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Comparison of drug-coated balloon with bare-metal stent in patients with symptomatic intracranial atherosclerotic stenosis: the AcoArt sICAS randomized clinical trial

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机构： [1]Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing, China. [2]Interventional Neuroradiology, Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China. [3]Department of Neurology, The Affiliated Hospital of Hebei University, Baoding, Hebei, China. [4]Department of Neurology and Radiology, Boston University School of Medicine, Boston, Massachusetts, USA. [5]Department of Neurosurgery, Shengjing Hospital of China Medical University, Shenyang, Liaoning, China. [6]Department of Neurology, Nanyang Central Hospital, Nanyang, Henan, China. [7]Department of Neurology, Shanxi Cardiovascular Hospital, Taiyuan, Shanxi, China. [8]Department of Cerebrovascular disease, Fujian Medical University Union Hospital, Fuzhou, Fujian, China. [9]Department of Neurology, First Affiliated Hospital of Shandong First Medical University, Jinan, Shandong, China. [10]Department of Neurology, Linyi People's Hospital, Linyi, Shandong, China. [11]Department of Neurosurgery, First Hospital of Shanxi Medical University, Taiyuan, Shanxi, China. [12]Department of Neurointervention, Second Hospital of Hebei Medical University, Shijiazhuang, Hebei, China. [13]Department of Neurology, Luoyang Central Hospital Affiliated to Zhengzhou University, Luoyang, Henan, China. [14]Department of Neurology, Taizhou Central Hospital, Taizhou, Zhejiang, China. [15]Department of Neurosurgery, The Third Medical Center Chinese People's Liberation Army, Beijing, China. [16]Department of Neurology, Sun Yat-Sen Memorial Hospital, Guangzhou, Guangdong, China. [17]Neurological Disease Center, Beijing Anzhen Hospital Affiliated to Capital Medical University, Beijing, China. [18]Interventional Neuroradiology, Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China zhongrongm@163.com maning_03@hotmail.com.

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Restenosis after stenting with a standard bare-metal stent (BMS) is the main cause of stroke recurrence for symptomatic intracranial atherosclerotic stenosis (sICAS). Whether a drug-coated balloon (DCB) could reduce the risk of restenosis for such patients is unknown. We aimed to investigate the efficacy and safety of DCB in reducing 6 month restenosis in patients with sICAS.A prospective, multicenter, randomized, open-label, blinded endpoint clinical trial was conducted at 13 stroke centers across China. Eligible patients aged 18-80 years with sICAS defined as a recent transient ischemic attack (<180 days) or ischemic stroke (14-180 days) before enrollment attributed to a 70-99% atherosclerotic stenosis of a major intracranial artery were recruited between June 4, 2021 and September 15, 2022 (final follow-up: April 13, 2023). Patients were randomly assigned to receive a DCB (n=90) or BMS at a 1:1 ratio. The primary outcome was the post-procedure incidence of restenosis in the target lesion at 6 months (165-225 days). The safety outcome was post-procedure target vessel-related stroke (hemorrhage or ischemia) or death at 30 days.Among 201 randomized patients, 180 were confirmed eligible (mean age 58 years) and completed the trial. Compared with BMS, DCB was associated with a lower rate of post-procedure incidence of restenosis in the target lesion at 6 months (6.9% vs 32.9%, OR 0.15, 95% CI 0.05 to 0.42, P=0.0003). Regarding the safety outcome, post-procedure target vessel-related stroke (hemorrhage or ischemia) or death at 30 days did not differ between the two groups (4.4% vs 5.6%, OR 0.79, 95%CI 0.21 to 3.05, P=0.73).DCB was superior to BMS in reducing the incidence of restenosis without increasing the risk of target vessel-related stroke or death within 6 months. Further trials comparing the outcomes of DCB with medical management for sICAS are warranted.ClinicalTrials.gov Identifier: NCT04631055.© Author(s) (or their employer(s)) 2025. No commercial re-use. See rights and permissions. Published by BMJ Group.

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大类 | 2 区

医学

小类 | 1 区神经成像 1 区外科

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Q1 NEUROIMAGING Q1 SURGERY

影响因子： 4.3 最新[2024版] 4.8 最新五年平均 0 出版当年[2025版] 0 出版当年五年平均 4.3 出版前一年[2024版]

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第一作者机构： [1]Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing, China.

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