Durable fluoropolymer drug-eluting stent versus bare-metal stent for the prevention of intracranial in-stent restenosis

BACKGROUND: The high incidence of in-stent restenosis (ISR) associated with bare-metal stents (BMS) undermines the viability of endovascular treatment as a treatment option for patients with severe symptomatic intracranial atherosclerotic stenosis (ICAS). The study aimed to evaluate whether durable fluoropolymer drug-eluting stents (DES) reduce the incidence of ISR compared with BMS in the treatment of severe ICAS. METHODS: This prospective, multicentre, open-label, blinded outcome clinical trial was conducted at 16 centres in China, enrolling patients with ischaemic stroke or transient ischaemic attack (<90 days) attributed to 70%-99% stenosis of an intracranial major artery. Eligible patients were randomly assigned to receive durable fluoropolymer DES or BMS for stenosis treatment. The primary outcome was ISR at 1 year postprocedure, which was defined as a stenosis rate of ≥50% occurring within or immediately adjacent to (within 5 mm) the stent. Secondary outcomes included symptomatic ISR and stroke or death within 30 days or stroke in the target vessel territory between 31 days and 1 year. RESULTS: Between 20 February 2023 and 10 April 2024, 156 patients were enrolled and assigned to receive DES (n=78) or BMS (n=78). The median age was 61 years (IQR 54-67), and 129 (82.7%) of 156 patients were male. At 1 year, the primary outcome occurred in 2.9% in the DES group versus 27.9% in the BMS group (risk difference -0.25, 95% CI -0.37 to -0.13, p<0.001). No significant differences were observed between the DES and BMS groups in symptomatic ISR (0% vs 2.9%, p=0.20) or in stroke or death within 30 days or stroke in the target vessel territory between 31 days and 1 year (7.7% vs 12.3%, p=0.45). CONCLUSIONS: Among patients with severe ICAS, treatment with durable fluoropolymer DES resulted in a lower 1-year ISR compared with BMS. TRIAL REGISTRATION NUMBER: NCT05719883.

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Journal
Journal of Neurology Neurosurgery & Psychiatry
Published
2026-06-17
DOI
https://doi.org/10.1136/jnnp-2026-338887
Primary Topic
Cerebrovascular and Carotid Artery Diseases
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article
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article

Durable fluoropolymer drug-eluting stent versus bare-metal stent for the prevention of intracranial in-stent restenosis

Zhikai Hou, Xin Lou, Weisheng Deng, Liangfu Zhu et al.
Journal of Neurology Neurosurgery & Psychiatry
Cerebrovascular and Carotid Artery Diseases
article

Durable fluoropolymer drug-eluting stent versus bare-metal stent for the prevention of intracranial in-stent restenosis

Zhikai Hou, Xin Lou, Weisheng Deng, Liangfu Zhu, Zhongrong Miao, Ning Ma, Weilun Fu, Han Jl, Jinglin Yuan, Xuan Wang, J K Han, Baixue Jia, Chun Chen, Yongjun Wang, Congguo Yin, Tianxiao Li, Jianglong Tu, Ying Yu, Chengbo Dai, Jieqing Wan, Xinguang Yang, Hongchao Shi, Yunfeng Zhang, Liyu Wang, Liping Wei
article en

Abstract

BACKGROUND: The high incidence of in-stent restenosis (ISR) associated with bare-metal stents (BMS) undermines the viability of endovascular treatment as a treatment option for patients with severe symptomatic intracranial atherosclerotic stenosis (ICAS). The study aimed to evaluate whether durable fluoropolymer drug-eluting stents (DES) reduce the incidence of ISR compared with BMS in the treatment of severe ICAS. METHODS: This prospective, multicentre, open-label, blinded outcome clinical trial was conducted at 16 centres in China, enrolling patients with ischaemic stroke or transient ischaemic attack (<90 days) attributed to 70%-99% stenosis of an intracranial major artery. Eligible patients were randomly assigned to receive durable fluoropolymer DES or BMS for stenosis treatment. The primary outcome was ISR at 1 year postprocedure, which was defined as a stenosis rate of ≥50% occurring within or immediately adjacent to (within 5 mm) the stent. Secondary outcomes included symptomatic ISR and stroke or death within 30 days or stroke in the target vessel territory between 31 days and 1 year. RESULTS: Between 20 February 2023 and 10 April 2024, 156 patients were enrolled and assigned to receive DES (n=78) or BMS (n=78). The median age was 61 years (IQR 54-67), and 129 (82.7%) of 156 patients were male. At 1 year, the primary outcome occurred in 2.9% in the DES group versus 27.9% in the BMS group (risk difference -0.25, 95% CI -0.37 to -0.13, p<0.001). No significant differences were observed between the DES and BMS groups in symptomatic ISR (0% vs 2.9%, p=0.20) or in stroke or death within 30 days or stroke in the target vessel territory between 31 days and 1 year (7.7% vs 12.3%, p=0.45). CONCLUSIONS: Among patients with severe ICAS, treatment with durable fluoropolymer DES resulted in a lower 1-year ISR compared with BMS. TRIAL REGISTRATION NUMBER: NCT05719883.

Journal of Neurology Neurosurgery & Psychiatry
Nanchang University (CN), Sun Yat-sen University (CN), Capital Medical University (CN), Nantong University (CN), Peking University (CN), Kunming Medical University (CN), Beijing Chao-Yang Hospital, Capital Medical University (CN), Renji Hospital (CN), Chinese General Hospital College of Nursing and Liberal Arts (PH), Meizhou City People's Hospital (CN), Affiliated Hospital of Nantong University (CN), Beijing Tian Tan Hospital (CN), National Clinical Research Center for Digestive Diseases (CN), Sun Yat-sen Memorial Hospital (CN), Shunyi Hospital of Beijing Traditional Chinese Medicine Hospital (CN), People's Liberation Army No. 150 Hospital (CN), Second Affiliated Hospital of Nanchang University (CN), Beijing Hospital (CN), First Affiliated Hospital of Kunming Medical University (CN), First Affiliated Hospital of Xi'an Jiaotong University (CN), Luoyang Central Hospital Affiliated to Zhengzhou University (CN), Henan Provincial People's Hospital (CN), Peking University Third Hospital (CN), Affiliated Hangzhou First People's Hospital, Westlake University, School of Medicine (CN), Guangdong Provincial People's Hospital (CN), Chinese People’s Liberation Army 263 hospital (CN), First Affiliated Hospital Zhejiang University (CN), Nanjing Medical University (CN)
Openalex Percentile: Top 8%
Cerebrovascular and Carotid Artery Diseases
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