People with atrial fibrillation at intermediate risk of stroke benefit from oral anticoagulants, clinical trial finds

by European Society of Cardiology

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Oral anticoagulant therapy lowered the risk of adverse clinical events compared with no anticoagulation in patients with atrial fibrillation at intermediate stroke risk, according to results from the SINGLE-AF trial presented in a Hot Line session at ESC Congress 2026 and published simultaneously in the New England Journal of Medicine.

Patients with atrial fibrillation (AF) are at increased risk of stroke. ESC Guidelines recommend oral anticoagulants for patients with AF at high risk of stroke with a Class I recommendation. The guidelines also suggest that oral anticoagulants should be considered in patients at intermediate risk, with a Class IIa recommendation.

Principal investigator of the SINGLE-AF trial Boyoung Joung from Yonsei University, Seoul, South Korea, said, "Evidence from observational studies with anticoagulants, particularly vitamin K antagonists, remains conflicting in those at intermediate risk. SINGLE-AF was conducted to provide the first evidence from a randomized trial on whether newer direct oral anticoagulants (DOACs) are beneficial in patients with AF at intermediate risk of stroke."

SINGLE-AF was an open-label trial conducted at 18 centers in South Korea. A total of 1,803 individuals with AF and an intermediate risk of stroke (defined as a CHA2DS2-VASc score of 1 in men or 2 in women) were randomized (1:1) to receive DOAC therapy (apixaban 5 mg twice daily or rivaroxaban 20 mg once daily) or no anticoagulation.

At 24 months, a 69% reduction in the primary endpoint—a composite of stroke, systemic embolism, major bleeding or cardiovascular death—was observed with DOACs vs. no anticoagulation (0.5% and 1.5%, respectively; P = 0.028; hazard ratio 0.31; 95% confidence interval 0.10 to 0.94).

The difference between the groups appeared to be driven by a lower incidence of ischemic stroke with DOAC therapy (0.1%) vs. no anticoagulant therapy (1.1%). There was no difference in major bleeding with DOAC therapy (0.3%) and without (0.5%).

Joung concluded, "We now have evidence from a randomized trial that patients with AF at intermediate stroke risk benefit from DOAC therapy, without an increase in major bleeding. Data from the SINGLE-AF trial may be used to inform future guideline recommendations and reimbursement policies."

Publication details

Daehoon Kim et al, Anticoagulation for Atrial Fibrillation with Intermediate Stroke Risk, New England Journal of Medicine (2026). DOI: 10.1056/nejmoa2607978

Journal information: New England Journal of Medicine

Key medical concepts

Ischemic Stroke

Clinical categories

CardiologyClinical pharmacology Provided by European Society of Cardiology Who's behind this story?

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Citation: People with atrial fibrillation at intermediate risk of stroke benefit from oral anticoagulants, clinical trial finds (2026, August 28) retrieved 31 August 2026 from https://medicalxpress.com/news/2026-08-people-atrial-fibrillation-intermediate-benefit.html This document is subject to copyright. Apart from any fair dealing for the purpose of private study or research, no part may be reproduced without the written permission. The content is provided for information purposes only.