, Torres, Ameen, Patel, Emmanuelle, Duceppe, Kurt, Ruetzler, Joel L, Parlow, Vikas, Tandon, Edith, Fleischmann, Carisi A, Polanczyk, Andre, Lamy, Sergey V, Astrakov, Mangala, Rao, William K K, Wu, Keyur, Bhatt, Miriam, de Nadal, Valery V, Likhvantsev, Pilar, Paniagua, Hector J, Aguado, Richard P, Whitlock, Michael H, McGillion, Michael, Prystajecky, Jessica, Vincent, John, Eikelboom, Ingrid, Copland, Kumar, Balasubramanian, Alparslan, Turan, Shrikant I, Bangdiwala, David, Stillo, Peter L, Gross, Teresa, Cafaro, Pascal, Alfonsi, Pavel S, Roshanov, Emilie P, Belley-Côté, Jessica, Spence, Toby, Richards, Tomas, VanHelder, William, McIntyre, Gordon, Guyatt, Salim, Yusuf, Kate, Leslie, Erin, Hittesdorf, UCL - SSS/IREC/CARD - Pôle de recherche cardiovasculaire, Devereaux, P J, Marcucci, Maura, Painter, Thomas W, Conen, David, Lomivorotov, Vladimir, Sessler, Daniel I, Chan, Matthew T V, Borges, Flavia K, Martínez-Zapata, María J, Wang, Chew-Yin, Xavier, Deni, Ofori, Sandra N, Wang, Michael K, Efremov, Sergey, Landoni, Giovanni, Kleinlugtenbelt, Ydo V, Szczeklik, Wojciech, Schmartz, Deni, Garg, Amit X, Short, Timothy G, Wittmann, Maria, Meyhoff, Christian S, Amir, Mohammed, Torres, David, Patel, Ameen, Duceppe, Emmanuelle, Ruetzler, Kurt, Parlow, Joel L, Tandon, Vika, Fleischmann, Edith, Polanczyk, Carisi A, Lamy, Andre, Astrakov, Sergey V, Rao, Mangala, Wu, William K K, Bhatt, Keyur, de Nadal, Miriam, Likhvantsev, Valery V, Paniagua, Pilar, Aguado, Hector J, Whitlock, Richard P, Mcgillion, Michael H, Prystajecky, Michael, Vincent, Jessica, Eikelboom, John, Copland, Ingrid, Balasubramanian, Kumar, Turan, Alparslan, Bangdiwala, Shrikant I, Stillo, David, Gross, Peter L, Cafaro, Teresa, Alfonsi, Pascal, Roshanov, Pavel S, Belley-Côté, Emilie P, Spence, Jessica, Richards, Toby, Vanhelder, Toma, Mcintyre, William, Guyatt, Gordon, Yusuf, Salim, Leslie, Kate, and Anesthesiology
Subjects: BLOOD-TRANSFUSION, HEMORRHAGE, Canada, Tranexamic Acid, MORTALITY, Surgical Procedures, Operative, BIMS, Humans, Hemorrhage, Thrombosis, General Medicine, Antifibrinolytic Agents
Abstract: BACKGROUND Perioperative bleeding is common in patients undergoing noncardiac surgery. Tranexamic acid is an antifibrinolytic drug that may safely decrease such bleeding. METHODS We conducted a trial involving patients undergoing noncardiac surgery. Patients were randomly assigned to receive tranexamic acid (1-g intravenous bolus) or placebo at the start and end of surgery (reported here) and, with the use of a partial factorial design, a hypotension-avoidance or hypertension-avoidance strategy (not reported here). The primary efficacy outcome was life-threatening bleeding, major bleeding, or bleeding into a critical organ (composite bleeding outcome) at 30 days. The pri- mary safety outcome was myocardial injury after noncardiac surgery, nonhemor- rhagic stroke, peripheral arterial thrombosis, or symptomatic proximal venous thromboembolism (composite cardiovascular outcome) at 30 days. To establish the noninferiority of tranexamic acid to placebo for the composite cardiovascular out- come, the upper boundary of the one-sided 97.5% confidence interval for the hazard ratio had to be below 1.125, and the one-sided P value had to be less than 0.025. RESULTS A total of 9535 patients underwent randomization. A composite bleeding outcome event occurred in 433 of 4757 patients (9.1%) in the tranexamic acid group and in 561 of 4778 patients (11.7%) in the placebo group (hazard ratio, 0.76; 95% confi- dence interval [CI], 0.67 to 0.87; absolute difference, −2.6 percentage points; 95% CI, −3.8 to −1.4; two-sided P
Published: 2022
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6. Rationale and design of the PeriOperative ISchemic Evaluation-3 (POISE-3): a randomized controlled trial evaluating tranexamic acid and a strategy to minimize hypotension in noncardiac surgery

Author: Maura Marcucci, Thomas W. Painter, David Conen, Kate Leslie, Vladimir V. Lomivorotov, Daniel Sessler, Matthew T. V. Chan, Flavia K. Borges, Maria J. Martínez Zapata, C. Y. Wang, Denis Xavier, Sandra N. Ofori, Giovanni Landoni, Sergey Efremov, Ydo V. Kleinlugtenbelt, Wojciech Szczeklik, Denis Schmartz, Amit X. Garg, Timothy G. Short, Maria Wittmann, Christian S. Meyhoff, Mohammed Amir, David Torres, Ameen Patel, Emmanuelle Duceppe, Kurtz Ruetzler, Joel L. Parlow, Vikas Tandon, Michael K. Wang, Edith Fleischmann, Carisi A. Polanczyk, Raja Jayaram, Sergey V. Astrakov, Mangala Rao, Tomas VanHelder, William K. K. Wu, Chao Chia Cheong, Sabry Ayad, Marat Abubakirov, Mikhail Kirov, Keyur Bhatt, Miriam de Nadal, Valery Likhvantsev, Pilar Paniagua Iglesisas, Hector J. Aguado, Michael McGillion, Andre Lamy, Richard P. Whitlock, Pavel Roshanov, David Stillo, Ingrid Copland, Jessica Vincent, Kumar Balasubramanian, Shrikant I. Bangdiwala, Bruce Biccard, Andrea Kurz, Sadeesh Srinathan, Shirley Petit, John Eikelboom, Toby Richards, Peter L. Gross, Pascal Alfonsi, Gordon Guyatt, Emily Belley-Cote, Jessica Spence, William McIntyre, Salim Yusuf, P. J. Devereaux, Marcucci, M., Painter, T. W., Conen, D., Leslie, K., Lomivorotov, V. V., Sessler, D., Chan, M. T. V., Borges, F. K., Martinez Zapata, M. J., Wang, C. Y., Xavier, D., Ofori, S. N., Landoni, G., Efremov, S., Kleinlugtenbelt, Y. V., Szczeklik, W., Schmartz, D., Garg, A. X., Short, T. G., Wittmann, M., Meyhoff, C. S., Amir, M., Torres, D., Patel, A., Duceppe, E., Ruetzler, K., Parlow, J. L., Tandon, V., Wang, M. K., Fleischmann, E., Polanczyk, C. A., Jayaram, R., Astrakov, S. V., Rao, M., Vanhelder, T., Wu, W. K. K., Cheong, C. C., Ayad, S., Abubakirov, M., Kirov, M., Bhatt, K., de Nadal, M., Likhvantsev, V., Iglesisas, P. P., Aguado, H. J., Mcgillion, M., Lamy, A., Whitlock, R. P., Roshanov, P., Stillo, D., Copland, I., Vincent, J., Balasubramanian, K., Bangdiwala, S. I., Biccard, B., Kurz, A., Srinathan, S., Petit, S., Eikelboom, J., Richards, T., Gross, P. L., Alfonsi, P., Guyatt, G., Belley-Cote, E., Spence, J., Mcintyre, W., Yusuf, S., Devereaux, P. J., University of Manitoba, Department of Anaesthesia, and Faculty of Health Sciences
Subjects: Medicine (General), Tranexamic acid, Perioperative bleeding, Noncardiac surgery, Blood Loss, Surgical, Medicine (miscellaneous), Perioperative hypotension, Perioperative Care, Antifibrinolytic Agents, Study Protocol, R5-920, Randomized controlled trial, Cardiovascular complications, Humans, Pharmacology (medical), Hypotension
Abstract: Background For patients undergoing noncardiac surgery, bleeding and hypotension are frequent and associated with increased mortality and cardiovascular complications. Tranexamic acid (TXA) is an antifibrinolytic agent with the potential to reduce surgical bleeding; however, there is uncertainty about its efficacy and safety in noncardiac surgery. Although usual perioperative care is commonly consistent with a hypertension-avoidance strategy (i.e., most patients continue their antihypertensive medications throughout the perioperative period and intraoperative mean arterial pressures of 60 mmHg are commonly accepted), a hypotension-avoidance strategy may improve perioperative outcomes. Methods The PeriOperative Ischemic Evaluation (POISE)-3 Trial is a large international randomized controlled trial designed to determine if TXA is superior to placebo for the composite outcome of life-threatening, major, and critical organ bleeding, and non-inferior to placebo for the occurrence of major arterial and venous thrombotic events, at 30 days after randomization. Using a partial factorial design, POISE-3 will additionally determine the effect of a hypotension-avoidance strategy versus a hypertension-avoidance strategy on the risk of major cardiovascular events, at 30 days after randomization. The target sample size is 10,000 participants. Patients ≥45 years of age undergoing noncardiac surgery, with or at risk of cardiovascular and bleeding complications, are randomized to receive a TXA 1 g intravenous bolus or matching placebo at the start and at the end of surgery. Patients, health care providers, data collectors, outcome adjudicators, and investigators are blinded to the treatment allocation. Patients on ≥ 1 chronic antihypertensive medication are also randomized to either of the two blood pressure management strategies, which differ in the management of patient antihypertensive medications on the morning of surgery and on the first 2 days after surgery, and in the target mean arterial pressure during surgery. Outcome adjudicators are blinded to the blood pressure treatment allocation. Patients are followed up at 30 days and 1 year after randomization. Discussion Bleeding and hypotension in noncardiac surgery are common and have a substantial impact on patient prognosis. The POISE-3 trial will evaluate two interventions to determine their impact on bleeding, cardiovascular complications, and mortality. Trial registration ClinicalTrials.gov NCT03505723. Registered on 23 April 2018.
Published: 2022
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7. Efficacy and safety of low intensity vitamin K antagonists in Western and East-Asian patients with left-sided mechanical heart valves

Author: Arjun K, Pandey, Ke, Xu, Li, Zhang, Saurabh, Gupta, John, Eikelboom, Renato D, Lopes, Mark, Crowther, Emilie P, Belley-Côté, and Richard P, Whitlock
Subjects: Vitamin K, Fibrinolytic Agents, Thromboembolism, Anticoagulants, Humans, Hemorrhage, Heart Valves
Abstract: The optimal INR target in patients with mechanical heart valves is unclear. Higher INR targets are often used in Western compared with East Asian countries. The objective of this systematic review and meta-analysis was to summarize the evidence for the efficacy and safety of lower versus higher INR targets in Western and East Asian left-sided mechanical heart valve patients. We searched Western databases including Cochrane CENTRAL, Medline, and Embase as well as Chinese databases including SinoMed, CNKI, and Wanfang Data in addition to grey literature for Randomized Controlled Trials (RCTs) and observational studies. We pooled risk ratios (RRs) using random-effects model. Low and high INR targets were defined by the individual studies. We identified nine RCTs, including six Western (n = 5496) and three East Asian (n = 209) trials, and 17 observational studies, including two Western (n = 3199) and 15 East Asian (n = 5485) studies. In the RCTs, lower compared with higher targets were associated with similar rates of thromboembolism (2.4 vs. 2.3%; RR: 1.14, 95% CI 0.82, 1.60, I
Published: 2021

8. Pulmonary embolism: update on diagnosis and management

Author: James D. Douketis, John Eikelboom, Graeme J. Hankey, and Paul C Kruger
Subjects: medicine.medical_specialty, medicine.drug_class, Lower risk, Asymptomatic, Dabigatran, 03 medical and health sciences, chemistry.chemical_compound, 0302 clinical medicine, Risk Factors, Edoxaban, Humans, Medicine, Clinical significance, 030212 general & internal medicine, Pregnancy, business.industry, Anticoagulant, General Medicine, medicine.disease, Pulmonary embolism, chemistry, Radiology, medicine.symptom, Pulmonary Embolism, business, medicine.drug
Abstract: Pulmonary embolism (PE) is a potentially life-threatening condition, mandating urgent diagnosis and treatment. The symptoms of PE may be non-specific; diagnosis therefore relies on a clinical assessment and objective diagnostic testing. A clinical decision rule can determine the pre-test probability of PE. If PE is "unlikely", refer for a D-dimer test. If the D-dimer result is normal, PE can be excluded. If D-dimer levels are increased, refer for chest imaging. If PE is "likely", refer for chest imaging. Imaging with computed tomography pulmonary angiogram is accurate and preferred for diagnosing PE, but may detect asymptomatic PE of uncertain clinical significance. Imaging with ventilation-perfusion (VQ) scan is associated with lower radiation exposure than computed tomography pulmonary angiogram, and may be preferred in younger patients and pregnancy. A low probability or high probability VQ scan is helpful for ruling out or confirming PE, respectively; however, an intermediate probability VQ scan requires further investigation. The direct oral anticoagulants have expanded the anticoagulation options for PE. These are the preferred anticoagulant for most patients with PE because they are associated with a lower risk of bleeding, and have the practical advantages of fixed dosage, no need for routine monitoring, and fewer drug interactions compared with vitamin K antagonists. Initial parenteral treatment is required before dabigatran and edoxaban.
Published: 2019
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9. Deep vein thrombosis: update on diagnosis and management

