Original Investigation

Major Bleeding With Apixaban vs Aspirin

JAMA Cardiology 10.1001/jamacardio.2025.4151

November 12, 2025 at 11:00 AM EST

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In patients with subclinical atrial fibrillation (SCAF) treated with apixaban or aspirin, what are the sites, severity, and factors associated with major bleeding?In this subanalysis of the Apixaban for the Reduction of Thromboembolism in Patients With Device-Detected Subclinical Atrial Fibrillation (ARTESiA) randomized clinical trial including 3961 patients, although the rate of major gastrointestinal bleeding was higher with apixaban compared with aspirin, critical site, intracranial bleeding, and fatal bleeding were similar between arms. Most major bleeding events in both groups were characterized by decreased hemoglobin and were not emergencies.This study found that in patients with SCAF, apixaban increased major gastrointestinal bleeding compared with aspirin but intracranial and fatal bleeding events were similar between groups; most bleeding events were nonemergencies characterized by a decrease in hemoglobin.

Corresponding Author: Deborah M. Siegal, MD, MSc, Ottawa Blood Diseases Centre, The Ottawa Hospital, 501 Smyth Rd, Box 201A, Ottawa, ON K1H 5S4, Canada (dsiegal@toh.ca).

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