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:

• Bleeding cessation could not be determined in 67 patients
• Cessation of bleeding could not be assess in 98 patients with ICH
• Bleeding stopped spontaneously in 2 patients.

Group B (n=202): Median time to intended surgery after infusion of idarucizumab was 1.6 hours.

• Normal hemostasis in 184 patients (93.4%), mildly abnormal in 10, and moderately abnormal in 3.
• Many received PRBC and other blood products during surgery

Laboratory markers:

100% reversal of abnormal ecarin clotting time or diluted thrombin time within 4 hours after the administration

Mortality

• 5 Day: Group A: 6.3% vs. Group B: 12.6%
• 30 Day: Group A: 13.5% vs. Group B: 12.6%
• 90 Day: Group A: 18.8% vs. Group B: 18.9%

 

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.

 

Additional Information

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:

• Group A: delirum 2.3%
• Group B: cardiac arrest 3.5%; septic shock 3.0%  

References

Pollack CV et al. Idarucizumab for dabigatran reversal - full cohort analysis. N Eng J Med 2017;377:431-41.