Author: Paul C Kruger, James D. Douketis, John Eikelboom, and Graeme J. Hankey
Subjects: medicine.medical_specialty, medicine.drug_class, Deep vein, Administration, Oral, Low molecular weight heparin, Dabigatran, Fibrin Fibrinogen Degradation Products, 03 medical and health sciences, chemistry.chemical_compound, 0302 clinical medicine, Edoxaban, Neoplasms, Humans, Medicine, cardiovascular diseases, 030212 general & internal medicine, Venous Thrombosis, Rivaroxaban, business.industry, Anticoagulant, Warfarin, Anticoagulants, General Medicine, Heparin, Low-Molecular-Weight, Surgery, medicine.anatomical_structure, chemistry, Disease Progression, Apixaban, Gastrointestinal Hemorrhage, Pulmonary Embolism, business, medicine.drug
Abstract: Diagnosis of deep vein thrombosis (DVT) requires a multifaceted approach that includes clinical assessment, evaluation of pre-test probability, and objective diagnostic testing. Common symptoms and signs of DVT are pain, swelling, erythema and dilated veins in the affected limb. The pre-test probability of DVT can be assessed using a clinical decision rule that stratifies DVT into "unlikely" or "likely". If DVT is "unlikely", refer for D-dimer test. If the D-dimer level is normal, DVT can be excluded; if the D-dimer level is increased, refer for compression ultrasound. If DVT is "likely", refer for compression ultrasound. When DVT is confirmed, anticoagulation is indicated to control symptoms, prevent progression and reduce the risk of post-thrombotic syndrome and pulmonary embolism. Anticoagulation may consist of a parenteral anticoagulant overlapped by warfarin or followed by a direct oral anticoagulant (DOAC) (dabigatran or edoxaban), or of a DOAC (apixaban or rivaroxaban) without initial parenteral therapy. DOACs are the preferred treatment for DVT because they are at least as effective, safer and more convenient than warfarin. DOACs may require dose reduction or avoidance in patients with renal dysfunction, and should be avoided in pregnancy. Recent evidence shows that DVT in patients with cancer may be treated with edoxaban (after discontinuation of 5 days of initial heparin or low molecular weight heparin [LMWH]) or rivaroxaban if patients prefer not to have daily injections of LMWH, but the risk of gastrointestinal bleeding is higher with DOACs than with LMWH in patients with gastrointestinal cancer.
Published: 2019
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10. Individual Patient Data from the Pivotal Randomized Controlled Trials of Non-Vitamin K Antagonist Oral Anticoagulants in Patients with Atrial Fibrillation (COMBINE AF): Design and Rationale: From the COMBINE AF (A Collaboration between Multiple institutions to Better Investigate Non-vitamin K antagonist oral anticoagulant use in Atrial Fibrillation) Investigators

Author: Anthony P, Carnicelli, Hwanhee, Hong, Robert P, Giugliano, Stuart J, Connolly, John, Eikelboom, Manesh R, Patel, Lars, Wallentin, David A, Morrow, Daniel, Wojdyla, Kaiyuan, Hua, Stefan H, Hohnloser, Jonas, Oldgren, Christian T, Ruff, Jonathan P, Piccini, Renato D, Lopes, John H, Alexander, and Christopher B, Granger
Subjects: Male, Academic Medical Centers, Aspirin, Databases, Factual, Information Dissemination, Embolism, Network Meta-Analysis, Anticoagulants, Stroke, Atrial Fibrillation, Humans, Multicenter Studies as Topic, Female, Warfarin, Computer Security, Aged, Randomized Controlled Trials as Topic
Abstract: Non-vitamin K antagonist oral anticoagulants (NOACs) are the preferred class of medications for prevention of stroke and systemic embolism in patients with atrial fibrillation unless contraindications exist. Five large, international, randomized, controlled trials of NOACs versus either warfarin or aspirin have been completed to date.COMBINE AF incorporates de-identified individual patient data from 77,282 patients with atrial fibrillation at risk for stroke randomized to NOAC, warfarin, or aspirin from 5 pivotal randomized controlled trials. All patients randomized in the constituent trials are included. Variables common to ≥3 of the constituent trials are included in the master database. Individual trial data sets from the 4 coordinating centers were combined at the Duke Clinical Research Institute. The final database will be securely shared with the 4 academic coordinating centers. The combined master database will be used to perform statistical analyses aimed at better understanding underlying risk factors and outcomes in patients with atrial fibrillation treated with oral anticoagulants, with a special focus on patient subgroups and uncommon outcomes. The initial analysis from COMBINE AF will be a network meta-analysis investigating the relative efficacy and safety of pooled higher-dose NOACs versus pooled lower-dose NOACs versus warfarin with respect to multiple time-to-event efficacy and safety outcomes. COMBINE AF is registered with PROSPERO (CRD42020178771).In conclusion, COMBINE AF provides a rich and robust database consisting of individual patient data and will offer opportunities to investigate oral anticoagulants across many patient subgroups. Data sharing and collaboration across academic institutions and investigators will serve as overarching themes.
Published: 2020

11. Risk profiles and one-year outcomes of patients with newly diagnosed atrial fibrillation in India: Insights from the GARFIELD-AF Registry

Author: Jitendra PS. Sawhney, Veerappa A. Kothiwale, Vikas Bisne, Rajashekhar Durgaprasad, Praveen Jadhav, Manoj Chopda, Velam Vanajakshamma, Ramdhan Meena, Govindan Vijayaraghavan, Kamaldeep Chawla, Jagan Allu, Karen S. Pieper, A. John Camm, Ajay K. Kakkar, Jean-Pierre Bassand, David A. Fitzmaurice, Samuel Z. Goldhaber, Shinya Goto, Sylvia Haas, Werner Hacke, Lorenzo G. Mantovani, Frank Misselwitz, Alexander G.G. Turpie, Martin van Eickels, Freek W.A. Verheugt, Gloria Kayani, Keith A.A. Fox, Bernard J. Gersh, Hector Lucas Luciardi, Harry Gibbs, Marianne Brodmann, Frank Cools, Antonio Carlos Pereira Barretto, Stuart J. Connolly, Alex Spyropoulos, John Eikelboom, Ramon Corbalan, Dayi Hu, Petr Jansky, Jørn Dalsgaard Nielsen, Hany Ragy, Pekka Raatikainen, Jean-Yves Le Heuzey, Harald Darius, Matyas Keltai, Sanjay Kakkar, Jitendra Pal Singh Sawhney, Giancarlo Agnelli, Giuseppe Ambrosio, Yukihiro Koretsune, Carlos Jerjes Sánchez Díaz, Hugo Ten Cate, Dan Atar, Janina Stepinska, Elizaveta Panchenko, Toon Wei Lim, Barry Jacobson, Seil Oh, Xavier Viñolas, Marten Rosenqvist, Jan Steffel, Pantep Angchaisuksiri, Ali Oto, Alex Parkhomenko, Wael Al Mahmeed, David Fitzmaurice, D.Y. Hu, K.N. Chen, Y.S. Zhao, H.Q. Zhang, J.Z. Chen, S.P. Cao, D.W. Wang, Y.J. Yang, W.H. Li, Y.H. Yin, G.Z. Tao, P. Yang, Y.M. Chen, S.H. He, Ying Wang, Yong Wang, G.S. Fu, X. Li, T.G. Wu, X.S. Cheng, X.W. Yan, R.P. Zhao, M.S. Chen, L.G. Xiong, P. Chen, Y. Jiao, Y. Guo, L. Xue, F.Z. Wang, H. Li, Z.M. Yang, C.L. Bai, J. Chen, J.Y. Chen, X. Chen, S. Feng, Q.H. Fu, X.J. Gao, W.N. Guo, R.H. He, X.A. He, X.S. Hu, X.F. Huang, B. Li, J. Li, L. Li, Y.H. Li, T.T. Liu, W.L. Liu, Y.Y. Liu, Z.C. Lu, X.L. Luo, T.Y. Ma, J.Q. Peng, X. Sheng, X.J. Shi, Y.H. Sun, G. Tian, K. Wang, L. Wang, R.N. Wu, Q. Xie, R.Y. Xu, J.S. Yang, L.L. Yang, Q. Yang, Y. Ye, H.Y. Yu, J.H. Yu, T. Yu, H. Zhai, Q. Zhan, G.S. Zhang, Q. Zhang, R. Zhang, Y. Zhang, W.Y. Zheng, B. Zhou, Z.H. Zhou, X.Y. Zhu, S. Kakkar, J.P.S. Sawhney, P. Jadhav, R. Durgaprasad, A.G. Ravi Shankar, R.K. Rajput, K. Bhargava, R. Sarma, A. Srinivas, D. Roy, U.M. Nagamalesh, M. Chopda, R. Kishore, G. Kulkarni, P. Chandwani, R.A. Pothiwala, M. Padinhare Purayil, S. Shah, K. Chawla, V.A. Kothiwale, B. Raghuraman, G. Vijayaraghavan, V.M. Vijan, G. Bantwal, V. Bisne, A. Khan, J.B. Gupta, S. Kumar, D. Jain, S. Abraham, D. Adak, A. Barai, H. Begum, P. Bhattacharjee, M. Dargude, D. Davies, B. Deshpande, P. Dhakrao, V. Dhyani, S. Duhan, M. Earath, A. Ganatra, S. Giradkar, V. Jain, R. Karthikeyan, L. Kasala, S. Kaur, S. Krishnappa, A. Lawande, B. Lokesh, N. Madarkar, R. Meena, P. More, D. Naik, K. Prashanth, M. Rao, N.M. Rao, N. Sadhu, D. Shah, M. Sharma, P. Shiva, S. Singhal, S. Suresh, V. Vanajakshamma, S.G. Panse, Y. Koretsune, S. Kanamori, K. Yamamoto, K. Kumagai, Y. Katsuda, K. Sadamatsu, F. Toyota, Y. Mizuno, I. Misumi, H. Noguchi, S. Ando, T. Suetsugu, M. Minamoto, Hiroshi Oda, K. Shiraishi, S. Adachi, K. Chiba, H. Norita, M. Tsuruta, T. Koyanagi, H. Ando, T. Higashi, K. Okada, S. Azakami, S. Komaki, K. Kumeda, T. Murayama, J. Matsumura, Y. Oba, R. Sonoda, K. Goto, K. Minoda, Y. Haraguchi, H. Suefuji, H. Miyagi, H. Kato, Tadashi Nakamura, Tsugihiro Nakamura, H. Nandate, R. Zaitsu, Yoshihisa Fujiura, A. Yoshimura, H. Numata, J. Ogawa, H. Tatematsu, Y. Kamogawa, K. Murakami, Y. Wakasa, M. Yamasawa, H. Maekawa, S. Abe, H. Kihara, S. Tsunoda, Katsumi Saito, Kazuyuki Saito, T. Fudo, K. Obunai, H. Tachibana, I. Oba, T. Kuwahata, S. Higa, M. Gushiken, T. Eto, H. Yoshida, D. Ikeda, Yoshitake Fujiura, M. Ishizawa, M. Nakatsuka, K. Murata, C. Ogurusu, M. Shimoyama, M. Akutsu, I. Takamura, F. Hoshino, N. Yokota, T. Iwao, K. Tsuchida, M. Takeuchi, Y. Hatori, Y. Kitami, Yoichi Nakamura, R. Oyama, M. Ageta, Hiroyuki Oda, Y. Go, K. Mishima, T. Unoki, S. Morii, Yuhei Shiga, H. Sumi, T. Nagatomo, K. Sanno, K. Fujisawa, Y. Atsuchi, T. Nagoshi, T. Seto, T. Tabuchi, M. Kameko, K. Nii, K. Oshiro, H. Takezawa, S. Nagano, N. Miyamoto, M. Iwaki, Yuichiro Nakamura, M. Fujii, M. Okawa, Masahiko Abe, Masatake Abe, Mitsunori Abe, T. Saito, T. Mito, K. Nagao, J. Minami, T. Mita, I. Sakuma, T. Taguchi, S. Marusaki, H. Doi, M. Tanaka, T. Fujito, M. Matsuta, T. Kusumoto, S. Kakinoki, K. Ashida, N. Yoshizawa, J. Agata, O. Arasaki, M. Manita, M. Ikemura, S. Fukuoka, H. Murakami, S. Matsukawa, Y. Hata, T. Taniguchi, T. Ko, H. Kubo, M. Imamaki, M. Akiyama, M. Inagaki, H. Odakura, T. Ueda, Y. Katsube, A. Nakata, H. Watanabe, M. Techigawara, M. Igarashi, K. Taga, T. Kimura, S. Tomimoto, M. Shibuya, M. Nakano, K. Ito, T. Seo, S. Hiramitsu, H. Hosokawa, M. Hoshiai, M. Hibino, K. Miyagawa, Hajime Horie, N. Sugishita, Yukio Shiga, A. Soma, K. Neya, Tetsuro Yoshida, Tomoki Yoshida, M. Mizuguchi, M. Ishiguro, T. Minagawa, M. Wada, H. Mukawa, F. Okuda, S. Nagasaka, Y. Abe, Sen Adachi, Susumu Adachi, T. Adachi, K. Akahane, T. Amano, K. Aoki, T. Aoyama, H. Arai, S. Arima, T. Arino, H. Asano, T. Asano, J. Azuma, T. Baba, T. Betsuyaku, H. Chibana, H. Date, J. Doiuchi, Y. Emura, M. Endo, Y. Fujii, R. Fujiki, A. Fujisawa, Y. Fujisawa, T. Fukuda, T. Fukui, N. Furukawa, T. Furukawa, W. Furumoto, T. Goto, M. Hamaoka, N. Hanazono, K. Hasegawa, T. Hatsuno, Y. Hayashi, K. Higuchi, K. Hirasawa, H. Hirayama, M. Hirose, S. Hirota, M. Honda, Hideki Horie, T. Ido, O. Iiji, H. Ikeda, K. Ikeda, K. Ikeoka, M. Imaizumi, H. Inaba, T. Inoue, F. Iseki, A. Ishihara, N. Ishioka, N. Ito, T. Iwase, H. Kakuda, J. Kamata, H. Kanai, H. Kanda, M. Kaneko, H. Kano, T. Kasai, T. Kato, Y. Kato, Y. Kawada, K. Kawai, K. Kawakami, S. Kawakami, T. Kawamoto, S. Kawano, J. Kim, T. Kira, H. Kitazawa, H. Kitazumi, T. Kito, T. Kobayashi, T. Koeda, J. Kojima, H. Komatsu, I. Komatsu, Y. Koshibu, T. Kotani, T. Kozuka, Y. Kumai, T. Kumazaki, I. Maeda, K. Maeda, Y. Maruyama, S. Matsui, K. Matsushita, Y. Matsuura, K. Mineoi, H. Mitsuhashi, N. Miura, S. Miyaguchi, S. Miyajima, H. Miyamoto, A. Miyashita, S. Miyata, I. Mizuguchi, A. Mizuno, T. Mori, O. Moriai, K. Morishita, O. Murai, Sho Nagai, Shunichi Nagai, E. Nagata, H. Nagata, A. Nakagomi, S. Nakahara, M. Nakamura, R. Nakamura, N. Nakanishi, T. Nakayama, R. Nakazato, T. Nanke, J. Nariyama, Y. Niijima, H. Niinuma, Y. Nishida, Y. Nishihata, K. Nishino, H. Nishioka, K. Nishizawa, I. Niwa, K. Nomura, S. Nomura, M. Nozoe, T. Ogawa, N. Ohara, M. Okada, K. Okamoto, H. Okita, M. Okuyama, H. Ono, T. Ono, Y. Onuki Pearce, S. Oriso, A. Ota, E. Otaki, Y. Saito, H. Sakai, N. Sakamoto, Y. Sakamoto, Y. Samejima, Y. Sasagawa, H. Sasaguri, A. Sasaki, T. Sasaki, Kazuki Sato, Kiyoharu Sato, M. Sawano, S. Seki, Y. Sekine, Y. Seta, K. Sezaki, N. Shibata, Y. Shiina, H. Shimono, Y. Shimoyama, T. Shindo, H. Shinohara, R. Shinohe, T. Shinozuka, T. Shirai, T. Shiraiwa, Y. Shozawa, T. Suga, C. Sugimoto, Kazuo Suzuki, Keita Suzuki, Shu Suzuki, Shunji Suzuki, Susumu Suzuki, Y. Suzuki, M. Tada, A. Taguchi, T. Takagi, Y. Takagi, K. Takahashi, S. Takahashi, H. Takai, C. Takanaka, S. Take, H. Takeda, K. Takei, K. Takenaka, T. Tana, G. Tanabe, K. Taya, H. Teragawa, S. Tohyo, S. Toru, Y. Tsuchiya, T. Tsuji, K. Tsuzaki, H. Uchiyama, O. Ueda, Y. Ueyama, N. Wakaki, T. Wakiyama, T. Washizuka, M. Watanabe, T. Yamada, T. Yamagishi, H. Yamaguchi, Kenichi Yamamoto, Kentaro Yamamoto, Kunihiko Yamamoto, T. Yamamoto, M. Yamaura, M. Yamazoe, K. Yasui, Y. Yokoyama, K. Yoshida, T.W. Lim, C.K. Ching, C.G. Foo, J.H. Chow, D.D. Chen, F.R. Jaufeerally, Y.M. Lee, G. Lim, W.T. Lim, S. Thng, S.Y. Yap, C. Yeo, S. Oh, H.N. Pak, J.-B. Kim, J.H. Kim, S.-W. Jang, D.H. Kim, D.R. Ryu, S.W. Park, D.-K. Kim, D.J. Choi, Y.S. Oh, M.-C. Cho, S.-H. Kim, H.-K. Jeon, D.-G. 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Y., Angchaisuksiri, P., Chawanadelert, S., Mongkolwongroj, P., Kanokphatcharakun, K., Cheewatanakornkul, S., Laksomya, T., Pattanaprichakul, S., Chantrarat, T., Rungaramsin, S., Silaruks, S., Wongcharoen, W., Siriwattana, K., Likittanasombat, K., Katekangplu, P., Boonyapisit, W., Cholsaringkarl, D., Chatlaong, B., Chattranukulchai, P., Santanakorn, Y., Hutayanon, P., Khunrong, P., Bunyapipat, T., Jai-Aue, S., Kaewsuwanna, P., Bamungpong, P., Gunaparn, S., Hongsuppinyo, S., Inphontan, R., Khattaroek, R., Khunkong, K., Kitmapawanont, U., Kongsin, C., Naratreekoon, B., Ninwaranon, S., Phangyota, J., Phrommintikul, A., Phunpinyosak, P., Pongmorakot, K., Poomiphol, S., Pornnimitthum, N., Pumprueg, S., Ratchasikaew, S., Sanit, K., Sawanyawisuth, K., Silaruks, B., Sirichai, R., Sriwichian, A., Suebjaksing, W., Sukklad, P., Suttana, T., Tangsirira, A., Thangpet, O., Tiyanon, W., Vorasettakarnkij, Y., Wisaratapong, T., Wongtheptien, W., Wutthimanop, A., Yawila, S., Oto, A., Altun, A., Ozdogru, I., Ozdemir, K., Yilmaz, O., Aydinlar, A., Yilmaz, M. 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A., Lincoln, T., Malone, E., Merliss, A., Merritt, D., Minardo, J., Mooso, B., Orosco, C., Palumbo, V., Parker, M., Parrott, T., Paserchia, S., Pearl, G., Peterson, J., Pickelsimer, N., Purcell, T., Raynor, J., Raziano, S., Richard, C., Richardson, T., Robertson, C., Sage, A., Sanghera, T., Shaw, P., Shoemaker, J., Smith, K., Stephanie, B., Thatcher, A., Theobald, H., Thompson, N., Treasure, L., Tripti, T., Verdi, C., and Worthy, V.
Subjects: Registrie, Male, Time Factors, Anticoagulant therapy, Arrhythmia, Atrial fibrillation, GARFIELD-AF, 030204 cardiovascular system & hematology, Electrocardiography, 0302 clinical medicine, Risk Factors, Anticoagulant therapy, Arrhythmia, Atrial fibrillation, GARFIELD-AF, Aged, Atrial Fibrillation, Female, Follow-Up Studies, Humans, Incidence, India, Prevalence, Prognosis, Prospective Studies, Survival Rate, Thromboembolism, Registries, Risk Assessment, Medicine, 030212 general & internal medicine, Prospective cohort study, Incidence (epidemiology), cardiovascular system, medicine.symptom, Cardiology and Cardiovascular Medicine, Risk assessment, Human, medicine.medical_specialty, Time Factor, RD1-811, Prognosi, Follow-Up Studie, 03 medical and health sciences, Internal medicine, Diseases of the circulatory (Cardiovascular) system, cardiovascular diseases, Risk factor, Survival rate, Fibrillation, business.industry, Risk Factor, ta3121, medicine.disease, Clinical trial, Prospective Studie, RC666-701, Surgery, Clinical and Preventive Cardiology, business
Abstract: Background: The Global Anticoagulant Registry in the FIELD–Atrial Fibrillation (GARFIELD-AF) is an ongoing prospective noninterventional registry, which is providing important information on the baseline characteristics, treatment patterns, and 1-year outcomes in patients with newly diagnosed non-valvular atrial fibrillation (NVAF). This report describes data from Indian patients recruited in this registry. Methods and results: A total of 52,014 patients with newly diagnosed AF were enrolled globally; of these, 1388 patients were recruited from 26 sites within India (2012–2016). In India, the mean age was 65.8 years at diagnosis of NVAF. Hypertension was the most prevalent risk factor for AF, present in 68.5% of patients from India and in 76.3% of patients globally (P
Published: 2018
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12. Effect of Colchicine vs Usual Care Alone on Intubation and 28-Day Mortality in Patients Hospitalized With COVID-19

