This multicenter, prospective, open-label study evaluated whether 5 g of intravenous idarucizumab would be able to reverse the anticoagulant effect of dabigatran in patients who had uncontrolled bleeding (group A; n=301) or were about to undergo an urgent procedure (group B; n= 202).
In group A, 137 patients (45.5%) presented with gastrointestinal bleeding and 98 (32.6%) presented with intracranial haemorrhage; among the patients who could be assessed, the median time to the cessation of bleeding was 2.5 hours.
In group B, the median time to the initiation of the intended procedure was 1.6 hours; periprocedural haemostasis was assessed as normal in 93.4% of the patients, mildly abnormal in 5.1%, and moderately abnormal in 1.5%.
At 90 days, thrombotic events had occurred in 6.3% of the patients in group A and in 7.4% in group B, and the mortality rate was 18.8% and 18.9%, respectively. There were no serious adverse safety signals.
In summary, idarucizumab is effective for dabigatran reversal among patients who have uncontrolled bleeding or will be undergoing urgent surgery. Post marketing surveillance will help to further assess its safety with respect to thrombotic events.