OBJECTIVES : In the RE-LY trial, dabigatran showed a favourable safety and efficacy profile compared to vitamin K antagonists (VKA).

This study described under real-world practice the management of patients with non-valvular atrial fibrillation (NVAF) treated with dabigatran presenting to the emergency department/room (ED) with GIB and urogenital bleeding (UGB) prior to the availability of idarucizumab.

METHODS : Observational chart abstraction study collecting data from 44 sites in the United States (US) and Canada, enrolling NVAF patients presenting to the ED between October 28, 2010 and August 1, 2013 with acute GIB or UGB and evidence of dabigatran use within 5 days before the bleeding event. Patients were followed until discharge.

RESULTS : The study included 220 patients (66%, n=145, from the US). Mean age was 76.1 years (standard deviation: 10.3), 108 (49%) were female and 84 (38%) were taking concomitant medications known to increase the risk of bleeding. GIB was observed in 161 (73%) and UGB in 63 (29%, 4 with concomitant GIB). At least one intervention was recorded for 170 patients (77%), discontinuation of dabigatran being the most common (n=157, 71%), followed by transfusion/infusion (n=81, 36.8%). The majority received packed red blood cell transfusions (60/81, 74.1%). Average duration of ED visit was 7.6 ± 8.5 hours and 148 (67%) patients were admitted to the hospital. At discharge, 169 (77%) patients had their bleeding event resolved, 42 (19%) still had some symptoms and 9 (4%, n=8 GIB, 1 UGB) had died.

CONCLUSIONS : Bleeding incidence is low for patients treated with dabigatran, limiting the number of patients that can be assessed. Real world outcomes of GIB and UGB were favorable in this time period early after approval of dabigatran, with mortality rates similar to those previously reported. Availability of idarucizumab adds to the available bleeding management options for patients taking dabigatran.