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Background
Patients with extensive ischaemic change are often excluded from endovascular thrombectomy .
经常将有广泛缺血性改变的患者排除在血管内血栓切除术之外。
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We aimed to synthesise the evidence from recent trials in these patients by performing a systematic review and individual patient data meta-analysis to estimate treatment benefit , including within clinical and imaging subgroups .
我们旨在通过进行系统评价和个体患者数据荟萃分析,综合近期试验中的证据,以估计这些患者的治疗效益,包括在临床和影像学亚组中。
Methods
In this systematic review and meta-analysis , we searched PubMed and Embase for randomised trials published between March 1, 2018, and March 1, 2025, that evaluated efficacy and safety of endovascular thrombectomy compared with medical management in patients with large-core ischaemic stroke (based on an Alberta Stroke Program Early CT Score [ASPECTS] of ≤5 or estimated ischaemic core ≥50 mL ) presenting within 24 h of onset .
在这项系统评价和荟萃分析中,我们检索了PubMed和Embase数据库,寻找在2018年3月1日至2025年3月1日期间发表的随机试验,这些试验评估了在出现大核心缺血性中风(基于阿尔伯塔中风计划早期CT评分[ASPECTS]≤5或估计的缺血核心≥50毫升)的患者中,与药物管理相比,血管内血栓切除术的疗效和安全性,这些患者在症状发作后24小时内接受治疗。
Individual patient-level data from all eligible trials were obtained .
所有符合条件的试验的患者个体数据均已被获取。
A central imaging core laboratory readjudicated ASPECTS and reanalysed ischaemic core volume .
一个中心影像核心实验室重新评估了ASPECTS评分并重新分析了缺血核心体积。
A two-stage meta-analysis with random-effects model was used to evaluate the distribution of 90-day modified Rankin Scale (mRS) scores (the primary outcome ) using adjusted pooled generalised odds ratios (aGenORs).
使用随机效应模型的两阶段荟萃分析,利用调整后的汇总广义比值比(aGenORs)评估了90天改良Rankin量表(mRS)评分(主要结果)的分布情况。
Missing data were handled by multiple imputation .
缺失数据通过多重插补法处理。
Safety outcomes were all-cause mortality within 90-day follow-up and neurological worsening within 24-48 h of randomisation , reported as adjusted pooled relative risk (aRR); and symptomatic intracerebral haemorrhage within 36 h of randomisation (reported as risk difference ).
安全性结果包括90天随访期间的全因死亡率和随机化后24-48小时内的神经功能恶化,报告为调整后的汇总相对风险(aRR);以及随机化后36小时内的症状性脑内出血,报告为风险差异。
Subgroup analyses based on clinical and imaging characteristics were done , including subgroups defined by ischaemic core volume , ASPECTS , and time window from onset to randomisation .
根据临床和影像特征进行了亚组分析,包括根据缺血核心体积、ASPECTS以及从发病到随机化的时间窗定义的亚组。
The meta-analysis was registered with PROSPERO (CRD420251058584).
该荟萃分析已在PROSPERO注册(CRD420251058584)。
Results
We included 1886 patients (944 assigned to endovascular thrombectomy and 942 assigned to medical management ) from six trials .
我们纳入了来自六项试验的1886名患者(其中944名被分配接受血管内血栓切除术,942名被分配接受药物管理)。
Baseline characteristics were similar between treatment groups .
治疗组之间的基线特征相似。
At day 90, the distribution of mRS scores was improved in patients in the endovascular thrombectomy group (median score 4 [IQR 3-6]; n=940) versus those in the medical management group (5 [4-6]; n=931; aGenOR 1·63 [95% CI 1·42-1·88], p<0·0001).
在第90天时,血管内血栓切除术组患者的mRS评分分布(中位数评分4 [IQR 3-6];n=940)相较于内科管理组(5 [4-6];n=931;aGenOR 1·63 [95% CI 1·42-1·88],p<0·0001)有所改善。
The endovascular thrombectomy group also had reduced mortality (292 [31·1%]) compared with the medical management group (347 [37·3%]; aRR 0·82 [95% CI 0·70-0·97], p=0·022).
血管内血栓切除术组的死亡率也有所降低(292 [31·1%]),与内科管理组(347 [37·3%];aRR 0·82 [95% CI 0·70-0·97],p=0·022)相比。
No significant differences were observed in symptomatic intracranial haemorrhage (ten [1·1%] of 944 vs nine [1·0%] of 942 patients ; pooled unadjusted risk difference -0·17 percentage points [95% CI -1·01 to 0·67], p=0·69) or neurological worsening (197 [22·0%] of 896 patients vs 161 [17·9%] of 899; aRR 1·19 [0·87-1·62], p=0·27).
在症状性颅内出血(944名患者中有10名[1.1%],与942名患者中的9名[1.0%];汇总未调整风险差异为-0.17个百分点[95%置信区间-1.01至0.67],p=0.69)或神经功能恶化(896名患者中有197名[22.0%],与899名患者中的161名[17.9%];调整后相对风险为1.19[0.87-1.62],p=0.27)方面未观察到显著差异。
Improved functional outcomes with endovascular thrombectomy were consistent across clinical and imaging subgroups , except for those with an estimated ischaemic core volume of 150 mL or greater , in whom point estimates favoured endovascular thrombectomy , particularly in the early time window (0-6 h ), but wide 95% CIs limited interpretation .
除了那些估计缺血核心体积为150毫升或更大的患者外,血管内血栓切除术改善功能结果在临床和影像学亚组中是一致的,在这些患者中,点估计值倾向于血管内血栓切除术,特别是在早期时间窗口(0-6小时),但宽广的95%置信区间限制了解释。
interpretation
Endovascular thrombectomy was associated with improved functional outcomes and reduced mortality versus medical management in patients with large-core ischaemic stroke presenting within 24 h of onset .
在发病后24小时内出现大核心缺血性中风的患者中,血管内血栓切除术与改善功能结果和降低死亡率相关,与内科治疗相比。
With the exception of very extensive ischaemic changes (core volume ≥150 mL ) presenting beyond 6 h , where evidence remains limited , benefit was sustained across ASPECTS and ischaemic core strata for patients presenting up to 24 h after onset .
除了在6小时后出现非常广泛的缺血性改变(核心体积≥150 mL)的患者外,其中证据仍然有限,对于发病后24小时内出现的患者,无论ASPECTS和缺血核心范围如何,其益处都得到了维持。
本文献翻译由 AI 辅助生成,仅供文献精读与英语学习参考。临床决策请以 PubMed / PMC 原文为准。
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