News: Trial shows win for direct oral anticoagulant therapy in lower-risk Afib
Emerging data favored oral anticoagulation for lower-risk patients with atrial fibrillation (Afib), researchers found. Direct oral anticoagulant (DOAC) therapy reduced the risk of composite cardiovascular events at 24 months compared with no anticoagulation, among patients with Afib and one thromboembolic risk factor in the SINGLE-AF trial.
SINGLE-AF was a multicenter open-label trial conducted in South Korea from 2020 to 2023. Eligible participants were Afib patients with a CHA2DS2-VASc score of 1 for men and 2 for women.
DOACs are the established first-line therapy for people with Afib with two or more risk factors for stroke. The evidence was consistent regarding their prevention of stroke or systemic embolism. Given an accompanying higher risk of gastrointestinal bleeding, however, their use is limited in lower-risk patients for fear of tipping the scale to more harm than benefit.
SINGLE-AF is the first randomized trial to support a clinical benefit to DOAC therapy in these patients, the researchers found. The study, however, logged very few primary endpoint events, with an annual stroke incidence of just 0.6% without anticoagulation and 0.15% with DOACs. Therefore, the results may overestimate the true magnitude of benefit from DOACs in the intermediate-risk setting, the authors concluded.
"Given the lower-than-expected number of end-point events, the precision of the estimated treatment effect is limited, and these findings should be interpreted with caution," researchers wrote.
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