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扩大大缺血性卒中患者的可治疗影像学谱:一项随机临床试验的亚组分析。

Expanding the Treatable Imaging Profile in Patients With Large Ischemic Stroke: Subanalysis From a Randomized Clinical Trial.

机构信息

Division of Stroke Care Unit (M.I.), National Cerebral and Cardiovascular Center, Suita, Japan.

Department of Cerebrovascular Medicine (M.I., K.T.), National Cerebral and Cardiovascular Center, Suita, Japan.

出版信息

Stroke. 2024 Jul;55(7):1730-1738. doi: 10.1161/STROKEAHA.124.046828. Epub 2024 May 28.

DOI:10.1161/STROKEAHA.124.046828
PMID:38804134
Abstract

BACKGROUND

We aimed to examine the boundary of the ischemic core volume in patients undergoing endovascular thrombectomy (EVT) versus those receiving medical management to determine the minimum optimal size for favorable treatment outcomes.

METHODS

This is a prespecified substudy of the RESCUE-Japan LIMIT (Recovery by Endovascular Salvage for Cerebral Ultra-Acute Embolism-Japan Large Ischemic Core Trial). Patients with large vessel occlusion were enrolled between November 2018 and September 2021 with a National Institutes of Health Stroke Scale score of at least 6 on admission and an Alberta Stroke Program Early Computed Tomography Score value of 3 to 5. We investigated the correlation between optimal quantified ischemic core volume, assessed solely using magnetic resonance diffusion-weighted imaging, and functional outcomes (modified Rankin Scale score, 0-3) at 90 days by predictive marginal plots. Final infarct volume and safety outcomes (symptomatic intracerebral hemorrhage and mortality) were also assessed.

RESULTS

Of the 203 cases, 168 patients (85 in the EVT group versus 83 in the medical management group) were included. The median (interquartile range) core volume was 94 (65-160) mL in patients with EVT and 115 (71-141) mL in the medical management group (=0.72). The predictive marginal probabilities of the 2 groups intersected at 128 mL for estimating functional outcomes. Symptomatic intracerebral hemorrhage and mortality within 90 days had overlay margins through all core volumes in both groups. The median final infarct volume (interquartile range) was smaller in the EVT group (142 [80-223] mL versus 211 [123-289] mL in the medical management group; <0.001).

CONCLUSIONS

In this prespecified analysis of a randomized clinical trial involving patients with large ischemic strokes, patients with an estimated core volume of up to 128 mL on diffusion-weighted imaging benefit from EVT.

REGISTRATION

URL: https://www.clinicaltrials.gov; Unique identifier: NCT03702413.

摘要

背景

我们旨在研究接受血管内血栓切除术(EVT)与接受药物治疗的患者的缺血核心体积边界,以确定获得良好治疗效果的最小最佳体积。

方法

这是 RESCUE-Japan LIMIT(通过血管内拯救治疗大脑超急性栓塞-日本大缺血核心试验)的预先指定子研究。2018 年 11 月至 2021 年 9 月期间,纳入了血管闭塞的患者,其入院时 NIHSS 评分至少为 6,且 Alberta 卒中项目早期 CT 评分值为 3 至 5。我们通过预测边缘图研究了仅使用磁共振弥散加权成像评估的最佳量化缺血核心体积与 90 天时的功能结局(改良 Rankin 量表评分,0-3)之间的相关性。还评估了最终梗死体积和安全性结局(症状性颅内出血和死亡率)。

结果

在 203 例患者中,168 例患者(EVT 组 85 例,药物治疗组 83 例)纳入研究。EVT 组的核心体积中位数(四分位距)为 94(65-160)mL,药物治疗组为 115(71-141)mL(=0.72)。两组预测边缘概率在 128mL 处交叉,用于估计功能结局。两组在所有核心体积范围内,症状性颅内出血和 90 天内死亡率的重叠边缘。EVT 组的中位最终梗死体积(四分位距)较小(142[80-223]mL 比药物治疗组的 211[123-289]mL;<0.001)。

结论

在这项针对大缺血性脑卒中患者的随机临床试验的预设分析中,在弥散加权成像上估计核心体积达 128mL 以内的患者可从 EVT 中获益。

注册信息

网址:https://www.clinicaltrials.gov;唯一标识符:NCT03702413。

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