Safety of Oral Anticoagulation in Patients With Prior Intracranial Hemorrhage

Oral anticoagulation was associated with a reduced risk for ischemic stroke and increased risk for intracranial hemorrhage in patients with atrial fibrillation and prior intracranial hemorrhage.

Oral anticoagulation is associated with reduced risk for ischemic stroke and increased risk for recurrent intracranial hemorrhage in patients with atrial fibrillation, according to findings published in the Journal of Neurology, Neurosurgery & Psychiatry.

Anticoagulation is effective in reducing stroke risk in those with atrial fibrillation, but its use in individuals with prior intracranial hemorrhage remains controversial due to recurrent bleeding concerns. Researchers conducted a systematic review and meta-analysis of randomized controlled trials comparing oral anticoagulation with no anticoagulation in patients with atrial fibrillation and a history of intracranial hemorrhage.

The researchers identified 4 eligible randomized controlled trials (N=653) that compared the initiation of oral anticoagulation using either direct oral anticoagulants or vitamin K antagonists with avoidance of anticoagulation. The analysis focused on stroke prevention and bleeding outcomes, with ischemic stroke and recurrent intracranial hemorrhage serving as co-primary endpoints.

Patients treated with oral anticoagulation had a significantly reduced risk for ischemic stroke compared with those who did not receive anticoagulation (risk ratio [RR], 0.23; 95% CI, 0.06-0.91). However, patients with anticoagulation also experienced a significantly higher risk for recurrent intracranial hemorrhage (RR, 3.60; 95% CI, 1.40-9.30). The researchers found no meaningful difference between groups in overall mortality (RR, 0.93; 95% CI, 0.59-1.46) or cardiovascular death (RR, 1.01; 95% CI, 0.32-3.18).

These findings highlight the importance of a nuanced, patient-centred approach to anticoagulation, balancing the benefits of stroke prevention against the potential for severe bleeding complications.

Anticoagulation was further associated with an increased risk for major bleeding events (RR, 2.49; 95% CI, 1.29-4.81), but a lower incidence of major cardiovascular events (RR, 0.64; 95% CI, 0.44-0.94). When the researchers evaluated the combined risk for stroke and recurrent intracranial hemorrhage as a single composite outcome, they found no statistically significant difference between treatment groups (RR, 0.72; 95% CI, 0.42-1.24).

Subgroup analyses and sensitivity assessments indicated that the overall results were influenced by specific trials, particularly those with larger sample sizes or differing control group treatments. The location of the prior intracranial hemorrhage (lobar vs non-lobar) did not significantly alter bleeding risk.

Study limitations include a small number of studies, differences in trial protocols, and a lack of individual patient data, which precluded time-to-event analyses. Additionally, heterogeneity in outcome definitions and follow-up durations may have affected consistency of results.

“These findings highlight the importance of a nuanced, patient-centred approach to anticoagulation, balancing the benefits of stroke prevention against the potential for severe bleeding complications,” the study authors concluded.

References:

D’Anna L, Bax F, Abu-Rumeileh S, et al. Oral anticoagulation versus no anticoagulation for stroke prevention in patients with intracranial haemorrhage and atrial fibrillation: an updated meta-analysis of randomised controlled trials. J Neurol Neurosurg Psychiatry. Published online July 22, 2025. doi:10.1136/jnnp-2025-336169