缺血核心真的重要吗?继 TESLA、TENSION 和 LASTE 之后的大型核心试验的最新系统回顾和元分析

Mohammad AlMajali, Mahmoud Dibas, Malik Ghannam, M. Galecio-Castillo, Abdullah Al Qudah, Farid Khasiyev, J. Vivanco-Suarez, A. Rodriguez-Calienes, M. Farooqui, Sophie Shogren, Fawaz AlMajali, Albert Yoo, Edgar A. Samaniego, T. Jovin, A. Sarraj, S. Ortega‐Gutierrez
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引用次数: 0

摘要

随着血栓切除术紧急抢救大面积前循环缺血性卒中 (TESLA)、血栓切除术在卒中扩展病变和扩展时间窗 (TENSION) 中的疗效和安全性 (Efficacy and Safety of Thrombectomy In Stroke with Extended Lesion and Extended Time Window) 以及大面积卒中治疗评估 (LASTE) 试验的开展,支持在急性缺血性卒中大面积核心区患者中使用血管内血栓切除术 (EVT) 的现有证据有所增加,提供了最初试验未包括的其他亚组的重要信息。我们的目的是通过对汇总数据进行全面荟萃分析,研究EVT对急性缺血性卒中大核心患者的疗效和安全性,并根据几个亚组(包括发病时的核心梗死)进行分层。 我们进行了系统检索,以确定在治疗急性缺血性脑卒中大核心患者时,EVT 与内科治疗(MM)进行比较的随机对照试验,大核心定义为非对比 CT 上阿尔伯塔卒中计划早期 CT [计算机断层扫描] 评分≤5,和/或 CT-灌注/MR 弥散上估计缺血核心≥50 mL。主要结果是90天改良Rankin量表(mRS)评分的变化分析。次要结果包括功能独立性(mRS 评分 0-2)、独立行走能力(mRS 评分 0-3)、90 天死亡率和症状性颅内出血。通过随机效应荟萃分析计算了mRS评分移位的汇总几率比,并对其他结果采用了风险比(RR),将EVT与单纯MM进行了比较。 在筛选出的3402篇标题和摘要中,共纳入了6项随机对照试验,1886名患者。与单纯MM相比,EVT组患者的mRS转为更低(几率比[OR],1.49 [95% CI,1.24-1.79])。此外,与 MM 相比,EVT 与更高的功能独立率(19.5% 对 7.5%,RR,2.49 [95% CI,1.92-3.24])、独立行走率(36.5% 对 19.9%,RR,1.91 [95% CI,1.51-2.43])和无症状颅内出血率(5.5% 对 3.2%,RR,1.73 [95% CI,1.01-2.95])相关。两组患者的死亡率没有差异(31.5% 对 36.8%,RR,0.86 [95% CI,0.72-1.02])。重要的是,与单纯 MM 相比,EVT 始终与阿尔伯塔省卒中计划早期 CT 评分 3-5 级(OR,1.60 [95% CI,1.10-2.32])和阿尔伯塔省卒中计划早期 CT 评分 0-2 级(OR,1.45 [95% CI,1.17-1.80])的 mRS 评分降低相关。 我们的结果证实了 EVT 对急性大核心缺血性卒中的疗效,并表明在所有艾伯塔省卒中计划早期 CT 评分类别中都有一致的获益。目前的大血管闭塞选择范式将核心作为 EVT 选择的效应调节因子,这些结果代表了这一范式的重要转变。
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Does the Ischemic Core Really Matter? An Updated Systematic Review and Meta‐Analysis of Large Core Trials After TESLA, TENSION, and LASTE
The available evidence supporting the use of endovascular thrombectomy (EVT) in acute ischemic stroke patients with large core has increased with the recent release of the Thrombectomy for Emergent Salvage of Large Anterior Circulation Ischemic Stroke (TESLA), Efficacy and Safety of Thrombectomy In Stroke with Extended Lesion and Extended Time Window (TENSION), and Large Stroke Therapy Evaluation (LASTE) trials, providing critical information on additional subgroups not included in initial trials. We aimed to study the efficacy and safety of EVT in patients with acute ischemic stroke with large core and stratify by several subgroups including core infarct at presentation, using a comprehensive meta‐analysis of aggregate data. We executed a systematic search to identify randomized controlled trials that compared EVT to medical management (MM) for the treatment of patients with acute ischemic stroke with large core, defined as Alberta Stroke Program Early CT [Computed Tomography] Score ≤5 on noncontrast CT and/or estimated ischemic core ≥50 mL on CT‐perfusion/MR diffusion. The primary outcome was the shift analysis in the 90‐day modified Rankin scale (mRS) score. Secondary outcomes included functional independence (mRS score 0–2), independent ambulation (mRS score 0–3), 90‐day mortality, and symptomatic intracranial hemorrhage. Pooled odds ratios were calculated for shift mRS score through the random‐effects meta‐analyses, and risk ratios (RRs) were used for the other outcomes, comparing EVT with MM alone. Out of 3402 titles and abstracts screened, 6 randomized controlled trials with 1886 patients were included. The EVT group had a higher shift toward a lower mRS than MM alone (odds ratio [OR], 1.49 [95% CI, 1.24–1.79]). Furthermore, the use of EVT was associated with higher rates of functional independence (19.5% versus 7.5%, RR, 2.49 [95% CI, 1.92–3.24]), independent ambulation (36.5% versus 19.9%, RR, 1.91 [95% CI, 1.51–2.43]), and symptomatic intracranial hemorrhage (5.5% versus 3.2%, RR, 1.73 [95% CI, 1.01–2.95]) compared with MM. There was no difference between the 2 groups regarding mortality (31.5% versus 36.8%, RR, 0.86 [95% CI, 0.72–1.02]). Importantly, EVT was consistently associated with a shift toward a lower mRS score in both Alberta Stroke Program Early CT Score 3–5 (OR, 1.60 [95% CI, 1.10–2.32]) and Alberta Stroke Program Early CT Score 0–2 (OR, 1.45 [95% CI, 1.17–1.80]) when compared with MM alone. Our results confirm the efficacy of EVT for acute ischemic stroke with large core and suggest a consistent benefit across all Alberta Stroke Program Early CT Score categories. These results represent an important shift in the current large vessel occlusion selection paradigm that currently considers core as an effect modifier for EVT selection.
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