Jia, Baixue, Zhang, Xuelei, Ma, Ning, Mo, Dapeng, Gao, Feng, Sun, Xuan, Song, Ligang, Liu, Lian, Deng, Yiming, Xu, Xiaotong, Zhang, Yong, Liu, Zengpin, Guan, Sheng, Zhang, Fan, Li, Bing, Zheng, Hongbo, Liu, Xinfeng, Liu, Yajie, Chen, Kangning, Shuai, Jie, Wan, Jieqing, Wang, Jun, Shi, Xiangqun, Li, Tianxiao, Chang, Binge, Liebeskind, David S., Yu, Wengui, and Miao, Zhongrong
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 included in the analysis, with 132 participants randomly assigned to the DES group and 131 to the BMS group. The 1-year ISR rate was lower in the DES group than in the BMS group (10 [9.5%] vs 32 [30.2%]; odds ratio, 0.24; 95% CI, 0.11-0.52; P