机构：[1]Department of Stroke Center, Changhai Hospital, Naval Military Medical University, Shanghai, China[2]Department of Neurosurgery, The First People’s Hospital of Changzhou, Changzhou, China[3]Zhongshan City People’s Hospital, Zhongshan, China[4]Department of Neurology, The Second Nanning People’s Hospital, Nanning, China[5]Department of Neurology, Affiliated Hangzhou First People’s Hospital, Zhejiang University School of Medical, Hangzhou, China, [6]Department of Neurology, The First Hospital of Jilin University, Jilin, China[7]Department of Neurology, China-Japan Union Hospital of Jilin University, Jilin, China吉林大学中日联谊医院[8]Department of Neurosurgery, Tangdu Hospital the Fourth Military Medical University, Xi’an, China[9]Department of Neurosurgery, The Affiliated Hospital of Guizhou Medical University, Guizhou, China[10]The Fifth Affiliated Hospital of Sun Yat-Sen University, Zhuhai, China[11]Henan Provincial People’s Hospital, Zhengzhou, China[12]PLA Strategic Support Force Characteristic Medical Center, Beijing, China[13]Department of Neurosurgery, The Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, China[14]Guangdong Provincial Hospital of Traditional Chinese Medicine, Guangzhou, China广东省中医院[15]Department of Neurology, The Third People’s Hospital of Hubei Province, Wuhan, China, [16] The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China[17]Nanjing First Hospital, Nanjing Medical University, Nanjing, China[18]Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine, Shanghai, China[19]Medical Research & Biometrics Center, National Center for Cardiovascular Disease, China[20]Zhuhai Ton-Bridge Medical Tech. Co., Ltd., Zhuhai, China
Purpose: The Tonbridge stent is a novel retriever with several design improvements which aim to achieve promising flow reperfusion in the treatment of acute ischemic stroke (AIS). We conducted a randomized controlled, multicenter, non-inferiority trial to compare the safety and efficacy of the Tonbridge stent with the Solitaire FR. Methods: AIS patients aged 18-85 years with large vessel occlusion in anterior circulation who could undergo puncture within 6 h of symptom onset were included. Randomization was performed on a 1:1 ratio to thrombectomy with either the Tonbridge stent or the Solitaire FR. The primary efficacy endpoint was successful reperfusion using a modified thrombolysis in cerebral infarction score (mTICI) of 2b/3. Safety outcomes were symptomatic intracranial hemorrhage (sICH) within 24 +/- 6 h and all-cause mortality within 90 days. A clinically relevant non-inferiority margin of 12% was chosen as the acceptable difference between groups. Secondary endpoints included time from groin puncture to reperfusion, National Institutes of Health Stroke Scale (NIHSS) score at 24 h and at 7 days, and a modified Rankin Scale (mRS) score of 0-2 at 90 days. Results: A total of 220 patients were enrolled; 104 patients underwent thrombectomy with the Tonbridge stent and 104 were treated with the Solitaire FR. In all test group patients, the Tonbridge was used as a single retriever without rescuing by other thrombectomy devices. Angioplasty with balloon and/or stent was performed in 26 patients in the Tonbridge group and 16 patients in the Solitaire group (p = 0.084). Before angioplasty, 86.5% of those in the Tonbridge group and 81.7% of those in the Solitaire group reached successful reperfusion (p = 0.343). Finally, more patients in the Tonbridge group achieved successful reperfusion (92.3 vs. 84.6%, 95% CI of difference value 0.9-16.7%, p < 0.0001). There were no significant differences on sICH within 24 +/- 6 h between the two groups. All-cause mortality within 90 days was 13.5% in the Tonbridge group and 16.3% in the Solitaire group (p = 0.559). We noted no significant differences between groups on the NIHSS at either 24 h or 7 days and the mRS of 0-2 at 90 days. Conclusion: The trial indicated that the Tonbridge stent was non-inferior to the Solitaire FR within 6 h of symptom onset in cases of large vessel occlusion stroke.
基金：
Zhuhai Ton-Bridge Medical Tech; National Natural Science FoundationNational Natural Science Foundation of China (NSFC) [82071287]
第一作者机构：[1]Department of Stroke Center, Changhai Hospital, Naval Military Medical University, Shanghai, China
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推荐引用方式(GB/T 7714)：
Yongxin Zhang,Weilong Hua,Zifu Li,et al.Efficacy and Safety of a Novel Thrombectomy Device in Patients With Acute Ischemic Stroke: A Randomized Controlled Trial[J].FRONTIERS IN NEUROLOGY.2021,12:doi:10.3389/fneur.2021.686253.
APA：
Yongxin Zhang,Weilong Hua,Zifu Li,Ya Peng,Zhian Han...&Pengfei Yang.(2021).Efficacy and Safety of a Novel Thrombectomy Device in Patients With Acute Ischemic Stroke: A Randomized Controlled Trial.FRONTIERS IN NEUROLOGY,12,
MLA：
Yongxin Zhang,et al."Efficacy and Safety of a Novel Thrombectomy Device in Patients With Acute Ischemic Stroke: A Randomized Controlled Trial".FRONTIERS IN NEUROLOGY 12.(2021)
