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Idarucizumab for Dabigatran Reversal
Study Questions:
What are the thrombotic and bleeding outcomes associated with the use of idarucizumab to reverse dabigatran anticoagulation in patients with uncontrolled bleeding or undergoing an urgent procedure?
Methods:
The RE-VERSE AD authors performed an open-label study of 5 g intravenous infusion of idarucizumab in patients taking dabigatran who presented with uncontrolled bleeding (group A) or who required an urgent surgical procedure (group B). The primary endpoint was the maximal percentage of anticoagulant reversal (diluted thrombin time or ecarin clotting time) within 4 hours of idarucizumab administration. Secondary endpoints included restoration of hemostasis (assessed by clinician) and safety measures (including recurrent thrombosis).
Results:
The study enrolled 503 patients, 301 in group A (uncontrolled bleeding) and 202 in group B (urgent surgical procedure). Dabigatran reversal was achieved in 100% of patients within 4 hours of idarucizumab administration. In group A, the median time to cessation of bleeding was 2.5 hours. In group B, the mediation time to initiation of the intended procedure was 1.6 hours, and periprocedural hemostasis was assessed as normal in 93.4% of patients. At 90 days, thrombotic events occurred in 6.3% of patients in group A and 7.4% of patients in group B. Mortality rate at 90 days was 18.8% in group A and 18.9% in group B.
Conclusions:
The authors concluded that idarucizumab rapidly and safely reversed the anticoagulant effect of dabigatran in emergent situations.
Perspective:
This complete report of the RE-VERSE AD study highlights the rapid and effective reversal of dabigatran anticoagulation in emergent situations. Although the study design was open label without a comparator arm, it still provides reassuring data for clinicians and patients using dabigatran. Most impressively, surgeons assessed surgical hemostasis as normal in over 90% of cases after idarucizumab administration. How the high (~19%) mortality rate would compare to a placebo arm is unknown, especially since anticoagulation was restarted in 73% of group A and 90% of group B patients. Nonetheless, since idarucizumab is the lone specific reversal agent currently available for any of the direct oral anticoagulants, it serves an important role in patients currently taking dabigatran or in patients requiring an oral anticoagulant who are at increased risk of bleeding.
Keywords: Antibodies, Monoclonal, Anticoagulants, Antithrombins, Blood Coagulation, Hemorrhage, Hemostasis, Surgical, Infusions, Intravenous, Secondary Prevention, Surgical Procedures, Operative, Thrombin Time, Thrombosis, Vascular Diseases
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