Institute of Cardiovascular Sciences, University of Birmingham, IBR 136, Wolfson Drive, Birmingham B15 2TT, UK.
Department of Cardiology, University Heart and Vascular Centre Hamburg, University Medical Centre Hamburg Eppendorf, Martinistraße 52, 20246 Hamburg, Germany.
Eur Heart J Cardiovasc Pharmacother. 2022 Dec 15;9(1):47-57. doi: 10.1093/ehjcvp/pvac042.
Patients with atrial fibrillation (AF) treated with oral anticoagulation still suffer from cardiovascular complications including cardiovascular death, stroke, and major bleeding. To identify risk factors for predicting stroke and bleeding outcomes in anticoagulated patients, we assessed 2-year outcomes in patients with AF treated with edoxaban in routine care. We also report the age-adjusted risk predictors of clinical outcomes.
The Edoxaban Treatment in Routine Clinical Practice for Patients With Non-Valvular Atrial Fibrillation (ETNA-AF) Europe (NCT02944019) is a prospective, multi-centre, post-authorisation, observational study with an overall 4-year follow-up conducted in 825 centres enrolling edoxaban-treated patients in 10 European countries. Of the 13 133 patients with AF (mean age: 73.6 ± 9.5 years), 5682 (43.3%) were female. At the 2-year follow-up, 9017/13 133 patients were still on edoxaban; 1830 discontinued treatment including 937 who died (annualised event rate of all-cause death was 3.87%). 518 (2.14%) patients died of cardiovascular causes; 234 (0.97%) experienced major bleeding and 168 (0.70%) experienced stroke or systemic embolic events (SEE). Intracranial haemorrhage was noted in 49 patients (0.20%). History of transient ischaemic attack (TIA) at baseline was the strongest predictor of ischaemic stroke or SEE (Wald χ2: 73.63; P < 0.0001). Low kidney function at baseline was the strongest predictor of major bleeding (Wald χ2: 30.68; P < 0.0001). History of heart failure (HF) was the strongest predictor of all-cause (Wald χ2: 146.99; P < 0.0001) and cardiovascular death (Wald χ2: 100.38; P < 0.0001).
Patients treated with edoxaban in ETNA-AF-Europe reported low 2-year event rates in unselected AF patients. Prior stroke, reduced kidney function, and HF identify patients at high risk of stroke, bleeding and all-cause/cardiovascular death, respectively.
接受口服抗凝治疗的心房颤动（AF）患者仍会发生心血管并发症，包括心血管死亡、卒中和大出血。为了确定预测抗凝治疗患者卒中和出血结局的危险因素，我们评估了在常规护理中接受依度沙班治疗的 AF 患者的 2 年结局。我们还报告了年龄调整后临床结局的风险预测因素。
依度沙班治疗非瓣膜性心房颤动常规临床实践中的患者（ETNA-AF-Europe）（NCT02944019）是一项前瞻性、多中心、上市后、观察性研究，总体随访 4 年，在 825 个中心进行，招募了 10 个欧洲国家接受依度沙班治疗的患者。在 13133 例 AF 患者中（平均年龄：73.6±9.5 岁），5682 例（43.3%）为女性。在 2 年随访时，13133 例患者中有 9017 例仍在接受依度沙班治疗；1830 例停止治疗，其中 937 例死亡（全因死亡率的年化事件率为 3.87%）。518 例（2.14%）患者因心血管原因死亡；234 例（0.97%）发生大出血，168 例（0.70%）发生卒中和全身性栓塞事件（SEE）。49 例（0.20%）患者发生颅内出血。基线时短暂性脑缺血发作（TIA）病史是缺血性卒中和 SEE 的最强预测因素（Wald χ2：73.63；P<0.0001）。基线时肾功能降低是大出血的最强预测因素（Wald χ2：30.68；P<0.0001）。心力衰竭（HF）病史是全因（Wald χ2：146.99；P<0.0001）和心血管死亡（Wald χ2：100.38；P<0.0001）的最强预测因素。
在 ETNA-AF-Europe 中接受依度沙班治疗的患者报告了未经选择的 AF 患者的低 2 年事件率。既往卒中、肾功能降低和 HF 分别识别出卒中、出血和全因/心血管死亡风险较高的患者。
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