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Safety and Efficacy of Rapamycin-Eluting Vertebral Stents in Patients With Symptomatic Extracranial Vertebral Artery Stenosis

Background and Purpose: Drug-eluting stents generally have superior performance to bare metal stents in the treatment of vertebral artery stenosis (VAS). This prospective, multicenter, and single-arm clinical trial was initiated to assess in-stent restenosis (ISR) and midterm outcome after rapamycin...

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Autores principales: Ma, Gaoting, Song, Ligang, Ma, Ning, Raynald, Shuai, Jie, Wu, Wei, Wan, Jieqing, Zhao, Zhenwei, Li, Guangjian, Yin, Sen, Ding, Shenghao, Li, Jiang, Jia, Baixue, Tong, Xu, Mo, Dapeng, Gao, Feng, Sun, Xuan, Deng, Yiming, Huo, Xiaochuan, Li, Wei, Chen, Kangning, Miao, Zhongrong
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Frontiers Media S.A. 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8662782/
https://www.ncbi.nlm.nih.gov/pubmed/34899552
http://dx.doi.org/10.3389/fneur.2021.649426
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author Ma, Gaoting
Song, Ligang
Ma, Ning
Raynald,
Shuai, Jie
Wu, Wei
Wan, Jieqing
Zhao, Zhenwei
Li, Guangjian
Yin, Sen
Ding, Shenghao
Li, Jiang
Jia, Baixue
Tong, Xu
Mo, Dapeng
Gao, Feng
Sun, Xuan
Deng, Yiming
Huo, Xiaochuan
Li, Wei
Chen, Kangning
Miao, Zhongrong
author_facet Ma, Gaoting
Song, Ligang
Ma, Ning
Raynald,
Shuai, Jie
Wu, Wei
Wan, Jieqing
Zhao, Zhenwei
Li, Guangjian
Yin, Sen
Ding, Shenghao
Li, Jiang
Jia, Baixue
Tong, Xu
Mo, Dapeng
Gao, Feng
Sun, Xuan
Deng, Yiming
Huo, Xiaochuan
Li, Wei
Chen, Kangning
Miao, Zhongrong
author_sort Ma, Gaoting
collection PubMed
description Background and Purpose: Drug-eluting stents generally have superior performance to bare metal stents in the treatment of vertebral artery stenosis (VAS). This prospective, multicenter, and single-arm clinical trial was initiated to assess in-stent restenosis (ISR) and midterm outcome after rapamycin-eluting stent placement in patients with symptomatic extracranial VAS. Methods: The subjects underwent angiographic follow-up at 6 months and final clinical follow-up at 12 months. The primary efficacy endpoint was ISR at 6 months. Secondary endpoints included technical success, target lesion-related transient ischemic attack (TIA), stroke, or death, and all-cause TIA, stroke, or death during the 12-month follow-up period. Results: A total of 104 stents were implanted in the 101 patients and 83 patients (82.2%) completed angiographic follow-up at 6 months. The technical success rate was 86.1% (87/101); mean in-stent stenosis rate was 25.1 ± 17.1% and ISR rate was 5.9% (95% CI: 0.8–10.9%). All the patients with ISR were completely asymptomatic and no stent fractures were observed during angiographic follow-up. At the 12-month clinical follow-up, target lesion-related TIA, stroke, or death had occurred in two (2.0%) patients and all-cause TIA, stroke, or death had occurred in six (6.1%) patients. Conclusion: The placement of rapamycin-eluting stents in patients with symptomatic extracranial VAS yields favorable ISR results and showed a trend of favorable safety outcomes including low rates of perioperative complications and late stroke. However, further study is needed to establish the long-term clinical benefits of this stent in the treatment of VA disease.
