养老院中患有房颤的患者使用直接口服抗凝剂与华法林的比较效果和安全性：一项回顾性队列研究。
Comparative Effectiveness and Safety of Direct Oral Anticoagulants vs Warfarin among Nursing Home Residents with Atrial Fibrillation: A Retrospective Cohort Study.
机构信息
Center for Drug Safety and Effectiveness, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA; Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.
Center for Drug Safety and Effectiveness, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA; Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.
出版信息
J Am Med Dir Assoc. 2024 Dec;25(12):105294. doi: 10.1016/j.jamda.2024.105294. Epub 2024 Oct 4.
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.
目的
养老院的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的口服抗凝剂（DOAC）与华法林在 NVAF 养老院居民中的真实世界比较安全性和有效性。
设计
使用 2011 年 1 月至 2018 年 12 月 100%全国最低数据组和链接医疗保险索赔的回顾性队列研究。
设置和参与者
长期护理养老院中年龄≥66 岁的居民，参加收费服务医疗保险。我们纳入了新开始口服抗凝剂的 NVAF 诊断个体。
方法
我们确定了 DOAC（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。结果是缺血性卒中/全身性栓塞、大出血、肺炎（阴性对照结果）和全因死亡的住院治疗。我们使用逆概率治疗加权竞争风险回归模型进行临床结局分析，以及 Cox 比例风险回归进行全因死亡分析。
结果
在 38983 名新开始抗凝治疗的个体中，19366 名（49.7%）开始使用 DOAC，19617 名（50.3%）开始使用华法林。在逆概率治疗加权分析中，与华法林相比，DOAC 使用与缺血性卒中/全身性栓塞之间没有统计学显著关联[每 100 人年 4.5 至 4.7 例事件；调整后的危险比（aHR），0.94；95%CI，0.84-1.05]或大出血[每 100 人年 12.6 至 12.4 例事件；aHR，1.03；95%CI，0.96-1.10]。DOAC 治疗与全因死亡风险略有降低但具有统计学意义相关（每 100 人年 48.1 至 49.0 例事件；IPTW 分析 aHR，0.95；95%CI，0.91-0.98）。
结论和意义
在 NVAF 养老院居民中，DOAC 和华法林与缺血性卒中/全身性栓塞和大出血的风险相似。然而，使用 DOAC 与全因死亡率降低略有相关。
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