Rivaroxaban with or without Aspirin in Stable Cardiovascular Disease.

N Engl J Med

From the Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, ON (J.W.E., S.J.C., J.B., R.G.H., O.S., E.M.L., S.S.A., D.L., S.Y.), and Institut Universitaire de Cardiologie et de Pneumologie de Québec, Quebec, QC (G.R.D.) - both in Canada; Estudios Clínicos Latino América and Instituto Cardiovascular de Rosario, Rosario, Argentina (R.D.); Amphia Ziekenhuis and Werkgroep Cardiologische Centra Nederland (WCN), Utrecht, the Netherlands (M.A.); Cardiocenter, University Hospital Kralovske Vinohrady and Third Faculty of Medicine, Charles University, Prague, Czech Republic (P.W.); Osaka International Cancer Institute, Osaka, Japan (M.H.); Instituto Dante Pazzanese de Cardiologia (A.A.), and Hospital do Coração (L.S.P.), São Paulo; University of Washington Medical Center (K.R.H.B.) and University of Washington (J.P.), Seattle; Brigham and Women's Hospital Heart and Vascular Center, Harvard Medical School, Boston (D.L.B.); FuWai Hospital, Beijing (J.Z., Y.L.); National Association of Hospital Cardiologists Research Center (ANMCO), Florence, Italy (A.P.M.); Research Institute, Fundación Oftalmológica de Santander (FOSCAL)-Bucaramanga, Bucaramanga, Colombia (P.L.-J.); National University of Ireland, Galway (M.O.); Thrombosis Research Institute and University College London, London (A.K.K.), Centre for Cardiovascular Science, University of Edinburgh, Edinburgh (K.A.A.F.), and University of Glasgow, Glasgow (T.J.G.) - all in the United Kingdom; Collegium Medicum Jagiellonian University, Krakow, Poland (T.J.G); Institute of Cardiology, Kiev, Ukraine (A.N.P.); University of Würzburg and University Hospital, Würzburg (G.E., S.S.), and Bayer, Leverkusen (N.C.B., F.M., E.C.) - all in Germany; Semmelweis University, Budapest, Hungary (M.K.); Karolinska Institutet, Stockholm (L.R.); National Research Center for Preventative Medicine, Moscow (N.P.); University of Philippines, Manila (A.L.D.); Universidad de La Frontera, Temuco, Chile (F.L.); University of Cape Town, Cape Town, South Africa (P.J.C.); University of Aalborg, Copenhagen (C.T.-P.); University of Leuven, Leuven, Belgium (P.B.V.); University of Medicine and Pharmacology, Carol Davila University and Emergency Hospital, Bucharest, Romania (D.V.); Catholic University of Korea, Seoul, South Korea (J.-H.K.); Monash University, Melbourne, VIC, Australia (A.M.T.); Lady Davis Carmel Medical Center, Haifa, Israel (B.S.L.); Facultad de Ciencias de la Salud Eugenio Espejo-Universidad Tecnológica Equinoccial, Quito, Ecuador (C.F.); Universiti Teknologi Mara, Selangor, Malaysia (K.Y.); Université Paris Diderot, Hôpital Bichat, Assistance Publique-Hôpitaux de Paris, Paris (P.G.S.); and Turku University Central Hospital and Turku University, Turku, Finland (K.P.M.).

Published: October 2017

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. (Funded by Bayer; COMPASS ClinicalTrials.gov number, NCT01776424 .).

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