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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2021
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oai:doaj.org-article:2b5873288cfe47908a328992362e51e32021-12-01T08:14:32ZSafety and Efficacy of Rapamycin-Eluting Vertebral Stents in Patients With Symptomatic Extracranial Vertebral Artery Stenosis1664-229510.3389/fneur.2021.649426https://doaj.org/article/2b5873288cfe47908a328992362e51e32021-11-01T00:00:00Zhttps://www.frontiersin.org/articles/10.3389/fneur.2021.649426/fullhttps://doaj.org/toc/1664-2295Background 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.Gaoting MaLigang SongNing Ma RaynaldJie ShuaiWei WuJieqing WanZhenwei ZhaoGuangjian LiSen YinShenghao DingJiang LiBaixue JiaXu TongDapeng MoFeng GaoXuan SunYiming DengXiaochuan HuoWei LiKangning ChenZhongrong MiaoFrontiers Media S.A.articlevertebral artery stenosisdrug-eluting stentsymptomatic stenosisin-stent restenosisobjective performance criterionNeurology. Diseases of the nervous systemRC346-429ENFrontiers in Neurology, Vol 12 (2021) |
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DOAJ |
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| topic |
vertebral artery stenosis drug-eluting stent symptomatic stenosis in-stent restenosis objective performance criterion Neurology. Diseases of the nervous system RC346-429 |
| spellingShingle |
vertebral artery stenosis drug-eluting stent symptomatic stenosis in-stent restenosis objective performance criterion Neurology. Diseases of the nervous system RC346-429 Gaoting Ma Ligang Song Ning Ma Raynald Jie Shuai Wei Wu Jieqing Wan Zhenwei Zhao Guangjian Li Sen Yin Shenghao Ding Jiang Li Baixue Jia Xu Tong Dapeng Mo Feng Gao Xuan Sun Yiming Deng Xiaochuan Huo Wei Li Kangning Chen Zhongrong Miao Safety and Efficacy of Rapamycin-Eluting Vertebral Stents in Patients With Symptomatic Extracranial Vertebral Artery Stenosis |
| 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. |
| format |
article |
| author |
Gaoting Ma Ligang Song Ning Ma Raynald Jie Shuai Wei Wu Jieqing Wan Zhenwei Zhao Guangjian Li Sen Yin Shenghao Ding Jiang Li Baixue Jia Xu Tong Dapeng Mo Feng Gao Xuan Sun Yiming Deng Xiaochuan Huo Wei Li Kangning Chen Zhongrong Miao |
| author_facet |
Gaoting Ma Ligang Song Ning Ma Raynald Jie Shuai Wei Wu Jieqing Wan Zhenwei Zhao Guangjian Li Sen Yin Shenghao Ding Jiang Li Baixue Jia Xu Tong Dapeng Mo Feng Gao Xuan Sun Yiming Deng Xiaochuan Huo Wei Li Kangning Chen Zhongrong Miao |
| author_sort |
Gaoting Ma |
| title |
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_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_sort |
safety and efficacy of rapamycin-eluting vertebral stents in patients with symptomatic extracranial vertebral artery stenosis |
| publisher |
Frontiers Media S.A. |
| publishDate |
2021 |
| url |
https://doaj.org/article/2b5873288cfe47908a328992362e51e3 |
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