Comparison of Drug-Eluting Stent With Bare-Metal Stent in Patients With Symptomatic High-grade Intracranial Atherosclerotic Stenosis

作者：Baixue Jia, Xuelei Zhang, Ning Ma, Dapeng Mo, Feng Gao, Xuan Sun, Ligang Song, Lian Liu, Yiming Deng, Xiaotong Xu, Yong Zhang, Zengpin Liu, Sheng Guan, Fan Zhang, Bing Li, Hongbo Zheng, Xinfeng Liu, Yajie Liu, Kangning Chen, Jie Shuai, Jieqing Wan, Jun Wang, Xiangqun Shi, Tianxiao Li, Binge Chang, David S. Liebeskind, Wengui Yu, Zhongrong Miao, NOVA Trial Investigators, Xiaochuan Huo, Xiaoqing Li, Gang Luo, Bo Wang, Wentao Gong, Tonghui Liu, Guangwen Li, Xianhui Su, Tao Quan, Guodong Xu, Liang Ma, Hongliang Wu, Huilong Zhang, Fayun Hu, Rui Liu, Qiushi Lv, Kaifeng Li, Guangjian Li, Fei Wei, Shenghao Ding, Hui Su, Guozhen Zhang, Ziliang Wang · 发表于：JAMA Neurology · 年份：2022 · DOI：10.1001/jamaneurol.2021.4804 · 被引用次数：125 · 研究领域：Cerebrovascular and Carotid Artery Diseases、Coronary Interventions and Diagnostics、Acute Ischemic Stroke Management

Importance: In-stent restenosis (ISR) is the primary reason for stroke recurrence after intracranial stenting in patients who were treated with a standard bare-metal stent (BMS). Whether a drug-eluting stent (DES) could reduce the risk of ISR in intracranial atherosclerotic stenosis (ICAS) remains unclear. Objective: To investigate whether a DES can reduce the risk of ISR and stroke recurrence in patients with symptomatic high-grade ICAS. Design, Settings, and Participants: A prospective, multicenter, open-label randomized clinical trial with blinded outcome assessment was conducted from April 27, 2015, to November 16, 2018, at 16 medical centers in China with a high volume of intracranial stenting. Patients with symptomatic high-grade ICAS were enrolled, randomized, and followed up for 1 year. Intention-to-treat data analysis was performed from April 1 to May 22, 2021. Interventions: Patients were randomly assigned to receive DES (NOVA intracranial sirolimus-eluting stent system) or BMS (Apollo intracranial stent system) treatment in a 1:1 ratio. Main Outcomes and Measures: The primary efficacy end point was ISR within 1 year after the procedure, which was defined as stenosis that was greater than 50% of the luminal diameter within or immediately adjacent to (within 5 mm) the implanted stent. The primary safety end point was any stroke or death within 30 days after the procedure. Results: A total of 263 participants (194 men [73.8%]; median [IQR] age, 58 [52-65] years) were ...