Author: Rafael, Diaz, Andrés, Orlandini, Noelia, Castellana, Alberto, Caccavo, Pablo, Corral, Gonzalo, Corral, Carolina, Chacón, Pablo, Lamelas, Fernando, Botto, María Luz, Díaz, Juan Manuel, Domínguez, Andrea, Pascual, Carla, Rovito, Agustina, Galatte, Franco, Scarafia, Omar, Sued, Omar, Gutierrez, Sanjit S, Jolly, José M, Miró, John, Eikelboom, Mark, Loeb, Aldo Pietro, Maggioni, Deepak L, Bhatt, Salim, Yusuf, and Adriana P, Steren
Subjects: Adult, Inflammation, Male, SARS-CoV-2, Research, Anti-Inflammatory Agents, COVID-19, Standard of Care, General Medicine, Middle Aged, Respiration, Artificial, Hospitalization, Online Only, Infectious Diseases, Adrenal Cortex Hormones, Intubation, Intratracheal, Humans, Female, Colchicine, Original Investigation, Aged
Abstract: Key Points Question Does colchicine prevent intubation and mortality in hospitalized patients with COVID-19 pneumonia? Findings In this randomized clinical trial of 1279 patients hospitalized with COVID-19, patients allocated to receive colchicine plus usual care or to usual care alone demonstrated no significant difference in the coprimary outcome of mechanical ventilation or 28-day mortality. Meaning This randomized clinical trial found that colchicine did not significantly reduce the need for mechanical ventilation or 28-day mortality in patients hospitalized with COVID-19 pneumonia., This randomized clinical trial assesses the efficacy of colchicine in preventing mechanical ventilation and mortality in hospitalized patients with COVID-19 pneumonia., Importance Hospitalized patients with COVID-19 pneumonia have high rates of morbidity and mortality. Objective To assess the efficacy of colchicine in hospitalized patients with COVID-19 pneumonia. Design, Setting, and Participants The Estudios Clínicos Latino América (ECLA) Population Health Research Institute (PHRI) COLCOVID trial was a multicenter, open-label, randomized clinical trial performed from April 17, 2020, to March 28, 2021, in adults with confirmed or suspected SARS-CoV-2 infection followed for up to 28 days. Participants received colchicine vs usual care if they were hospitalized with COVID-19 symptoms and had severe acute respiratory syndrome or oxygen desaturation. The main exclusion criteria were clear indications or contraindications for colchicine, chronic kidney disease, and negative results on a reverse transcription–polymerase chain reaction test for SARS-CoV-2 before randomization. Data were analyzed from June 20 to July 25, 2021. Interventions Patients were assigned in a 1:1 ratio to usual care or usual care plus colchicine. Colchicine was administered orally in a loading dose of 1.5 mg immediately after randomization, followed by 0.5 mg orally within 2 hours of the initial dose and 0.5 mg orally twice a day for 14 days or discharge, whichever occurred first. Main Outcomes and Measures The first coprimary outcome was the composite of a new requirement for mechanical ventilation or death evaluated at 28 days. The second coprimary outcome was death at 28 days. Results A total of 1279 hospitalized patients (mean [SD] age, 61.8 [14.6] years; 449 [35.1%] women and 830 [64.9%] men) were randomized, including 639 patients in the usual care group and 640 patients in the colchicine group. Corticosteroids were used in 1171 patients (91.5%). The coprimary outcome of mechanical ventilation or 28-day death occurred in 160 patients (25.0%) in the colchicine group and 184 patients (28.8%) in the usual care group (hazard ratio [HR], 0.83; 95% CI, 0.67-1.02; P = .08). The second coprimary outcome, 28-day death, occurred in 131 patients (20.5%) in the colchicine group and 142 patients (22.2%) in the usual care group (HR, 0.88; 95% CI, 0.70-1.12). Diarrhea was the most frequent adverse effect of colchicine, reported in 68 patients (11.3%). Conclusions and Relevance This randomized clinical trial found that compared with usual care, colchicine did not significantly reduce mechanical ventilation or 28-day mortality in patients hospitalized with COVID-19 pneumonia. Trial Registration ClinicalTrials.gov Identifier: NCT04328480
Published: 2021
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13. Defining high bleeding risk in patients undergoing percutaneous coronary intervention: a consensus document from the Academic Research Consortium for High Bleeding Risk

