New Oral Anticoagulants and the Risk of Intracranial Hemorrhage: Traditional and Bayesian Meta-Analysis and Mixed Treatment Comparison of Randomized Trials of New Oral Anticoagulants in Atrial Fibrillation

Study Questions:

What is the performance of novel oral anticoagulants (NOACs) in reducing risk of intracranial hemorrhage (ICH)?

Methods:

This was a meta-analysis of randomized trials that compared NOACs with conventional anticoagulants, aspirin, or placebo for stroke prevention in patients with atrial fibrillation (AF). Statistical analyses were used to perform a comparison with all comparators and among themselves.

Results:

The authors identified six studies (one administering dabigatran, two administering rivaroxban, and three administering apixaban), with NOACs being compared against two comparators (warfarin and aspirin) in a population of 57,491 patients. NOACs significantly reduced the risk of ICH against all comparators (odds ratio, 0.49; 95% confidence interval, 0.36-0.65). There was no statistically significant difference among the three NOACs. Dabigatran 110 mg twice daily was associated with a rate of bleeding comparable to that of aspirin (0.45% vs. 0.46%, respectively).

Conclusions:

In this meta-analysis, NOACs were uniformly associated with a reduced risk of ICH when used for stroke prevention in AF, when compared to conventional anticoagulants or aspirin.

Perspective:

The current analysis provides important insight to inform decision making about anticoagulation in patients with AF and risk for ICH. The limitations of the meta-analysis aside, these data may suggest that NOACs are acceptable and safe options in patients with AF at risk of ICH, but qualifying for thromboprophylaxis for ischemic stroke.

Clinical Topics: Anticoagulation Management

Keywords: Stroke, Intracranial Hemorrhages, Warfarin


< Back to Listings