SINGLE-AF Trial Finds DOACs Benefit AF Patients With Intermediate Stroke Risk
Blood-thinning medicines may reduce serious complications in people with atrial fibrillation who have an intermediate risk of stroke, according to the randomised SINGLE-AF trial, published simultaneously in the New England Journal of Medicine.
The study included 1,803 people with atrial fibrillation and an intermediate stroke risk based on the CHA₂DS₂-VASc score. Participants were randomly assigned to receive a direct oral anticoagulant (DOAC) or no routine anticoagulation.
After 24 months, 0.5% of patients taking a DOAC experienced stroke, systemic embolism, major bleeding, or cardiovascular death, compared with 1.5% of those not routinely receiving anticoagulation. This represented a 69% lower relative risk for the combined outcome.
Stroke occurred less often in the DOAC group, with three cases compared with 10 among patients who did not receive routine anticoagulation. However, the individual differences were not statistically significant, partly because the overall number of events was very small.
The trial was conducted across 18 centres in South Korea. Most participants had paroxysmal atrial fibrillation, and the average age was about 60 years.
Serious adverse events occurred at similar rates in both groups, affecting 8.9% of DOAC-treated patients and 9.3% of those in the control group. There were no myocardial infarctions or cardiovascular deaths during the study.
Researchers said the findings provide the first randomised evidence suggesting that DOAC treatment could benefit some patients with intermediate stroke risk.
Experts also cautioned that taking a blood thinner long term carries costs, bleeding concerns and lifestyle considerations. The results may not apply to all populations, particularly because the trial was conducted only in South Korea and excluded people with chronic kidney disease.
Overall, the findings support a more informed discussion between patients and doctors about anticoagulation. Larger international studies are needed to confirm whether routine DOAC therapy should be recommended for this intermediate-risk group.
REFERENCE: Paulus Kirchhof; Anticoagulation for Atrial Fibrillation with a Single Risk Factor for Stroke; New England Journal of Medicine; 2026; DOI: 10.1056/NEJMe2610344
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