Author: Marco Valgimigli, Takeshi Kimura, Robert W. Yeh, Martin B. Leon, Dominick J. Angiolillo, Roxana Mehran, Mitchell W. Krucoff, Stuart J. Pocock, Yoshiaki Mitsutake, Ernest Spitzer, P. F.Adrian Magee, Andrew Farb, Akihide Konishi, Matthew J. Price, Davide Capodanno, Olivier Varenne, Ute Windhoevel, Roisin Colleran, Philip Urban, C. Michael Gibson, Darren Mylotte, Donald E. Cutlip, Thomas Cuisset, Hyo-Soo Kim, John C. Laschinger, Stefan James, Michael Haude, John Gregson, Marie Claude Morice, John Eikelboom, Norman Stockbridge, Sunil V. Rao, Pedro Eerdmans, Robert A. Byrne, Hôpital de la Tour, Cardiovascular Research Foundation, Technische Universität Munchen - Université Technique de Munich [Munich, Allemagne] (TUM), University of Florida [Gainesville] (UF), University of Catania [Italy], Centre recherche en CardioVasculaire et Nutrition = Center for CardioVascular and Nutrition research (C2VN), Aix Marseille Université (AMU)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE), Hôpital de la Timone [CHU - APHM] (TIMONE), Harvard Medical School [Boston] (HMS), AUTRES, McMaster University [Hamilton, Ontario], U.S. Food and Drug Administration (FDA), London School of Hygiene and Tropical Medicine (LSHTM), Lukaskrankenhaus, Uppsala University, Seoul National University Hospital, Kyoto University, Pharmaceuticals and Medical Devices Agency, Columbia University [New York], National University of Ireland [Galway] (NUI Galway), Scripps Clinic [San Diego, CA, USA], Duke Clinical Research Institute, Duke University Medical Center, Erasmus University Medical Center [Rotterdam] (Erasmus MC), University of Bern, Hôpital Cochin [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Cardiovascular European Research Center, Beth Israel Deaconess Medical Center [Boston] (BIDMC), Hôpital Privé Jacques Cartier [Massy], The ARC-HBR group was entirely funded by multiple industry sponsors. Sponsors participated as observers in both meetings and were provided a copy of the document before submission. The contributing companies were Abbott Vascular, Alvimedica, Amgen, AstraZeneca, Biosensors, Biotronik, Boston Scientific, Celonova, Chiesi, Cordis, Daiichi Sankyo, Edwards Lifesciences, Janssen, Medinol, Medtronic, Orbusneich, Portola, Sanofi, Sinomed, Sahajanand Medical Technologies, and Terumo.Conflict of interest: Dr Colleran received financial compensation for her contribution to the preparation of this document. In accordance with the ARC charter, none of the other participants received fees or honoraria for their participation in the meetings or their contribution to this document. Dr Urban reports receiving speaker and consulting honoraria as an individual from Biosensors-Europe, Sinomed, and Terumo, participating in paid review activities (Clinical End Point Committee, Data Safety Monitoring Board) for Edward Lifesciences, Terumo, and Abbott Vascular, and serving as a medical codirector at the Cardiovascular European Research Center, a contract research organization based in Massy, France. Dr Mehran reports consultant fees to the institution from Abbott Laboratories and Spectranetics/Philips/Valcano Corp, consulting fees from Boston Scientific, Cardiovascular Systems Inc, Medscape, Siemens Medical Solutions, Regeneron Pharmaceuticals Inc, Roivant Sciences Inc, and Sanofi, being the spouse of a consultant for Abiomed and The Medicines Company, research funding to the institution from AstraZeneca, Bayer, Beth Israel Deaconess Hospital, BMS, CSL Behring, Eli Lilly and DSI, Medtronic, Novartis Pharmaceuticals, and Orbus Neich, scientific advisory board fees from PLx Opco Inc, dba PLx Pharma Inc, scientific advisory board fees to the institution from Bristol-Myers Squibb, executive committee fees from Janssen Pharmaceuticals and Osprey Medical, speaker engagements for Abbott Laboratories, equity from Claret Medical and Elixir Medical, and Data Safety Monitoring Board fees to the institution from Atermark Research Partners. Dr Angiolillo reports payments, consulting fees, or honoraria from Amgen, Aralez, AstraZeneca, Bayer, Biosensors, Boehringer Ingelheim, Bristol-Myers Squibb, Chiesi, Daiichi-Sankyo, Eli Lilly, Haemonetics, Janssen, Merck, PLx Pharma Inc, Pfizer, Sanofi, and The Medicines Company, fees for participation in review activities from CeloNova and St. Jude Medical, institutional grants from Amgen, AstraZeneca, Bayer, Biosensors, CeloNova, CSL Behring, Daiichi-Sankyo, Eisai, Eli Lilly, Gilead, Janssen, Matsutani Chemical Industry Co, Merck, Novartis, Osprey Medical, and Renal Guard Solutions, and funding from the Scott R. MacKenzie Foundation and the National Institutes of Health/National Center for Advancing Translational Sciences Clinical and Translational Science Award to the University of Florida UL1 TR000064 and National Institutes of Health/National Human Genome Research Institute U01 HG007269. Dr Byrne reports lecture fees from B. Braun Melsungen AG, Biotronik, Boston Scientific, and Micell Technologies and research funding to the institution from Boston Scientific and Celonova Biosciences. Dr Capodanno reports personal fees from Abbott Vascular, Bayer, Daiichi Sankyo, Pfizer, and AstraZeneca. Dr Cutlip reports receiving consultant fees from Celonova Biosciences and academic salary support from the Baim Institute for Clinical Research, an academic research organization in Boston, MA. Dr Eikelboom reports consulting fees and grant support from AstraZeneca, Bayer, Boehringer-Ingelheim, Bristol-Myers Squibb, Daiichi-Sankyo, Eli Lilly, GlaxoSmithKline, Pfizer, Janssen, and Sanofi-Aventis. Dr Gibson reports being chief executive officer of the Baim Institute for Clinical Research, in addition to receiving research grant funding from Angel Medical Corp, Bayer Corp, CSL Behring, Janssen Pharmaceuticals, Johnson & Johnson Corp, and Portola Pharmaceuticals, consultant fees from Amarin Pharama, Amgen, Bayer Corp, Boehringer Ingelheim, Boston Clinical Research Institute, Boston Scientific, Cardiovascular Research Foundation, CSL Behring, Chiesi, Duke Clinical Research Institute, Eli Lilly and Company, Gilead Sciences, Inc, Impact Bio LTD, Janssen Pharmaceuticals, Johnson & Johnson Corp, The Medicines Company, MedImmune, Medtelligence, Merck & Co, Inc, Microport, Novo Nordisk, PERT Consortium, Pharma Mar, Portola Pharmaceuticals, Sanofi, Somahlution, Vereseon Corporation, and Web MD, and royalties as a contributor from UpToDate in Cardiovascular Medicine. Dr Gregson reports personal fees from Edwards Lifesciences, MvRX, Amarin Corp, and BioSensors. Dr Haude reports grant support from Biotronik, Orbus Neich, AbboF, Medtronic, and Cardiac Dimensions, speaker’s bureau fees from Biotronik, Orbus Neich, AbboF, Medtronic, Lilly, Philips/ Volcano, and Cardiac Dimensions (Proctor), and consultant fees from Biotronik, Orbus Neich, and AbboF. Dr James reports institutional research grants from AstraZeneca, Bayer, Jansen, The Medicines Company, Abbot Vascular, and Boston Scientific, as well as honoraria from AstraZeneca, Bayer, and Medtronic. Dr Kimura reports consulting fees or honoraria from Abbott Vascular Japan Co, Ltd, Kowa Co, Ltd, Kowa Pharmaceutical Co Ltd, Sanofi K.K., Nippon Boehringer Ingelheim Co, Ltd, and Bristol-Myers Squibb K.K., as well as grant support from Otsuka Pharmaceutical Co, Ltd, Daiichi Sankyo Co, Ltd, Mitsubishi Tanabe Pharma Corp, Takeda Pharmaceutical Co Ltd, and Nippon Boehringer Ingelheim Co, Ltd. Dr Leon reports receiving research grants from Abbott Vascular, Boston Scientific, Medtronic, Biosensors, and SinomedEquity-Medinol. Dr Mylotte reports speaker fees from Biosensors and institutional research grants from Biosensors and Medtronic. Dr Pocock has served on steering committees or data monitoring committees for trials sponsored by AstraZeneca, Bayer, Boehringer Ingelheim, Boston Scientific, Idorsia, Janssen, Medtronic, Novartis, Novo Nordisk, and Vifor, and has received grant funding from AstraZeneca and Merck. Dr Price reports receiving consulting honoraria from AstraZeneca, Chiesi USA, Medtronic, Boston Scientific, and Abbott Vascular/St Jude Medical, speaker’s bureau/fees from AstraZeneca, Chiesi USA, Medtronic, Boston Scientific, Abbott Vascular/St Jude Medical, and ACIST Medical, and institutional research grants from Daiichi-Sankyo. Dr Valgimigli reports grants and personal fees from Abbott, AstraZeneca, and Terumo, personal fees from Chiesi, Bayer, Daiichi Sankyo, Amgen, Alvimedica, Biosensors, and Idorsia, and grants from Medicure. Dr Varenne reports receiving consulting and research grants from Boston Scientific, Abbott Vascular, AstraZeneca, and Servier. Dr Yeh reports consulting and research grants from Abbott Vascular and Boston Scientific, research grants from Abiomed and AstraZeneca, and consulting fees from Biosense Webster, Medtronic, and Teleflex. Dr Krucoff reports receiving consulting and research grants from Abbott Vascular, Biosensors, Boston Scientific, Cook Medical, Medtronic, and OrbusNeich. Dr Morice is the chief executive officer of the Cardiovascular European Research Center, the contract research organization organizing the ARC-HBR initiative. The other authors report no conflicts., Kyoto University [Kyoto], Cardiology, and Prémilleux, Annick
Subjects: Percutaneous, protocole de recherche, medicine.medical_treatment, [SDV]Life Sciences [q-bio], Cardiologie et système cardiovasculaire, 030204 cardiovascular system & hematology, 0302 clinical medicine, maladie coronaire, Cardiac and Cardiovascular Systems, 030212 general & internal medicine, Aged, 80 and over, education.field_of_study, Clinical Trials as Topic, Kardiologi, Frailty, hémorragie, European research, Dual Anti-Platelet Therapy, Anemia, Drug-Eluting Stents, 3. Good health, ddc, Europe, [SDV] Life Sciences [q-bio], Treatment Outcome, Current Opinion, Metals, Stents, clinical trial protocols as topic, Safety, hemorrhage, Cardiology and Cardiovascular Medicine, medicine.medical_specialty, Asia, Consensus, Population, Clinical Decision-Making, 610 Medicine & health, Risk Assessment, Medication Adherence, Food and drug administration, 03 medical and health sciences, Physiology (medical), Hypertension, Portal, medicine, Humans, In patient, Acute Coronary Syndrome, Renal Insufficiency, Chronic, Intensive care medicine, education, Aged, business.industry, percutaneous coronary intervention, Percutaneous coronary intervention, Data interpretation, Fibrosis, Thrombocytopenia, United States, Clinical trial, Cardiology and cardiovascular system, business
Abstract: Identification and management of patients at high bleeding risk undergoing percutaneous coronary intervention are of major importance, but a lack of standardization in defining this population limits trial design, data interpretation, and clinical decision-making. The Academic Research Consortium for High Bleeding Risk (ARC-HBR) is a collaboration among leading research organizations, regulatory authorities, and physician-scientists from the United States, Asia, and Europe focusing on percutaneous coronary intervention–related bleeding. Two meetings of the 31-member consortium were held in Washington, DC, in April 2018 and in Paris, France, in October 2018. These meetings were organized by the Cardiovascular European Research Center on behalf of the ARC-HBR group and included representatives of the US Food and Drug Administration and the Japanese Pharmaceuticals and Medical Devices Agency, as well as observers from the pharmaceutical and medical device industries. A consensus definition of patients at high bleeding risk was developed that was based on review of the available evidence. The definition is intended to provide consistency in defining this population for clinical trials and to complement clinical decision-making and regulatory review. The proposed ARC-HBR consensus document represents the first pragmatic approach to a consistent definition of high bleeding risk in clinical trials evaluating the safety and effectiveness of devices and drug regimens for patients undergoing percutaneous coronary intervention.
Published: 2019
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14. Rivaroxaban for Thromboprophylaxis in High-Risk Ambulatory Patients with Cancer

Author: Alok A, Khorana, Gerald A, Soff, Ajay K, Kakkar, Saroj, Vadhan-Raj, Hanno, Riess, Ted, Wun, Michael B, Streiff, David A, Garcia, Howard A, Liebman, Chandra P, Belani, Eileen M, O'Reilly, Jai N, Patel, Habte A, Yimer, Peter, Wildgoose, Paul, Burton, Ujjwala, Vijapurkar, Simrati, Kaul, John, Eikelboom, Robert, McBane, Kenneth A, Bauer, Nicole M, Kuderer, Gary H, Lyman, and David, Seastone
Subjects: Oral, Adult, Male, medicine.medical_specialty, Administration, Oral, Antineoplastic Agents, Hemorrhage, Kaplan-Meier Estimate, 030204 cardiovascular system & hematology, law.invention, 03 medical and health sciences, 0302 clinical medicine, Randomized controlled trial, Double-Blind Method, Rivaroxaban, law, Risk Factors, Neoplasms, 80 and over, medicine, Humans, 030212 general & internal medicine, Intensive care medicine, Aged, Aged, 80 and over, Intention-to-treat analysis, business.industry, Incidence (epidemiology), Incidence, Cancer, General Medicine, Venous Thromboembolism, Middle Aged, medicine.disease, Intention to Treat Analysis, Clinical trial, Treatment Outcome, Administration, Ambulatory, Female, business, Venous thromboembolism, medicine.drug, Factor Xa Inhibitors
Abstract: Ambulatory patients receiving systemic cancer therapy are at varying risk for venous thromboembolism. However, the benefit of thromboprophylaxis in these patients is uncertain.In this double-blind, randomized trial involving high-risk ambulatory patients with cancer (Khorana score of ≥2, on a scale from 0 to 6, with higher scores indicating a higher risk of venous thromboembolism), we randomly assigned patients without deep-vein thrombosis at screening to receive rivaroxaban (at a dose of 10 mg) or placebo daily for up to 180 days, with screening every 8 weeks. The primary efficacy end point was a composite of objectively confirmed proximal deep-vein thrombosis in a lower limb, pulmonary embolism, symptomatic deep-vein thrombosis in an upper limb or distal deep-vein thrombosis in a lower limb, and death from venous thromboembolism and was assessed up to day 180. In a prespecified supportive analysis involving the same population, the same end point was assessed during the intervention period (first receipt of trial agent to last dose plus 2 days). The primary safety end point was major bleeding.Of 1080 enrolled patients, 49 (4.5%) had thrombosis at screening and did not undergo randomization. Of the 841 patients who underwent randomization, the primary end point occurred in 25 of 420 patients (6.0%) in the rivaroxaban group and in 37 of 421 (8.8%) in the placebo group (hazard ratio, 0.66; 95% confidence interval [CI], 0.40 to 1.09; P = 0.10) in the period up to day 180. In the prespecified intervention-period analysis, the primary end point occurred in 11 patients (2.6%) in the rivaroxaban group and in 27 (6.4%) in the placebo group (hazard ratio, 0.40; 95% CI, 0.20 to 0.80). Major bleeding occurred in 8 of 405 patients (2.0%) in the rivaroxaban group and in 4 of 404 (1.0%) in the placebo group (hazard ratio, 1.96; 95% CI, 0.59 to 6.49).In high-risk ambulatory patients with cancer, treatment with rivaroxaban did not result in a significantly lower incidence of venous thromboembolism or death due to venous thromboembolism in the 180-day trial period. During the intervention period, rivaroxaban led to a substantially lower incidence of such events, with a low incidence of major bleeding. (Funded by Janssen and others; CASSINI ClinicalTrials.gov number, NCT02555878.).
Published: 2019

15. Bleeding with Direct Oral Anticoagulants vs Warfarin: Clinical Experience

Author: Geno J. Merli and John Eikelboom
Subjects: medicine.medical_specialty, Pyridines, Pyridones, Antidotes, Administration, Oral, Hemorrhage, Context (language use), 030204 cardiovascular system & hematology, Dabigatran, Direct oral anticoagulants, 03 medical and health sciences, chemistry.chemical_compound, Clinical trials, 0302 clinical medicine, Rivaroxaban, Edoxaban, Atrial Fibrillation, Humans, Medicine, Apixaban, 030212 general & internal medicine, Bleeding management, Intensive care medicine, Medicine(all), business.industry, Warfarin, Anticoagulants, Atrial fibrillation, General Medicine, medicine.disease, Stroke, Clinical trial, Thiazoles, Clinical Trials, Phase III as Topic, chemistry, Anesthesia, Emergency Medicine, Pyrazoles, business, medicine.drug
Abstract: The risk of bleeding in the setting of anticoagulant therapy continues to be re-evaluated following the introduction of a new generation of direct oral anticoagulants (DOACs). Interruption of DOAC therapy and supportive care may be sufficient for the management of patients who present with mild or moderate bleeding, but in those with life-threatening bleeding, a specific reversal agent is desirable. We review the phase 3 clinical studies of dabigatran, rivaroxaban, apixaban, and edoxaban in patients with nonvalvular atrial fibrillation, in the context of bleeding risk and management.
Published: 2016
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16. The Ross procedure versus prosthetic and homograft aortic valve replacement: a systematic review and meta-analysis

