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直接口服抗凝剂与华法林用于日本≥85岁房颤患者的临床结局:一项单中心观察性研究

Clinical Outcomes of Direct Oral Anticoagulants and Warfarin in Japanese Patients with Atrial Fibrillation Aged ≥ 85 Years: A Single-Center Observational Study.

作者信息

Naganuma Miyoko, Shiga Tsuyoshi, Hagiwara Nobuhisa

机构信息

Department of Pharmacy, International University of Health and Welfare Atami Hospital, Atami, Japan.

Department of Cardiology, Tokyo Women's Medical University, Tokyo, Japan.

出版信息

Drugs Real World Outcomes. 2020 Dec;7(4):325-335. doi: 10.1007/s40801-020-00209-4.

Abstract

BACKGROUND

Increasing age is associated with an increase in stroke in patients with nonvalvular atrial fibrillation (NVAF). Elderly patients have several comorbidities and increased bleeding risk.

OBJECTIVE

The aim of this study was to evaluate the clinical outcomes of Japanese patients with NVAF aged ≥ 85 years who were treated with direct oral anticoagulants (DOACs) or warfarin.

METHODS

We retrospectively studied the records of 358 patients with NVAF aged ≥ 85 years who had taken DOACs or warfarin between 2014 and 2018. The primary endpoints were the first occurrences of thromboembolic and bleeding events and death. The secondary endpoint was the discontinuation of oral anticoagulation (OAC) therapy.

RESULTS

During a median follow-up period of 17 months, 24 patients died. The incidence (per 100 patient-years [PY]) of thromboembolic events was 1.8 in patients treated with DOACs and 2.2 in those treated with warfarin (adjusted subdistribution hazard ratio [SHR] 0.69; 95% confidence interval [CI] 0.23-2.12 in a competing model), and the incidence of major bleeding events was 3.1 and 4.2 in patients treated with DOACs and warfarin, respectively (adjusted SHR 0.95; 95% CI 0.32-2.86). The most common cause of bleeding events was gastrointestinal bleeding. A total of 33 patients permanently discontinued OAC therapy, at a median age of 89 years and with no differences between DOACs and warfarin. The most common reason for discontinuing OAC therapy was bleeding events.

CONCLUSION

Our results revealed that the incidences of thromboembolism and major bleeding among patients with NVAF aged ≥ 85 years were similar for those treated with DOACs and those treated with warfarin. Approximately 10% of patients permanently discontinued OAC therapy.

摘要

背景

年龄增长与非瓣膜性心房颤动(NVAF)患者中风风险增加相关。老年患者存在多种合并症且出血风险增加。

目的

本研究旨在评估年龄≥85岁的日本NVAF患者接受直接口服抗凝剂(DOACs)或华法林治疗的临床结局。

方法

我们回顾性研究了2014年至2018年间358例年龄≥85岁且服用DOACs或华法林的NVAF患者的记录。主要终点是血栓栓塞和出血事件及死亡的首次发生。次要终点是口服抗凝(OAC)治疗的中断。

结果

在中位随访期17个月期间,24例患者死亡。接受DOACs治疗的患者血栓栓塞事件发生率(每100患者年[PY])为1.8,接受华法林治疗的患者为2.2(竞争模型中的调整后亚分布风险比[SHR]为0.69;95%置信区间[CI]为0.23 - 2.12),接受DOACs和华法林治疗的患者大出血事件发生率分别为3.1和4.2(调整后SHR为0.95;95%CI为0.32 - 2.86)。出血事件最常见的原因是胃肠道出血。共有33例患者永久停用OAC治疗,中位年龄为89岁,DOACs组和华法林组之间无差异。停用OAC治疗最常见的原因是出血事件。

结论

我们的结果显示,年龄≥85岁的NVAF患者中,接受DOACs治疗和接受华法林治疗的患者血栓栓塞和大出血发生率相似。约10%的患者永久停用OAC治疗。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/95cf/7581660/6ed8ec24ef62/40801_2020_209_Fig1_HTML.jpg

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