DOACs Cut AF Events 69% in Intermediate-Risk Patients — SkimNews
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- SINGLE-AF trial investigators reported a 69% reduction in serious cardiovascular events when intermediate-risk atrial fibrillation patients received direct oral anticoagulants (DOACs) instead of no anticoagulation, presenting the findings at ESC Congress 2026 and publishing simultaneously in the New England Journal of Medicine.
- Professor Boyoung Joung of Yonsei University in Seoul served as principal investigator of the open-label, 18-center South Korean trial, which randomized 1,803 AF patients with a CHA2DS2-VASc score of 1 (men) or 2 (women) to apixaban 5 mg twice daily, rivaroxaban 20 mg once daily, or no anticoagulation.
- After 24 months, serious events — the composite of stroke, systemic embolism, major bleeding, and cardiovascular death — occurred in 0.5% of DOAC patients versus 1.5% of untreated patients (hazard ratio 0.31; 95% CI 0.10–0.94; p=0.028), with the gap driven largely by fewer ischemic strokes (0.1% vs 1.1%).
- Major bleeding occurred in 0.3% of DOAC recipients versus 0.5% of controls, blunting the safety concern that had made clinicians hesitant to anticoagulate intermediate-risk AF patients.
- Current ESC Guidelines list anticoagulation for intermediate-risk AF only as something that "should be considered" — weaker than the strong recommendation for high-risk patients — because earlier vitamin K antagonist data produced conflicting observational results in this group.
- Joung said the SINGLE-AF data may be used to inform future guideline recommendations and reimbursement policies, marking the first randomized evidence specifically targeting the anticoagulation gray zone in AF care.
Why it matters: Intermediate-risk AF patients — the group for whom ESC guidelines currently only 'should consider' anticoagulation — now have the first randomized evidence supporting DOAC therapy: 69% fewer serious events with no bleeding penalty. ESC guideline committees reviewing SINGLE-AF data may upgrade the recommendation, reshaping reimbursement and standard-of-care access for this AF population.
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