Tuesday, 18 August 2015

Idarucizumab for dabigatran reversal. NEJM June 2015.

Dabigatran is an oral thrombin inhibitor that is licensed for prevention of stroke in patients with non-valvular atrial fibrillation and prevention and treatment of venous thromboembolism. Although dabigatran is associated with less serious bleeding than warfarin, when life-threatening bleeding occurs. Current management of bleeding on dabigatran is limited to dialysis or supportive treatment with blood products which is only partially effective. Idarucizumab is a monoclonal antibody fragment which binds dabigatran with an affinity that is 350 times as high as with thrombin. Consequently, idarucizumab binds free and thrombin-bound dabigatran and neutralizes its activity.

This paper is an interim analysis of the first 90 patients enrolled in an ongoing, multicenter, prospective cohort study with the aim of recruiting 300 patients. Inclusion criteria are patients over 18 years of age taking dabigatran who present with life-threatening bleed or those requiring urgent surgery requiring dabigatran reversal. Idarucizumab was found to normalise diluted thrombin time and ecarin clotting time in 88 to 98% of patients, an effect which was evident within minutes of administration. Concentration of unbound dabigatran remained below 20ng/mL (no clinical effect) at 24 hours in 79% of patients. 1 patient had a thrombotic event within 72 hours after idarucizumab administration. These early results show promising signs that idarucizumab will be routinely used in the near future for dabigatran reversal.

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