- Question
- Is rivaroxaban noninferior to vitamin K antagonists for preventing cardiovascular events in patients with rheumatic heart disease-associated atrial fibrillation?
- Design
- Phase 3, randomized, open-label (unmasked) noninferiority trial that enrolled 4565 patients; 4531 were included in the final analysis. Follow-up was approximately 4 years according to the registry.
- Population
- Patients with atrial fibrillation and echocardiographically documented rheumatic heart disease who had at least one of: CHA2DS2VASc score ≥ 2, mitral-valve area ≤ 2 cm2, left atrial spontaneous echo contrast, or left atrial thrombus. Mean age was 50.5 years and 72.3% were women.
- Intervention
- Standard-dose rivaroxaban: 20 mg once daily, or 15 mg once daily if creatinine clearance was 15-49 ml/min.
- Control
- Dose-adjusted vitamin K antagonist titrated to an INR of 2.0-3.0.
- Primary outcome
- Composite of stroke, systemic embolism, myocardial infarction, or death from vascular (cardiac or noncardiac) or unknown causes. The primary safety outcome was ISTH major bleeding.
- Results
- A primary-outcome event occurred in 560 patients with rivaroxaban and 446 with vitamin K antagonist; survival curves were nonproportional. Restricted mean survival time was 1599 days with rivaroxaban and 1675 days with the vitamin K antagonist (difference -76 days; 95% CI -121 to -31; P<0.001). Death was more frequent with rivaroxaban (1608 vs. 1680 days; difference -72 days; 95% CI -117 to -28).
- Safety
- There was no significant between-group difference in major bleeding. Permanent discontinuation of trial medication was more common with rivaroxaban at all visits.
- Conclusion
- In rheumatic heart disease-associated atrial fibrillation, vitamin K antagonist therapy led to a lower rate of the composite of cardiovascular events or death than rivaroxaban, without more bleeding.
- Why it matters
- It showed that in this population the direct oral anticoagulant was not an equivalent alternative and reinforced vitamin K antagonists as the treatment of choice.
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 18, 2026