- Question
- Does a rivaroxaban-based antithrombotic strategy, compared with an antiplatelet-based one, better prevent death and thromboembolic events after successful transcatheter aortic-valve replacement (TAVR) in patients without an established indication for oral anticoagulation?
- Design
- International multicenter, randomized, open-label (unmasked), active-controlled, event-driven trial with 1644 patients. Median follow-up was 17 months, and the data and safety monitoring board terminated the trial prematurely because of safety concerns.
- Population
- Patients who had undergone successful TAVR and had no established indication for oral anticoagulation.
- Intervention
- Rivaroxaban 10 mg daily, plus aspirin 75 to 100 mg daily for the first 3 months.
- Control
- Aspirin 75 to 100 mg daily plus clopidogrel 75 mg daily for the first 3 months (antiplatelet group).
- Primary outcome
- Primary efficacy outcome: composite of death or thromboembolic events. Primary safety outcome: major, disabling, or life-threatening bleeding.
- Results
- Death or a first thromboembolic event occurred in 105 patients with rivaroxaban and 78 with antiplatelet therapy (9.8 vs 7.2 per 100 person-years; HR 1.35; 95% CI 1.01 to 1.81; P = 0.04). There were 64 deaths in the rivaroxaban group and 38 in the antiplatelet group (HR 1.69; 95% CI 1.13 to 2.53).
- Safety
- Major, disabling, or life-threatening bleeding occurred in 46 patients with rivaroxaban and 31 with antiplatelet therapy (4.3 vs 2.8 per 100 person-years; HR 1.50; 95% CI 0.95 to 2.37; P = 0.08).
- Conclusion
- In patients without an indication for oral anticoagulation after successful TAVR, the rivaroxaban-based strategy was associated with a higher risk of death or thromboembolic complications and a higher risk of bleeding than the antiplatelet-based strategy.
- Why it matters
- The trial discouraged routine rivaroxaban anticoagulation after TAVR when there is no other indication to anticoagulate, and reinforced the role of antiplatelet therapy in this setting.
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