Safer stroke prevention strategies are needed for patients with atrial fibrillation after intracranial hemorrhage

by European Society of Cardiology

edited by Sadie Harley, reviewed by Andrew Zinin

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Edoxaban did not reduce stroke or systemic embolism but increased major bleeding in high-risk patients with atrial fibrillation who had had an intracranial hemorrhage, according to results presented in a Hot Line session at ESC Congress 2026.

Atrial fibrillation (AF) is the most common form of irregular heart rhythm and a leading cause of ischemic stroke, where a blood clot cuts off the blood supply to part of the brain.

Oral anticoagulants such as edoxaban are highly effective at preventing ischemic stroke in patients with AF, but they come with concerns over bleeding risk. These concerns are amplified in patients with AF who have had a prior intracranial hemorrhage, which includes bleeding within or around the brain.

"The ideal strategy to prevent ischemic stroke is uncertain in patients with AF and a prior intracranial hemorrhage, as these patients have been excluded from the large landmark trials assessing oral anticoagulants," noted Professor Ashkan Shoamanesh from McMaster University, Hamilton, Canada, the principal investigator of the ENRICH-AF trial.

"This leaves us with a challenging clinical dilemma that is becoming more frequent with our aging population. Data from small studies indicate that oral anticoagulation may result in net overall benefit among survivors of intracranial hemorrhage with AF. We conducted the large ENRICH-AF trial to evaluate the efficacy and safety of oral anticoagulants further in these patients," he explained.

This was an investigator-initiated, open-label, blinded-endpoint, event-driven trial conducted across 174 sites in 20 countries. Patients with high-risk AF and prior intracranial hemorrhage were enrolled. Following Data and Safety Monitoring Board review in 2023, no further patients with lobar intraparenchymal hemorrhage or convexity subarachnoid hemorrhage were included because of safety concerns.

Eligible participants were randomized (1:1) to edoxaban 60 mg once daily (with dose adjustments to 30 mg daily according to the label) or no anticoagulation (no antithrombotic therapy or single antiplatelet therapy, as determined by the clinician). The study population included 948 patients who had a mean age of 77 years, and 39% were women.

Over an average of 28 months of follow-up, edoxaban did not significantly reduce the primary endpoint of stroke (including ischemic and hemorrhagic stroke) or systemic embolism compared with no anticoagulation (11.8% versus 12.8%; hazard ratio [HR] 0.88; 95% confidence interval [CI] 0.61 to 1.26; p = 0.48).

Ischemic stroke and myocardial infarction were significantly reduced with edoxaban versus no anticoagulation; however, this benefit was offset by an almost threefold excess in hemorrhagic stroke.

The primary safety outcome of the International Society on Thrombosis and Hemostasis major bleeding occurred in 11.6% of patients with edoxaban and 5.2% with no anticoagulation (HR 2.23; 95% CI 1.39 to 3.59; p<0.001).

"Our findings do not support the use of edoxaban in unselected patients with AF after intracranial hemorrhage but highlight the need for an individualized decision-making approach," commented Shoamanesh.

"Ongoing trials, including the double-blind, randomized ASPIRE trial comparing apixaban versus aspirin, will add to the evidence base. Additionally, a prospective, individual participant data meta-analysis of all trials (COCROACH) will ultimately provide useful additional insights on how best to individualize optimal stroke prevention in this very vulnerable patient population," he concluded.

Key medical concepts

Atrial FibrillationIntracranial Hemorrhagesedoxaban

Clinical categories

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

Sadie Harley

BSc Life Sciences & Ecology. Microbiology lab background with pharmaceutical news experience in oil, gas, and renewable industries. Full profile →

Andrew Zinin

Master's in physics with research experience. Long-time science news enthusiast. Plays key role in Science X's editorial success. Full profile →

Citation: Safer stroke prevention strategies are needed for patients with atrial fibrillation after intracranial hemorrhage (2026, August 31) retrieved 31 August 2026 from https://medicalxpress.com/news/2026-08-safer-strategies-patients-atrial-fibrillation.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.