新型国产取栓装置用于急性缺血性卒中治疗的有效性及安全性研究OACSTPCD
Comparative efficacy and safety of novel domestic-made thrombectomy device versus Solitaire FR for acute ischemic stroke due to acute large vessel occlusion
目的 评估新型国产取栓装置(Swebus支架)实施颅内大血管闭塞取栓介入治疗的有效性和安全性.方法 采用多中心、前瞻性、随机对照试验设计,将16 家医院卒中中心自2020 年5 月至2022 年9 月收治的234 例发病24h内的急性颅内大血管闭塞患者,通过随机区组、随机信件形式分为试验组(Swebus支架取栓,114 例)和对照组(Solitaire FR支架取栓,120 例).通过血管造影明确颅内大血管急性闭塞,术后根据改良脑梗死溶栓(mTICI)试验评估主要有效性结局指标[术后即刻血管再通(mTICI分级≥2b级)],次要有效性结局指标为术后24h美国国立卫生研究院卒中量表(NIHSS)评分和术后90d预后良好[改良Rankin量表(mRS)评分≤2 分]率、股动脉穿刺至血管再通或再通失败时间,通过术后24h内严重不良事件发生率、症状性颅内出血发生率及术后90d脑血管性死亡发生率评估治疗安全性.结果 试验组与对照组的术后即刻血管再通率差异无统计学意义[96.5%(110/114)比92.5%(111/120),P = 0.169],术后90d预后良好率[54.4%(62/114)比49.2%(59/119),P =0.463]、股动脉穿刺至血管再通或再通失败时间[(73±44)min比(78±50)min,P =0.487]、术后24 h NIHSS评分[12.5(7.0,20)分比12.0(6.5,20)分,P =0.794]差异均无统计学意义.两组术中至术后24h严重不良事件发生率[13.2%(15/114)比13.3%(16/120),P =0.968]、术后24h内症状性颅内出血发生率[10.5%(12/114)比12.5%(15/120),P =0.637)、术后90d脑血管性死亡发生率[11.4%(13/114)比10.0%(12/120),P =0.728]差异均无统计学意义.结论 新型国产支架Swebus支架用于颅内大血管闭塞性急性缺血性卒中取栓治疗的有效性和安全性不劣于Solitaire FR支架.
Objective To evaluate the efficacy and safety of endovascular treatment using the novel domestic-made thrombectomy device(Swebus)in patients with acute intracranial large vessel occlusion.Methods This study was a multicenter,prospective,randomized,controlled trial.All 234 patients with acute intracranial large vessel occlusion within 24 h from onset at 16 Chinese stroke centers from May 2020 to September 2022 were randomly assigned into an experimental group(Swebus device,114 cases)and a control group(Solitaire FR device,120 cases).Digital subtraction angiography confirmed intracranial large vessel occlusion.The grade of modified thrombolysis in cerebral infarction(mTICI grade≥2b)immediately after the procedure is the primary efficacy outcome at the end of procedure.The National Institute of Health stroke scale(NIHSS)score at 24 h,the rate of good prognosis(modified Rankin scale[mRS]score less than 2)and the time from puncture to achieving successful or failed recanalization is the secondary outcome.Safety indicators consist of the incidences of serious adverse event,symptomatic intracranial hemorrhage within 24 h and cerebrovascular morality within 90 days.Results There was no statistically significant difference between the experimental group and the control group in the rate of immediate recanalization(96.5%[110/114]vs.92.5%[111/120],P = 0.169),good prognosis within 90 d(54.4%[62/114]vs.49.2%[59/119],P =0.463),time from puncture to achieving successful or failed recanalization([73±44]min vs.[78±50]min,P =0.487),and NIHSS scores within 24h(12.5[7.0,20.0])points vs.12.0[6.5,20.0]points,P =0.794).No significant differences were found in the incidences of serious adverse event within 24 h of thrombectomy(13.2%[15/114]vs.13.3%[16/120],P =0.968),symptomatic intracranial hemorrhage within 24 h(10.5%[12/114]vs.12.5%[15/120],P =0.637)and cerebrovascular morality within 90 d(11.4%[13/114]vs.10.0%[12/120],P =0.728)between two groups.Conclusion The novel domestic-made device(Swebus)is non-inferior to Solitaire FR in the efficacy and safety of endovascular treatment for patients with acute ischemic stroke due to large vessel occlusion.
彭日煊;罗继昌;王亚冰;焦力群;新型国产取栓装置评估课题组
100053 北京,首都医科大学宣武医院神经外科
机械取栓急性缺血性卒中新型国产支架颅内大血管闭塞
Mechanical thrombectomyAcute ischemic strokeNovel domestic-made retrieve stentIntracranial large vessel occlusion
《中国脑血管病杂志》 2024 (001)
14-21 / 8
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