Seguridad y efectividad del edoxabán en la práctica clínica tras un año de seguimiento en España. Registro ETNA-AF-EUROPE

Abstract

Introduction and objectivesTo ascertain the safety and effectiveness of edoxaban in clinical practice in Spain after one-year of follow-up among patients with atrial fibrillation. MethodsETNA-AF-EUROPE is a non-interventional, post-authorization study performed in 10 European countries. Data after one-year of follow-up, comparing those patients from Spain with the rest of Europe are presented. ResultsA total of 824 patients in Spain and 13 224 in the rest of Europe were included. In Spain, mean age was 73.9 ± 9.9 years, 45.8% were women, CHA2DS2-VASc and HAS-BLED were 3.2 ± 1.4 and 2.3 ± 1.0, respectively. 75.4% of patients were taking edoxaban 60 mg and the remaining 24.6% edoxaban 30 mg. Overall, 84.2% of patients were taking the appropriate dose of edoxaban. Compared with the rest of Europe, in Spain the proportion of patients ≥ 85 years was higher, as well as the thromboembolic risk (CHA2DS2-VASc ≥ 2: 90.2% vs 87.5%; P = .02), but with a lower bleeding risk (HAS-BLED ≥ 3: 40.4% vs 49.2%; P < .01). No significant differences were observed regarding the dose of edoxaban. In Spain, the annualized incidence of ischemic stroke was 0.5%, cardiovascular mortality 1.63%, major bleeding 1.39% and intracranial hemorrhage 0.13%. Except for the incidence of major bleeding or clinically relevant non-major bleeding that was more common in Spain compared with the rest of Europe, no significant differences were observed in the rest of events. ConclusionsIn clinical practice in Spain, patients with atrial fibrillation treated with edoxaban have a low incidence of bleeding and thromboembolic risk.