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急性椎基底动脉闭塞的血管内治疗(VERITAS):一项系统评价和个体患者数据荟萃分析

Endovascular therapy for acute vertebrobasilar occlusion (VERITAS): a systematic review and individual patient data meta-analysis.

作者信息

Nogueira Raul G, Jovin Tudor G, Liu Xinfeng, Hu Wei, Langezaal Lucianne C M, Li Chuanhui, Dai Qiliang, Tao Chunrong, Mont'Alverne Francisco J A, Ji Xunming, Liu Rui, Li Rui, Dippel Diederik W J, Wu Chuanjie, Zhu Wusheng, Xu Pengfei, van Zwam Wim H, Wu Longfei, Zhang Chao, Michel Patrik, Chen Jian, Wang Li, Puetz Volker, Zhao Wenbo, Liu Tianlong, Audebert Heinrich J, Chen Zhongjun, Pontes-Neto Octavio M, Yi Tingyu, Moran Timothy P, Doheim Mohamed F, Schonewille Wouter J

机构信息

UPMC Stroke Institute, Departments of Neurology and Neurosurgery, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.

Departments of Neurology, Cooper University Healthcare and Cooper Medical School of Rowan University, Camden, NJ, USA.

出版信息

Lancet. 2025 Jan 4;405(10472):61-69. doi: 10.1016/S0140-6736(24)01820-8. Epub 2024 Dec 12.

DOI:10.1016/S0140-6736(24)01820-8
PMID:39674187
Abstract

BACKGROUND

Trials of endovascular therapy for basilar artery occlusion, including vertebral occlusion extending into the basilar artery, have shown inconsistent results. We aimed to pool data to estimate safety and efficacy and to explore the benefit across pre-specified subgroups through individual patient data meta-analysis.

METHODS

VERITAS was a systematic review and meta-analysis that pooled patient-level data from trials that recruited patients with vertebrobasilar ischaemic stroke who were randomly assigned to treatment with either endovascular therapy or standard medical treatment alone. We included studies done between Jan 1, 2010, and Sept 1, 2023. The primary outcome was 90-day favourable functional status (modified Rankin Scale [mRS] score 0-3, with a score of 3 indicating moderate disability). Safety outcomes were symptomatic intracranial haemorrhage and 90-day mortality.

FINDINGS

We screened 934 titles and abstracts. Of these, seven (<1%) full texts were screened. We included four trials (ATTENTION, BAOCHE, BASICS, and BEST). The pooled data included 988 patients (556 [56%] in the intervention groups and 432 [44%] in the control groups; median age 67 years [IQR 58-74]; 686 (69%) were male and 302 (31%) were female). 904 (91%) patients were randomly assigned within 12 h of estimated stroke onset. Three RCTs were done in a Chinese population and one included European and Brazilian patients. The proportion of patients achieving favourable functional status was higher in the endovascular therapy than control group (90-day mRS score 0-3 in 251 [45%] participants vs 128 [30%]; adjusted common odds ratio 2·41 [95% CI 1·78-3·26]; p<0·0001). Endovascular therapy led to an increase in functional independence (mRS score 0-2 in 194 [35%] participants vs 89 [21%]; 2·52 [1·82-3·48]; p<0·0001) as well as a reduction in both the degree of overall disability (2·09 [1·61-2·71]; p<0·0001) and mortality (198 [36%] of 556 patients vs 196 [45%] of 432; 0·60 [0·45-0·80]; p<0·0001) at 90 days, despite higher rates of symptomatic intracranial haemorrhage (30 [5%] of 548 vs two [<1%] of 413; 11·98 [2·82-50·81]; p<0·0001). Heterogeneity of treatment effect was noted for baseline stroke severity (uncertain effect in baseline National Institutes of Health Stroke Scale <10) and occlusion site (greater benefit with more proximal occlusions) but not across subgroups defined by age, sex, baseline posterior circulation Alberta Stroke Program Early CT Score, presence of atrial fibrillation or intracranial atherosclerotic disease, and time from onset to imaging.

INTERPRETATION

VERITAS supports the robust benefit of endovascular therapy in patients with vertebrobasilar artery occlusion with moderate to severe symptoms, with approximately 2·5-times increased likelihood of achieving a favourable functional outcome. Despite a significant increase in symptomatic intracranial haemorrhage risk, endovascular therapy for vertebrobasilar artery occlusion was associated with a significant reduction in both overall disability and mortality. Although the benefit of endovascular therapy remains uncertain for patients vertebrobasilar artery occlusion presenting with mild stroke severity and extensive infarcts on neuroimaging, we found a significant clinical benefit across a range of patients with vertebrobasilar artery occlusion.

FUNDING

None.

摘要

背景

针对基底动脉闭塞(包括延伸至基底动脉的椎动脉闭塞)的血管内治疗试验结果并不一致。我们旨在汇总数据以评估安全性和有效性,并通过个体患者数据荟萃分析探索预先设定亚组中的获益情况。

方法

VERITAS是一项系统评价和荟萃分析,汇总了来自招募椎基底动脉缺血性卒中患者的试验中的患者水平数据,这些患者被随机分配接受血管内治疗或单纯标准药物治疗。我们纳入了2010年1月1日至2023年9月1日期间开展的研究。主要结局是90天时良好的功能状态(改良Rankin量表[mRS]评分0 - 3,3分表示中度残疾)。安全性结局是症状性颅内出血和90天死亡率。

结果

我们筛选了934篇标题和摘要。其中,筛选了7篇(<1%)全文。我们纳入了四项试验(ATTENTION、BAOCHE、BASICS和BEST)。汇总数据包括988例患者(干预组556例[56%],对照组432例[44%];中位年龄67岁[IQR 58 - 74];686例(69%)为男性,302例(31%)为女性)。904例(91%)患者在估计卒中发作后12小时内被随机分组。三项随机对照试验在中国人群中开展,一项纳入了欧洲和巴西患者。血管内治疗组患者获得良好功能状态的比例高于对照组(251例[45%]参与者90天mRS评分0 - 3,对照组为128例[30%];校正共同比值比2.41[95%CI 1.78 - 3.26];p<0.0001)。血管内治疗导致功能独立性增加(194例[35%]参与者mRS评分0 - 2,对照组为89例[21%];2.52[1.82 - 3.48];p<0.0001),同时90天时总体残疾程度降低(2.09[1.61 - 2.71];p<0.0001)以及死亡率降低(556例患者中的198例[36%],对照组432例中的196例[45%];0.60[0.45 - 0.80];p<0.0001),尽管症状性颅内出血发生率更高(548例中的30例[5%],对照组413例中的2例[<1%];11.98[2.82 - 50.81];p<0.0001)。对于基线卒中严重程度(基线美国国立卫生研究院卒中量表<10时效应不确定)和闭塞部位(近端闭塞获益更大),观察到治疗效果存在异质性,但在按年龄、性别、基线后循环阿尔伯塔卒中项目早期CT评分、心房颤动或颅内动脉粥样硬化疾病的存在以及从发病到成像的时间定义的亚组中不存在异质性。

解读

VERITAS支持血管内治疗对有中度至重度症状的椎基底动脉闭塞患者有显著获益,实现良好功能结局的可能性增加约2.5倍。尽管症状性颅内出血风险显著增加,但椎基底动脉闭塞的血管内治疗与总体残疾和死亡率的显著降低相关。尽管血管内治疗对神经影像学显示轻度卒中严重程度和广泛梗死的椎基底动脉闭塞患者的获益仍不确定,但我们发现血管内治疗对一系列椎基底动脉闭塞患者有显著临床获益。

资金来源

无。

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