Stroke

Is apixaban safer than aspirin for intracranial bleeding risk?

July 4, 2025

Study details: This meta-analysis evaluated the relative risk of intracranial hemorrhage (ICH) with apixaban vs. aspirin in ischemic stroke prevention. Researchers reviewed randomized controlled trials from major databases, including only those reporting ICH events. Three trials met inclusion criteria, encompassing 10,626 patients and 74 ICH events. The Mantel-Haenszel method was used for pooled analysis, with sensitivity analyses assessing robustness and the secondary outcome of hemorrhagic stroke.

Results: The pooled relative risk of ICH with apixaban vs. aspirin was 0.67 (95% confidence interval [CI], 0.43–1.08; P=0.10), indicating no statistically significant difference, but a numerically lower risk with apixaban. Sensitivity analyses and secondary outcomes (hemorrhagic stroke: relative risk, 0.72; 95% CI, 0.39–1.31) were consistent.

Clinical impact: These findings challenge the perception that aspirin is safer than apixaban regarding ICH risk. For patients at risk of cardioembolic stroke, apixaban (5 mg bid in most trials) shouldn’t be withheld due to ICH concerns, and may be preferred over aspirin given its superior efficacy for stroke prevention and at least comparable safety profile for ICH.

Source:

Daghlas I, et al. (2025, June 4). Stroke. Risk of Intracranial Hemorrhage With Apixaban Versus Aspirin Therapy: A Meta-Analysis of Randomized Controlled Trials. https://pubmed.ncbi.nlm.nih.gov/40464082/