- Question
- Does direct oral anticoagulant therapy benefit patients with atrial fibrillation at intermediate stroke risk compared with no anticoagulation?
- Design
- Multicenter, open-label, adjudicator-masked, superiority trial conducted in South Korea; 1803 patients randomized 1:1. The main follow-up was 24 months.
- Population
- Patients with atrial fibrillation and intermediate stroke risk, defined by a CHA2DS2-VASc score of 1 in men and 2 in women. Mean age was 60.4 years and 23.7% were women.
- Intervention
- A direct oral anticoagulant (apixaban or rivaroxaban, with dose reduction when criteria were met) for 2 years.
- Control
- Standard treatment without anticoagulation.
- Primary outcome
- Composite of stroke, systemic embolism, major bleeding, or death from cardiovascular causes at 24 months.
- Results
- A primary end-point event occurred in 4 patients (cumulative incidence 0.5%) in the anticoagulant group and in 13 (1.5%) in the no-anticoagulant group (difference -1.0 percentage points; 95% CI -2.0 to -0.1; P = 0.03; HR 0.31; 95% CI 0.10 to 0.94). Stroke occurred in 3 patients (0.3%) with anticoagulation and in 10 (1.1%) without.
- Safety
- Systemic embolism and major bleeding appeared similar between groups, and no cardiovascular deaths occurred in either group. Serious adverse events occurred in 80 patients (8.9%) with anticoagulation and in 84 (9.3%) without.
- Conclusion
- Among patients with atrial fibrillation at intermediate stroke risk, DOAC therapy lowered the risk of the composite of stroke, systemic embolism, major bleeding, or cardiovascular death at 24 months compared with no anticoagulation.
- Why it matters
- It provides randomized evidence for an anticoagulation indication that previously rested on weaker support, in an intermediate-risk group where the treatment decision was uncertain.
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