Idarucizumab in Patients With GI Bleeding

Study Questions:

What is the efficacy and safety of idarucizumab for urgent dabigatran reversal in patients with major gastrointestinal (GI) bleeding?


The authors identified patients with uncontrollable GI bleeding who required anticoagulation reversal between June 2014 and July 2016 in the RE-VERSE AD study. Patients were followed for 90 days following their initial presentation. The primary endpoint was maximum reversal of dabigatran anticoagulation within 4 hours after administration of idarucizumab.


GI bleeding occurred in 137 patients in the RE-VERSE AD study, of which 84% were adjudicated as major or life-threatening. These occurred in the upper GI tract (48, 35%), lower GI tract (43, 31%), and either both or an unknown location (46, 34%). Complete dabigatran reversal occurred in 118/121 patients (98%) with an elevated diluted thrombin time at presentation, and 95/131 patients (73%) with an elevated ecarin clotting time. Bleeding cessation within 24 hours was reported in 92/134 patients (69%) after a mean duration of 2.4 hours (interquartile range [IQR], 2.0-3.9 hours). Packed red blood cell transfusion was given to 113 patients (83%). During the 90-day follow-up, six patients (4%) had a post-reversal thromboembolic event, five of which occurred in patients who did not resume anticoagulation. Some form of anticoagulation was restarted in 91 patients (66%) after a median of 61 days (IQR, 6-38 days). During follow-up, 20 patients (15%) died.


The authors concluded that idarucizumab demonstrates rapid and complete reversal of dabigatran activity in nearly all patients with GI bleeding.


GI bleeding is one of the most common and potentially severe adverse reactions to anticoagulation. This analysis demonstrates efficacy and relative safety of idarucizumab administration for patients taking dabigatran. Although 4% of patients subsequently suffered ischemic events, nearly all of those patients had not resumed anticoagulation. It is important to restart some form of anticoagulation once the source of GI bleeding has been controlled, whenever possible, so as to prevent thrombotic events.

Keywords: Antibodies, Monoclonal, Humanized, Anticoagulants, Antithrombins, Blood Coagulation, Erythrocyte Transfusion, Hemorrhage, Lower Gastrointestinal Tract, Secondary Prevention, Thrombin Time, Upper Gastrointestinal Tract, Vascular Diseases

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