摘要目的:探讨国产RECO脑血流恢复装置(RECO支架)取栓治疗急性颅内大血管闭塞的有效性及安全性。方法:采用多中心、前瞻性、随机、开放、对照试验设计，将7家医院卒中中心自2014年2月至2016年8月收治的136例急性颅内大血管闭塞患者分成试验组(RECO支架取栓，67例)和对照组(Solitaire支架取栓，69例)，对比分析2组患者治疗有效性及安全性的差异，其中主要疗效终点为术后闭塞血管成功再通[改良脑梗死溶栓分级(mTICI)≥2级]，次要疗效终点为预后良好(术后90 d改良Rankin量表评分≤2分)、穿刺至主要疗效终点时间或血管未成功再通者的手术结束时间、术后90 d内死亡；安全性终点为任何与器械相关的严重不良事件、症状性颅内出血及术后24 h内严重不良事件。结果:试验组与对照组间术后闭塞血管成功再通率(91.0% vs. 86.9%)差异无统计学意义( P>0.05)，预后良好率(62.7% vs. 46.4%)、穿刺至主要疗效终点时间或血管未成功再通者的手术结束时间[(85.4±47.0) min vs. (89.9±53.3) min]、术后90 d内死亡率(13.4% vs. 23.2%)差异亦均无统计学意义( P>0.05)。试验组及对照组中均没有发生任何与器械相关的严重不良事件，并且2组间症状性颅内出血发生率(1.5% vs. 7.4%)、术后24 h内严重不良事件发生率[死亡(1.5% vs. 1.4%)、脑疝(4.5% vs. 0.0%)]差异均无统计学意义( P>0.05)。 结论:国产RECO支架是一款治疗急性颅内大血管闭塞有效安全的机械取栓装置。

abstractsObjective:To explore the efficacy and safety of domestic RECO flow restoration device in acute intracranial large-vessel occlusion (LVO).Methods:This study was a multicenter, prospective, randomized, open, controlled trial; 136 patients with acute intracranial LVO at 7 Chinese stroke centers from February 2014 to August 2016 were randomly assigned into an experimental group (thrombectomy by RECO device, n=67) and a control group (thrombectomy by Solitaire device, n=69). The efficacy and safety of patients from the two groups were compared and analyzed. The primary efficacy end point was set as achievement of good recanalization (modified thrombolysis in cerebral infarction [mTICI] grading≥2); the secondary efficacy end points included good prognosis (modified Rankin scale scores≤2 90 d after thrombectomy), time from puncture to achieving good recanalization/time from puncture to final angiogram on condition that good recanalization was not gained, or mortality within 90 d of thrombectomy. The safety end points included any device-related serious adverse events, symptomatic intracerebral hemorrhage or serious adverse events within 24 of thrombectomy. Results:There was no statistically significant difference between the experimental group and the control group in successful rate of good recanalization (91.0% vs. 86.9%), good prognosis rate (62.7% vs. 46.4%), time from puncture to achieving good recanalization/time from puncture to final angiogram on condition that good recanalization was not gained([85.4±47.0] min vs. [89.9±53.3] min), and mortality within 90 d of thrombectomy (13.4% vs. 23.2%, P>0.05). There were no device-related serious adverse events in all patients. No significant differences were found in the incidences of symptomatic intracranial hemorrhage (1.5% vs. 7.4%) or serious adverse events (death [1.5% vs. 1.4%] and brain hernia [4.5% vs. 0.0%]) between the two groups ( P>0.05). Conclusion:The domestic RECO flow restoration device is an effective and safe mechanical thrombectomy stent retriver for acute intracranial LVO.