- Question
- Is edoxaban noninferior to vitamin K antagonists in patients with atrial fibrillation after successful transcatheter aortic-valve replacement (TAVR)?
- Design
- Multicenter, prospective, randomized, open-label, adjudicator-masked trial enrolling 1426 patients (713 per group). A hierarchical plan tested efficacy and then safety for noninferiority, with a margin of 1.38 for the upper boundary of the 95% CI.
- Population
- Patients with atrial fibrillation (almost all prevalent before TAVR) requiring oral anticoagulation after successful TAVR. Mean age was 82.1 years and 47.5% were women.
- Intervention
- Edoxaban-based regimen given once daily, at 60 mg or 30 mg according to the local label.
- Control
- Vitamin K antagonist-based regimen, with dose adjusted to maintain the target range.
- Primary outcome
- Efficacy: composite of death from any cause, myocardial infarction, ischemic stroke, systemic thromboembolism, valve thrombosis, or major bleeding. Safety: major bleeding.
- Results
- The composite efficacy outcome occurred at 17.3 per 100 person-years with edoxaban and 16.5 with vitamin K antagonists (HR 1.05; 95% CI 0.85 to 1.31; P = 0.01 for noninferiority). Death from any cause or stroke: 10.0 vs 11.7 per 100 person-years (HR 0.85; 95% CI 0.66 to 1.11).
- Safety
- Major bleeding was 9.7 per 100 person-years with edoxaban and 7.0 with vitamin K antagonists (HR 1.40; 95% CI 1.03 to 1.91; P = 0.93 for noninferiority), mainly driven by more gastrointestinal bleeding with edoxaban.
- Conclusion
- Edoxaban was noninferior to vitamin K antagonists for the composite of adverse clinical events, but with a higher incidence of major bleeding.
- Why it matters
- It provided randomized evidence on the use of a direct oral anticoagulant in patients with atrial fibrillation after TAVR, showing a trade-off between comparable efficacy and greater bleeding risk.
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