Comparison of Drug-Eluting Stent With Bare-Metal Stent in Patients With Symptomatic High-grade Intracranial Atherosclerotic Stenosis: A Randomized Clinical Trial
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, 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
Abstract
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 < .001). The DES group also had a significantly lower ischemic stroke recurrence rate from day 31 to 1 year (1 [0.8%] vs 9 [6.9%]; hazard ratio, 0.10; 95% CI, 0.01-0.80; P = .03). No significant difference in the rate of any stroke or death within 30 days was observed between the DES and BMS groups (10 [7.6%] vs 7 [5.3%]; odds ratio, 1.45; 95% CI, 0.54-3.94; P = .46).
Conclusions and relevance: This trial found that, compared with BMSs, DESs reduced the risks of ISR and ischemic stroke recurrence in patients with symptomatic high-grade ICAS. Further investigation into the safety and efficacy of DESs is warranted.
Trial registration: ClinicalTrials.gov Identifier: NCT02578069.
Conflict of interest statement
Conflict of Interest Disclosures: Dr Liebeskind reported receiving consultant fees from Stryker Imaging Core Lab outside the submitted work. No other disclosures were reported.
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Source: PubMed