Idarucizumab for Dabigatran Reversal — Full Cohort Analysis



Title: Idarucizumab for Dabigatran Reversal — Full Cohort Analysis

Pollack, CV et al.


 

What You Need to Know:

According to results of a full cohort analysis, idarucizumab, a fragment of a monoclonal antibody, was found to effectively reverse the anticoagulant effect of dabigatran in a rapid and safe fashion.

Trial Design:

  • Prospective, open-label study evaluated the effectiveness of idarucizumab at reversing the anticoagulant effect of dabigatran
  • A total of 503 patients receiving dabigatran were enrolled; group A consisted of patients with uncontrolled bleeding (n=301) and group B included patients that were about to have surgery or another invasive procedure (n=202)
  • Patients received 5g of idarucizumab intravenously
  • Primary endpoint: “the maximum percentage reversal of the anticoagulant effect of dabigatran within 4 hours after the administration of idarucizumab, on the basis of the diluted thrombin time or ecarin clotting time”
  • Secondary endpoints: hemostasis restoration, safety measures

Key Outcomes:

  • Median maximum percentage reversal of dabigatran: 100% (95% CI: 100, 100) based on both the diluted thrombin time and the ecarin clotting time
  • Group A patients: 45.5% experienced gastrointestinal bleeding (137/301), 32.6% experienced intracranial hemorrhage (98/301)
  • The median time to bleeding cessation for group A patients was 2.5 hours
  • “In group B, the median time to the initiation of the intended procedure was 1.6 hours; periprocedural hemostasis was assessed as normal in 93.4% of the patients, mildly abnormal in 5.1%, and moderately abnormal in 1.5%”
  • Thrombotic events at 90 days: occurred in 6.3% of group A patients and 7.4% of group B patients
  • Mortality rate: 18.8% for group A patients and 18.9% for group B patients
  • No serious adverse safety signals were reported