- Question
- Is apixaban, an oral direct factor Xa inhibitor, at least as effective as warfarin for preventing stroke and systemic embolism in atrial fibrillation, and what is its bleeding profile?
- Design
- Randomized, double-blind, noninferiority trial in 18201 patients with a median follow-up of 1.8 years. Key secondary objectives were superiority for the primary outcome, major bleeding and death from any cause.
- Population
- Patients with atrial fibrillation and at least one additional risk factor for stroke.
- Intervention
- Apixaban 5 mg twice daily.
- Control
- Warfarin with a target INR of 2.0 to 3.0.
- Primary outcome
- Ischemic or hemorrhagic stroke, or systemic embolism.
- Results
- The primary outcome occurred at 1.27% per year with apixaban versus 1.60% per year with warfarin (HR 0.79; 95% CI 0.66 to 0.95; P<0.001 for noninferiority; P=0.01 for superiority). Death from any cause was 3.52% versus 3.94% (HR 0.89; 95% CI 0.80 to 0.99; P=0.047).
- Safety
- Major bleeding was 2.13% per year with apixaban versus 3.09% with warfarin (HR 0.69; 95% CI 0.60 to 0.80; P<0.001). Hemorrhagic stroke was 0.24% versus 0.47% per year (HR 0.51; 95% CI 0.35 to 0.75; P<0.001).
- Conclusion
- In atrial fibrillation, apixaban was superior to warfarin in preventing stroke or systemic embolism, caused less bleeding and was associated with lower mortality.
- Why it matters
- It showed that a direct oral anticoagulant could improve efficacy, safety and survival at the same time compared with the standard vitamin K antagonist, supporting its use as an alternative to warfarin in atrial fibrillation.
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 7, 2026