Edoxaban Treatment in routiNe clinical prActice in patients with non-valvular Atrial Fibrillation (ETNA-AF) in Iberia: Baseline data.

INTRODUCTION AND OBJECTIVES

Atrial fibrillation (AF) is the most common form of arrhythmia worldwide and a significant health burden. Edoxaban, a recent novel oral anticoagulant (NOAC), is being investigated in the European real-world ETNA-AF study of patients with non-valvular atrial fibrillation (NVAF). The aim of this study was to characterize the Iberian edoxaban-treated cohort of ETNA-AF at baseline and to compare it with previously retrieved Portuguese data.

METHODS

Patients with NVAF treated with edoxaban and followed in Portuguese and Spanish centers were consecutively enrolled between June 2017 and January 2018. Only patients with a previous clinical decision to receive edoxaban were included. Patients' baseline demographic and clinical parameters, medical history, and AF-related characteristics were retrieved.

RESULTS

A total of 892 NVAF patients, with a mean age of 73.9 years, were included, 75.3% of whom received high-dose (60 mg) and 24.7% low-dose (30 mg) edoxaban. Most patients (55.9%) were male. Of the patients receiving 30 mg and 60 mg edoxaban, 55.9% and 37.9%, respectively, had an estimated CHADS-VASc score ≥4. Previous bleeding event rates were low, with a predominance of clinically relevant non-major bleeding (1.9%). Most patients (47.5%) with NVAF had paroxysmal AF, followed by 26.4% with permanent AF. Median overall CHADS-VASc score was 3.0 and median HAS-BLED score was 2.0. Previous treatments mostly included vitamin K antagonists (35.7%). A considerably higher proportion of patients on low-dose edoxaban required dose adjustments (71.4% vs. 8.6%). Overall adherence to label dosing recommendations was 86.5%.

CONCLUSIONS

This study provides valuable data on disease and patient profiles and will provide valuable insights into disease management and progression, as well as the safety, effectiveness, and patterns of cardiovascular events associated with edoxaban.