This study included patients taking dabigatran who required anticoagulation reversal due to serious bleeding or need for an urgent procedure. In patients with serious bleeding who could be assessed (n=35), haemostasis was restored at a median of 11.4 hours. In patients who underwent an urgent procedure (n=36), normal intraoperative haemostasis was reported in 33, and mildly or moderately abnormal haemostasis was reported in 2 patients and 1 patient, respectively.
Idarucizumab is a fully humanised monoclonal antibody fragment which has a highly specific binding affinity with dabigatran therefore reversing any anticoagulant activity of dabigatran and its metabolites. It has been filed for approval in the US, EU and Canada for use in patients requiring an antidote to dabigatran.