Department of Neurology and Stroke Center (L.M., A.A.P., F.S., V.L.A., C.T., S.T., B.W., J.F., A.Z., T.D., U.F., N.P., G.M.D.M., H.G., L.H.B., P.A.L., S.T.E.), University Hospital Basel and University of Basel, Switzerland.
Neurology and Neurorehabilitation, University Department of Geriatric Medicine Felix Platter, University of Basel, Switzerland (L.M., C.T., H.G., S.T.E.).
Stroke. 2021 Nov;52(11):3472-3481. doi: 10.1161/STROKEAHA.120.033862. Epub 2021 Jul 27.
Data on the effectiveness and safety of direct oral anticoagulants (DOACs) versus vitamin K antagonists (VKAs) in patients with stroke attributable to atrial fibrillation (AF) who were dependent on the daily help of others at hospital discharge are scarce.
Based on prospectively obtained data from the observational Novel-Oral-Anticoagulants-in-Ischemic-Stroke-Patients-longterm registry from Basel, Switzerland, we compared the occurrence of the primary outcome—the composite of recurrent ischemic stroke, major bleeding, and all-cause death—among consecutive patients with AF-stroke treated with either VKAs or DOACs between patients dependent (defined as modified Rankin Scale score, 3–5) and patients independent at discharge. We used simple, adjusted, and weighted Cox proportional hazards regression to account for potential confounders.
We analyzed 801 patients (median age 80 years, 46% female), of whom 391 (49%) were dependent at discharge and 680 (85%) received DOACs. Over a total follow-up of 1216 patient-years, DOAC- compared to VKA-treated patients had a lower hazard for the composite outcome (hazard ratio [HR], 0.58 [95% CI, 0.42–0.81]), as did independent compared to dependent patients (HR, 0.54 [95% CI, 0.40–0.71]). There was no evidence that the effect of anticoagulant type (DOAC versus VKA) on the hazard for the composite outcome differed between dependent (HRdependent, 0.68 [95% CI, 0.45–1.01]) and independent patients (HRindependent, 0.44 [95% CI, 0.26–0.75]) in the simple model (Pinteraction=0.212). Adjusted (HRdependent, 0.74 [95% CI, 0.49–1.11] and HRindependent, 0.51 [95% CI, 0.30–0.87]; Pinteraction=0.284) and weighted models (HRdependent, 0.79 [95% CI, 0.48–1.31] and HRindependent, 0.46 [95% CI, 0.26–0.81]; Pinteraction=0.163) yielded concordant results. Secondary analyses focusing on the individual components of the composite outcome were consistent to the primary analyses.
The benefits of DOACs in patients with atrial fibrillation with a recent stroke were maintained among patients who were dependent on the help of others at discharge.
URL: https://www.clinicaltrials.gov; Unique identifier: NCT03826927.
在因房颤（AF）导致卒中且出院时需要他人日常帮助的患者中，关于直接口服抗凝剂（DOACs）与维生素 K 拮抗剂（VKAs）在有效性和安全性方面的数据较为匮乏。
我们基于瑞士巴塞尔 Novel-Oral-Anticoagulants-in-Ischemic-Stroke-Patients-longterm 观察性注册研究前瞻性获得的数据，比较了连续接受 VKAs 或 DOACs 治疗的 AF 卒中患者中，依赖（定义为改良 Rankin 量表评分 3-5 分）与出院时独立的患者之间，主要结局（复发性缺血性卒中、大出血和全因死亡的复合结局）的发生情况。我们使用简单、调整和加权 Cox 比例风险回归来考虑潜在的混杂因素。
我们分析了 801 例患者（中位年龄 80 岁，46%为女性），其中 391 例（49%）在出院时依赖他人，680 例（85%）接受了 DOAC 治疗。在总计 1216 患者-年的随访中，与 VKA 治疗相比，DOAC 治疗的复合结局风险较低（风险比[HR]，0.58[95%置信区间，0.42-0.81]），与依赖相比，独立的患者风险也较低（HR，0.54[95%置信区间，0.40-0.71]）。在简单模型中，没有证据表明抗凝药物类型（DOAC 与 VKA）对复合结局风险的影响在依赖（HRdependent，0.68[95%置信区间，0.45-1.01]）和独立患者（HRindependent，0.44[95%置信区间，0.26-0.75]）之间存在差异（Pinteraction=0.212）。在调整（HRdependent，0.74[95%置信区间，0.49-1.11]和 HRindependent，0.51[95%置信区间，0.30-0.87]；Pinteraction=0.284）和加权模型（HRdependent，0.79[95%置信区间，0.48-1.31]和 HRindependent，0.46[95%置信区间，0.26-0.81]；Pinteraction=0.163）中得出的结果一致。重点关注复合结局各组成部分的次要分析结果与主要分析结果一致。
在出院时需要他人帮助的房颤伴近期卒中患者中，DOAC 治疗的获益仍可维持。
