Logo image
Back
Rivaroxaban with or without Aspirin in Stable Cardiovascular Disease
Journal article   Open access   Peer reviewed

Rivaroxaban with or without Aspirin in Stable Cardiovascular Disease

John W Eikelboom, Stuart J Connolly, Jackie Bosch, Gilles R Dagenais, Robert G Hart, Olga Shestakovska, Rafael Diaz, Marco Alings, Eva M Lonn, Sonia S Anand, …
The New England journal of medicine, Vol.377(14), pp.1319-1330
10/05/2017
DOI: 10.1056/NEJMoa1709118
PMID: 28844192
url
https://doi.org/10.1056/NEJMoa1709118View
Published (Version of record) Open Access

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 .).
 Aged Aspirin - adverse effects Aspirin - therapeutic use Atherosclerosis - complications Atherosclerosis - drug therapy Cardiovascular Diseases - drug therapy Cardiovascular Diseases - mortality Cardiovascular Diseases - prevention & control Double-Blind Method Drug Therapy, Combination Factor Xa Inhibitors - adverse effects Factor Xa Inhibitors - therapeutic use Female Hemorrhage - chemically induced Humans Male Middle Aged Platelet Aggregation Inhibitors - adverse effects Platelet Aggregation Inhibitors - therapeutic use Rivaroxaban - adverse effects Rivaroxaban - therapeutic use Secondary Prevention - methods

Details

Metrics

10 Record Views
1951 Times Cited - Web of Science
Logo image