{
  "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.",
  "authors": [
    {
      "affiliations": [
        "Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing, China"
      ],
      "name": "Gaoting Ma"
    },
    {
      "affiliations": [
        "Interventional Neuroradiology, Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China"
      ],
      "name": "Dapeng Sun"
    },
    {
      "affiliations": [
        "Interventional Neuroradiology, Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China"
      ],
      "name": "BaiXue Jia"
    },
    {
      "affiliations": [
        "Department of Neurology, The Affiliated Hospital of Hebei University, Baoding, Hebei, China"
      ],
      "name": "Li Ling"
    },
    {
      "affiliations": [
        "Department of Neurology and Radiology, Boston University School of Medicine, Boston, Massachusetts, USA"
      ],
      "name": "Thanh N Nguyen"
    },
    {
      "affiliations": [
        "Interventional Neuroradiology, Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China"
      ],
      "name": "Xuan Sun"
    },
    {
      "affiliations": [
        "Department of Neurosurgery, Shengjing Hospital of China Medical University, Shenyang, Liaoning, China"
      ],
      "name": "Bo Yu"
    },
    {
      "affiliations": [
        "Department of Neurology, Nanyang Central Hospital, Nanyang, Henan, China"
      ],
      "name": "Changming Wen"
    },
    {
      "affiliations": [
        "Department of Neurology, Shanxi Cardiovascular Hospital, Taiyuan, Shanxi, China"
      ],
      "name": "Tao Cheng"
    },
    {
      "affiliations": [
        "Department of Cerebrovascular disease, Fujian Medical University Union Hospital, Fuzhou, Fujian, China"
      ],
      "name": "Wenhuo Chen"
    },
    {
      "affiliations": [
        "Department of Neurology, First Affiliated Hospital of Shandong First Medical University, Jinan, Shandong, China"
      ],
      "name": "Ju Han"
    },
    {
      "affiliations": [
        "Department of Neurology, Linyi People's Hospital, Linyi, Shandong, China"
      ],
      "name": "Hongxing Han"
    },
    {
      "affiliations": [
        "Department of Neurosurgery, First Hospital of Shanxi Medical University, Taiyuan, Shanxi, China"
      ],
      "name": "Geng Guo"
    },
    {
      "affiliations": [
        "Department of Neurointervention, Second Hospital of Hebei Medical University, Shijiazhuang, Hebei, China"
      ],
      "name": "Jianghua Yu"
    },
    {
      "affiliations": [
        "Department of Neurology, Luoyang Central Hospital Affiliated to Zhengzhou University, Luoyang, Henan, China"
      ],
      "name": "Liping Wei"
    },
    {
      "affiliations": [
        "Department of Neurology, Taizhou Central Hospital, Taizhou, Zhejiang, China"
      ],
      "name": "Rui Huang"
    },
    {
      "affiliations": [
        "Department of Neurosurgery, The Third Medical Center Chinese People’s Liberation Army, Beijing, China"
      ],
      "name": "Gengsheng Mao"
    },
    {
      "affiliations": [
        "Department of Neurology, Sun Yat-Sen Memorial Hospital, Guangzhou, Guangdong, China"
      ],
      "name": "Qingyu Shen"
    },
    {
      "affiliations": [
        "Department of Neurology, Sun Yat-Sen Memorial Hospital, Guangzhou, Guangdong, China"
      ],
      "name": "Xinguang Yang"
    },
    {
      "affiliations": [
        "Interventional Neuroradiology, Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China"
      ],
      "name": "Bo Wang"
    },
    {
      "affiliations": [
        "Interventional Neuroradiology, Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China"
      ],
      "name": "Gang Luo"
    },
    {
      "affiliations": [
        "Neurological Disease Center, Beijing Anzhen Hospital Affiliated to Capital Medical University, Beijing, China"
      ],
      "name": "Xiaochuan Huo"
    },
    {
      "affiliations": [
        "Interventional Neuroradiology, Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China"
      ],
      "name": "Feng Gao"
    },
    {
      "affiliations": [
        "Interventional Neuroradiology, Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China"
      ],
      "name": "Dapeng Mo"
    },
    {
      "affiliations": [
        "Interventional Neuroradiology, Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China"
      ],
      "name": "Ning Ma"
    },
    {
      "affiliations": [
        "Interventional Neuroradiology, Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China"
      ],
      "name": "Zhongrong Miao"
    }
  ],
  "title": "Comparison of drug-coated balloon with bare-metal stent in patients with symptomatic intracranial atherosclerotic stenosis: the AcoArt sICAS randomized clinical trial",
  "uid": "1873403d-bb34-51a3-b211-a520f6377515"
}