LAUSR

Idarucizumab was introduced in Europe in December 2015 as an antidote to dabigatran. Whether reversing the anticoagulant effect of dabigatran actually reduces the risk of bleeding complications and mortality remains sparsely described. No randomized placebo-controlled trial evaluating the efficacy of idarucizumab has been conducted. Therefore, evaluation of real-world data is of major importance to further investigate the use of idarucizumab in daily clinical practice. We aimed to investigate the real-world use of idarucizumab and associated clinical outcomes. The study was conducted as an observational case series. Using our regional electronic patient record, all patients treated with idarucizumab from market introduction to end of 2019 were identified. We had complete coverage of the use of idarucizumab at a large University Hospital in Denmark. During Spring 2020, we will also include patients from regional hospitals. A total of 39 patients were treated with idarucizumab. All patients but one received dabigatran due to atrial fibrillation. Indications for idarucizumab use were “need for acute surgery” in 21 (54%), “bleeding” in 14 (36%), “prior to thrombolysis” in two (5%), and “dabigatran intoxication” due to renal failure in two (5%, one presenting with bleeding and one patient without). No patients were treated with activated carbon or dialysis. A total of five patients (13%) experienced bleeding within 30 days after infusion and none had thromboembolic complications. After 30 days follow-up, 32 (82%) patients were alive and 29 restarted anticoagulant treatment (19 lowmolecular-weight heparin, 11 dabigatran, one rivaroxaban, and one apixaban). Among patients treated with idarucizumab, few experienced adverse outcomes and the 30-day survival rate was high. In line with observations from the REVERSE-AD trial, our data supports that idarucizumab is safe in patients experiencing life-threatening bleeding or needing acute surgery. Type of funding source: Private grant(s) and/or Sponsorship. Main funding source(s): Unrestricted research grant from Boehringer Ingelheim