Efficacy and Safety of a Novel Thrombectomy Device in Patients With Acute Ischemic Stroke: A Randomized Controlled Trial

Yongxin Zhang, Weilong Hua, Zifu Li, Ya Peng, Zhian Han, Tong Li, Congguo Yin, Shoucun Wang, Guangxian Nan, Zhenwei Zhao, Hua Yang, Bin Zhou, Tianxiao Li, Yiling Cai, Jianmin Zhang, Guifu Li, Xiaoxiang Peng, Sheng Guan, Junshan Zhou, Ming Ye, Liqin Wang, Lei Zhang, Bo Hong, Yongwei Zhang, Jieqing Wan, Yang Wang, Qing Zhu, Jianmin Liu, Pengfei Yang, Yongxin Zhang, Weilong Hua, Zifu Li, Ya Peng, Zhian Han, Tong Li, Congguo Yin, Shoucun Wang, Guangxian Nan, Zhenwei Zhao, Hua Yang, Bin Zhou, Tianxiao Li, Yiling Cai, Jianmin Zhang, Guifu Li, Xiaoxiang Peng, Sheng Guan, Junshan Zhou, Ming Ye, Liqin Wang, Lei Zhang, Bo Hong, Yongwei Zhang, Jieqing Wan, Yang Wang, Qing Zhu, Jianmin Liu, Pengfei Yang

Abstract

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. Clinical Trial Registration:ClinicalTrials.gov, number: NCT03210623.

Keywords: acute ischemic stroke; large vessel occlusion; reperfusion; stent; thrombectomy.

Conflict of interest statement

QZ was employed by the company Zhuhai Ton-Bridge Medical Tech. Co., Ltd. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. The authors declare that this study received funding from Zhuhai Ton-Bridge Medical Tech. Co., Ltd. The funder had the following involvement in the study: study design.

Copyright © 2021 Zhang, Hua, Li, Peng, Han, Li, Yin, Wang, Nan, Zhao, Yang, Zhou, Li, Cai, Zhang, Li, Peng, Guan, Zhou, Ye, Wang, Zhang, Hong, Zhang, Wan, Wang, Zhu, Liu and Yang.

Figures

Figure 1
Figure 1
The Tonbridge device and the unique design of the longitudinal spiral opening along its tubular surface.
Figure 2
Figure 2
Randomization and treatment of the patients.

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