Normalization of dilute thrombin time was achieved in 98% of patients with acute bleeding and 93% of patients requiring an invasive procedure. The primary endpoint of this study was reversal of the anticoagulant effects of dabigatran based upon dilute thrombin or ecarin clotting times secondary endpoints included clinical resolution of bleeding and patients were followed for at least one month. The total dose of 5 g was determined based on calculations of the required dose to neutralize 99% of the total body dabigatran in patients enrolled in the RE-LY study. Patients received two doses of idarucizumab 2.5 g IV, with both doses delivered within a span of 15 minutes. The reasons for urgent invasive procedures varied widely, but included skeletal fractures in several patients (21%). Among patients enrolled for serious bleeding, the site of bleeding was the GI tract or intracranial in 39% and 35%, respectively. Approximately two-thirds of patients were receiving dabigatran at a dose of 110 mg twice daily, while most of the remainder received 150 mg twice daily. Patients were predominantly elderly (median age 77 years) receiving anticoagulation mostly for atrial fibrillation (96% of patients enrolled). This manuscript reports results of an interim analysis of 90 patients on the study.

RE-VERSE AD is an ongoing prospective cohort study evaluating the efficacy of idarucizumab in reversing the anticoagulant effects of dabigatran in patients with serious bleeding and patients requiring an urgent invasive procedure. Idarucizumab is a monoclonal antibody fragment that binds dabigatran with high affinity, and has been in development as a reversal agent for patients receiving dabigatran anticoagulation.

One major factor for both clinicians and patients when choosing between warfarin and newer direct oral anticoagulants (DOACs) has been the lack of a suitable reversal agent for the management of serious bleeding or urgent invasive procedures.

Among patients receiving dabigatran who develop serious bleeding or need an urgent invasive procedure, does idarucizumab reverse the anticoagulant effects of dabigatran?Īmong patients receiving dabigatran who develop serious bleeding or need an urgent invasive procedure, idarucizumab reverses the anticoagulant effects of dabigatran within minutes of administration.ĭabigatran is an orally administered direct thrombin inhibitor approved by the FDA for use in patients with non-valvular atrial fibrillation, DVT/PE, and for VTE prophylaxis after hip surgery, based in part upon data from RE-LY and RE-COVER studies.

Reversal of pradaxa anticoagulant