SINGLE-AF trial: DOACs cut serious events 69% in intermediate-risk AF patients

September 27, 2026 at 06:56 PM2 min

This digest was compiled by AI from multiple sources — links to the originals are below.

The SINGLE-AF trial found that direct oral anticoagulants reduced serious cardiovascular events by 69% in atrial fibrillation patients at intermediate stroke risk. The 1,803-patient randomized trial, presented at ESC Congress 2026, compared apixaban or rivaroxaban against no anticoagulation. Major bleeding was not increased, with rates of 0.3% versus 0.5%.

Key Facts

The SINGLE-AF trial enrolled 1,803 patients with atrial fibrillation and intermediate stroke risk across 18 medical centers in South Korea.
The primary endpoint—a composite of stroke, systemic embolism, major bleeding, and cardiovascular death—occurred in 0.5% of patients on DOACs versus 1.5% on no anticoagulation (hazard ratio 0.31, p=0.028).
Ischemic stroke occurred in 0.1% of patients taking DOACs compared with 1.1% of those receiving no anticoagulation.
Major bleeding rates were 0.3% in the DOAC group and 0.5% in the no-anticoagulation group.
The trial was presented during a Hot Line session at ESC Congress 2026 and published simultaneously in the New England Journal of Medicine.

Trial Design

SINGLE-AF was an open-label randomized trial conducted at 18 medical centers in South Korea. Researchers enrolled 1,803 people with atrial fibrillation and an intermediate risk of stroke, defined as a CHA2DS2-VASc score of 1 in men or 2 in women. Participants were randomized 1:1 to receive either direct oral anticoagulants—apixaban 5 mg twice daily or rivaroxaban 20 mg once daily—or no anticoagulation. The trial was led by Professor Boyoung Joung from Yonsei University in Seoul, South Korea.

Efficacy and Safety Results

After 24 months, the primary endpoint occurred in 0.5% of patients receiving DOACs compared with 1.5% of those receiving no anticoagulation, a 69% relative reduction. The difference was driven largely by fewer ischemic strokes: 0.1% in the DOAC group versus 1.1% in the no-anticoagulation group. Major bleeding did not increase, with rates of 0.3% in the DOAC group and 0.5% in the no-anticoagulation group. The hazard ratio for the primary endpoint was 0.31 with a 95% confidence interval of 0.10 to 0.94 and p=0.028.

Clinical Context

ESC Guidelines strongly recommend oral anticoagulants for atrial fibrillation patients at high stroke risk, but the recommendation is less definitive for intermediate-risk patients. Earlier observational research with vitamin K antagonists produced mixed results in this intermediate-risk group. Professor Joung stated that SINGLE-AF provides the first randomized evidence on whether newer direct oral anticoagulants benefit patients with atrial fibrillation at intermediate stroke risk.