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; 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. CONCLUSIONS: 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.
| Original language | English |
|---|---|
| Pages (from-to) | 1319-1330 |
| Number of pages | 12 |
| Journal | New England Journal of Medicine |
| Volume | 377 |
| Issue number | 14 |
| DOIs | |
| Publication status | Published - 5 Oct 2017 |
Authors (Note for portal: view the doc link for the full list of authors)
- Authors
- Eikelboom, J.W. and Connolly, S.J. and Bosch, J. and Dagenais, G.R. and Hart, R.G. and Shestakovska, O. and Diaz, R. and Alings, M. and Lonn, E.M. and Anand, S.S. and Widimsky, P. and Hori, M. and Avezum, A. and Piegas, L.S. and Branch, K.R.H. and Probstfield, J. and Bhatt, D.L. and Zhu, J. and Liang, Y. and Maggioni, A.P. and Lopez-Jaramillo, P. and OâDonnell, M. and Kakkar, A.K. and Fox, K.A.A. and Parkhomenko, A.N. and Ertl, G. and Störk, S. and Keltai, M. and Ryden, L. and Pogosova, N. and Dans, A.L. and Lanas, F. and Commerford, P.J. and Torp-Pedersen, C. and Guzik, T.J. and Verhamme, P.B. and Vinereanu, D. and Kim, J.-H. and Tonkin, A.M. and Lewis, B.S. and Felix, C. and Yusoff, K. and Steg, P.G. and Metsarinne, K.P. and Bruns, N.C. and Misselwitz, F. and Chen, E. and Leong, D. an
