Diagnostic and Interventional Neuroradiology, University Hospital Bern, University of Bern, Bern, Switzerland.
Neurology, Helsinki University Hospital, University of Helsinki, Helsinki, Finland.
Eur Stroke J. 2024 Dec;9(4):907-917. doi: 10.1177/23969873241249406. Epub 2024 May 17.
The benefit of endovascular therapy (EVT) among stroke patients with large ischemic core (ASPECTS 0-5) in the extended time window outside of trial settings remains unclear. We analyzed the effect of EVT among these stroke patients in real-world settings.
The CT for Late Endovascular Reperfusion (CLEAR) study recruited patients from 66 centers in 10 countries between 01/2014 and 05/2022. The extended time-window was defined as 6-24 h from last-seen-well to treatment. The primary outcome was shift of the 3-month modified Rankin scale (mRS) score. Safety outcomes included symptomatic intracranial hemorrhage (sICH) and mortality. Outcomes were analyzed with ordinal and logistic regressions.
Among 5098 screened patients, 2451 were included in the analysis (median age 73, 55% women). Of patients with ASPECTS 0-5 ( = 310), receiving EVT ( = 209/310) was associated with lower 3-month mRS when compared to medical management (median 4 IQR 3-6 vs 6 IQR 4-6; aOR 0.4, 95% CI 0.2-0.7). Patients undergoing EVT had higher sICH (11.2% vs 4.0%; aOR 4.1, 95% CI 1.2-18.8) and lower mortality (31.6% vs 58.4%, aOR 0.4; 95% CI 0.2-0.9) compared to medically managed patients. The relative benefit of EVT was comparable between patients with ASPECTS 0 and 5 and 6-10 in the extended time window (interaction aOR 0.9; 95% CI 0.5-1.7).
In the extended time window, patients with ASPECTS 0-5 may have preserved relative treatment benefit of EVT compared to patients with ASPECTS 6-10. These findings are in line with recent trials showing benefit of EVT among real-world patients with large ischemic core in the extended time window.
clinicaltrials.gov; Unique identifier: NCT04096248.
在临床试验设定的时间窗之外，对于大核心梗死区（ASPECTS 0-5）的卒中患者，血管内治疗（EVT）的获益仍不明确。本研究分析了在真实环境下这些卒中患者接受 EVT 的效果。
CT 用于晚期血管再灌注（CLEAR）研究于 2014 年 1 月至 2022 年 5 月在 10 个国家的 66 个中心招募患者。时间窗延长定义为从最后可评估时间至治疗的 6-24 小时。主要结局是 3 个月时改良 Rankin 量表（mRS）评分的变化。安全性结局包括症状性颅内出血（sICH）和死亡率。采用有序和逻辑回归分析结局。
在 5098 例筛选患者中，2451 例纳入分析（中位年龄 73 岁，55%为女性）。ASPECTS 0-5 的患者中（n=310），与药物治疗相比，接受 EVT（n=209/310）的患者 3 个月时 mRS 评分较低（中位数 4 个 IQR 3-6 比 6 个 IQR 4-6；优势比 0.4，95%置信区间 0.2-0.7）。行 EVT 的患者 sICH 发生率较高（11.2%比 4.0%；优势比 4.1，95%置信区间 1.2-18.8），死亡率较低（31.6%比 58.4%，优势比 0.4；95%置信区间 0.2-0.9）。与药物治疗组相比，在延长的时间窗内，ASPECTS 0 与 5 及 6-10 患者接受 EVT 的相对获益相当（交互优势比 0.9；95%置信区间 0.5-1.7）。
在延长的时间窗内，ASPECTS 0-5 的患者与 ASPECTS 6-10 的患者相比，可能仍保留有 EVT 的相对治疗获益。这些发现与最近的临床试验一致，即表明在延长的时间窗内，大核心梗死区的真实世界患者中 EVT 有获益。
clinicaltrials.gov；注册号：NCT04096248。
