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期刊来源：JAMA

原文链接：https://doi.org/10.1001/jama.2024.0589

摘要内容如下：

重要性

静脉溶栓（IVT）治疗急性缺血性卒中的益处随着症状发作时间的延长而下降，但尚不清楚IVT后行血栓切除术是否存在类似的时间依赖性。

目的

确定IVT联合血栓切除术与单独血栓切除术相比，其获益是否随着症状发作后的治疗时间而减少。

设计、设置和参与者

来自6项随机临床试验的个体参与者数据荟萃分析，比较IVT联合血栓切除术与单独血栓切除术。2017年1月至2021年7月，在15个国家的190个地点进行了注册。所有参与者均符合IVT和血栓切除术的条件，并直接在血栓切除术卒中中心就诊（n=2334）。本荟萃分析仅纳入前循环大血管闭塞患者（n=2313）。

曝光

从卒中症状发作到预期IVT给药的时间间隔以及IVT联合血栓切除术与单纯血栓切除术的治疗效果。

主要成果和措施

主要结果分析测试了分配的治疗（IVT加血栓切除术vs单独血栓切除术）与90天时残疾（7级改良Rankin量表[Mrs]评分范围，0[无症状]至6[死亡]；Mrs评分的最小临床重要差异（0-2:1.3%）随从症状发作到预期IVT给药的时间而变化。

结果

2313名受试者中，IVT加取栓组1160名，单纯取栓组1153名；中位年龄，71[IQR，62至78]岁；44.3%为女性），从症状发作到预期IVT给药的中位时间为2小时28分钟（IQR，1小时46分钟至3小时17分钟）。从症状发作到IVT预期给药的时间与分配的治疗与功能结果的相关性之间存在统计学上显著的交互作用（每1小时延迟的调整后共同优势比[OR]的比率为0.84[95%CI为0.72至0.97]，交互作用P=0.02）。IVT加血栓切除术的益处随着从症状发作到预期IVT给药的时间延长而减少（校正的普通OR 1步Mrs评分向改善方向移动，1小时为1.49[95%CI，1.13至1.96]，2小时为1.25[95%CI，1.04至1.49]，3小时为1.04[95%CI，0.88至1.23]）。对于Mrs评分为0、1或2的患者，1小时时预测的绝对风险差异为9%（95%CI，3%至16%），2小时时为5%（95%CI，1%至9%），3小时时为1%（95%CI，-3%至5%）。2小时20分钟后，与IVT加血栓切除术相关的获益无统计学意义，在3小时14分钟时，点估计与零关联交叉。

结论和相关性

在有血栓切除术能力的卒中中心就诊的患者中，IVT联合血栓切除术与单独血栓切除术相比，其获益具有时间依赖性，并且只有在从症状发作到预期IVT给药的时间较短的情况下，其获益才具有统计学意义。

英文原文如下：

Abstracts

Importance  The benefit of intravenous thrombolysis (IVT) for acute ischemic stroke declines with longer time from symptom onset, but it is not known whether a similar time dependency exists for IVT followed by thrombectomy.

Objective  To determine whether the benefit associated with IVT plus thrombectomy vs thrombectomy alone decreases with treatment time from symptom onset.

Design, Setting, and Participants  Individual participant data meta-analysis from 6 randomized clinical trials comparing IVT plus thrombectomy vs thrombectomy alone. Enrollment was between January 2017 and July 2021 at 190 sites in 15 countries. All participants were eligible for IVT and thrombectomy and presented directly at thrombectomy-capable stroke centers (n = 2334). For this meta-analysis, only patients with an anterior circulation large-vessel occlusion were included (n = 2313).

Exposure  Interval from stroke symptom onset to expected administration of IVT and treatment with IVT plus thrombectomy vs thrombectomy alone.

Main Outcomes and Measures  The primary outcome analysis tested whether the association between the allocated treatment (IVT plus thrombectomy vs thrombectomy alone) and disability at 90 days (7-level modified Rankin Scale [mRS] score range, 0 [no symptoms] to 6 [death]; minimal clinically important difference for the rates of mRS scores of 0-2: 1.3%) varied with times from symptom onset to expected administration of IVT.

Results  In 2313 participants (1160 in IVT plus thrombectomy group vs 1153 in thrombectomy alone group; median age, 71 [IQR, 62 to 78] years; 44.3% were female), the median time from symptom onset to expected administration of IVT was 2 hours 28 minutes (IQR, 1 hour 46 minutes to 3 hours 17 minutes). There was a statistically significant interaction between the time from symptom onset to expected administration of IVT and the association of allocated treatment with functional outcomes (ratio of adjusted common odds ratio [OR] per 1-hour delay, 0.84 [95% CI, 0.72 to 0.97], P = .02 for interaction). The benefit of IVT plus thrombectomy decreased with longer times from symptom onset to expected administration of IVT (adjusted common OR for a 1-step mRS score shift toward improvement, 1.49 [95% CI, 1.13 to 1.96] at 1 hour, 1.25 [95% CI, 1.04 to 1.49] at 2 hours, and 1.04 [95% CI, 0.88 to 1.23] at 3 hours). For a mRS score of 0, 1, or 2, the predicted absolute risk difference was 9% (95% CI, 3% to 16%) at 1 hour, 5% (95% CI, 1% to 9%) at 2 hours, and 1% (95% CI, -3% to 5%) at 3 hours. After 2 hours 20 minutes, the benefit associated with IVT plus thrombectomy was not statistically significant and the point estimate crossed the null association at 3 hours 14 minutes.

Conclusions and Relevance  In patients presenting at thrombectomy-capable stroke centers, the benefit associated with IVT plus thrombectomy vs thrombectomy alone was time dependent and statistically significant only if the time from symptom onset to expected administration of IVT was short.

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