Reversal of dabigatran by idarucizumab: when and how?

ABSTRACT

Introduction: Anticoagulants are highly effective in reducing the risk of embolism in patients with atrial fibrillation and in the treatment of venous thromboembolism. However, interfering with the coagulation system increases the risk of bleeding. Non-vitamin K oral anticoagulants (NOACs) are associated with a reduced risk of major and life-threatening bleeding compared to warfarin, but the absence of a specific reversal agent has caused concern among clinicians.

Areas covered: This article describes the indications for and practical use of idarucizumab, a specific reversal agent for the direct thrombin inhibitor dabigatran.

Expert commentary: Each year, 3-5% of anticoagulated patients will experience major bleeding and about 10% will require invasive interventions. While most of these situations can be managed without the need for a reversal agent, the ability to promptly switch off anticoagulant activity is likely beneficial in severe bleeding situations and can help to avoid delays and improve safety in the management of patients requiring urgent procedures. Idarucizumab rapidly and completely reverses the anticoagulant effect of dabigatran in vitro, in healthy volunteers, and in patients presenting with severe bleeding or requiring urgent procedures. Further clinical data will help to understand the clinical impact of rapid reversal on the outcome of bleeding patients.

KEYWORDS:

• Idarucizumab
• NOACs
• dabigatran
• reversal agent
• anticoagulants

Declaration of interest

A Greinacher has received consultancy fees from Bayer, Boehringer, Astra-Zeneca and GSK. He has received payment for lectures from Aspen, Boehringer, NovoNordisk, Bayer Healthcare, BMS and GSK. Study support (third-party funding) has been provided by Bayer, Boehringer and Aspen. T Vanassche recieved speaker fees from Boehringer Ingelheim. P Verhamme received honoraria for lectures and consultancy from Boehringer Ingelheim, Bayer, Daiichi Sankyo, Pfizer and research support from Boehringer Ingelheim, Bayer, Sanofi and LeoPharma. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.