Journal article
Rivaroxaban with or without Aspirin in Stable Cardiovascular Disease
The New England journal of medicine, Vol.377(14), pp.1319-1330
10/05/2017
DOI: 10.1056/NEJMoa1709118
PMID: 28844192
Abstract
We evaluated whether rivaroxaban alone or in combination with aspirin would be more effective than aspirin alone for secondary cardiovascular prevention.
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.
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; P<0.001; z=-4.126), but major bleeding events occurred in more patients in the rivaroxaban-plus-aspirin group (288 patients [3.1%] vs. 170 patients [1.9%]; hazard ratio, 1.70; 95% CI, 1.40 to 2.05; P<0.001). There was no significant difference in intracranial or fatal bleeding between these two groups. There were 313 deaths (3.4%) in the rivaroxaban-plus-aspirin group as compared with 378 (4.1%) in the aspirin-alone group (hazard ratio, 0.82; 95% CI, 0.71 to 0.96; P=0.01; threshold P value for significance, 0.0025). The primary outcome did not occur in significantly fewer patients in the rivaroxaban-alone group than in the aspirin-alone group, but major bleeding events occurred in more patients in the rivaroxaban-alone group.
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 .).
Details
- Title: Subtitle
- Rivaroxaban with or without Aspirin in Stable Cardiovascular Disease
- Creators
- John W Eikelboom - Population Health Research InstituteStuart J Connolly - McMaster UniversityJackie Bosch - Population Health Research InstituteGilles R Dagenais - Institut Universitaire de Cardiologie et de Pneumologie de QuébecRobert G Hart - Population Health Research InstituteOlga Shestakovska - Population Health Research InstituteRafael DiazMarco AlingsEva M Lonn - Population Health Research InstituteSonia S Anand - Population Health Research InstitutePetr Widimsky - Charles UniversityMasatsugu Hori - Osaka International Cancer InstituteAlvaro Avezum - Instituto Dante Pazzanese de CardiologiaLeopoldo S Piegas - Hospital do CoraçãoKelley R H Branch - University of Washington Medical CenterJeffrey Probstfield - Seattle UniversityDeepak L Bhatt - Brigham and Women's HospitalJun Zhu - Fu Wai HospitalYan Liang - Fu Wai HospitalAldo P MaggioniPatricio Lopez-JaramilloMartin O'DonnellAjay K Kakkar - University College LondonKeith A A Fox - University of EdinburghAlexander N ParkhomenkoGeorg Ertl - Universitätsklinikum WürzburgStefan Störk - University of WürzburgMatyas Keltai - Semmelweis UniversityLars Ryden - Karolinska InstitutetNana Pogosova - National Research Center for Preventive MedicineAntonio L Dans - University of the Philippines ManilaFernando Lanas - Universidad de La FronteraPatrick J Commerford - University of Cape TownChristian Torp-PedersenTomek J GuzikPeter B Verhamme - KU LeuvenDragos Vinereanu - Carol Davila University of Medicine and PharmacyJae-Hyung KimAndrew M Tonkin - Monash UniversityBasil S Lewis - Carmel Medical CenterCamilo Felix - Universidad UTEKhalid Yusoff - Universiti Teknologi MARAP Gabriel Steg - Délégation Paris 7Kaj P Metsarinne - Turku University HospitalNancy Cook BrunsFrank Misselwitz - BayerEdmond Chen - BayerDarryl Leong - Population Health Research InstituteSalim Yusuf - Population Health Research InstituteCardiovascular Outcomes for People Using Anticoagulation Strategies (COMPASS) InvestigatorsTomas Kovarnik (Contributor) - Electrical and Computer Engineering
- Resource Type
- Journal article
- Publication Details
- The New England journal of medicine, Vol.377(14), pp.1319-1330
- DOI
- 10.1056/NEJMoa1709118
- PMID
- 28844192
- ISSN
- 0028-4793
- eISSN
- 1533-4406
- Language
- English
- Date published
- 10/05/2017
- Academic Unit
- Electrical and Computer Engineering
- Record Identifier
- 9984627297302771
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