Category: Toxicology
Keywords: dabigatran reversal, Idarucizumab (PubMed Search)
Posted: 8/25/2017 by Hong Kim, MD
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Full cohort analysis idarucizumab for dabigatran associated bleeding was recently published in NEJM.
This study evaluated the laboratory correction of elevated ecarin clotting time or diluted thrombin time induced by dabigatran and time to either cessation of bleeding (Group A: patients with GI bleeding, traumatic bleeding, or ICH) or time to surgery (Group B: patients requiring surgical intervention within 8 hours).
Findings
Group A (n=301): Median time to the cessation of bleeding was 2.5 hours in 134 patients.
HOWEVER:
Group B (n=202): Median time to intended surgery after infusion of idarucizumab was 1.6 hours.
Laboratory markers:
100% reversal of abnormal ecarin clotting time or diluted thrombin time within 4 hours after the administration
Mortality
Conclusion
Authors concluded thate idaurcizumab is an "effective" reversal agent for dabigatran.
Overall, the findings are more promising compared to the interim analysis that was published in 2015.
Other findings:
Infusion of idarucizumab decreased the dabigatran level from 110 ng/mL (Group A) and 73.6 ng/mL (Group B) to < 20 ng/mL.
Rebound levels of > 20 ng/mL were noted in 191 patients after 12 – 24 hours after idarucizumab adminiatration
Thrombotic events occured in 24 patients (14 in Group A and 10 in Group B) within 30 days after treatment
Serious adverse events occured in 23.3% of the patients within 5 days.
Most frequent events were:
Pollack CV et al. Idarucizumab for dabigatran reversal - full cohort analysis. N Eng J Med 2017;377:431-41.
