Abstract：
BACKGROUND: To assess long-term effectiveness and safety of edoxaban in Europe.
RESULTS: 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; CHA2DS2-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%).
CONCLUSIONS: 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.
RESULTS: 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; CHA2DS2-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%).
CONCLUSIONS: 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.
摘要：
背景：评估依度沙班在欧洲的长期有效性和安全性。
结果：ETNA-AF-Europe，一个潜在的，跨国公司,多中心,授权后，观察性研究与欧洲药品管理局达成一致.主要和次要目标评估真实世界的安全性（包括出血和死亡）和有效性（包括卒中，全身栓塞事件和临床使用依度沙班)，分别。13,164例患者的中位（四分位数范围）年龄为75.0（68.0-80.0）岁；CHA2DS2-VASc和HAS-BLED评分分别为3.0（2.0-4.0）和2.0（1.0-2.0），分别。随访时间为3.98（3.21-4.05）年。基线时服用依度沙班30mg（n=3042）的患者年龄较大（80.0vs73.0岁），更有可能被研究者评估为虚弱(27.0%vs6.6%),并且合并症多于依度沙班60mg组(n=9617;缺失给药信息n=505).在整个人群中，全因死亡和心血管死亡的年度事件发生率，依度沙班60mg和依度沙班30mg组分别为4.1%,2.8%和8.4%，和1.0%，0.7%和2.0%，分别。在整个随访期间，中风的年化比率相对恒定，在总体人群中,短暂性脑缺血发作和全身性栓塞的发生率<1%.任何主要和主要胃肠道出血的发生率都很低，依度沙班30与60mg组的比率略高。颅内出血并不常见（0.2%）。
结论：在欧洲房颤患者中，依度沙班长期治疗与卒中和大出血的年发病率较低且相对恒定相关.两种批准剂量之间结果的差异可归因于临床特征的差异。
结果：ETNA-AF-Europe，一个潜在的，跨国公司,多中心,授权后，观察性研究与欧洲药品管理局达成一致.主要和次要目标评估真实世界的安全性（包括出血和死亡）和有效性（包括卒中，全身栓塞事件和临床使用依度沙班)，分别。13,164例患者的中位（四分位数范围）年龄为75.0（68.0-80.0）岁；CHA2DS2-VASc和HAS-BLED评分分别为3.0（2.0-4.0）和2.0（1.0-2.0），分别。随访时间为3.98（3.21-4.05）年。基线时服用依度沙班30mg（n=3042）的患者年龄较大（80.0vs73.0岁），更有可能被研究者评估为虚弱(27.0%vs6.6%),并且合并症多于依度沙班60mg组(n=9617;缺失给药信息n=505).在整个人群中，全因死亡和心血管死亡的年度事件发生率，依度沙班60mg和依度沙班30mg组分别为4.1%,2.8%和8.4%，和1.0%，0.7%和2.0%，分别。在整个随访期间，中风的年化比率相对恒定，在总体人群中,短暂性脑缺血发作和全身性栓塞的发生率<1%.任何主要和主要胃肠道出血的发生率都很低，依度沙班30与60mg组的比率略高。颅内出血并不常见（0.2%）。
结论：在欧洲房颤患者中，依度沙班长期治疗与卒中和大出血的年发病率较低且相对恒定相关.两种批准剂量之间结果的差异可归因于临床特征的差异。
