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支架取栓术治疗串联性颈动脉病变患者的随机初步研究

A randomized pilot study of patients with tandem carotid lesions undergoing thrombectomy.

机构信息

Division of Neurology, Centre Hospitalier de l'Université de Montréal, 900, rue St-Denis, R04-758 H2X 0A9 Montréal, Québec, Canada; Neurovascular Group, Axe Neurosciences, Centre de Recherche du Centre Hospitalier de l'Université de Montréal, 900, rue St-Denis, R04-758 H2X 0A9 Montréal, Québec, Canada; Department of Neurosciences, Faculté de Médecine, Université de Montréal, 900, rue St-Denis, R04-758 H2X 0A9 Montréal, Québec, Canada.

Division of Neurology, Centre Hospitalier de l'Université de Montréal, 900, rue St-Denis, R04-758 H2X 0A9 Montréal, Québec, Canada; Neurovascular Group, Axe Neurosciences, Centre de Recherche du Centre Hospitalier de l'Université de Montréal, 900, rue St-Denis, R04-758 H2X 0A9 Montréal, Québec, Canada; Department of Neurosciences, Faculté de Médecine, Université de Montréal, 900, rue St-Denis, R04-758 H2X 0A9 Montréal, Québec, Canada.

出版信息

J Neuroradiol. 2020 Nov;47(6):416-420. doi: 10.1016/j.neurad.2019.08.003. Epub 2019 Sep 26.

DOI:10.1016/j.neurad.2019.08.003
PMID:31563589
Abstract

BACKGROUND AND PURPOSE

The optimal management of patients with tandem lesions (TL), or cervical internal carotid artery (c-ICA) steno-occlusive pathology and ipsilateral intracranial occlusion, who are undergoing endovascular thrombectomy (EVT) remains unknown. We sought to establish the feasibility of a trial designed to address this question.

MATERIALS AND METHODS

The Endovascular Acute Stroke Intervention (EASI) study was a single-centre randomized trial comparing EVT to medical therapy for large-vessel occlusion stroke. Patients with TL receiving EVT were randomly allocated to acute c-ICA stenting or no stenting. The primary outcome was the proportion of patients with a modified Rankin Scale (mRS) score of 0-2 at 90 days. Safety outcomes were symptomatic intracranial hemorrhage (sICH) at 24hours and mortality at 90 days.

RESULTS

Of 301 patients included in EASI between 2013 and 2018, 24 (8.0%) with TL were randomly allocated to acute stenting (n=13) or no stenting (n=11). Baseline characteristics were balanced. Eight (61.5%; 95% CI 35.5%-82.3%) and 7 (63.6%; 95% CI 35.4%-84.9%) patients, respectively, had a favorable outcome (mRS 0-2; P=1.0). One non-stented patient had a symptomatic intracerebral hemorrhage.

CONCLUSIONS

This pilot trial of patients with TL undergoing EVT suggests that a sufficiently powered larger TL trial comparing acute c-ICA stenting to no stenting is feasible.

CLINICAL TRIAL REGISTRATION

URL: http://www.clinicaltrials.gov. Unique identifier: NCT02157532.

摘要

背景与目的

接受血管内血栓切除术(EVT)的串联病变(TL)或颈内动脉(c-ICA)狭窄闭塞性病变和同侧颅内闭塞患者的最佳治疗方法仍不清楚。我们旨在建立一项旨在解决这一问题的试验的可行性。

材料与方法

血管内急性卒中干预(EASI)研究是一项单中心随机试验,比较了 EVT 与大血管闭塞性卒中的药物治疗。接受 EVT 的 TL 患者被随机分配接受急性 c-ICA 支架置入术或不支架置入术。主要结局是 90 天时改良 Rankin 量表(mRS)评分 0-2 的患者比例。安全性结局为 24 小时症状性颅内出血(sICH)和 90 天时死亡率。

结果

在 2013 年至 2018 年期间纳入 EASI 的 301 例患者中,24 例(8.0%)TL 患者被随机分配接受急性支架置入术(n=13)或不支架置入术(n=11)。基线特征平衡。分别有 8 例(61.5%;95%CI 35.5%-82.3%)和 7 例(63.6%;95%CI 35.4%-84.9%)患者的结局良好(mRS 0-2;P=1.0)。1 例未支架置入的患者发生症状性颅内出血。

结论

这项接受 EVT 的 TL 患者的试验表明,一项比较急性 c-ICA 支架置入术与不支架置入术的大型 TL 试验具有足够的功率是可行的。

临床试验注册

网址:http://www.clinicaltrials.gov。唯一标识符:NCT02157532。

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