Effectiveness and safety of edoxaban in patients with atrial fibrillation:data from the Danish Nationwide Cohort

Aims Edoxaban treatment for stroke prevention in atrial fibrillation (AF) has mainly been investigated in randomized controlled trials, and data reflecting clinical practice are limited. We ascertained the clinical effectiveness and safety of edoxaban 30 and 60 mg once daily among Danish patients with AF. Methods and results This was an observational study based on Danish nationwide registries collecting information for administrative purposes. From June 2016 through November 2018, we identified 3405 patients initiating edoxaban. After exclusions, 2285 AF patients were followed for the effectiveness outcome of thromboembolism (ischaemic stroke and/ or systemic embolism) and bleeding outcomes (composite of major bleeding, gastrointestinal bleeding, and intracranial haemorrhage), as well as bleeding requiring hospitalization. Population mean age was 75 years and 43% were female; 643 patients received the 30 mg edoxaban dosage regimen and 1642 initiated 60 mg edoxaban. During follow-up, we observed 41 thromboembolic events and 89 bleeding events of which 40 events required hospitalization. Among patients with 30 mg edoxaban, the rate (per 100 person-years) of thromboembolism was 2.07 vs. 1.62 for 60 mg edoxaban. Rates of bleeding were similar for the two dosages at -3.85. Bleeding requiring hospitalization occurred at a rate of 1.74 for 30 mg edoxaban and 1.69 with 60 mg edoxaban. Conclusion In this nationwide cohort of Caucasian AF patients treated with edoxaban for stroke prevention, the clinical effectiveness and safety were in line with data from the ENGAGE AF-TIMI 48 trial. Studies investigating comparative effectiveness and safety for edoxaban in comparison with other choices of antithrombotic treatment options are needed.