- Question
- In patients with atrial fibrillation and stable coronary artery disease, is rivaroxaban monotherapy noninferior in efficacy and safer than rivaroxaban combined with an antiplatelet agent?
- Design
- Multicenter, open-label, randomized trial conducted in Japan enrolling 2236 patients. It was stopped early because of increased mortality in the combination-therapy group.
- Population
- Patients with atrial fibrillation who had undergone percutaneous coronary intervention or coronary-artery bypass grafting more than 1 year earlier, or who had angiographically confirmed coronary artery disease not requiring revascularization.
- Intervention
- Rivaroxaban monotherapy, a non-vitamin K antagonist oral anticoagulant.
- Control
- Combination therapy with rivaroxaban plus a single antiplatelet agent.
- Primary outcome
- Efficacy: composite of stroke, systemic embolism, myocardial infarction, unstable angina requiring revascularization, or death from any cause, analyzed for noninferiority (margin 1.46). Safety: major bleeding by ISTH criteria, analyzed for superiority.
- Results
- Monotherapy was noninferior for the efficacy end point, with rates of 4.14% vs 5.75% per patient-year (HR 0.72; 95% CI 0.55 to 0.95; P<0.001 for noninferiority). Major bleeding was lower with monotherapy: 1.62% vs 2.76% per patient-year (HR 0.59; 95% CI 0.39 to 0.89; P = 0.01 for superiority).
- Safety
- Major bleeding was significantly less frequent with monotherapy than with combination therapy.
- Conclusion
- In patients with atrial fibrillation and stable coronary artery disease, rivaroxaban monotherapy was noninferior for efficacy and superior for safety compared with combination therapy.
- Why it matters
- It supported using an anticoagulant alone, without an added antiplatelet agent, in patients with atrial fibrillation and stable coronary artery disease, lowering bleeding risk without loss of efficacy.
Card generated automatically with AI from the abstract of the original publication and the trial registry; every figure was checked against those sources. It may contain errors: verify the data at the source before using it for clinical decisions.
Generated on October 14, 2026