1. Rivaroxaban with or without Aspirin in Stable Cardiovascular Disease
- Author
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Stephane Ederhy, Gilmar Reis, Andrzej Rynkiewicz, Keith Fox, Luca Padua, Helene ABERGEL, Andrew Murphy, Andrzej Szuba, YAN CARLOS DUARTE VERA, Pawel Maga, Scott Berkowitz, Roxana Buzas, Alexey Repin, Gregory Ducrocq, Olga Barbarash, Anton Sadomov, Grzegorz Gajos, Miguel Urina, David McEneaney, Richard Tytus, Dmitriy Panov, Angelika Chachaj, Weimar Kunz Sebba Barroso Souza, Akihiko Takahashi, Salim Yusuf, Mpiko Ntsekhe, Elena Gromova, David Halon, Richard Cheng, Marcello Galvani, Rohan Poulter, JUAN PABLO YEPEZ ALVARAN, Sara Doimo, Kim Houlind, Marcelo Arruda Nakazone, Avinainder Singh, Fabrice Martens, Aldo Pietro Maggioni, Fredrik Folke, Miroslav Brtko, Peter Verhamme, Laszlo Koranyi, Bart Meuris, ALVARO AVEZUM, Boris Vesga, Cyrille Boulogne, Peter Sinnaeve, Zhanna Sizova, Marianna Janion, Crina Julieta Sinescu, Laurent BERTOLETTI, Susanne Brenner, Jaroslav Hlubocký, ELENA BOBESCU, Michelle Canavan, Kamil Bury, Elena Nalesnik, Robert Mikulik, Yaroslav Malynovsky, Liudmyla Parkhomenko, Andrea Barbieri, Philippe Gabriel STEG, Kelley Branch, Olga Shestakovska, Jan Fedacko, Khairul Shafiq Ibrahim, Nicolae-Dan Tesloianu, Daniel Pella, Paul Fedak, Pavel Kaplan, Shirley Jansen, Martin O'Donnell, Marlena Broncel, Fernando Lanas, Stefan Störk, Natalia Garganeeva, Heyman Luckraz, CARLOS AUGUSTO CELEMIN FLOREZ, Larysa Mishchenko, Amos Katz, Jaroslava Paulasova Schwabova, Patricio Lopez-Jaramillo, Gustavo Aroca, Monika Możdżan, Zoltan Varallyay, María José Paucar, Tim Ramsay, Fernando Botto, Muhammad Imran Abdul Hafidz, Juan Esteban Gómez-Mesa, Kaijian Hou, Miroslav Spacek, Tomasz Guzik, Diego Rizzotti, Jackie Bosch, Shrikant Bangdiwala, Robert Welsh, Vojtěch Novotný, Andriy Bazylevych, Niall Mahon, Serhii Serik, Irina PARVU, Daniel Turek, Laurent Feldman, Dmitry Zateyshchikov, Mykola Bychkov, Yury Vasyuk, Camilo Felix, James Cotton, DHAYRA KAREM BARRETO, Sergey Kozhukhov, Sergio Zimmermann, Whady Hueb, AP-HP - Hôpital Bichat - Claude Bernard [Paris], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Université Paris Diderot - Paris 7 (UPD7), Biomedical Engineering and Physics, Other departments, ACS - Amsterdam Cardiovascular Sciences, Pulmonology, Graduate School, Radiology and Nuclear Medicine, and AGEM - Amsterdam Gastroenterology Endocrinology Metabolism
- Subjects
Male ,030204 cardiovascular system & hematology ,law.invention ,0302 clinical medicine ,Rivaroxaban ,Randomized controlled trial ,law ,Hemorrhage/chemically induced ,Secondary Prevention ,Atherosclerosis/complications ,030212 general & internal medicine ,Myocardial infarction ,Factor Xa Inhibitors/adverse effects ,Rivaroxaban/adverse effects ,Stroke ,risk ,Aspirin ,oral rivaroxaban ,Research Support, Non-U.S. Gov't ,Hazard ratio ,General Medicine ,Middle Aged ,trial ,Clopidogrel ,3. Good health ,Multicenter Study ,Cardiovascular Diseases ,Randomized Controlled Trial ,Platelet aggregation inhibitor ,Drug Therapy, Combination ,Female ,secondary prevention ,medicine.drug ,Platelet Aggregation Inhibitors/adverse effects ,medicine.medical_specialty ,venous thromboembolism ,Hemorrhage ,Aspirin/adverse effects ,03 medical and health sciences ,Secondary Prevention/methods ,Double-Blind Method ,Internal medicine ,Journal Article ,medicine ,Humans ,Aged ,clopidogrel ,business.industry ,ta3121 ,Atherosclerosis ,atherothrombotic events ,medicine.disease ,Surgery ,Cardiovascular Diseases/drug therapy ,business ,Platelet Aggregation Inhibitors ,[SDV.MHEP]Life Sciences [q-bio]/Human health and pathology ,Factor Xa Inhibitors - Abstract
BACKGROUND: We evaluated whether rivaroxaban alone or in combination with aspirin would be more effective than aspirin alone for secondary cardiovascular prevention.METHODS: In this double-blind trial, we randomly assigned 27,395 participants with stable atherosclerotic vascular disease to receive rivaroxaban (2.5 mg twice daily) plus aspirin (100 mg once daily), rivaroxaban (5 mg twice daily), or aspirin (100 mg once daily). The primary outcome was a composite of cardiovascular death, stroke, or myocardial infarction. The study was stopped for superiority of the rivaroxaban-plus-aspirin group after a mean follow-up of 23 months.RESULTS: The primary outcome occurred in fewer patients in the rivaroxaban-plus-aspirin group than in the aspirin-alone group (379 patients [4.1%] vs. 496 patients [5.4%]; hazard ratio, 0.76; 95% confidence interval [CI], 0.66 to 0.86; PCONCLUSIONS: Among patients with stable atherosclerotic vascular disease, those assigned to rivaroxaban (2.5 mg twice daily) plus aspirin had better cardiovascular outcomes and more major bleeding events than those assigned to aspirin alone. Rivaroxaban (5 mg twice daily) alone did not result in better cardiovascular outcomes than aspirin alone and resulted in more major bleeding events. (Funded by Bayer; COMPASS ClinicalTrials.gov number, NCT01776424 .).
- Published
- 2017
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