Sonolysis during carotid endarterectomy: randomised controlled trial.

Methods

Multicentre, phase 3, double blind, randomised controlled trial.

多中心、第三阶段、双盲、随机对照试验。

16 European centres.

16个欧洲中心。

1004 patients (mean age 68 years; 312 (31%) female) were enrolled in the study between 20 August 2015 and 14 October 2020 until the interim analysis was performed.

共有1004名患者（平均年龄68岁；312名（31%）为女性）在2015年8月20日至2020年10月14日期间参与了这项研究，直至进行中期分析。

Sonolysis (n=507) versus sham procedure (n=497).

超声溶栓(n=507)与假手术(n=497)的比较。

The primary endpoint was the composite incidenceof ischaemic stroke, transient ischaemic attack, and death within 30 days.

主要终点是30天内缺血性中风、短暂性脑缺血发作和死亡的综合发生率。

The incidenceof new ischaemic lesions on follow-up brain magnetic resonance imaging was the main substudy endpoint, and incidenceof intracranial bleeding was the main safety endpoint.

随访脑磁共振成像上新发缺血性病变的发生率是主要的次要研究终点，颅内出血的发生率是主要的安全性终点。

Results

The results favoured the sonolysis group for the primary endpoint (11 (2.2%) v 38 (7.6%); risk difference -5.5%, 95% confidence interval(CI) -8.3% to -2.8%; P<0.001), as well as in the substudy for magnetic resonance imaging detected new ischaemic lesions (20/236 (8.5%) v 39/224 (17.4%); risk difference -8.9%, -15% to -2.8%; P=0.004).

结果支持超声溶栓组在主要终点上（11（2.2%）对38（7.6%）；风险差异-5.5%，95%置信区间（CI）-8.3%至-2.8%；P<0.001），以及在磁共振成像检测到的新发缺血性病变的次要研究中（20/236（8.5%）对39/224（17.4%）；风险差异-8.9%，-15%至-2.8%；P=0.004）。

Sensitivity analysis resulted in a risk ratio for sonolysis of 0.25 (95% CI 0.11 to 0.56) for ischaemic stroke and 0.23 (0.07 to 0.73) for transient ischaemic attack within 30 days.

敏感性分析显示，对于缺血性中风，声溶栓的风险比为0.25（95%置信区间0.11至0.56），对于短暂性脑缺血发作，风险比为0.23（95%置信区间0.07至0.73），均发生在30天内。

Sonolysis was found to be safe, and 94.4% of patients in the sonolysis group were free from serious adverse events 30 days after the procedure.

研究发现，声溶栓是安全的，且在治疗后30天内，94.4%的声溶栓组患者未发生严重不良事件。

Conclusions

Sonolysis was safe for patients undergoing carotid endarterectomy and resulted in a significant reduction in the composite incidenceof ischaemic stroke, transient ischaemic attack, and death within 30 days.

超声溶栓对于接受颈动脉内膜切除术的患者是安全的，并且在30天内显著降低了缺血性中风、短暂性脑缺血发作和死亡的综合发生率。

trial_registration

Clinicaltrials.gov NCT02398734.

Clinicaltrials.gov NCT02398734。