Author: Emilie P. Belley-Côté, Ali Alsagheir, Hatim Alraddadi, Michael W.A. Chu, Dominic Parry, John Eikelboom, Ismail Bouhout, Dan M Dorobantu, Kevin J. Um, William F. McIntyre, Matthias Bossard, Ismail El-Hamamsy, Graham R. McClure, Hugo Lortie, Richard P. Whitlock, Kevin Kim, Serban Stoica, Saurabh Gupta, and Maral Ouzounian
Subjects: Pulmonary and Respiratory Medicine, Adult, medicine.medical_specialty, Adolescent, medicine.medical_treatment, Heart Valve Diseases, 030204 cardiovascular system & hematology, law.invention, 03 medical and health sciences, Young Adult, 0302 clinical medicine, Postoperative Complications, Aortic valve replacement, Randomized controlled trial, law, Internal medicine, Medicine, Humans, Child, Aged, Bioprosthesis, Heart Valve Prosthesis Implantation, business.industry, Ross procedure, Confounding, Infant, General Medicine, Middle Aged, medicine.disease, Allografts, Confidence interval, 030228 respiratory system, Meta-analysis, Relative risk, Aortic Valve, Child, Preschool, Heart Valve Prosthesis, Surgery, Observational study, Cardiology and Cardiovascular Medicine, business
Abstract: OBJECTIVES Young adults undergoing aortic valve replacement (AVR) have decreased life expectancy compared to matched controls. The Ross procedure aims to improve valve lifespan while avoiding anticoagulation. We prepared a systematic review and meta-analysis to assess the Ross procedure compared to conventional AVR. METHODS We searched MEDLINE, EMBASE and Cochrane CENTRAL for studies evaluating the Ross procedure versus any conventional AVR in adult patients. We performed screening, full-text assessment, risk of bias evaluation and data collection independently and in duplicate. We evaluated the risk of bias with the ROBINS-I and Cochrane tools and quality of evidence with the GRADE framework. We pooled data using the random- and fixed-effects models. RESULTS Thirteen observational studies and 2 randomized controlled trials (RCTs) were identified (n = 5346). No observational study was rated as having low risk of bias. The Ross procedure was associated with decreased late mortality in observational and RCT data [mean length of follow-up 2.6 years, relative risk (RR) 0.56, 95% confidence interval (CI) 0.38-0.84, I2 = 58%, very low quality]. The RCT estimate of effect was similar (mean length of follow-up 8.8 years, RR 0.33, 95% CI 0.11-0.96, I2 = 66%, very low quality). No difference was observed in mortality
Published: 2018

17. Dabigatran in patients with myocardial injury after non-cardiac surgery (MANAGE) : an international, randomised, placebo-controlled trial

Author: P J Devereaux, Emmanuelle Duceppe, Gordon Guyatt, Vikas Tandon, Reitze Rodseth, Bruce M Biccard, Denis Xavier, Wojciech Szczeklik, Christian S Meyhoff, Jessica Vincent, Maria Grazia Franzosi, Sadeesh K Srinathan, Jason Erb, Patrick Magloire, John Neary, Mangala Rao, Prashant V Rahate, Navneet K Chaudhry, Bongani Mayosi, Miriam de Nadal, Pilar Paniagua Iglesias, Otavio Berwanger, Juan Carlos Villar, Fernando Botto, John W Eikelboom, Daniel I Sessler, Clive Kearon, Shirley Pettit, Mukul Sharma, Stuart J Connolly, Shrikant I Bangdiwala, Purnima Rao-Melacini, Andreas Hoeft, Salim Yusuf, P.J. Devereaux, Shrikant I. Bangdiwala, Stuart Connolly, John Eikelboom, Janice Pogue, Daniel I. Sessler, Sara Di Diodato, Zora Gasic, Louise J. Mastrangelo, Sarah H. Molnar, Jennifer L. Swanson, Makayla L. Tosh, Jennifer R. Wells, Rafael Diaz, Clara K. Chow, Beatriz Gonzales, Skarlet Vásquez, Petr Jansky, Radovan Dušek, Christian S. Meyhoff, Pierre Coriat, Maria Wittmann, Gerald Yonga, Nandini Mathur, Elena Seletti, German Malaga, Bernadette A. Tumanan-Mendoza, Maria Pamela A. Tagle, Bruce M. Biccard, Pablo Alonso-Coello, Ekaterine Popova, Martin Shields, Yannick Le Manach, Paul Moayyedi, Sander van Zanten, Edith Fleischmann, Amit Garg, Kamilu Karaye, Edward McFalls, Alben Sigamani, Emilie Belley-Côté, Grzegorz Biedroń, Flavia Borges, Steffan Frosi Stella, Christian Haarmark Nielsen, Darryl P. Leong, Jessica Spence, Allen Tran, Katarzyna Wawrzycka-Adamczyk, Stephen S. Yang, Terence Yung, D. George Wyse, Davy Cheng, David E. Johnstone, George A. Wells, Philip Joseph, Ameen Patel, Krysten Gregus, Kelly Lawrence, Lindsay Doharris, David Conen, Jason Cheung, Jim Douketis, Douglas Wright, Spencer Wikkerink, William Dechert, Mohamed Panju, Khalid Azzam, Theodore Rapanos, Tomas Van Helder, Anjali Shroff, Jacqueline Hare, Biniam Kidane, Thang Nguyen, Larissa Leydier, Vanessa Bayaraa, Joel Parlow, Deborah A. DuMerton, Amar Thakrar, Jessica Shelley, Benoit Deligne, Roberta Daila Carling, Marko Mrkobrada, George K. Dresser, Michael J. Jacka, David Hornstein, Gerrit B. Winkelaar, Zoeb Hussain Haider, Pravina Prashant Lanjewar, Valsamma Varughese, Rajneesh Calton, Hemani Ahuja, Preetha George, Ambika Sharma, Keyur Sureshchandra Bhatt, Dhaval Odhavajibhai Mangukiya, Karshan Vira Nandaniya, Viral Vasantrai Parekh, Ashok Bhaskaran Pillai, Vidya P. Menon, Sanjay Channappa Desai, Ravinder Singh Sidhu, Sandeep Kumar Gupta, Robbie K. George, T.R. Gurunath, Leanne W. Drummond, Alexandra M. Torborg, Belinda S. Küsel, Prebashini Naidoo, Datshana P. Naidoo, Chantal Rajah, Zane Farina, Richard Peter von Rahden, Simphiwe Gumede, Chishala Chishala, Ettienne Coetzee, Robert A. Dyer, Johan Diedericks, Piotr Bielański, Bogusz Kaczmarek, Dorota Studzińska, Maciej Zaniewski, Marek Józef Libura, Tomasz Mikołaj Zacharias-Nalichowski, Aurelia A.S. Sega, Jakub Salwa, Mateusz Kózka, Jacek Górka, Anna Wludarczyk, Ilona Nowak-Kózka, Paweł Szczepan Grudzień, Jaroslaw W. Gucwa, Michał Piotr Słowiaczek, Paweł P.D. Dobosz, Ismail Gögenur, Jens Ravn Eriksen, Tine Borup, Tove Kirkegaard, Dan Isbye, Asger Sonne, Lars S. Rasmussen, Sofie Pedersen, Hannibal Troensegaard, Camilla L. Duus, Benedikte M. Halle, Ossian N. Gundel, Katrine F. Bernholm, Kristian Rønsholt Martinsen, Søren Pedersen, Theis S. Itenov, Elena Camio, Carles Vázquez, Silvia Matarin, Esther Cano, Jesús Álvarez-García, Inmaculada India, Aránzazu González-Osuna, Marc Vives, Elena Rosselló, Ana B. Serrano, Maurizio Turiel, Lorenzo Drago, Chiara Colombo, Federica Marra, Lucio Mos, Franco Arteni, Rosalba Lembo, Alessandro Ortalda, Simonetta Passarani, Zhirajr Mokini, Estevao Lanna Figueiredo, Gustavo Fonseca Werner, Joao Luiz Petriz, Lilia Nigro Maia, Ricardo R. Bergo, Dalton Bertolim Precoma, José Francisco Kerr Saraiva, Oscar Gomez Vilamajo, Eduardo Allegrini, Mariano Benzadón, Maria Leonor Parody, Ernesto A. Duronto, Adrián C. Ingaramo, Gustavo Adolfo Parra, Danny Novoa, Scott A. Miller, Sabu Thomas, Sudhakar P. Karlapudi, Mohamad H. Bourji, Subhash Banerjee, Anita Gupta, Isaac O. Opole, Michal Fischer, Victor Lecaros Mendoza, Eugenio Borja Reyes, Richard J. Pierson, Martin O. Shields, Vincent Piriou, Kai Zacharowski, Aida Rotta-Rotta, Main Paper, Sadeesh K. Srinathan, Prashant Rahate, Navneet Chaudhry, Bogani Mayosi, and Mike Sharma
Subjects: Male, medicine.medical_specialty, Myocardial Infarction, Placebo-controlled study, Hemorrhage, 030204 cardiovascular system & hematology, Placebo, Antithrombins, Dabigatran, law.invention, Peripheral Arterial Disease, 03 medical and health sciences, 0302 clinical medicine, Randomized controlled trial, 030202 anesthesiology, law, Internal medicine, medicine, Humans, Perioperative Period, Stroke, Aged, Aged, 80 and over, business.industry, Hazard ratio, Proton Pump Inhibitors, Thrombosis, Venous Thromboembolism, General Medicine, Perioperative, Placebo Effect, medicine.disease, Troponin, Clinical trial, Treatment Outcome, Female, business, Omeprazole, medicine.drug
Abstract: Summary Background Myocardial injury after non-cardiac surgery (MINS) increases the risk of cardiovascular events and deaths, which anticoagulation therapy could prevent. Dabigatran prevents perioperative venous thromboembolism, but whether this drug can prevent a broader range of vascular complications in patients with MINS is unknown. The MANAGE trial assessed the potential of dabigatran to prevent major vascular complications among such patients. Methods In this international, randomised, placebo-controlled trial, we recruited patients from 84 hospitals in 19 countries. Eligible patients were aged at least 45 years, had undergone non-cardiac surgery, and were within 35 days of MINS. Patients were randomly assigned (1:1) to receive dabigatran 110 mg orally twice daily or matched placebo for a maximum of 2 years or until termination of the trial and, using a partial 2-by-2 factorial design, patients not taking a proton-pump inhibitor were also randomly assigned (1:1) to omeprazole 20 mg once daily, for which results will be reported elsewhere, or matched placebo to measure its effect on major upper gastrointestinal complications. Research personnel randomised patients through a central 24 h computerised randomisation system using block randomisation, stratified by centre. Patients, health-care providers, data collectors, and outcome adjudicators were masked to treatment allocation. The primary efficacy outcome was the occurrence of a major vascular complication, a composite of vascular mortality and non-fatal myocardial infarction, non-haemorrhagic stroke, peripheral arterial thrombosis, amputation, and symptomatic venous thromboembolism. The primary safety outcome was a composite of life-threatening, major, and critical organ bleeding. Analyses were done according to the intention-to-treat principle. This trial is registered with ClinicalTrials.gov, number NCT01661101. Findings Between Jan 10, 2013, and July 17, 2017, we randomly assigned 1754 patients to receive dabigatran (n=877) or placebo (n=877); 556 patients were also randomised in the omeprazole partial factorial component. Study drug was permanently discontinued in 401 (46%) of 877 patients allocated to dabigatran and 380 (43%) of 877 patients allocated to placebo. The composite primary efficacy outcome occurred in fewer patients randomised to dabigatran than placebo (97 [11%] of 877 patients assigned to dabigatran vs 133 [15%] of 877 patients assigned to placebo; hazard ratio [HR] 0·72, 95% CI 0·55–0·93; p=0·0115). The primary safety composite outcome occurred in 29 patients (3%) randomised to dabigatran and 31 patients (4%) randomised to placebo (HR 0·92, 95% CI 0·55–1·53; p=0·76). Interpretation Among patients who had MINS, dabigatran 110 mg twice daily lowered the risk of major vascular complications, with no significant increase in major bleeding. Patients with MINS have a poor prognosis; dabigatran 110 mg twice daily has the potential to help many of the 8 million adults globally who have MINS to reduce their risk of a major vascular complication. Funding Boehringer Ingelheim and Canadian Institutes of Health Research.
Published: 2018

18. Antiplatelet therapy and the effects of B vitamins in patients with previous stroke or transient ischaemic attack: a post-hoc subanalysis of VITATOPS, a randomised, placebo-controlled trial

Author: Badrisyah Idris, Angelo Costa, Eugenio Pucci, Graeme Hankey, Alan McDougall, Jafri Malin Abdullah, Cathie Sudlow, John Eikelboom, Peter Dedeken, Malcolm Robert Macleod, John Gommans, Geert Vanhooren, C.J.M. Klijn, and J. David Spence
Subjects: Male, medicine.medical_specialty, Placebo-controlled study, Clinical Neurology, Placebo, law.invention, Folic Acid, Randomized controlled trial, Double-Blind Method, law, Internal medicine, medicine, Humans, Myocardial infarction, Stroke, Aged, Proportional Hazards Models, business.industry, Hazard ratio, Articles, Middle Aged, medicine.disease, Vitamin B 6, B vitamins, Vitamin B 12, Treatment Outcome, Ischemic Attack, Transient, Vitamin B Complex, Physical therapy, Platelet aggregation inhibitor, Female, Neurology (clinical), business, Platelet Aggregation Inhibitors, Follow-Up Studies
Abstract: Summary Background Previous studies have suggested that any benefits of folic acid-based therapy to lower serum homocysteine in prevention of cardiovascular events might be offset by concomitant use of antiplatelet therapy. We aimed to establish whether there is an interaction between antiplatelet therapy and the effects of folic acid-based homocysteine-lowering therapy on major vascular events in patients with stroke or transient ischaemic attack enrolled in the vitamins to prevent stroke (VITATOPS) trial. Methods In the VITATOPS trial, 8164 patients with recent stroke or transient ischaemic attack were randomly allocated to double-blind treatment with one tablet daily of placebo or B vitamins (2 mg folic acid, 25 mg vitamin B 6 , and 500 μg vitamin B 12 ) and followed up for a median 3·4 years (IQR 2·0–5·5) for the primary composite outcome of stroke, myocardial infarction, or death from vascular causes. In our post-hoc analysis of the interaction between antiplatelet therapy and the effects of treatment with B vitamins on the primary outcome, we used Cox proportional hazards regression before and after adjusting for imbalances in baseline prognostic factors in participants who were and were not taking antiplatelet drugs at baseline and in participants assigned to receive B vitamins or placebo. We also assessed the interaction in different subgroups of patients and different secondary outcomes. The VITATOPS trial is registered with ClinicalTrials.gov, number NCT00097669, and Current Controlled Trials, number ISRCTN74743444. Findings At baseline, 6609 patients were taking antiplatelet therapy and 1463 were not. Patients not receiving antiplatelet therapy were more likely to be younger, east Asian, and disabled, to have a haemorrhagic stroke or cardioembolic ischaemic stroke, and to have a history of hypertension or atrial fibrillation. They were less likely to be smokers and to have a history of peripheral artery disease, hypercholesterolaemia, diabetes, ischaemic heart disease, and a revascularisation procedure. Of the participants taking antiplatelet drugs at baseline, B vitamins had no significant effect on the primary outcome (488 patients in the B-vitamins group [15%] vs 519 in the placebo group [16%]; hazard ratio [HR] 0·94, 95% CI 0·83–1·07). By contrast, of the participants not taking antiplatelet drugs at baseline, B vitamins had a significant effect on the primary outcome (123 in the B-vitamins group [17%] vs 153 in the placebo group [21%]; HR 0·76, 0·60–0·96). The interaction between antiplatelet therapy and the effect of B vitamins on the primary outcome was significant after adjusting for imbalance in the baseline variables (adjusted p for interaction=0·0204). Interpretation Our findings support the hypothesis that antiplatelet therapy modifies the potential benefits of lowering homocysteine with B-vitamin supplementation in the secondary prevention of major vascular events. If validated, B vitamins might have a role in the prevention of ischaemic events in high-risk individuals with an allergy, intolerance, or lack of indication for antiplatelet therapy. Funding Australia National Health and Medical Research Council, UK Medical Research Council, Singapore Biomedical Research Council, and Singapore National Medical Research Council.
Published: 2012
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19. Dabigatran versus warfarin in patients with atrial fibrillation

