The first direct oral anticoagulant (DOAC) was approved nearly a decade ago, yet there remains apprehension in transitioning to wide-spread use despite demonstrated efficacy and ease of use. One limitation is the absence of a reversal agent for patients on DOACs who develop significant bleeding or require emergent surgery. Idarucizumab is a humanized monoclonal antibody fragment which binds dabigatran and rapidly reverses anticoagulant activity.<\/p>\n
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The Reversal Effects of Idarucizumab on Active Dabigatran (RE-VERSE AD) multicenter prospective single-cohort study enrolled 503 patients taking dabigatran with uncontrollable or life threatening bleeding (Group A, n = 301) or need for urgent surgical or invasive procedures (Group B, n = 202) to receive a standard dose of idarucizumab 5 g intravenously. A control group was not included based on pretrial investigations demonstrating safety and efficacy in reversing dabigatran, and withholding the drug was regarded as unethical.<\/p>\n
The primary endpoint was maximum percentage reversal of anticoagulant effect based on diluted thrombin time (dTT) or ecarin clotting time (ECT) with complete reversal defined as a decrease in dTT or ECT to normal level. Of the 461 patients with abnormal baseline dTT or ECT, 100% experienced complete reversal within 4 hours of administration. This effect was sustained for 24 hours in the majority of patients, with only 9 (1.8%) patients requiring additional doses of Idarucizumab. Secondary endpoints were restoration of hemostasis and safety measures, which were generally favorable.<\/p>\n
Safety concerns included thrombotic events necessitating re-initiation of anticoagulation (4.8% at 30 days, 6.8% at 90 days) and hypersensitivity to the medication (0.6%).<\/p>\n