Background and Purpose:Evidence about the utility of ultrasound-enhanced thrombolysis (sonothrombolysis) in patients with acute ischemic stroke (AIS) is conflicting. We aimed to evaluate the safety and efficacy of sonothrombolysis in patients with AIS with large vessel occlusion, by analyzing individual patient data of available randomized-controlled clinical trials.Methods:We included all available randomized-controlled clinical trials comparing sonothrombolysis with or without addition of microspheres (treatment group) to intravenous thrombolysis alone (control group) in patients with AIS with large vessel occlusion. The primary outcome measure was the rate of complete recanalization at 1 to 36 hours following intravenous thrombolysis initiation. We present crude odds ratios (ORs) and ORs adjusted for the predefined variables of age, sex, baseline stroke severity, systolic blood pressure, and onset-to-treatment time.Results:We included 7 randomized controlled clinical trials that enrolled 1102 patients with AIS. A total of 138 and 134 confirmed large vessel occlusion patients were randomized to treatment and control groups respectively. Patients randomized to sonothrombolysis had increased odds of complete recanalization compared with patients receiving intravenous thrombolysis alone (40.3% versus 22.4%; OR, 2.17 [95% CI, 1.03–4.54]; adjusted OR, 2.33 [95% CI, 1.02–5.34]). The likelihood of symptomatic intracranial hemorrhage was not significantly different between the 2 groups (7.3% versus 3.7%; OR, 2.03 [95% CI, 0.68–6.11]; adjusted OR, 2.55 [95% CI, 0.76–8.52]). No differences in the likelihood of asymptomatic intracranial hemorrhage, 3-month favorable functional and 3-month functional independence were documented.Conclusions:Sonothrombolysis was associated with a nearly 2-fold increase in the odds of complete recanalization compared with intravenous thrombolysis alone in patients with AIS with large vessel occlusions. Further study of the safety and efficacy of sonothrombolysis is warranted.

中文翻译：

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急性缺血性卒中伴大血管闭塞患者的超声溶栓：个体患者数据荟萃分析

背景和目的：关于超声增强溶栓（超声溶栓）在急性缺血性卒中（AIS）患者中的效用的证据是相互矛盾的。我们旨在通过分析现有随机对照临床试验的个体患者数据，评估超声溶栓治疗大血管闭塞 AIS 患者的安全性和有效性。方法：我们纳入了所有可用的随机对照临床试验，比较超声溶栓加或不加微球（治疗组）单独静脉溶栓（对照组）用于大血管闭塞的 AIS 患者。主要结局指标是静脉溶栓开始后 1 至 36 小时的完全再通率。我们提供了原始优势比 (ORs) 和针对年龄、性别、基线卒中严重程度、收缩压和开始治疗时间。结果：我们纳入了 7 项随机对照临床试验，纳入了 1102 名 AIS 患者。共有 138 名和 134 名确诊的大血管闭塞患者分别被随机分配到治疗组和对照组。与仅接受静脉溶栓治疗的患者相比，随机接受超声溶栓治疗的患者完全再通的几率增加（40.3% vs 22.4%；OR，2.17 [95% CI，1.03–4.54]；调整后的 OR，2.33 [95% CI，1.02–5.34] ）。两组出现症状性颅内出血的可能性没有显着差异（7.3% 对 3.7%；OR，2.03 [95% CI，0.68–6.11]；调整后的 OR，2.55 [95% CI，0.76–8.52]）。无症状颅内出血的可能性没有差异，记录了 3 个月良好的功能和 3 个月的功能独立。结论：与大血管闭塞的 AIS 患者单独静脉溶栓相比，超声溶栓与完全再通的几率增加近 2 倍相关。有必要进一步研究超声溶栓的安全性和有效性。