Meta-analysis of randomized controlled trials on the risk of bleeding with dabigatran.

Bloom et al. performed an interesting meta-analysis of five randomized controlled trials (RCTs) on the risk of bleeding with dabigatran. They compared the risk of bleeding and all-cause mortality of dabigatran with that of vitamine K antagonists (VKAs) in patients treated for atrial fibrillation or venous thromboembolism. Indeed, as expected, they found that dabigatran was not associated with an increased risk of major bleeding compared with VKAs (relative risk [RR] 0.92) and that it was associated with a decreased risk of intracranial bleeding (RR 0.40) but with an increased risk of gastrointestinal bleeding. Unfortunately, patients included in these RCTs were highly selected and these optimistic results conflict with data coming from both the regulatory agencies and the pharmacovigilance registries. Major bleeding is reported in real life. We still have to be prudent with dabigatran! Up to now, no antidote is available and a specific test (diluted thrombin time) is performed in some large centers, but not everywhere, and is not available all the time.

– Charles-Marc Samama