No increased risk of brain bleed with DOAC vs antiplatelet therapy in AF patients

In the treatment of patients with atrial fibrillation (AF), direct oral anticoagulants (DOACs) do not contribute to an increased risk of intracranial haemorrhage compared with antiplatelet therapy, according to the results of a systematic review and meta-analysis.

Researchers searched multiple online databases for randomized clinical trials in which DOAC therapy was compared with single-agent antiplatelet therapies. Trials with follow-up duration of less than 30 days or a sample size of less than 200 were excluded.

Nine randomized clinical trials that involved 45,494 participants met the inclusion criteria and were included in the meta-analysis. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses reporting guideline was followed, and a random-effects meta-analysis model was used.

Pooled data showed that DOAC therapy was not associated with increased odds of intracranial haemorrhage, the primary outcome, relative to antiplatelet therapy (0.55 percent vs 0.48 percent over a mean follow-up of 17.1 months; odds ratio [OR], 1.15, 95 percent confidence interval [CI], 0.71–1.88). However, heterogeneity was found across the trials (I2, 53.7 percent).

When looking at individual DOACs, the respective point estimates for intracranial haemorrhage were as follows: rivaroxaban, OR, 2.09 (95 percent CI, 1.20–3.64); dabigatran, OR, 1.00 (95 percent CI, 0.61–1.64); and apixaban, OR, 0.72 (95 percent CI, 0.44–1.17).

Overall, the odds of major haemorrhage were greater with DOAC therapy than with antiplatelet therapy (2.41 percent vs 1.76 percent over a mean trial follow-up of 15.5 months; OR, 1.39, 95 percent CI, 1.07–1.80). The point estimate by agent were as follows: rivaroxaban, OR, 1.91 (95 percent CI, 1.22–3.00); dabigatran, OR, 1.21 (95 percent CI, 0.86–1.69); and apixaban, OR, 1.09 (95 percent CI, 0.73–1.63).