Cardiology Department, Coimbra University Hospital and Medical School, Coimbra, Portugal.
Rev Port Cardiol (Engl Ed). 2020 Nov;39(11):651-662. doi: 10.1016/j.repc.2020.09.003. Epub 2020 Nov 13.
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.
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.
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%.
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.
心房颤动（AF）是全球最常见的心律失常形式，也是一个重大的健康负担。依度沙班是一种新型的口服抗凝药物（NOAC），正在欧洲真实世界 ETNA-AF 研究中对非瓣膜性心房颤动（NVAF）患者进行研究。本研究的目的是描述 ETNA-AF 中接受依度沙班治疗的伊比利亚人群的基线特征，并将其与之前检索到的葡萄牙数据进行比较。
2017 年 6 月至 2018 年 1 月期间，连续纳入在葡萄牙和西班牙中心接受依度沙班治疗的 NVAF 患者。仅纳入之前有临床决策接受依度沙班治疗的患者。检索患者的基线人口统计学和临床参数、病史和与 AF 相关的特征。
共纳入 892 例 NVAF 患者，平均年龄为 73.9 岁，其中 75.3%接受高剂量（60mg）依度沙班，24.7%接受低剂量（30mg）依度沙班。大多数患者（55.9%）为男性。接受 30mg 和 60mg 依度沙班的患者中，分别有 55.9%和 37.9%的 CHADS-VASc 评分≥4。先前出血事件发生率较低，以临床相关非重大出血为主（1.9%）。大多数 NVAF 患者（47.5%）为阵发性 AF，其次为永久性 AF（26.4%）。总的 CHADS-VASc 评分中位数为 3.0，HAS-BLED 评分中位数为 2.0。之前的治疗大多包括维生素 K 拮抗剂（35.7%）。需要调整剂量的低剂量依度沙班患者比例明显较高（71.4% vs. 8.6%）。总体上，标签剂量建议的依从率为 86.5%。
本研究提供了有关疾病和患者特征的有价值数据，将为依度沙班相关疾病管理和进展以及安全性、有效性和心血管事件模式提供有价值的见解。
