SINGLE-AF: DOACs Cut AF Events 69% With No Bleeding Risk — SkimNews
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- The SINGLE-AF trial found that direct oral anticoagulants cut serious clinical events by 69% versus no anticoagulation in 1,803 atrial fibrillation patients at intermediate stroke risk across 18 South Korean centers.
- Serious events occurred in 0.5% of patients on DOACs versus 1.5% on no anticoagulation (hazard ratio 0.31; 95% CI 0.10–0.94, p=0.028), driven mainly by fewer ischemic strokes (0.1% vs 1.1%).
- Major bleeding did not increase with DOAC therapy, occurring in 0.3% of treated patients versus 0.5% in the control group.
- Participants were randomized to apixaban 5 mg twice daily or rivaroxaban 20 mg once daily, with a primary endpoint combining stroke, systemic embolism, major bleeding, and cardiovascular death over 24 months.
- Principal investigator Boyoung Joung of Yonsei University said the results provide the first randomized evidence for DOACs in intermediate-risk AF and may inform future ESC guideline recommendations.
- The findings were presented at ESC Congress 2026 and published simultaneously in the New England Journal of Medicine, filling a gap where prior observational data on anticoagulants in this risk tier had been conflicting.
Why it matters: Roughly 1.5% of intermediate-risk AF patients experienced serious events without anticoagulation versus 0.5% on DOACs — a 69% relative reduction with no bleeding penalty. ESC guidelines currently list anticoagulation as merely 'to be considered' in this gray-zone population, meaning this randomized evidence could shift guideline language from weak to strong and reshape reimbursement decisions for millions of AF patients worldwide.
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