国产RECO支架取栓治疗急性颅内大血管闭塞的有效性及安全性研究  

Efficacy and safety of domestic RECO flow restoration device in acute intracranial large-vessel occlusion

作　　者：曹洁[1] 林航 林敏 柯开富[3] 张云峰[3] 张勇[4] 郑维红[5] 陈星宇[5] 王苇[6] 张猛 宣井岗[1] 彭亚[1] Cao Jie;Lin Hang;Lin Min;Ke Kaifu;Zhang Yunfeng;Zhang Yong;Zheng Weihong;Chen Xingyu;Wang Wei;Zhang Meng;Xuan Jinggang;Peng Ya(Department of Neurosurgery,Changzhou First People's Hospital(Third Affiliated Hospital of Suzhou University),Changzhou 213003,China;Department of Neurology,900th Hospital of PLA Joint Logistic Support Force,Fuzhou 350025,China;Department of Neurology,Affiliated Hospital of Nantong University,Nantong 226001,China;Department of Neurology,Affiliated Hospital of Qingdao University,Qingdao 266005,China;Department of Neurology,Sun Yat-sen Hospital,Xiamen University,Xiamen 361004,China;Medical Imaging Center,First People's Hospital of Yangzhou,Yangzhou 225001,China;Department of Neurology,Army Medical University,Chongqing 400042,China)

机构地区：[1]常州市第一人民医院(苏州大学附属第三医院)神经外科,213003 [2]解放军联勤保障部队第九〇〇医院神经内科,福州350025 [3]南通大学附属医院神经内科,南通226001 [4]青岛大学附属医院神经内科,青岛266005 [5]厦门大学附属中山医院神经内科,厦门361004 [6]扬州市第一人民医院医学影像中心,225001 [7]陆军军医大学陆军特色医学中心神经内科,重庆400042

出　　处：《中华神经医学杂志》2020年第5期462-469,共8页Chinese Journal of Neuromedicine

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。Objective 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≤290 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.

关 键 词：RECO支架 机械取栓装置 颅内大血管闭塞 有效性 安全性 

分 类 号：R651[医药卫生—外科学] R74[医药卫生—临床医学]