Comparative efficacy and safety of novel domestic-made thrombectomy device versus Solitaire FR for acute ischemic stroke due to acute large vessel occlusion
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.
Mechanical thrombectomyAcute ischemic strokeNovel domestic-made retrieve stentIntracranial large vessel occlusion
国家科技期刊平台
NSTL
万方数据
维普