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spelling pubmed-86627822021-12-11 Safety and Efficacy of Rapamycin-Eluting Vertebral Stents in Patients With Symptomatic Extracranial Vertebral Artery Stenosis Ma, Gaoting Song, Ligang Ma, Ning Raynald, Shuai, Jie Wu, Wei Wan, Jieqing Zhao, Zhenwei Li, Guangjian Yin, Sen Ding, Shenghao Li, Jiang Jia, Baixue Tong, Xu Mo, Dapeng Gao, Feng Sun, Xuan Deng, Yiming Huo, Xiaochuan Li, Wei Chen, Kangning Miao, Zhongrong Front Neurol Neurology Background and Purpose: Drug-eluting stents generally have superior performance to bare metal stents in the treatment of vertebral artery stenosis (VAS). This prospective, multicenter, and single-arm clinical trial was initiated to assess in-stent restenosis (ISR) and midterm outcome after rapamycin-eluting stent placement in patients with symptomatic extracranial VAS. Methods: The subjects underwent angiographic follow-up at 6 months and final clinical follow-up at 12 months. The primary efficacy endpoint was ISR at 6 months. Secondary endpoints included technical success, target lesion-related transient ischemic attack (TIA), stroke, or death, and all-cause TIA, stroke, or death during the 12-month follow-up period. Results: A total of 104 stents were implanted in the 101 patients and 83 patients (82.2%) completed angiographic follow-up at 6 months. The technical success rate was 86.1% (87/101); mean in-stent stenosis rate was 25.1 ± 17.1% and ISR rate was 5.9% (95% CI: 0.8–10.9%). All the patients with ISR were completely asymptomatic and no stent fractures were observed during angiographic follow-up. At the 12-month clinical follow-up, target lesion-related TIA, stroke, or death had occurred in two (2.0%) patients and all-cause TIA, stroke, or death had occurred in six (6.1%) patients. Conclusion: The placement of rapamycin-eluting stents in patients with symptomatic extracranial VAS yields favorable ISR results and showed a trend of favorable safety outcomes including low rates of perioperative complications and late stroke. However, further study is needed to establish the long-term clinical benefits of this stent in the treatment of VA disease. Frontiers Media S.A. 2021-11-26 /pmc/articles/PMC8662782/ /pubmed/34899552 http://dx.doi.org/10.3389/fneur.2021.649426 Text en Copyright © 2021 Ma, Song, Ma, Raynald, Shuai, Wu, Wan, Zhao, Li, Yin, Ding, Li, Jia, Tong, Mo, Gao, Sun, Deng, Huo, Li, Chen and Miao. https://creativecommons.org/licenses/by/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
spellingShingle Neurology
Ma, Gaoting
Song, Ligang
Ma, Ning
Raynald,
Shuai, Jie
Wu, Wei
Wan, Jieqing
Zhao, Zhenwei
Li, Guangjian
Yin, Sen
Ding, Shenghao
Li, Jiang
Jia, Baixue
Tong, Xu
Mo, Dapeng
Gao, Feng
Sun, Xuan
Deng, Yiming
Huo, Xiaochuan
Li, Wei
Chen, Kangning
Miao, Zhongrong
Safety and Efficacy of Rapamycin-Eluting Vertebral Stents in Patients With Symptomatic Extracranial Vertebral Artery Stenosis
title Safety and Efficacy of Rapamycin-Eluting Vertebral Stents in Patients With Symptomatic Extracranial Vertebral Artery Stenosis
title_full Safety and Efficacy of Rapamycin-Eluting Vertebral Stents in Patients With Symptomatic Extracranial Vertebral Artery Stenosis
title_fullStr Safety and Efficacy of Rapamycin-Eluting Vertebral Stents in Patients With Symptomatic Extracranial Vertebral Artery Stenosis
title_full_unstemmed Safety and Efficacy of Rapamycin-Eluting Vertebral Stents in Patients With Symptomatic Extracranial Vertebral Artery Stenosis
title_short Safety and Efficacy of Rapamycin-Eluting Vertebral Stents in Patients With Symptomatic Extracranial Vertebral Artery Stenosis
title_sort safety and efficacy of rapamycin-eluting vertebral stents in patients with symptomatic extracranial vertebral artery stenosis
topic Neurology
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8662782/
https://www.ncbi.nlm.nih.gov/pubmed/34899552
http://dx.doi.org/10.3389/fneur.2021.649426
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