症状性颅内动脉狭窄的支架置入术与药物治疗：一项随机试验的长期随访
Stenting Versus Medical Therapy for Symptomatic Intracranial Artery Stenosis: Long-Term Follow-Up of a Randomized Trial.
作者信息
Gao Peng, He Xiaoxin, Wang Haibo, Wang Tao, Wang Daming, Shi Huaizhang, Li Tianxiao, Zhao Zhenwei, Cai Yiling, Wu Wei, He Weiwen, Yu Jia, Zheng Bingjie, Feng Xuebing, Derdeyn Colin P, Dmytriw Adam A, Wu Yangfeng, Zhao Guoguang, Jiao Liqun
机构信息
Departments of Neurosurgery and Interventional Neuroradiology, Xuanwu Hospital, Capital Medical University, Beijing, China (P.G., X.H., T.W., X.F., G.Z., L.J.).
Clinical Research Institute, Institute of Advanced Clinical Medicine, Peking University, Beijing, China (H.W., Y.W.).
出版信息
Stroke. 2025 May;56(5):1128-1137. doi: 10.1161/STROKEAHA.124.049602. Epub 2025 Mar 18.
BACKGROUND
Whether the long-term benefit of stroke prevention when stenting is added to medical therapy (MT) over MT alone for symptomatic severe intracranial artery stenosis offsets the perioperative risks of the stenting has not been directly evaluated in a randomized trial. We aimed to compare the long-term (>3 years) effect of stenting versus MT alone in patients with symptomatic severe intracranial artery stenosis in a randomized trial.
METHODS
We extended the follow-up of 358 subjects enrolled in a multicenter, open-label, randomized trial conducted at 8 centers in China. Patients with transient ischemic attack or stroke attributed to severe intracranial stenosis (70% to 99%) were recruited between March 5, 2014, and November 10, 2016. The primary outcome was a composite of stroke or death within 30 days or stroke in the territory of the qualifying artery beyond 30 days. Other secondary outcomes included stroke in the territory of the qualifying artery, as well as disabling stroke or death after enrollment.
RESULTS
A total of 358 patients (stenting 176 versus MT 182) were recruited from March 5, 2014, and followed up till January 22, 2024. The median duration of follow-up was 7.4 years (interquartile range, 6.0-8.0). The primary outcome was not significantly different (stenting 14.8% versus MT 14.3%; hazard ratio, 1.02 [95% CI, 0.58-1.77]; =0.97). No significant difference was found between groups for the secondary outcomes: stroke in the territory of qualifying artery (14.8% versus 14.3%; hazard ratio, 1.02 [95% CI, 0.58-1.77]; =0.97), disabling stroke or death (16.5% versus 14.3%; hazard ratio, 1.12 [95% CI, 0.66-1.91]; =0.70), and death (9.1% versus 7.1%; hazard ratio, 1.22 [95% CI, 0.58-2.58]; =0.60).
CONCLUSIONS
This study provides compelling evidence that, even over prolonged observed periods, the addition of stenting to MT does not confer additional benefits to MT alone in patients with symptomatic severe intracranial artery stenosis. These results underscore the importance of MT as the cornerstone of long-term stroke prevention in this patient population.
REGISTRATION
URL: https://www.clinicaltrials.gov; Unique identifier: NCT01763320.
背景
对于症状性严重颅内动脉狭窄患者，在药物治疗（MT）基础上加用支架置入术预防卒中的长期获益是否能抵消支架置入术的围手术期风险，尚未在随机试验中得到直接评估。我们旨在通过一项随机试验比较支架置入术与单纯MT对症状性严重颅内动脉狭窄患者的长期（>3年）影响。
方法
我们对在中国8个中心进行的一项多中心、开放标签、随机试验中纳入的358名受试者进行了随访延长。2014年3月5日至2016年11月10日期间招募了因严重颅内狭窄（70%至99%）导致短暂性脑缺血发作或卒中的患者。主要结局是30天内卒中或死亡或30天后在责任动脉供血区域发生卒中的复合结局。其他次要结局包括责任动脉供血区域的卒中，以及入组后的致残性卒中和死亡。
结果
2014年3月5日至2024年1月22日共招募了358例患者（支架置入组176例，MT组182例）。中位随访时间为7.4年（四分位间距，6.0 - 8.0）。主要结局无显著差异（支架置入组14.8%，MT组14.3%；风险比，1.02 [95%CI，0.58 - 1.77]；P = 0.97）。次要结局在两组间也未发现显著差异：责任动脉供血区域的卒中（14.8%对14.3%；风险比，1.02 [95%CI，0.58 - 1.77]；P = 0.97）、致残性卒中和死亡（16.5%对14.3%；风险比，1.12 [95%CI，0.66 - 1.91]；P = 0.70）以及死亡（9.1%对7.1%；风险比，1.22 [95%CI，0.58 - 2.58]；P = 0.60）。
结论
本研究提供了有力证据，即对于症状性严重颅内动脉狭窄患者，即使在长期观察期内，在MT基础上加用支架置入术相较于单纯MT并无额外获益。这些结果强调了MT作为该患者群体长期卒中预防基石的重要性。
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