- Question
- In patients with atrial fibrillation who had an acute coronary syndrome or underwent PCI and are taking a P2Y12 inhibitor, which antithrombotic regimen is best in terms of bleeding: apixaban versus a vitamin K antagonist, and aspirin versus placebo?
- Design
- International randomized trial with a 2 x 2 factorial design enrolling 4614 patients from 33 countries. The anticoagulant comparison was open-label, while aspirin was compared with a matching placebo for 6 months.
- Population
- Patients with atrial fibrillation who had an acute coronary syndrome or had undergone percutaneous coronary intervention and planned to take a P2Y12 inhibitor.
- Intervention
- Apixaban (5 mg or 2.5 mg twice daily per the registry) and, in the second randomization, aspirin 81 mg once daily.
- Control
- A vitamin K antagonist in the first randomization and matching placebo for aspirin in the second.
- Primary outcome
- Major or clinically relevant nonmajor bleeding, assessed separately for apixaban versus vitamin K antagonist and for aspirin versus placebo.
- Results
- Major or clinically relevant nonmajor bleeding occurred in 10.5% with apixaban versus 14.7% with a vitamin K antagonist (HR 0.69; 95% CI 0.58 to 0.81; P<0.001 for both noninferiority and superiority), and in 16.1% with aspirin versus 9.0% with placebo (HR 1.89; 95% CI 1.59 to 2.24; P<0.001). Death or hospitalization was lower with apixaban (23.5% vs. 27.4%; HR 0.83; 95% CI 0.74 to 0.93; P = 0.002).
- Safety
- Aspirin significantly increased bleeding compared with placebo, with no difference in death or hospitalization or in ischemic events. Ischemic events with apixaban were similar to those with the vitamin K antagonist.
- Conclusion
- In these patients, an apixaban-based regimen without aspirin led to less bleeding and fewer hospitalizations, without significant differences in ischemic events, compared with regimens including a vitamin K antagonist, aspirin, or both.
- Why it matters
- It supported using a direct oral anticoagulant plus a P2Y12 inhibitor while omitting aspirin as a strategy to reduce bleeding in this common clinical scenario.
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