Population Health Sciences Program, Morningside Graduate School of Biomedical Sciences, University of Massachusetts Chan Medical School, Worcester, MA, 01655, USA.
Division of Epidemiology, Department of Population and Quantitative Health Services, University of Massachusetts Chan Medical School, 55 N Lake Ave, Worcester, MA, 01655, USA.
BMC Geriatr. 2024 Jul 19;24(1):619. doi: 10.1186/s12877-024-05186-9.
Nursing home residents with atrial fibrillation are at high risk for ischemic stroke, but most are not treated with anticoagulants. This study compared the effectiveness and safety between oral anticoagulant (OAC) users and non-users.
We conducted a new-user retrospective cohort study by using Minimum Data Set 3.0 assessments linked with Medicare claims. The participants were Medicare fee-for-service beneficiaries with atrial fibrillation residing in US nursing homes between 2011 and 2016, aged ≥ 65 years. The primary outcomes were occurrence of an ischemic stroke or systemic embolism (effectiveness), occurrence of intracranial or extracranial bleeding (safety) and net clinical outcome (effectiveness or safety outcomes). Secondary outcomes included total mortality and a net clinical and mortality outcome. Cox proportional hazards and Fine and Grey models estimated multivariable adjusted hazard ratios (aHRs) and sub-distribution hazard ratios (sHRs).
Outcome rates were low (effectiveness: OAC: 0.86; non-users: 1.73; safety: OAC: 2.26; non-users: 1.75 (per 100 person-years)). OAC use was associated with a lower rate of the effectiveness outcome (sHR: 0.69; 95% Confidence Interval (CI): 0.61-0.77), higher rates of the safety (sHR: 1.70; 95% CI: 1.58-1.84) and net clinical outcomes (sHR: 1.20; 95% CI: 1.13-1.28) lower rate of all-cause mortality outcome (sHR: 0.60; 95% CI: 0.59-0.61), and lower rate of the net clinical and mortality outcome (sHR: 0.60; 95% CI: 0.59-0.61). Warfarin users, but not DOAC users, had a higher rate of the net clinical outcome versus OAC non-users.
Our results support the benefits of treatment with OACs to prevent ischemic strokes and increase longevity, while highlighting the need to weigh apparent benefits against elevated risk for bleeding. Results were consistent with net favorability of DOACs versus warfarin.
养老院中患有心房颤动的患者存在发生缺血性中风的高风险，但大多数患者并未接受抗凝治疗。本研究比较了口服抗凝剂（OAC）使用者与非使用者之间的有效性和安全性。
我们通过使用最低数据集 3.0 评估并与医疗保险索赔相联系，进行了一项新用户回顾性队列研究。参与者为 2011 年至 2016 年期间居住在美国养老院、年龄≥65 岁且患有心房颤动的医疗保险付费服务受益人。主要结局为发生缺血性中风或全身性栓塞（有效性）、颅内或颅外出血（安全性）和净临床结局（有效性或安全性结局）。次要结局包括总死亡率和净临床和死亡率结局。Cox 比例风险和 Fine 和 Grey 模型估计多变量调整后的风险比（aHR）和亚分布风险比（sHR）。
结局发生率较低（有效性：OAC：0.86；非使用者：1.73；安全性：OAC：2.26；非使用者：1.75（每 100 人年））。OAC 使用与较低的有效性结局发生率相关（sHR：0.69；95%置信区间（CI）：0.61-0.77）、较高的安全性结局发生率（sHR：1.70；95%CI：1.58-1.84）和净临床结局发生率（sHR：1.20；95%CI：1.13-1.28）、较低的全因死亡率结局发生率（sHR：0.60；95%CI：0.59-0.61）和较低的净临床和死亡率结局发生率（sHR：0.60；95%CI：0.59-0.61）。华法林使用者而非直接口服抗凝剂使用者与 OAC 非使用者相比，净临床结局发生率更高。
我们的研究结果支持使用 OAC 治疗以预防缺血性中风和延长寿命的益处，同时强调需要权衡出血风险增加的明显益处。结果与 DOAC 优于华法林的净获益一致。
