Key result
Idarucizumab, a specific antidote for dabigatran, normalized dilute thrombin time in 98% and 93% of patients in two groups studied, while andexanet alfa and ciraparantag are in development for other NOACs.
The development of specific antidotes like idarucizumab, andexanet alfa, and ciraparantag addresses a major clinical barrier by providing targeted reversal strategies for NOAC-associated life-threatening bleeding or emergent surgical needs.
Novel oral anticoagulants (NOACs) are increasingly used in clinical practice, but lack of commercially available reversal agents is a major barrier for mainstream use of these therapies. Specific antidotes to NOACs are under development. Idarucizumab (aDabi-Fab, BI 655075) is a novel humanized mouse monoclonal antibody that binds dabigatran and reverses its anticoagulant effect. In a recent Phase III study (Reversal Effects of Idarucizumab on Active Dabigatran), a 5 g intravenous infusion of idarucizumab resulted in the normalization of dilute thrombin time in 98% and 93% of the two groups studied, with normalization of ecarin-clotting time in 89% and 88% patients. Two other antidotes, andexanet alfa (PRT064445) and ciraparantag (PER977) are also under development for reversal of NOACs. In this review, we discuss commonly encountered management issues with NOACs such as periprocedural management, laboratory monitoring of anticoagulation, and management of bleeding. We review currently available data regarding specific antidotes to NOACs with respect to pharmacology and clinical trials.
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Asirvatham et al. (2016) conducted a review in Bleeding or need for urgent surgery in patients on novel oral anticoagulants. Specific antidotes (idarucizumab, andexanet alfa, ciraparantag) was evaluated. Idarucizumab, a specific antidote for dabigatran, normalized dilute thrombin time in 98% and 93% of patients in two groups studied, while andexanet alfa and ciraparantag are in development for other NOACs.
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