Activated prothrombin complex concentrate for dabigatran-associated bleeding.

Dabigatran is a (relatively) novel oral anticoagulant directed exclusively against thrombin. Its efficacy and safety were shown to be at least as good as that of vitamin K antagonists (warfarin) in the prevention and treatment of thrombotic disease in patients with atrial fibrillation and venous thromboembolism, respectively. However, there is no established strategy to reverse anticoagulation with dabigatran in case of serious hemorrhagic complications. The authors describe four patients who presented with a major bleeding episode while anticoagulated with dabigatran and who were administered an activated prothrombin complex concentrate (aPCC). After the administration of the aPCC, the clinical condition in all four patients stabilized and all patients eventually recovered from the bleeding complication. There was no effect of the aPCC administration on hemostatic parameters.

This is one of the first clinical reports on the use of aPCC in dabigatran-associated bleeding and, as such, this is a useful case series. However, as the authors admit in their discussion, these four cases do not provide sufficient evidence to advocate the use of aPCC as a reversal agent for dabigatran. As the half-life of dabigatran is relatively short, a spontaneous clinical recovery is as likely as an effect of the aPCC. In addition, aPCCs are known for their prothrombotic complications, which may be particularly worrisome in patients requiring anticoagulation for prevention or treatment of thrombosis. Lastly, the authors do not discuss that mounting evidence suggesting that the oral factor Xa agents can be reversed much more easily by the administration of conventional (not activated) prothrombin complex concentrates.

– Marcel Levi