Edoxaban for Stroke Prevention in Atrial Fibrillation in Spain and Portugal: 4-Year Follow-Up of the Observational ETNA-AF-Europe Study.

Background/

Objectives

Edoxaban is a non-vitamin K antagonist oral anticoagulant indicated in patients with non-valvular atrial fibrillation to prevent stroke and systemic embolism. The objective was to obtain real-world data on the safety and effectiveness of edoxaban in routine care among patients with atrial fibrillation.

Methods

ETNA-AF-Europe was a multinational, multicenter, prospective, post-authorization observational study. Its objectives were to assess the real-world safety of edoxaban (bleeding events and mortality) and its effectiveness by evaluating stroke, systemic embolic events, and cardiovascular events over 4 years. This article presents the results for Spain and Portugal.

Results

In Spain and Portugal, 931 patients were included in the full analysis set. At baseline, 75.3% of patients were receiving edoxaban 60 mg, and 23.3% were receiving edoxaban 30 mg. Participants receiving 30 mg were older, more likely to be frail, and had a higher prevalence of comorbidities. The annualized rates of all-cause death (8.1% vs. 2.5%) and CV death (2.9% vs. 1.2%) were higher in patients receiving 30 mg than in patients receiving 60 mg. The annualized rates of bleeding events and stroke were higher in patients receiving edoxaban 30 mg.

Conclusions

The results obtained in clinical practice verified the long-term effectiveness and safety of edoxaban, with low annualized event rates. The differences in outcomes according to edoxaban dose may be attributable to the underlying indication associated with each dose level and to clinical differences between patients.