{
  "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.",
  "authors": [
    {
      "affiliations": [
        "Department of Interventional Neuroradiology, Beijing Tiantan Hospital, Capital Medical University, Beijing, Beijing, China",
        "China National Clinical Research Center for Neurological Diseases, Beijing, Beijing, China"
      ],
      "name": "Ying Yu"
    },
    {
      "affiliations": [
        "China National Clinical Research Center for Neurological Diseases, Beijing, Beijing, China",
        "Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, Beijing, China"
      ],
      "name": "Xuan Wang"
    },
    {
      "affiliations": [
        "Department of Interventional Neuroradiology, Henan Provincial People’s Hospital, Zhengzhou, Henan, China"
      ],
      "name": "Liangfu Zhu"
    },
    {
      "affiliations": [
        "Department of Neurology, Guangdong Provincial People’s Hospital, Guangzhou, Guangdong, China"
      ],
      "name": "Chengbo Dai"
    },
    {
      "affiliations": [
        "Department of Neurology, Meizhou People’s Hospital, Meizhou, Guangdong, China"
      ],
      "name": "Weisheng Deng"
    },
    {
      "affiliations": [
        "Stroke Center, Affiliated Hospital of Nantong University, Nantong, Jiangsu, China"
      ],
      "name": "Yunfeng Zhang"
    },
    {
      "affiliations": [
        "Department of Interventional Vascular Surgery, Peking University Third Hospital, Beijing, Beijing, China"
      ],
      "name": "Jin-Tao Han"
    },
    {
      "affiliations": [
        "Department of Neurology, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shanxi, China"
      ],
      "name": "Jianfeng Han"
    },
    {
      "affiliations": [
        "Department of Neurology, Luoyang Central Hospital Affiliated to Zhengzhou University, Luoyang, Henan, China"
      ],
      "name": "Liping Wei"
    },
    {
      "affiliations": [
        "Department of Neurology, The Second Affiliated Hospital of Nanchang University, Nanchang, Jiangxi, China"
      ],
      "name": "Jianglong Tu"
    },
    {
      "affiliations": [
        "Department of Neurology, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, Guangdong, China"
      ],
      "name": "Xinguang Yang"
    },
    {
      "affiliations": [
        "Department of Neurosurgery, Renji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, Shanghai, China"
      ],
      "name": "Jieqing Wan"
    },
    {
      "affiliations": [
        "Department of Neurology, Hangzhou First People's Hospital, Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, Zhejiang, China"
      ],
      "name": "Congguo Yin"
    },
    {
      "affiliations": [
        "Department of Neurology, Nanjing First Hospital, Affiliated Nanjing Hospital of Nanjing Medical University, Nanjing, Jiangsu, China"
      ],
      "name": "Hongchao Shi"
    },
    {
      "affiliations": [
        "Department of Neurology, Beijing Daxing District People’s Hospital, Beijing, Beijing, China"
      ],
      "name": "Jinglin Yuan"
    },
    {
      "affiliations": [
        "Neurointervention Department, Beijing Shunyi Hospital, Beijing, Beijing, China"
      ],
      "name": "Liyu Wang"
    },
    {
      "affiliations": [
        "Department of Neurology, The First Affiliated Hospital of Kunming Medical University, Kunming, Yunnan, China"
      ],
      "name": "Chun Chen"
    },
    {
      "affiliations": [
        "Department of Neurosurgery, Beijing Chao-Yang Hospital, Capital Medical University, Beijing, Beijing, China"
      ],
      "name": "Weilun Fu"
    },
    {
      "affiliations": [
        "Department of Interventional Neuroradiology, Beijing Tiantan Hospital, Capital Medical University, Beijing, Beijing, China"
      ],
      "name": "Baixue Jia"
    },
    {
      "affiliations": [
        "Department of Interventional Neuroradiology, Beijing Tiantan Hospital, Capital Medical University, Beijing, Beijing, China",
        "China National Clinical Research Center for Neurological Diseases, Beijing, Beijing, China"
      ],
      "name": "Zhikai Hou"
    },
    {
      "affiliations": [
        "Department of Radiology, Chinese People's Liberation Army General Hospital, Beijing, Beijing, China"
      ],
      "name": "Xin Lou"
    },
    {
      "affiliations": [
        "Department of Interventional Neuroradiology, Beijing Tiantan Hospital, Capital Medical University, Beijing, Beijing, China",
        "China National Clinical Research Center for Neurological Diseases, Beijing, Beijing, China"
      ],
      "name": "Zhongrong Miao"
    },
    {
      "affiliations": [
        "China National Clinical Research Center for Neurological Diseases, Beijing, Beijing, China",
        "Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, Beijing, China"
      ],
      "name": "Yongjun Wang"
    },
    {
      "affiliations": [
        "Department of Interventional Neuroradiology, Henan Provincial People’s Hospital, Zhengzhou, Henan, China"
      ],
      "name": "Tianxiao Li"
    },
    {
      "affiliations": [
        "Department of Interventional Neuroradiology, Beijing Tiantan Hospital, Capital Medical University, Beijing, Beijing, China",
        "China National Clinical Research Center for Neurological Diseases, Beijing, Beijing, China"
      ],
      "name": "Ning Ma"
    }
  ],
  "title": "Durable fluoropolymer drug-eluting stent versus bare-metal stent for the prevention of intracranial in-stent restenosis",
  "uid": "30b07aac-3f88-5c69-8ec4-53a7b22f9493"
}