直接口服抗凝药与华法林在患有心房颤动的养老院居民中的有效性和安全性比较:回顾性队列研究

IF 4.2 2区 医学 Q2 GERIATRICS & GERONTOLOGY Journal of the American Medical Directors Association Pub Date : 2024-10-04 DOI:10.1016/j.jamda.2024.105294
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引用次数: 0

摘要

目的:养老院居民通常被排除在临床试验之外,包括评估非瓣膜性心房颤动(NVAF)等常见疾病治疗方法的试验。我们旨在量化直接作用口服抗凝药(DOACs)与华法林在患有非瓣膜性心房颤动(NVAF)的疗养院居民中的实际安全性和有效性比较:回顾性队列研究,使用100%的国家最低数据集和2011年1月至2018年12月的医疗保险索赔链接:年龄≥66 岁的长期护理疗养院住院患者,参加付费服务的医疗保险。我们纳入了被诊断为 NVAF 的新开始使用口服抗凝药物的患者:我们确定了DOACs(阿哌沙班、达比加群、利伐沙班和依度沙班)与华法林的暴露情况。结果为缺血性中风/系统性栓塞住院、大出血、肺炎(阴性对照结果)和全因死亡。我们对临床结果采用了逆概率治疗加权竞争风险回归模型,对全因死亡采用了考克斯比例危险度回归模型:在新开始使用抗凝药物的 38,983 人中,19,366 人(49.7%)开始使用 DOACs,19,617 人(50.3%)开始使用华法林。在逆治疗概率加权分析中,与华法林相比,使用 DOAC 与缺血性中风/系统性栓塞(每 100 人年 4.5 例 vs 4.7 例;调整后危险比 [aHR],0.94;95% CI,0.84-1.05)或大出血(每 100 人年 12.6 例 vs 12.4 例;aHR,1.03;95% CI,0.96-1.10)之间没有统计学意义上的显著关联。使用 DOACs 可适度降低全因死亡风险(48.1 vs 49.0 例/100 人-年;IPTW 分析 aHR,0.95;95% CI,0.91-0.98),但具有统计学意义:在患有 NVAF 的疗养院居民中,DOACs 和华法林与缺血性中风/系统性栓塞和大出血的风险相似。然而,使用 DOACs 会略微降低全因死亡风险。
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Comparative Effectiveness and Safety of Direct Oral Anticoagulants vs Warfarin among Nursing Home Residents with Atrial Fibrillation: A Retrospective Cohort Study

Objective

Residents of nursing homes are usually excluded from clinical trials, including trials to assess treatments for common conditions such as nonvalvular atrial fibrillation (NVAF). We aimed to quantify the real-world comparative safety and effectiveness of direct-acting oral anticoagulants (DOACs) vs warfarin among nursing home residents with NVAF.

Design

Retrospective cohort study using 100% national Minimum Data Set and linked Medicare claims from January 2011 through December 2018.

Setting and Participants

Long-term care nursing home residents aged ≥66 years enrolled in fee-for-service Medicare. We included individuals diagnosed with NVAF newly initiating oral anticoagulants.

Methods

We identified exposure to DOACs (apixaban, dabigatran, rivaroxaban, and edoxaban) vs warfarin. Outcomes were hospitalization for ischemic stroke/systemic embolism, major bleeding, pneumonia (negative control outcome), and all-cause death. We used inverse probability of treatment weighting competing risk regression models for clinical outcomes and Cox proportional hazards regression for all-cause death.

Results

Of 38,983 individuals newly initiating anticoagulants, 19,366 (49.7%) initiated DOACs and 19,617 (50.3%) initiated warfarin. In the inverse probability of treatment weighting analysis, compared with warfarin, there was no statistically significant association between DOAC use and ischemic stroke/systemic embolism [4.5 vs 4.7 events per 100 person-years; adjusted hazard ratio (aHR), 0.94; 95% CI, 0.84–1.05] or major bleeding (12.6 vs 12.4 events per 100 person-years; aHR, 1.03; 95% CI, 0.96–1.10). DOACs use was associated with a modest but statistically significant lower risk of all-cause death (48.1 vs 49.0 events per 100 person-years; IPTW analysis aHR, 0.95; 95% CI, 0.91–0.98).

Conclusions and Implications

Among nursing home residents with NVAF, DOACs and warfarin were associated with a similar risk of ischemic stroke/systemic embolism and major bleeding. However, the use of DOACs was associated with a slightly reduced risk of all-cause mortality.
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来源期刊
CiteScore
11.10
自引率
6.60%
发文量
472
审稿时长
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期刊介绍: JAMDA, the official journal of AMDA - The Society for Post-Acute and Long-Term Care Medicine, is a leading peer-reviewed publication that offers practical information and research geared towards healthcare professionals in the post-acute and long-term care fields. It is also a valuable resource for policy-makers, organizational leaders, educators, and advocates. The journal provides essential information for various healthcare professionals such as medical directors, attending physicians, nurses, consultant pharmacists, geriatric psychiatrists, nurse practitioners, physician assistants, physical and occupational therapists, social workers, and others involved in providing, overseeing, and promoting quality
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