Author: Job Harenberg, Paul Matthew Pasco, Mario Talajic, Leopoldo Piegas, Kosta Kostov, Ales Tomek, Konstantin Ramshev, Cetin Erol, David McEneaney, Julián Pérez-Villacastín, Tilemachos Zafeiridis, Salim Yusuf, Espen Fengsrud, David Halon, Graeme Hankey, Ru San Tan, David Tanne, ALVARO AVEZUM, Antonis Manolis, Fabio Turazza, Grethe Andersen, John Eikelboom, Valentin Kokorin, Juan Manuel Escudier Villa, JOSEP BRUGADA, Luis Cunha, Joaquin J Alonso, Stefan Engelter, Pedro Adragao, Geert Vanhooren, Sergey Golitsyn, Andrzej Budaj, Sam Schulman, Connolly, Sj, Ezekowitz, Md, Yusuf, S, Eikelboom, J, Oldgren, J, Parekh, A, Pogue, J, Reilly, Pa, Themeles, E, Varrone, J, Wang, S, Alings, M, Xavier, D, Zhu, J, Diaz, R, Lewis, B, Darius, H, Diener, Hc, Joyner, Cd, Wallentin, L, RE LY Steering, Committee, Investigators, Pizzolato, Gilberto, Other departments, Cardiology, and ACS - Amsterdam Cardiovascular Sciences
Subjects: Male, Stroke Atrial fibrillation anticoagulation, Pyridines, medicine.drug_class, Embolism, Myocardial Infarction, Management of atrial fibrillation, Hemorrhage, Dabigatran, Double-Blind Method, Atrial Fibrillation, medicine, Humans, Prodrugs, Dyspepsia, Stroke, Aged, Proportional Hazards Models, HAS-BLED, Chi-Square Distribution, business.industry, Anticoagulant, Warfarin, Anticoagulants, Idarucizumab, General Medicine, Middle Aged, medicine.disease, Liver, Anesthesia, Benzimidazoles, Female, business, PER977, Follow-Up Studies, medicine.drug
Abstract: Udgivelsesdato: 2009-Sep-17 BACKGROUND: Warfarin reduces the risk of stroke in patients with atrial fibrillation but increases the risk of hemorrhage and is difficult to use. Dabigatran is a new oral direct thrombin inhibitor. METHODS: In this noninferiority trial, we randomly assigned 18,113 patients who had atrial fibrillation and a risk of stroke to receive, in a blinded fashion, fixed doses of dabigatran--110 mg or 150 mg twice daily--or, in an unblinded fashion, adjusted-dose warfarin. The median duration of the follow-up period was 2.0 years. The primary outcome was stroke or systemic embolism. RESULTS: Rates of the primary outcome were 1.69% per year in the warfarin group, as compared with 1.53% per year in the group that received 110 mg of dabigatran (relative risk with dabigatran, 0.91; 95% confidence interval [CI], 0.74 to 1.11; P
Published: 2009
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20. ACP Journal Club: mechanical left atrial appendage closure was noninferior and superior to warfarin in atrial fibrillation

Author: Vinai, Bhagirath, Jacqueline, Bosch, and John, Eikelboom
Subjects: Male, Prosthesis Implantation, Stroke, Atrial Fibrillation, Embolism, Humans, Atrial Appendage, Female, Warfarin
Published: 2015

21. Exposure to ABO-nonidentical blood associated with increased in-hospital mortality in patients with group A blood

Author: Menaka, Pai, Richard, Cook, Rebecca, Barty, John, Eikelboom, Ker-Ai, Lee, and Nancy, Heddle
Subjects: Aged, 80 and over, Male, Blood Grouping and Crossmatching, Blood Group Incompatibility, Humans, Transfusion Reaction, Female, Hospital Mortality, Middle Aged, ABO Blood-Group System, Aged, Retrospective Studies
Abstract: Transfusing ABO-compatible blood avoids most acute hemolytic reactions, but donor units that are ABO compatible are not necessarily ABO identical. Emerging data have raised concerns that ABO-nonidentical blood products lead to adverse outcomes.A large multihospital registry (Transfusion Registry for Utilization, Surveillance, and Tracking) was used to determine the association between exposure to ABO-nonidentical blood and in-hospital mortality. Cox regression analyses controlled for sex, age, hemoglobin, creatinine, and in-hospital interventions and stratified by age of blood and admission year.Data from 18,843 non-group O patients admitted between 2002 and 2011 and receiving at least 1 unit of blood were analyzed. Overall, group A patients had significantly increased risk of in-hospital death upon receiving a nonidentical unit (RR , 1.79; 95% CI, 1.20-2.67; p = 0.005). There was no evidence of increased risk for group B or AB patients. Similar results were seen when only patients with circulatory disorders were considered. When patients with an injury or poisoning diagnosis were excluded, the risk of in-hospital death after receiving a non-identical unit was significantly higher in group A patients and significantly lower in Group B patients.Our study demonstrates an adverse effect of ABO-nonidentical blood in a broad range of patients with group A blood, after adjustment for potential confounders. Further research in this area is required to study possible mechanisms. Increased mortality associated with exposure to nonidentical blood in these patients would have a substantial impact at the population level; it would challenge how blood suppliers manage inventory and recruit donors and how health care providers administer blood.
Published: 2015

22. Exploratory studies on the age of transfused blood and in-hospital mortality in patients with cardiovascular diagnoses

Author: Nancy M, Heddle, John, Eikelboom, Yang, Liu, Rebecca, Barty, and Richard J, Cook
Subjects: Male, Time Factors, Blood Preservation, Cardiovascular Diseases, Risk Factors, Humans, Female, Hospital Mortality, Middle Aged, Erythrocyte Transfusion, Aged, Follow-Up Studies, Retrospective Studies
Abstract: The objective was to examine the association between blood storage duration and in-hospital mortality in a large cohort of cardiovascular patients transfused between 2002 and 2011.Cox regression models were fitted to assess the effect of red blood cell (RBC) storage duration on risk of in-hospital mortality in cardiovascular patients (2002-2011). Time-dependent covariates summarizing the maximum age of RBCs transfused per individual were included as continuous or categorical variables. Models were stratified by cumulative number of RBCs transfusions and other potential confounders. Exploratory analyses were performed by period (Period I, April 2002 to March 2006; Period II, April 2006 to October 2011) and controlling for fiscal year of admission.A total of 9669 patients received 46,868 RBCs. The median number of RBC units transfused was 3 (interquartile range [IQR], 2-5); the median age of RBCs was 17 days (IQR, 13-23 days). The progressive increase in risk of in-hospital mortality with transfusion of older blood observed previously was not seen in the larger cohort (hazard ratio, 01.00; p = 0.692); significantly different effects were observed between periods (p = 0.016), but the difference between periods was no longer significant upon stratification by fiscal year of admission (interaction p = 0.094).The analysis of a large cohort of cardiovascular patients showed no association between storage age of blood and in-hospital mortality. This finding is inconsistent with those of our previous report that analyzed a smaller cohort.
Published: 2014

23. Myocardial Injury after Noncardiac Surgery: A Large, International, Prospective Cohort Study Establishing Diagnostic Criteria, Characteristics, Predictors, and 30-day Outcomes

Author: Fernando, Botto, Pablo, Alonso-Coello, Matthew T V, Chan, Juan Carlos, Villar, Denis, Xavier, Sadeesh, Srinathan, Gordon, Guyatt, Patricia, Cruz, Michelle, Graham, C Y, Wang, Otavio, Berwanger, Rupert M, Pearse, Bruce M, Biccard, Valsa, Abraham, German, Malaga, Graham S, Hillis, Reitze N, Rodseth, Deborah, Cook, Carisi A, Polanczyk, Wojciech, Szczeklik, Daniel I, Sessler, Tej, Sheth, Gareth L, Ackland, Martin, Leuwer, Amit X, Garg, Yannick, Lemanach, Shirley, Pettit, Diane, Heels-Ansdell, Giovanna, Luratibuse, Michael, Walsh, Robert, Sapsford, Holger J, Schünemann, Andrea, Kurz, Sabu, Thomas, Marko, Mrkobrada, Lehana, Thabane, Hertzel, Gerstein, Pilar, Paniagua, Peter, Nagele, Parminder, Raina, Salim, Yusuf, P J, Devereaux, Matthew J, McQueen, Mohit, Bhandari, Jackie, Bosch, Norman, Buckley, Clara K, Chow, Richard, Halliwell, Stephen, Li, Vincent W, Lee, John, Mooney, Mariana V, Furtado, Erica, Suzumura, Eliana, Santucci, Katia, Leite, Jose Amalth do Espirirto, Santo, Cesar A P, Jardim, Alexandre Biasi, Cavalcanti, Helio Penna, Guimaraes, Michael J, Jacka, Finlay, McAlister, Sean, McMurtry, Derek, Townsend, Neesh, Pannu, Sean, Bagshaw, Amal, Bessissow, Emmanuelle, Duceppe, John, Eikelboom, Javier, Ganame, James, Hankinson, Stephen, Hill, Sanjit, Jolly, Andre, Lamy, Elizabeth, Ling, Patrick, Magloire, Guillaume, Pare, Deven, Reddy, David, Szalay, Jacques, Tittley, Jeff, Weitz, Richard, Whitlock, Saeed, Darvish-Kazim, Justin, Debeer, Peter, Kavsak, Clive, Kearon, Richard, Mizera, Martin, O'Donnell, Matthew, McQueen, Jehonathan, Pinthus, Sebastian, Ribas, Marko, Simunovic, Vikas, Tandon, Tomas, Vanhelder, Mitchell, Winemaker, Sarah, McDonald, Paul, O'Bryne, Ameen, Patel, James, Paul, Zubin, Punthakee, Karen, Raymer, Omid, Salehian, Fred, Spencer, Stephen, Walter, Andrew, Worster, Anthony, Adili, Catherine, Clase, Mark, Crowther, James, Douketis, Azim, Gangji, Paul, Jackson, Wendy, Lim, Peter, Lovrics, Sergio, Mazzadi, William, Orovan, Jill, Rudkowski, Mark, Soth, Maria, Tiboni, Rey, Acedillo, Amit, Garg, Ainslie, Hildebrand, Ngan, Lam, Danielle, Macneil, Pavel S, Roshanov, Sadeesh K, Srinathan, Clare, Ramsey, Philip St, John, Laurel, Thorlacius, Faisal S, Siddiqui, Hilary P, Grocott, Andrew, McKay, Trevor W R, Lee, Ryan, Amadeo, Duane, Funk, Heather, McDonald, James, Zacharias, Olga Lucía, Cortés, Maria Stella, Chaparro, Skarlett, Vásquez, Alvaro, Castañeda, Silvia, Ferreira, Pierre, Coriat, Denis, Monneret, Jean Pierre, Goarin, Cristina Ibanez, Esteve, Catherine, Royer, Georges, Daas, Gordon Y S, Choi, Tony, Gin, Lydia C W, Lit, Alben, Sigamani, Atiya, Faruqui, Radhika, Dhanpal, Smitha, Almeida, Joseph, Cherian, Sultana, Furruqh, Lalita, Afzal, Preetha, George, Shaveta, Mala, Holger, Schünemann, Paola, Muti, Enrico, Vizza, G S Y, Ong, Marzida, Mansor, Alvin S B, Tan, Ina I, Shariffuddin, V, Vasanthan, N H M, Hashim, A Wahab, Undok, Ushananthini, Ki, Hou Yee, Lai, Wan Azman, Ahmad, Azad H A, Razack, Vanessa, Valderrama-Victoria, Javier D, Loza-Herrera, Maria, De Los Angeles Lazo, Aida, Rotta-Rotta, Barbara, Sokolowska, Jacek, Musial, Jacek, Gorka, Pawel, Iwaszczuk, Mateusz, Kozka, Maciej, Chwala, Marcin, Raczek, Tomasz, Mrowiecki, Bogusz, Kaczmarek, Bruce, Biccard, Hussein, Cassimjee, Dean, Gopalan, Theroshnie, Kisten, Aine, Mugabi, Prebashini, Naidoo, Rubeshan, Naidoo, Reitze, Rodseth, David, Skinner, Alex, Torborg, Gerard, Urrutia, Mari Luz, Maestre, Miquel, Santaló, Raúl, Gonzalez, Adrià, Font, Cecilia, Martínez, Xavier, Pelaez, Marta, De Antonio, Jose Marcial, Villamor, Jesús Alvarez, García, Maria José, Ferré, Ekaterina, Popova, Ignacio, Garutti, Carmen, Fernández, Maria, Palencia, Susana, Díaz, Teresa, Del Castillo, Alberto, Varela, Angeles, de Miguel, Manuel, Muñoz, Patricia, Piñeiro, Gabriel, Cusati, Maria, Del Barrio, Maria José, Membrillo, David, Orozco, Fidel, Reyes, Robert J, Sapsford, Julian, Barth, Julian, Scott, Alistair, Hall, Simon, Howell, Michaela, Lobley, Janet, Woods, Susannah, Howard, Joanne, Fletcher, Nikki, Dewhirst, C, Williams, A, Rushton, I, Welters, M, Leuwer, Rupert, Pearse, Gareth, Ackland, Ahsun, Khan, Edyta, Niebrzegowska, Sally, Benton, Andrew, Wragg, Andrew, Archbold, Amanda, Smith, Eleanor, McAlees, Cheryl, Ramballi, Neil, Macdonald, Marta, Januszewska, Robert, Stephens, Anna, Reyes, Laura Gallego, Paredes, Pervez, Sultan, David, Cain, John, Whittle, Ana Gutierrez, Del Arroyo, Zhuo, Sun, Patrick S, Finnegan, Cameron, Egan, Hooman, Honar, Aram, Shahinyan, Krit, Panjasawatwong, Alexander Y, Fu, Sihe, Wang, Edmunds, Reineks, Jane, Blood, Megan, Kalin, David, Gibson, and Troy, Wildes
Subjects: Male, Myocardial Ischemia, surgical technique, Article, Cohort Studies, Age Distribution, Postoperative Complications, Troponin T, Humans, preoperative care, human, Prospective Studies, outcome assessment, Aged, Hardware_MEMORYSTRUCTURES, troponin T, ComputingMilieux_THECOMPUTINGPROFESSION, predictive value, Research Diagnostic Criteria, heart muscle injury, Middle Aged, Prognosis, major clinical study, mortality, clinical feature, Patient Outcome Assessment, peroperative complication, priority journal, Surgical Procedures, Operative, prognosis, purl.org/pe-repo/ocde/ford#3.02.09 [https]
Abstract: Background: Myocardial injury after noncardiac surgery (MINS) was defined as prognostically relevant myocardial injury due to ischemia that occurs during or within 30 days after noncardiac surgery. The study's four objectives were to determine the diagnostic criteria, characteristics, predictors, and 30-day outcomes of MINS. Methods: In this international, prospective cohort study of 15,065 patients aged 45 yr or older who underwent in-patient noncardiac surgery, troponin T was measured during the first 3 postoperative days. Patients with a troponin T level of 0.04 ng/ml or greater (elevated abnormal laboratory threshold) were assessed for ischemic features (i.e., ischemic symptoms and electrocardiography findings). Patients adjudicated as having a nonischemic troponin elevation (e.g., sepsis) were excluded. To establish diagnostic criteria for MINS, the authors used Cox regression analyses in which the dependent variable was 30-day mortality (260 deaths) and independent variables included preoperative variables, perioperative complications, and potential MINS diagnostic criteria. Results: An elevated troponin after noncardiac surgery, irrespective of the presence of an ischemic feature, independently predicted 30-day mortality. Therefore, the authors' diagnostic criterion for MINS was a peak troponin T level of 0.03 ng/ml or greater judged due to myocardial ischemia. MINS was an independent predictor of 30-day mortality (adjusted hazard ratio, 3.87; 95% CI, 2.96-5.08) and had the highest population-attributable risk (34.0%, 95% CI, 26.6-41.5) of the perioperative complications. Twelve hundred patients (8.0%) suffered MINS, and 58.2% of these patients would not have fulfilled the universal definition of myocardial infarction. Only 15.8% of patients with MINS experienced an ischemic symptom. Conclusion: Among adults undergoing noncardiac surgery, MINS is common and associated with substantial mortality.
Published: 2014

