Kirchhof Paulus, Bakhai Ameet, de Asmundis Carlo, de Groot Joris R, Deharo Jean Claude, Kelly Peter, Lopez-de-Sa Esteban, Monteiro Pedro, Fronk Eva-Maria, Lamparter Mathias, Laeis Petra, Smolnik Rüdiger, Steffel Jan, Waltenberger Johannes, Weiss Thomas W, De Caterina Raffaele
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, Hamburg 20246, Germany; German Center for Cardiovascular Sciences (DZHK), Partner Site Hamburg/Kiel/Lübeck, Germany.
Department of Cardiology, Royal Free London NHS Foundation Trust, Pond Street, London NW3 2QG, UK.
Int J Cardiol. 2024 Aug 1;408:132118. doi: 10.1016/j.ijcard.2024.132118. Epub 2024 Apr 30.
To assess long-term effectiveness and safety of edoxaban in Europe.
ETNA-AF-Europe, a prospective, multinational, multi-centre, post-authorisation, observational study was conducted in agreement with the European Medicines Agency. The primary and secondary objectives assessed real-world safety (including bleeding and deaths) and effectiveness (including stroke, systemic embolic events and clinical edoxaban use), respectively. Median (interquartile range) age of the 13,164 patients was 75.0 (68.0-80.0) years; CHADS-VASc and HAS-BLED scores were 3.0 (2.0-4.0) and 2.0 (1.0-2.0), respectively. Follow-up duration was 3.98 (3.21-4.05) years. Patients on edoxaban 30 mg (n = 3042) at baseline were older (80.0 vs 73.0 years), more likely assessed as frail by investigators (27.0% vs 6.6%) and had more comorbidities than those on edoxaban 60 mg (n = 9617; missing dosing information for n = 505). Annualised event rates of all-cause and cardiovascular death in the overall population, edoxaban 60 mg and edoxaban 30 mg groups were 4.1%, 2.8% and 8.4%, and 1.0%, 0.7% and 2.0%, respectively. Annualised rates of stroke were relatively constant throughout the follow-up, transient ischaemic attack and systemic embolism were < 1% in the overall population. Rates of any major and major gastrointestinal bleeding were low, with slightly higher rates for edoxaban 30 vs 60 mg group. Intracranial haemorrhage was uncommon (0.2%).
In European patients with AF, long-term therapy with edoxaban is associated with low and relatively constant annualised rates of stroke and major bleeding. Differences in outcomes between the two approved doses are attributable to differences in clinical characteristics.
评估在欧洲使用依度沙班的长期有效性和安全性。
ETNA-AF-Europe是一项前瞻性、跨国、多中心、上市后观察性研究，按照欧洲药品管理局的要求开展。主要和次要目标分别评估了真实世界中的安全性（包括出血和死亡情况）和有效性（包括卒中、全身性栓塞事件以及依度沙班的临床使用情况）。13164例患者的年龄中位数（四分位间距）为75.0（68.0 - 80.0）岁；CHADS-VASc和HAS-BLED评分分别为3.0（2.0 - 4.0）和2.0（1.0 - 2.0）。随访时长为3.98（3.21 - 4.05）年。基线时服用30mg依度沙班的患者（n = 3042）年龄更大（80.0岁 vs 73.0岁），被研究者评估为身体虚弱的可能性更高（27.0% vs 6.6%），且合并症比服用60mg依度沙班的患者（n = 9617；505例给药信息缺失）更多。总体人群、依度沙班60mg组和依度沙班30mg组的全因死亡和心血管死亡年化发生率分别为4.1%、2.8%和8.4%，以及1.0%、0.7%和2.0%。在整个随访期间，卒中的年化发生率相对稳定，总体人群中短暂性脑缺血发作和全身性栓塞的发生率<1%。任何严重及严重胃肠道出血的发生率较低，依度沙班30mg组的发生率略高于60mg组。颅内出血不常见（0.2%）。
在欧洲房颤患者中，依度沙班长期治疗的卒中及严重出血年化发生率较低且相对稳定。两种批准剂量的疗效差异归因于临床特征的不同。
