We aimed to provide detailed utilization data on the total use of non-vitamin K antagonist oral anticoagulants (NOACs) since their introduction in 2008. Using the nationwide Danish National Prescription Registry, we identified all individuals filling prescriptions for NOACs 2008-2016. We reported the development in incident and prevalent users and explored baseline characteristics and treatment persistence according to treatment indication. A total of 126,691 NOAC users were identified within the Danish population of 5.7 million inhabitants. The annual incidence and prevalence increased rapidly reaching 10 and 17 per 1000 individuals in 2016. Patients received NOACs due to atrial fibrillation (AF) (43%), venous thromboembolism (VTE) prophylaxis after arthroplastic surgery (17%), VTE (12%) and no registered indication (28%). The most frequently used NOAC was rivaroxaban (n = 52,431), followed by dabigatran (n = 47,067), apixaban (n = 27,116) and edoxaban (n = 77). The proportion of AF and VTE patients initiating low-dose NOACs were between 23% and 50%. Patients treated with NOAC for VTE primarily received rivaroxaban. We observed a trend towards increased use of apixaban and rivaroxaban at the expense of dabigatran. Treatment persistence was highly dependent on treatment indication. Persistence to NOAC after 3 years was only 62% in AF compared to 28% for VTE. We documented an accelerating increase in the use of all four NOACs in the first 8 years after introduction. We have identified areas requiring further attention, including reasons for missing indications, potential inappropriate dosing and low long-term persistence with NOACs in patients with AF.

No abstract

No abstract

Background 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. Purpose We aimed to investigate the real-world use of idarucizumab and associated clinical outcomes. Methods 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. Results 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). Conclusion 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. Funding Acknowledgement Type of funding source: Private grant(s) and/or Sponsorship. Main funding source(s): Unrestricted research grant from Boehringer Ingelheim