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大缺血核心患者血管内血栓切除术与单纯药物治疗的疗效比较:急性缺血性卒中血管内治疗患者选择优化(SELECT)研究的二次分析

Outcomes of Endovascular Thrombectomy vs Medical Management Alone in Patients With Large Ischemic Cores: A Secondary Analysis of the Optimizing Patient's Selection for Endovascular Treatment in Acute Ischemic Stroke (SELECT) Study.

作者信息

Sarraj Amrou, Hassan Ameer E, Savitz Sean, Sitton Clark, Grotta James, Chen Peng, Cai Chunyan, Cutter Gary, Imam Bita, Reddy Sujan, Parsha Kaushik, Pujara Deep, Riascos Roy, Vora Nirav, Abraham Michael, Kamal Haris, Haussen Diogo C, Barreto Andrew D, Lansberg Maarten, Gupta Rishi, Albers Gregory W

机构信息

Department of Neurology, University of Texas McGovern Medical School, Houston.

Department of Neurology, University of Texas Rio Grande Valley, Harlingen.

出版信息

JAMA Neurol. 2019 Oct 1;76(10):1147-1156. doi: 10.1001/jamaneurol.2019.2109.

Abstract

IMPORTANCE

The efficacy and safety of endovascular thrombectomy (EVT) in patients with large ischemic cores remains unknown, to our knowledge.

OBJECTIVE

To compare outcomes in patients with large ischemic cores treated with EVT and medical management vs medical management alone.

DESIGN, SETTING, AND PARTICIPANTS: This prespecified analysis of the Optimizing Patient's Selection for Endovascular Treatment in Acute Ischemic Stroke (SELECT) trial, a prospective cohort study of imaging selection that was conducted in 9 US comprehensive stroke centers, enrolled patients between January 2016 and February 2018, and followed them up for 90 days. Patients with moderate to severe stroke and anterior circulation large-vessel occlusion presenting up to 24 hours from the time they were last known to be well were eligible for the cohort. Of these, patients with large ischemic cores on computed tomography (CT) (Alberta Stroke Program Early CT Score <6) or CT perfusion scanning (a volume with a relative cerebral blood flow <30% of ≥50 cm3) were included in analyses.

EXPOSURES

Endovascular thrombectomy with medical management (MM) or MM only.

MAIN OUTCOMES AND MEASURES

Functional outcomes at 90 days per modified Rankin scale; safety outcomes (mortality, symptomatic intracerebral hemorrhage, and neurological worsening).

RESULTS

A total of 105 patients with large ischemic cores on either CT or CT perfusion images were included: 71 with Alberta Stroke Program Early CT Scores of 5 or less (EVT, 37; MM, 34), 74 with cores of 50 cm3 or greater on CT perfusion images (EVT, 39; MM, 35), and 40 who had large cores on both CT and CT perfusion images (EVT, 14; MM, 26). The median (interquartile range) age was 66 (60-75) years; 45 patients (43%) were female. Nineteen of 62 patients (31%) who were treated with EVT achieved functional independence (modified Rankin Scale scores, 0-2) vs 6 of 43 patients (14%) treated with MM only (odds ratio [OR], 3.27 [95% CI, 1.11-9.62]; P = .03). Also, EVT was associated with better functional outcomes (common OR, 2.12 [95% CI, 1.05-4.31]; P = .04), less infarct growth (44 vs 98 mL; P = .006), and smaller final infarct volume (97 vs 190 mL; P = .001) than MM. In the odds of functional independence, there was a 42% reduction per 10-cm3 increase in core volume (adjusted OR, 0.58 [95% CI, 0.39-0.87]; P = .007) and a 40% reduction per hour of treatment delay (adjusted OR, 0.60 [95% CI, 0.36-0.99]; P = .045). Of 10 patients who had EVT with core volumes greater than 100 cm3, none had a favorable outcome.

CONCLUSIONS AND RELEVANCE

Although the odds of good outcomes for patients with large cores who receive EVT markedly decline with increasing core size and time to treatment, these data suggest potential benefits. Randomized clinical trials are needed.

摘要

重要性

据我们所知,血管内血栓切除术(EVT)治疗大面积缺血核心患者的疗效和安全性尚不清楚。

目的

比较接受EVT联合药物治疗与单纯药物治疗的大面积缺血核心患者的预后。

设计、地点和参与者:这是对急性缺血性卒中血管内治疗优化患者选择(SELECT)试验的预先设定分析,该试验是一项前瞻性队列影像学选择研究,在美国9个综合卒中中心进行,于2016年1月至2018年2月纳入患者,并对其进行90天的随访。中度至重度卒中且前循环大血管闭塞、距最后一次已知健康状态达24小时内的患者符合该队列标准。其中,计算机断层扫描(CT)(阿尔伯塔卒中项目早期CT评分<6)或CT灌注扫描显示大面积缺血核心(相对脑血流量<30%且体积≥50 cm³的区域)的患者纳入分析。

暴露因素

血管内血栓切除术联合药物治疗(MM)或仅接受MM治疗。

主要结局和测量指标

改良Rankin量表评估的90天时功能结局;安全性结局(死亡率、症状性脑出血和神经功能恶化)。

结果

共纳入105例CT或CT灌注图像显示大面积缺血核心的患者:71例阿尔伯塔卒中项目早期CT评分为5分或更低(EVT组37例,MM组34例),74例CT灌注图像上核心体积≥50 cm³(EVT组39例,MM组35例),40例CT和CT灌注图像均显示大面积核心(EVT组14例,MM组26例)。中位(四分位间距)年龄为66(60 - 75)岁;4(43%)为女性。接受EVT治疗的62例患者中有19例(31%)实现功能独立(改良Rankin量表评分0 - 2分),而仅接受MM治疗的43例患者中有6例(14%)实现功能独立(优势比[OR],3.27[95%CI,1.11 - 9.62];P = 0.03)。此外,与MM相比,EVT与更好的功能结局(共同OR,2.12[95%CI,1.05 - 4.31];P = 0.04)、梗死灶增长较少(44 vs 98 mL;P = 0.006)以及最终梗死体积较小(97 vs 190 mL;P = 0.001)相关。在功能独立的可能性方面,核心体积每增加10 cm³,可能性降低4%(调整后OR,0.58[95%CI,0.39 - 0.87];P = 0.007),治疗延迟每增加1小时,可能性降低40%(调整后OR,0.60[95%CI,0.36 - 0.99];P = 0.045)。10例核心体积大于100 cm³接受EVT治疗的患者中,无一例获得良好结局。

结论及相关性

尽管接受EVT治疗的大面积核心患者获得良好结局的可能性随核心大小增加和治疗时间延长而显著下降,但这些数据表明存在潜在益处。需要进行随机临床试验。

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