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

IF 4.3 1区医学 Q1 NEUROIMAGING Journal of NeuroInterventional Surgery Pub Date : 2026-01-13 DOI:10.1136/jnis-2024-022768

Gaoting Ma, Dapeng Sun, BaiXue Jia, Li Ling, Thanh N Nguyen, Xuan Sun, Bo Yu, Changming Wen, Tao Cheng, Wenhuo Chen, Ju Han, Hongxing Han, Geng Guo, Jianghua Yu, Liping Wei, Rui Huang, Gengsheng Mao, Qingyu Shen, Xinguang Yang, Bo Wang, Gang Luo, Xiaochuan Huo, Feng Gao, Dapeng Mo, Ning Ma, Zhongrong Miao

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Abstract

Background: 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.

Methods: 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.

Results: 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).

Conclusion: 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.

Trial registration number: ClinicalTrials.gov Identifier: NCT04631055.

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药物包被球囊与裸金属支架治疗症状性颅内动脉粥样硬化性狭窄的比较：AcoArt sICAS随机临床试验

背景：标准裸金属支架（BMS）置入后再狭窄是症状性颅内动脉粥样硬化性狭窄（sICAS）患者卒中复发的主要原因。药物包被球囊（DCB）是否能降低此类患者再狭窄的风险尚不清楚。我们的目的是研究DCB在减少sICAS患者6个月再狭窄中的有效性和安全性。方法：在全国13个脑卒中中心进行前瞻性、多中心、随机、开放标签、盲法终点临床试验。符合条件的患者年龄为18-80岁，sICAS定义为近期短暂性脑缺血发作(结果：在201名随机患者中，180名患者确认符合条件（平均年龄58岁）并完成了试验。与BMS相比，DCB与术后6个月目标病变再狭窄发生率较低相关（6.9% vs 32.9%, OR 0.15, 95% CI 0.05 ~ 0.42， P=0.0003）。关于安全性结果，两组术后30天靶血管相关卒中（出血或缺血）或死亡发生率无差异（4.4% vs 5.6%, or 0.79, 95%CI 0.21 ~ 3.05， P=0.73）。结论：DCB在降低再狭窄发生率方面优于BMS，且未增加6个月内靶血管相关卒中或死亡的风险。进一步的试验比较DCB与sICAS的医疗管理的结果是有必要的。试验注册号：ClinicalTrials.gov标识符：NCT04631055。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Journal of NeuroInterventional Surgery NEUROIMAGING-SURGERY

CiteScore

9.50

自引率

14.60%

发文量

291

审稿时长

4-8 weeks

期刊介绍： The Journal of NeuroInterventional Surgery (JNIS) is a leading peer review journal for scientific research and literature pertaining to the field of neurointerventional surgery. The journal launch follows growing professional interest in neurointerventional techniques for the treatment of a range of neurological and vascular problems including stroke, aneurysms, brain tumors, and spinal compression.The journal is owned by SNIS and is also the official journal of the Interventional Chapter of the Australian and New Zealand Society of Neuroradiology (ANZSNR), the Canadian Interventional Neuro Group, the Hong Kong Neurological Society (HKNS) and the Neuroradiological Society of Taiwan.