Idarucizumab for reversal of direct thrombin inhibitor dabigatran

Idarucizumab for reversal of direct thrombin inhibitor dabigatran Idarucizumab is a monoclonal antibody fragment used to reverse the anticoagulant effect of direct thrombin inhibitor dabigatran. RE-VERSE AD (Reversal of Dabigatran Anticoagulant Effect With Idarucizumab) clinical trial evaluated the safety and efficacy of 5 g idarucizumab given intravenously [1]. An article on interim analysis of 90 patients was published first. In that report, 51 patients in group A of the study had serious bleeding while 39 patients in group B required an urgent procedure. Primary end point of the study was the maximum percentage reversal of the anticoagulant effect of dabigatran within four hours of administration of Idarucizumab. This was determined using dilute thrombin time or ecarin clotting time. Important secondary end point was restoration of hemostasis. Authors of the interim report concluded that Idarucizumab completely reversed the anticoagulant effect of dabigatran within minutes. One thrombotic event occurred within 3 days in a patient in whom anticoagulant had not been restarted. Major limitation of the study was lack of a control group. But it was deemed unethical to have a control group in the patients evaluated who were having either a life threatening bleeding or need for urgent surgery. Idarucizumab has an affinity for dabigatran that is about 350 times stronger than its affinity for thrombin. Idarucizumab does not bind known thrombin substrates and has no activity in coag...
Source: Cardiophile MD - Category: Cardiology Authors: Tags: Cardiology Source Type: blogs