A SYSTEMATIC review and meta-analysis of nine randomised clinical trials involving 45,494 participants found no significant difference in the risk of intracranial haemorrhage (ICH) between direct oral anticoagulants (DOACs) and single-agent antiplatelet therapy. These findings reinforce the safety of DOACs in atrial fibrillation treatment, addressing concerns about their potential association with intracranial bleeding.
The study aimed to evaluate whether DOAC therapy posed a greater risk of ICH compared with antiplatelet therapy, a concern that often influences treatment decisions for atrial fibrillation patients. Researchers conducted a systematic search of PubMed and Embase up to February 2024 and included nine trials meeting specific criteria. Eligible trials compared DOAC therapy with single-agent antiplatelet therapy, excluded those with a sample size under 200 or follow-up shorter than 30 days, and utilised the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines for reporting.
Over a mean follow-up of 17.1 months, ICH incidence was 0.55% for DOAC recipients and 0.48% for those on antiplatelet therapy. The odds ratio (OR) for ICH was 1.15 (95% CI, 0.71-1.88), demonstrating no statistically significant difference, although moderate heterogeneity was observed among the trials (I² = 53.7%). However, when examining specific agents, rivaroxaban showed a higher ICH risk (OR 2.09; 95% CI, 1.20-3.64), while dabigatran and apixaban did not. DOAC therapy was associated with a higher overall risk of major haemorrhage (2.41% vs 1.76%; OR 1.39; 95% CI, 1.07-1.80), with rivaroxaban again showing the most pronounced effect. These findings highlight important agent-specific differences in bleeding risk profiles.
The results suggest that DOACs are safe in terms of ICH risk compared with antiplatelet therapy, addressing a longstanding concern among clinicians and patients. However, the increased risk of major haemorrhage with DOAC therapy, particularly rivaroxaban, warrants careful agent selection and patient monitoring. Future research should focus on refining risk stratification to optimise clinical outcomes. These findings support adherence to current atrial fibrillation guidelines recommending DOACs for stroke prevention.
Katrina Thornber, EMJ
Reference
Coyle M et al. Risk of intracranial hemorrhage associated with direct oral anticoagulation vs antiplatelet therapy: a systematic review and meta-analysis. JAMA Netw Open. 2024;7(12):e2449017.