24. Modification of outcomes with aspirin or apixaban in relation to CHADS(2) and CHA(2)DS(2)-VASc scores in patients with atrial fibrillation: a secondary analysis of the AVERROES study

Author: Gregory Y H, Lip, Stuart, Connolly, Salim, Yusuf, Olga, Shestakovska, Greg, Flaker, Robert, Hart, Fernando, Lanas, Denis, Xavier, and John, Eikelboom
Subjects: Male, Aspirin, Pyridones, Hemorrhage, Middle Aged, Risk Assessment, Brain Ischemia, Stroke, Treatment Outcome, Fibrinolytic Agents, Risk Factors, Atrial Fibrillation, Multivariate Analysis, Health Status Indicators, Humans, Pyrazoles, Female, Aged, Proportional Hazards Models
Abstract: The impact of apixaban versus aspirin on ischemic stroke and major bleeding in relation to the CHADS(2) and CHA(2)DS(2)-VASc stroke risk scores in atrial fibrillation has not been investigated.In this secondary analysis of the AVERROES trial, our principal objective was to assess the effect of treatment with aspirin or apixaban on ischemic stroke and major bleeding, in relation to the CHADS(2)/CHA(2)DS(2)-VASc scores. We found no significant heterogeneity for treatment efficacy on ischemic stroke for apixaban when subdivided by stroke risk strata, based on CHADS(2)/CHA(2)DS(2)-VASc. Effects were consistent irrespective of baseline risk, and thus, absolute benefits were greatest in the high-risk groups. There was also no significant heterogeneity for apixaban versus aspirin with regard to major bleeding, when subdivided by CHADS(2)/CHA(2)DS(2)-VASc scores. In multivariable analysis, significant predictors of stroke on aspirin were age ≥75 years, prior stroke or transient ischemic attack, estimated glomerular filtration rate60 mL/min, and nonparoxysmal atrial fibrillation. Proportions of the study cohort classified as low/moderate/high risk using the CHADS(2) and CHA(2)DS(2)-VASc scores were 0.3%/71.7%/28.1% and0.1%/10.5%/89.5%, respectively.In an atrial fibrillation population, apixaban was superior to aspirin for stroke prevention, with similar rates of major bleeding, in the presence of one or more stroke risk factors, with consistency of the treatment effect by CHADS(2)/CHA(2)DS(2)-VASc scores.
Published: 2013

25. Processed residual pump blood in cardiac surgery: the Processed Residual Blood in Cardiac surgery trial

Author: Richard, Whitlock, Joseph, Mathew, John, Eikelboom, Ayman Mohammad, Al-Saleh, Fei, Yuan, and Kevin, Teoh
Subjects: Male, Cardiopulmonary Bypass, Humans, Ultrafiltration, Female, Coronary Artery Bypass, Middle Aged, Bloodless Medical and Surgical Procedures, Aged
Abstract: Processing residual cardiopulmonary bypass (CPB) volume via ultrafiltration may improve hemostasis and reduce transfusion through clearing activated complement, activated coagulation components, and proinflammatory cytokines. We sought to establish if processing residual CPB volume with ultrafiltration reduces homologous blood transfusion and bleeding.Adult patients undergoing isolated coronary artery bypass grafting (CABG) surgery were randomly assigned to receive processed (n = 99) or unprocessed (control; n = 98) residual CPB volume in this single-center randomized controlled trial. The intensive care unit team, patients, and assessors were blinded to treatment assignment and a transfusion protocol was followed. Surgeons were permitted to use retrograde autologous priming to minimize crystalloid pump prime.The processed study bag was of a smaller volume (280 [0, 550] mL vs. 590 [215, 726] mL; p0.01) but a higher hematocrit (29% [0%, 34%] vs. 23% [20%, 25%]; p0.01) than control. The rate of transfusion with homologous blood was 39% in both groups (p = 0.92). There was no difference in the volume transfused (processed 323 ± 585 mL vs. control 276 ± 520 mL; p = 0.56). There was also no difference in the proportion of patients transfused with any blood product (processed 44% vs. control 45%; p = 0.95) or in the volume of chest tube output (processed 600 [500, 940] mL vs. control 670 [490, 932] mL; p = 0.62).Ultrafiltration of residual CPB volume in adults undergoing isolated CABG surgery does not reduce the need for transfusion or bleeding.
Published: 2012

26. Periprocedural bleeding and thromboembolic events with dabigatran compared with warfarin: results from the Randomized Evaluation of Long-Term Anticoagulation Therapy (RE-LY) randomized trial

Author: Jeff S, Healey, John, Eikelboom, James, Douketis, Lars, Wallentin, Jonas, Oldgren, Sean, Yang, Ellison, Themeles, Hein, Heidbuchel, Hein, Heidbuchle, Alvaro, Avezum, Paul, Reilly, Stuart J, Connolly, Salim, Yusuf, and Michael, Ezekowitz
Subjects: Male, medicine.medical_specialty, Joint replacement, medicine.medical_treatment, Blood Loss, Surgical, Colonoscopy, Hemorrhage, Cataract Extraction, Dabigatran, law.invention, Brain Ischemia, Postoperative Complications, Randomized controlled trial, law, Risk Factors, Physiology (medical), Thromboembolism, medicine, Humans, Stroke, Aged, Aged, 80 and over, medicine.diagnostic_test, business.industry, Incidence, Warfarin, Cardiac Pacing, Artificial, Anticoagulants, Atrial fibrillation, Perioperative, Middle Aged, medicine.disease, Surgery, Anesthesia, beta-Alanine, Benzimidazoles, Female, Cardiology and Cardiovascular Medicine, business, medicine.drug, Follow-Up Studies
Abstract: Background— Dabigatran reduces ischemic stroke in comparison with warfarin; however, given the lack of antidote, there is concern that it might increase bleeding when surgery or invasive procedures are required. Methods and Results— The current analysis was undertaken to compare the periprocedural bleeding risk of patients in the Randomized Evaluation of Long-Term Anticoagulation Therapy (RE-LY) trial treated with dabigatran and warfarin. Bleeding rates were evaluated from 7 days before until 30 days after invasive procedures, considering only the first procedure for each patient. A total of 4591 patients underwent at least 1 invasive procedure: 24.7% of patients received dabigatran 110 mg, 25.4% received dabigatran 150 mg, and 25.9% received warfarin, P =0.34. Procedures included: pacemaker/defibrillator insertion (10.3%), dental procedures (10.0%), diagnostic procedures (10.0%), cataract removal (9.3%), colonoscopy (8.6%), and joint replacement (6.2%). Among patients assigned to either dabigatran dose, the last dose of study drug was given 49 (35–85) hours before the procedure on comparison with 114 (87–144) hours in patients receiving warfarin, P P =0.28; dabigatran 150 mg versus warfarin: relative risk, 1.09; 95% CI, 0.80 to 1.49; P =0.58. Among patients having urgent surgery, major bleeding occurred in 17.8% with dabigatran 110 mg, 17.7% with dabigatran 150 mg, and 21.6% with warfarin: dabigatran 110 mg; relative risk, 0.82; 95% CI, 0.48 to 1.41; P =0.47; dabigatran 150 mg: relative risk, 0.82; 95% CI, 0.50 to 1.35; P =0.44. Conclusions— Dabigatran and warfarin were associated with similar rates of periprocedural bleeding, including patients having urgent surgery. Dabigatran facilitated a shorter interruption of oral anticoagulation. Clinical Trial Registration— URL: http://www.clinicaltrials.gov . Unique identifier: NCT00262600.
Published: 2012

27. The reemergence of aspirin for the prevention of venous thromboembolism

Author: John, Eikelboom
Subjects: Aspirin, Thromboembolism, Anticoagulants, Humans, Venous Thromboembolism, Platelet Aggregation Inhibitors
Published: 2012

28. Apixaban versus aspirin in patients with atrial fibrillation and previous stroke or transient ischaemic attack: a predefined subgroup analysis from AVERROES, a randomised trial

Author: Job Harenberg, Mario Talajic, Yulia Moiseeva, Miguel Urina, Reza Farnoud, Salim Yusuf, Graeme Hankey, John Eikelboom, Olga Shestakovska, Martin O'Donnell, Marina Okoshi, Fernando Lanas, Thomas W Leung, Geert Vanhooren, Pedro Abizanda Soler, Marina Bentivoglio, Nikolai Furman, Ramón Rabuñal, Sergey Golitsyn, Ettore Beghi, Andrzej Budaj, Sam Schulman, Nataliya Poteshkina, Lawrence, J, Pogue, J, Synhorst, D, Adalet, K, Atar, D, Avezum, A, Budaj, A, Commerford, Pj, Dans, Al, De Caterina, R, Diener, Hc, Eikelboom, J, Connolly, Sj, Joyner, Cd, Hart, Rg, Lip, Gy, O'Donnell, M, Hohnloser, Sh, Hankey, Gj, Shestakovska, O, Yusuf, S, AVERROES steering, Committee, and Pizzolato, Gilberto
Subjects: Male, medicine.medical_specialty, Pyridones, medicine.drug_class, Medizin, Subgroup analysis, Fibrinolytic Agents, Internal medicine, Atrial Fibrillation, medicine, Humans, cardiovascular diseases, Stroke, Aged, Aged, 80 and over, Aspirin, stroke atrial fibrillation, business.industry, Hazard ratio, Atrial fibrillation, Middle Aged, Vitamin K antagonist, medicine.disease, Surgery, Treatment Outcome, Ischemic Attack, Transient, Cardiology, Pyrazoles, Female, Apixaban, Neurology (clinical), business, Fibrinolytic agent, medicine.drug
Abstract: Summary Background In the AVERROES study, apixaban, a novel factor Xa inhibitor, reduced the risk of stroke or systemic embolism in patients with atrial fibrillation who were at high risk of stroke but unsuitable for vitamin K antagonist therapy. We aimed to investigate whether the subgroup of patients with previous stroke or transient ischaemic attack (TIA) would show a greater benefit from apixaban compared with aspirin than would patients without previous cerebrovascular events. Methods In AVERROES, 5599 patients (mean age 70 years) with atrial fibrillation who were at increased risk of stroke and unsuitable for vitamin K antagonist therapy were randomly assigned to receive apixaban (5 mg twice daily) or aspirin (81–324 mg per day). The mean follow-up was 1·1 years. The primary efficacy outcome was stroke or systemic embolism; the primary safety outcome was major bleeding. Patients and investigators were masked to study treatment. In this prespecified subgroup analysis, we used Kaplan-Meier estimates of 1-year event risk and Cox proportional hazards regression models to compare the effects of apixaban in patients with and without previous stroke or TIA. AVERROES is registered at ClinicalTrials.gov, number NCT00496769. Findings In patients with previous stroke or TIA, ten events of stroke or systemic embolism occurred in the apixaban group (n=390, cumulative hazard 2·39% per year) compared with 33 in the aspirin group (n=374, 9·16% per year; hazard ratio [HR] 0·29, 95% CI 0·15–0·60). In those without previous stroke or TIA, 41 events occurred in the apixaban group (n=2417, 1·68% per year) compared with 80 in the aspirin group (n=2415, 3·06% per year; HR 0·51, 95% CI 0·35–0·74). The p value for interaction of the effects of aspirin and apixaban with previous cerebrovascular events was 0·17. Major bleeding was more frequent in patients with history of stroke or TIA than in patients without (HR 2·88, 95% CI 1·77–4·55) but risk of this event did not differ between treatment groups. Interpretation In patients with atrial fibrillation, apixaban is similarly effective whether or not patients have had a previous stroke or TIA. Given that those with previous stroke or TIA have a higher risk of stroke, the absolute benefits might be greater in these patients. Funding Bristol-Myers Squibb and Pfizer.
Published: 2012
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29. Endometriosis-associated ovarian carcinomas

Author: François Bertucci, John Eikelboom, Daniel Birnbaum, Centre de Recherche en Cancérologie de Marseille (CRCM), Aix Marseille Université (AMU)-Institut Paoli-Calmettes, and Fédération nationale des Centres de lutte contre le Cancer (FNCLCC)-Fédération nationale des Centres de lutte contre le Cancer (FNCLCC)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)
Subjects: Ovarian Neoplasms, business.industry, Endometriosis, Nuclear Proteins, [SDV.CAN]Life Sciences [q-bio]/Cancer, General Medicine, medicine.disease, DNA-binding protein, Article, DNA-Binding Proteins, Pancreatic Neoplasms, Text mining, Mutation (genetic algorithm), Mutation, medicine, Carcinoma, Cancer research, Adenocarcinoma, Ovarian carcinomas, Humans, Female, business, ComputingMilieux_MISCELLANEOUS, Transcription Factors
Abstract: International audience
Published: 2011
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30. Standardized reporting of bleeding complications for clinical investigations in acute coronary syndromes: a proposal from the academic bleeding consensus (ABC) multidisciplinary working group

