Comparing a novel Catfish flow restoration device and the Solitaire stent retriever for thrombectomy revascularisation in emergent largevessel occlusion stroke:a prospective randomised controlled study  

作　　者：Gang Luo Xiaoyan Yan Guodong Xiao Liping Wei Ya li kun Nai bi jiang Rongyao Ma Wenhuo Chen Chun Fang Zhiming Zhou Jieqing Wan Ya Peng Guilian Zhang Junfeng Zhao Li Li Haicheng Yuan Jin Wu Bing Li Fan Zhang Yuhong Cheng Feng Gao Zhongrong Miao 

机构地区：[1]Department of Intervention,Interventional Neuroradiology Center,Beijing Tiantan Hospital,Capital Medical University,Beijing,China [2]Department of Intervention,Interventional Neuroradiology Center,China National Clinical Research Center for Neurological Diseases,Beijing,China [3]Biostatistics,Peking University Clinical Research Institute,Beijing,China [4]Neurology,The Second Affiliated Hospital of Suzhou University,Jiangsu,China [5]Department of Neurology,Luoyang Central Hospital Affiliated to Zhengzhou University,Luoyang,Henan,China [6]Neurosurgery,Hotan District People's Hospital,Hotan,China [7]Neurology,Nanshi Hospital of Nanyang,Nanyang,China [8]Neurology,Zhangzhou Municipal Hospital of Fujian Province and Zhangzhou Affiliated Hospital of Fujian Medical University,Zhangzhou,Fujian,China [9]Department of Intervention,Tongji Hospital Affiliated to Tongji University,Shanghai,Shanghai,China [10]Department of Intervention,The First Affiliated Hospital of Wannan Medical College,Wuhu,Anhui,China [11]Department of Neurosurgery,Shanghai Jiao Tong University School of Medicine Affiliated Renji Hospital,Shanghai,China [12]Department of Neurosurgery,Changzhou No.1 People's Hospital,Changzhou,China [13]Neurology,The Second Affiliated Hospital of Xi'an Jiaotong University,Xi'an,China [14]Neurology,Siping Central People’s Hospital,Siping,China [15]Department of Intervention,Xijing Hospital of Air Force Military Medical University,Xi'an,China [16]Neurology,Qingdao Central Medical Group,Qingdao,China [17]Neurology,The Second Affiliated Hospital of Nanjing Medical University,Nanjing,China [18]Department of Intervention,Qindao University Medical College Affiliated Yantai Yuhuangding Hospital,Yantai,Shandong,China [19]Neurology,Hainan General Hospital/Hainan Affiliated Hospital of Hainan Medical University,Hainan,China [20]Department of Intervention,Linfen Central Hospital,Linfen,Shanxi,China

出　　处：《Stroke & Vascular Neurology》2023年第6期435-443,共9页卒中与血管神经病学（英文）

基　　金：from Beijing Hospitals Authority Youth Programme(Number QML20190505);National Key R&D Program(2018AAA0102600);Beijing Natural Science Foundation(Z220016),JSSK Neurocare Medical Co.,Ltd.

摘　　要：Background The Catfish stent retriever is a newly developed mechanical thrombectomy device for rapid recanalisation in emergent large vessel occlusion(ELVO)stroke.The current trial aimed to assess whether the Catfish stent retriever is non-inferior to the Solitaire stent retriever in terms of outcomes in ELVO stroke.Methods This was a randomised,prospective,parallel-group,multicentre,open-label,non-inferiority study conducted at 18 sites in China.The primary outcome was the proportion of cases with successful recanalisation(modified thrombolysis in cerebral infarction score of 2b or 3)following the procedure.Secondary efficacy outcomes included the National Institutes of Health Stroke Scale scores at 24 hours and 7 days or discharge if earlier,time from artery puncture to successful recanalisation and good clinical outcome(modified Rankin scale score≤2)at 90 days.Safety outcomes included symptomatic intracranial haemorrhage,all cause-death and severe adverse events at 90 days.Results Between 3 March 2019 and 5 June 2021,118 and 120 patients were randomly allocated to the Catfish and Solitaire groups,respectively.The primary endpoint after all endovascular procedures was non-inferior in the Catfish group(88.5%,100/113)than in the Solitaire group(87.7%,100/114),with a rate difference(RD)of 0.78%(95%CI-7.64 to-9.20;p=0.001).Sensitivity analysis only considering the per-protocol set also yielded similar results,with an RD of 0.83%(95%CI-7.03 to-8.70;p<0.001).Additionally,the proportions of cases with good clinical outcomes(47.8%vs 50.0%,p=0.739)and all-cause death rates(17.7%vs 18.8%,p=0.700)were similar in both groups at 90 days.Conclusions The Catfish stent retriever is an effective and safe device for endovascular recanalisation in ELVO stroke..

关 键 词：SOLITAIRE PROSPECTIVE throm 

分 类 号：R743.3[医药卫生—神经病学与精神病学]