- Question
- In patients with atrial fibrillation who have undergone successful percutaneous coronary intervention (PCI), is an edoxaban-based antithrombotic regimen safe in terms of bleeding compared with a vitamin K antagonist (VKA)-based regimen?
- Design
- Phase 3b, randomized 1:1, multicenter, open-label, non-inferiority trial with masked outcome evaluation, conducted at 186 sites in 18 countries; 1506 patients were randomized from 4 hours to 5 days after PCI and followed for 12 months.
- Population
- Adults (aged at least 18 years) with atrial fibrillation requiring oral anticoagulation and a successful PCI for stable coronary artery disease or acute coronary syndrome.
- Intervention
- Edoxaban 60 mg once daily (30 mg if creatinine clearance was 15-50 mL/min, body weight ≤60 kg, or use of potent P-glycoprotein inhibitors) plus a P2Y12 inhibitor for 12 months.
- Control
- A VKA combined with a P2Y12 inhibitor and aspirin 100 mg once daily for 1 to 12 months.
- Primary outcome
- Composite of major or clinically relevant non-major (CRNM) bleeding within 12 months.
- Results
- Major or CRNM bleeding occurred in 128 of 751 patients (17%; annualised rate 20.7%) with edoxaban and 152 of 755 (20%; annualised rate 25.6%) with VKA; HR 0.83 (95% CI 0.65-1.05; p=0.0010 for non-inferiority, HR margin 1.20; p=0.1154 for superiority).
- Conclusion
- The edoxaban-based regimen was non-inferior to the VKA-based regimen for bleeding, with no significant differences in ischaemic events.
- Why it matters
- It provided evidence that a direct oral anticoagulant combined with a P2Y12 inhibitor, without routine aspirin, is a valid alternative to a VKA-based regimen in patients with atrial fibrillation after PCI.
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