Author: Sunil V, Rao, John, Eikelboom, Ph Gabriel, Steg, A Michael, Lincoff, William S, Weintraub, Jean-Pierre, Bassand, A Koneti, Rao, C Michael, Gibson, John L, Petersen, Roxana, Mehran, Steven V, Manoukian, Richard, Charnigo, Kerry L, Lee, Mauro, Moscucci, Robert A, Harrington, and Mark, Sumeray
Subjects: medicine.medical_specialty, Future studies, business.industry, Incidence (epidemiology), Hemorrhage, Clinical trial, Group discussion, Fibrinolytic Agents, Multidisciplinary approach, Research Design, Hemorrhagic complication, Antithrombotic, medicine, Humans, Acute Coronary Syndrome, Cardiology and Cardiovascular Medicine, Intensive care medicine, business, Pharmaceutical industry
Abstract: Background Clinical trials of antithrombotic agents for the treatment of ACS routinely assess bleeding as a safety endpoint, but variation in bleeding definitions makes comparison of the relative safety of these agents difficult. Methods The ABC Multidisciplinary Working Group, an informal working group comprising clinical researchers and representatives from the US Food and Drug Administration, the National Institutes of Health, and the pharmaceutical industry, sought to develop a consensus approach to measuring the incidence and severity of bleeding complications during clinical trials of acute coronary syndromes (ACS). A meeting of the ABC was convened in April 2008 in Washington, DC, with the goal of developing a consensus approach to measuring the incidence and severity of hemorrhagic complications during clinical trials of ACS. Relevant literature on bleeding was reviewed through a series of short lectures and intensive group discussion. Results Using existing evidence on bleeding and outcomes as well as clinical judgment, criteria for the assessment of bleeding were developed through expert consensus. This consensus statement divides bleeding-related data elements into three categories: essential, recommended, and optional. Conclusions The ABC Group recommendations for collection and reporting of bleeding complications provide a framework for consistency in the collection of information on hemorrhagic complications in trials of ACS. Widespread adoption of the statement recommendations will facilitate understanding of the mechanisms of adverse outcomes after bleeding and comparisons of the relative safety of antithrombotic agents, as well as the interpretation of safety results from future studies.
Published: 2009

31. Postoperative low-molecular-weight heparin bridging is associated with an increase in wound hematoma following surgery for pacemakers and implantable defibrillators

Author: R N Marlene Robinson, Alexander G. Turpie, Stuart J. Connolly, Carlos A. Morillo, Adrian Baranchuk, Sebastian Ribas, Jeff S. Healey, Girish M. Nair, Sam Schulman, John Eikelboom, and Geoff Evans
Subjects: Male, medicine.medical_specialty, Pacemaker, Artificial, medicine.drug_class, Postoperative hematoma, Low molecular weight heparin, Hematoma, Surgical Wound Dehiscence, medicine, Humans, Aged, Postoperative Care, business.industry, Anticoagulants, Thrombosis, General Medicine, Heparin, Perioperative, Heparin, Low-Molecular-Weight, medicine.disease, Clopidogrel, Surgery, Defibrillators, Implantable, Regimen, Anesthesia, Female, Cardiology and Cardiovascular Medicine, business, Complication, medicine.drug
Abstract: Background: The perioperative management of patients receiving oral anticoagulation therapy (OAC) who undergo pacemaker (PM) and defibrillator (ICD) surgery remains controversial. Low-molecular-weight heparin (LMWH) is often used; however, wound hematoma is a common complication. Methods: At a single academic Canadian center, between July 2003 and June 2005, details of perioperative OAC bridging and the rate of wound hematoma requiring reoperation or interruption of OAC were reviewed for all patients receiving LMWH bridging for PM or ICD surgery. Results: A total of 148 PM/ICD patients underwent perioperative bridging with LMWH. A significant hematoma occurred in 23 patients, requiring reoperation in three patients. No patient died, developed infection, or stroke. The initial bridging regimen included LMWH (enoxaparin 1 mg/kg BID) given until evening prior to surgery, and reinitiated on postoperative day 3. In response to high rates of postoperative hematoma, subsequent protocols omitted the LMWH on the evening before surgery, all postoperative LMWH, or both. The use of LMWH the night before surgery had no effect on hematoma rates (12% vs 17%, P = 0.62); however, the use of any postoperative LMWH increased hematoma rates (23% vs 8%, P = 0.01). Hematoma rates were not increased in patients receiving acetylsalicylic acid (19% vs 16%, P = 0.62) or clopidogrel (25% vs 17%, P = 0.54). In a multivariate analysis, independent predictors of significant wound hematoma included postoperative LMWH (P = 0.001), a higher international normalized ratio on the day of surgery (P = 0.03), and male sex (P = 0.05). Conclusion: Elimination of postoperative LMWH was associated with a substantial reduction in hematoma rates following PM and ICD surgery.
Published: 2009

32. The pursuit of clinically relevant measures of platelet function after antiplatelet drug therapy

Author: John A, Cairns and John, Eikelboom
Subjects: Blood Platelets, Ticlopidine, Platelet Aggregation, Pyridines, Coronary Artery Disease, Thiophenes, Piperazines, Clopidogrel, Diabetes Complications, Risk Factors, Humans, Treatment Failure, Prasugrel Hydrochloride, Platelet Aggregation Inhibitors
Published: 2008

33. Clopidogrel resistance: more grist for the mill

Author: John A, Cairns and John, Eikelboom
Subjects: Ticlopidine, Treatment Outcome, Humans, Acute Coronary Syndrome, Angioplasty, Balloon, Coronary, Platelet Aggregation Inhibitors, Clopidogrel
Published: 2008

34. Bleeding Complications in Acute Coronary Syndromes and Percutaneous Coronary Intervention: Predictors, Prognostic Significance, and Paradigms for Reducing Risk

Author: Michele D. Voeltz, John Eikelboom, and Steven V. Manoukian
Subjects: Acute coronary syndrome, medicine.medical_specialty, Safety Management, medicine.drug_class, medicine.medical_treatment, Myocardial Ischemia, Low molecular weight heparin, Hemorrhage, Risk Assessment, Postoperative Complications, Predictive Value of Tests, Risk Factors, Antithrombotic, Reseach Articles, medicine, Humans, Risk factor, Angioplasty, Balloon, Coronary, Intensive care medicine, business.industry, Percutaneous coronary intervention, Anticoagulants, General Medicine, medicine.disease, Prognosis, Surgery, Clinical trial, Glycoprotein IIb/IIIa inhibitors, Conventional PCI, Cardiology and Cardiovascular Medicine, business, medicine.drug
Abstract: In clinical trials up to 30% of patients with acute coronary syndromes (ACS) or undergoing percutaneous coronary intervention (PCI) experience bleeding complications, and even higher rates have been reported in contemporary practice. A growing body of data suggests a strong correlation between bleeding and both short- and long-term adverse outcomes, including mortality, which is independent of baseline characteristics and remains evident in most trials, despite variations in the definition of major bleeding. Although the value of antithrombin and antiplatelet therapy in reducing the risk of ischemic events is well established, the mechanisms of action that confer the benefits of these therapies have an inherent tendency to increase the risk of bleeding complications. As a result, characterization of baseline hemorrhagic risk is critical and must be accomplished before selecting an antithrombotic therapy. Risk factors for bleeding may be divided into two categories: nonmodifiable (including age, gender, race, weight, renal insufficiency, anemia, and acuity of presentation) and modifiable (including choice of antithrombotic therapy and PCI procedural characteristics). Of these predictive factors, the choice, dosage, and duration of the antithrombin and/or antiplatelet regimen are perhaps the most readily modifiable, especially in patients with an increased risk of bleeding. This review explores the nature of the association between bleeding and adverse outcomes, including mortality; evaluates risk factors for bleeding; and examines mechanisms for reducing bleeding complications through the selection of appropriate antithrombotic therapy. Copyright © 2007 Wiley Periodicals, Inc.
Published: 2007

35. Suboptimal preventive practices in patients with carotid and peripheral vascular occlusive disease in a tertiary referral setting

Author: Lip, Gen Teh, Kishore, Sieunarine, John, Eikelboom, Frank J, Prendergast, Marcel A, Goodman, Karen, Joesbury, and Eilidth, Watt
Subjects: Male, Peripheral Vascular Diseases, Fibrinolytic Agents, Arteriosclerosis, Anticholesteremic Agents, Humans, Carotid Stenosis, Female, Antihypertensive Agents, Aged, Retrospective Studies
Abstract: Effective strategies for the prevention of adverse vascular events in patients with atherosclerotic vascular disease include smoking cessation, platelet inhibition, antihypertensives, hypoglycaemic and cholesterol lowering agents. The current literature suggests that these practices are suboptimal in patients with peripheral vascular disease (PVD). This study aims to examine and compare the use of preventive therapy in patients admitted for interventions related to peripheral and carotid atherosclerotic occlusive disease.All inpatients undergoing diagnostic or therapeutic procedures for occlusive disease of the lower limb and carotid artery at Royal Perth Hospital, Western Australia, between January 2000 and December 2000 were included in the study. Their medical charts were reviewed to measure the prevalence of the use of antithrombotic, antihypertensive and cholesterol-lowering therapies.Medical charts of 256 patients (97%) were reviewed during the study period. Carotid related procedures accounted for 26% of the sample. Overall, 80% were prescribed antithrombotic (antiplatelet or anticoagulation) therapy at the time of discharge. In the carotid group, 97% were on some form of antithrombotic therapy as opposed to 75% in the PVD group. Antihypertensive and cholesterol lowering therapies were used in 82% and 63%, respectively, of the carotid group vs 68% and 36% in the PVD group. Rates of preventive practices were lowest in the subgroup of PVD patients without a history of coronary or cerebrovascular disease.Preventive therapies are under utilized in patients with PVD. Effective strategies need to be developed to encourage the use of these adjunctive therapies in the long-term management of vascular patients.
Published: 2003

36. Nonbleeding complications of unfractionated and low-molecular weight heparins

Author: John Eikelboom
Subjects: Benzylamines, Fondaparinux, Liver, Polysaccharides, Anticoagulants, Azetidines, Humans, Heparin, Low-Molecular-Weight, Thrombocytopenia

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36 results on '"John Eikelboom"'

1. A Multicenter, Phase 2, Randomized, Placebo-Controlled, Double-Blind, Parallel-Group, Dose-Finding Trial of the Oral Factor XIa Inhibitor Asundexian to Prevent Adverse Cardiovascular Outcomes After Acute Myocardial Infarction

2. Great Debate: Triple antithrombotic therapy in patients with atrial fibrillation undergoing coronary stenting should be limited to 1 week

3. Advances in anticoagulation: patients with bioprosthetic heart valves

4. Efficacy and safety of low-dose colchicine in patients with coronary disease: a systematic review and meta-analysis of randomized trials

5. Tranexamic Acid in Patients Undergoing Noncardiac Surgery

6. Rationale and design of the PeriOperative ISchemic Evaluation-3 (POISE-3): a randomized controlled trial evaluating tranexamic acid and a strategy to minimize hypotension in noncardiac surgery

7. Efficacy and safety of low intensity vitamin K antagonists in Western and East-Asian patients with left-sided mechanical heart valves

8. Pulmonary embolism: update on diagnosis and management

9. Deep vein thrombosis: update on diagnosis and management

11. Risk profiles and one-year outcomes of patients with newly diagnosed atrial fibrillation in India: Insights from the GARFIELD-AF Registry

12. Effect of Colchicine vs Usual Care Alone on Intubation and 28-Day Mortality in Patients Hospitalized With COVID-19

13. Defining high bleeding risk in patients undergoing percutaneous coronary intervention: a consensus document from the Academic Research Consortium for High Bleeding Risk

14. Rivaroxaban for Thromboprophylaxis in High-Risk Ambulatory Patients with Cancer

15. Bleeding with Direct Oral Anticoagulants vs Warfarin: Clinical Experience

16. The Ross procedure versus prosthetic and homograft aortic valve replacement: a systematic review and meta-analysis

17. Dabigatran in patients with myocardial injury after non-cardiac surgery (MANAGE) : an international, randomised, placebo-controlled trial

18. Antiplatelet therapy and the effects of B vitamins in patients with previous stroke or transient ischaemic attack: a post-hoc subanalysis of VITATOPS, a randomised, placebo-controlled trial

19. Dabigatran versus warfarin in patients with atrial fibrillation

20. ACP Journal Club: mechanical left atrial appendage closure was noninferior and superior to warfarin in atrial fibrillation

21. Exposure to ABO-nonidentical blood associated with increased in-hospital mortality in patients with group A blood

22. Exploratory studies on the age of transfused blood and in-hospital mortality in patients with cardiovascular diagnoses

23. Myocardial Injury after Noncardiac Surgery: A Large, International, Prospective Cohort Study Establishing Diagnostic Criteria, Characteristics, Predictors, and 30-day Outcomes

24. Modification of outcomes with aspirin or apixaban in relation to CHADS(2) and CHA(2)DS(2)-VASc scores in patients with atrial fibrillation: a secondary analysis of the AVERROES study

25. Processed residual pump blood in cardiac surgery: the Processed Residual Blood in Cardiac surgery trial

26. Periprocedural bleeding and thromboembolic events with dabigatran compared with warfarin: results from the Randomized Evaluation of Long-Term Anticoagulation Therapy (RE-LY) randomized trial

27. The reemergence of aspirin for the prevention of venous thromboembolism

28. Apixaban versus aspirin in patients with atrial fibrillation and previous stroke or transient ischaemic attack: a predefined subgroup analysis from AVERROES, a randomised trial

29. Endometriosis-associated ovarian carcinomas

30. Standardized reporting of bleeding complications for clinical investigations in acute coronary syndromes: a proposal from the academic bleeding consensus (ABC) multidisciplinary working group

31. Postoperative low-molecular-weight heparin bridging is associated with an increase in wound hematoma following surgery for pacemakers and implantable defibrillators

32. The pursuit of clinically relevant measures of platelet function after antiplatelet drug therapy

33. Clopidogrel resistance: more grist for the mill

34. Bleeding Complications in Acute Coronary Syndromes and Percutaneous Coronary Intervention: Predictors, Prognostic Significance, and Paradigms for Reducing Risk

35. Suboptimal preventive practices in patients with carotid and peripheral vascular occlusive disease in a tertiary referral setting

36. Nonbleeding complications of unfractionated and low-molecular weight heparins

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36 results on '"John Eikelboom"'

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