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艾多沙班用于心房颤动常规临床治疗:韩国患者前瞻性观察性ETNA-AF研究的一年结局

Edoxaban treatment in atrial fibrillation in routine clinical care: One-year outcomes of the prospective observational ETNA-AF study in South Korean patients.

作者信息

Choi Eue-Keun, Choi Jong-Il, Park Hyoung-Seob, Hwang Gyo-Seung, Joung Boyoung, Kim Jong-Youn, Kim Dae-Hyeok, Shin Dong Gu, Park Hyung Wook

机构信息

Department of Internal Medicine Seoul National University College of Medicine, Seoul National, University Hospital Seoul South Korea.

Department of Internal Medicine Korea University College of Medicine, Korea University Anam Hospital Seoul South Korea.

出版信息

J Arrhythm. 2023 May 31;39(4):546-555. doi: 10.1002/joa3.12878. eCollection 2023 Aug.

Abstract

BACKGROUND

The real-world outcomes of edoxaban treatment in patients with atrial fibrillation (AF) were analyzed in the ETNA-AF (Edoxaban Treatment in Routine Clinical Practice) study involving data from multiple regional registries. This report addresses effectiveness and safety of edoxaban in the Korean ETNA-AF population.

METHODS

One-year data from 1887 Korean ETNA-AF participants were analyzed according to edoxaban dose and patient age and compared with results of other ETNA-AF registries.

RESULTS

Approximately 70% of patients received the recommended doses of edoxaban (60 mg/30 mg); non-recommended 60 mg and 30 mg doses were prescribed to 9.6% and 19.8% of the patients, respectively. The proportions of reference age (<65 years), youngest-old (65-74 years) and middle-old/oldest-old (≥75 years) groups were 21.4%, 40.2%, and 38.4%, respectively. Incidence of major or clinically relevant nonmajor bleeding was similar within dose (0.57%-1.71%) and age subgroups (1.26%-1.63%). Incidence of net clinical outcome, a composite of stroke, systemic embolic event, major bleeding, and all-cause mortality, was also comparable among dose subgroups (1.14%-3.10%) and age subgroups (2.28%-2.78%). The percentage of Korean patients receiving non-recommended 30 mg (19.8%) was over twice that of the European population (8.4%). However, the clinical outcomes were generally similar among different populations included in the ETNA-AF study.

CONCLUSIONS

The outcomes in the Korean ETNA-AF population are like those in the global ETNA-AF population, with overall low event rates of stroke, major bleeding and all-cause mortality across age and dose subgroups. Edoxaban can be used effectively and safely in specific populations of Korean AF patients, including the elderly.

摘要

背景

在ETNA-AF(艾多沙班在日常临床实践中的治疗)研究中,对多个地区登记处的数据进行了分析,以探讨艾多沙班治疗心房颤动(AF)患者的真实世界结局。本报告阐述了艾多沙班在韩国ETNA-AF人群中的有效性和安全性。

方法

根据艾多沙班剂量和患者年龄,对1887名韩国ETNA-AF参与者的一年数据进行分析,并与其他ETNA-AF登记处的结果进行比较。

结果

约70%的患者接受了推荐剂量的艾多沙班(60mg/30mg);分别有9.6%和19.8%的患者接受了未推荐的60mg和30mg剂量。参考年龄组(<65岁)、年轻老年人组(65-74岁)和中老年/最年长者组(≥75岁)的比例分别为21.4%、40.2%和38.4%。主要或临床相关非大出血的发生率在剂量亚组(0.57%-1.71%)和年龄亚组(1.26%-1.63%)中相似。净临床结局(中风、全身性栓塞事件、大出血和全因死亡率的综合指标)的发生率在剂量亚组(1.14%-3.10%)和年龄亚组(2.28%-2.78%)中也相当。接受未推荐30mg剂量的韩国患者比例(19.8%)是欧洲人群(8.4%)的两倍多。然而,ETNA-AF研究纳入的不同人群的临床结局总体相似。

结论

韩国ETNA-AF人群的结局与全球ETNA-AF人群相似,各年龄和剂量亚组的中风、大出血和全因死亡率总体事件率较低。艾多沙班可在包括老年人在内的特定韩国房颤患者人群中有效且安全地使用。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9540/10407161/edc3123e1d93/JOA3-39-546-g002.jpg

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