Photo by Piotr Bodzek
CHICAGO—Updated results from the RE-VERSE AD trial suggest idarucizumab, a humanized antibody fragment, can reverse the anticoagulant effect of dabigatran in emergency settings.
In this ongoing phase 3 trial, idarucizumab has normalized diluted thrombin time (dTT) and ecarin clotting time (ECT) in a majority of patients with uncontrolled or life-threatening bleeding and patients who required emergency surgery or an invasive procedure.
In addition, researchers said there have been no safety concerns related to idarucizumab in this trial.
These results were presented at the American College of Cardiology’s 65th Annual Scientific Session (abstract 1130M-05). The study was sponsored by Boehringer Ingelheim, the company that developed idarucizumab and dabigatran.
“The data from this new RE-VERSE AD interim analysis, of the first 123 patients, support earlier findings that show idarucizumab reverses the anticoagulant effect of dabigatran, including reversal in critically ill, high-risk patients in emergency care,” said Charles Pollack, MD, of Thomas Jefferson University in Philadelphia, Pennsylvania.
Dr Pollack and his colleagues presented data on 123 patients—66 with uncontrolled or life-threatening bleeding complications (Group A) and 57 patients requiring emergency surgery or an invasive procedure (Group B).
All of these patients received 5 g of idarucizumab. The primary endpoint of the study is the degree to which idarucizumab reversed the anticoagulant effect of dabigatran within 4 hours, measured by dTT and ECT.
Overall, 94 patients were evaluable for dTT and 112 for ECT. So 97% of evaluable patients (91/94) achieved full reversal of dTT, and 87% (97/112) achieved full reversal of ECT.
Among evaluable patients in Group A (n=48), the median subjective investigator-reported time to cessation of bleeding was 9.8 hours. For 92% of patients (44/48), bleeding stopped within 72 hours of idarucizumab administration.
Among evaluable patients in Group B (n=52), the mean time to surgery was 1.7 hours after receiving idarucizumab. Normal hemostasis during surgery was reported in 92% of patients (48/52).
Thromboembolic events occurred in 5 patients after idarucizumab administration—1 each at 48 hours, 7 days, 9 days, 13 days, and 24 days. None of these patients were receiving antithrombotic therapy at the time of their event.
However, most patients in both groups restarted anticoagulation after receiving idarucizumab—47 of 66 patients in Group A and 49 of 57 patients in Group B.
There were a total of 26 deaths—13 in each group. All of the deaths appeared to be related to the original reason for emergency admission to the hospital and/or to comorbidities.
