Stenting Versus Medical Therapy for Symptomatic Intracranial Artery Stenosis: Long-Term Follow-Up of a Randomized Trial.

IF 8.9 1区医学 Q1 CLINICAL NEUROLOGY Stroke Pub Date : 2025-05-01 Epub Date: 2025-03-18 DOI:10.1161/STROKEAHA.124.049602

Peng Gao, Xiaoxin He, Haibo Wang, Tao Wang, Daming Wang, Huaizhang Shi, Tianxiao Li, Zhenwei Zhao, Yiling Cai, Wei Wu, Weiwen He, Jia Yu, Bingjie Zheng, Xuebing Feng, Colin P Derdeyn, Adam A Dmytriw, Yangfeng Wu, Guoguang Zhao, Liqun Jiao

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Abstract

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]; P=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]; P=0.97), disabling stroke or death (16.5% versus 14.3%; hazard ratio, 1.12 [95% CI, 0.66-1.91]; P=0.70), and death (9.1% versus 7.1%; hazard ratio, 1.22 [95% CI, 0.58-2.58]; P=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.

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支架植入与药物治疗对症颅内动脉狭窄：一项随机试验的长期随访。

背景：对于有症状的严重颅内动脉狭窄，在药物治疗（MT）的基础上加入支架植入术预防卒中的长期获益是否能抵消支架植入术的围手术期风险，尚未在一项随机试验中直接评估。我们的目的是在一项随机试验中比较支架植入与单纯MT治疗有症状的严重颅内动脉狭窄患者的长期（bbb30 - 3年）效果。方法：我们扩大了在中国8个中心进行的一项多中心、开放标签、随机试验的358名受试者的随访。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而发生短暂性脑缺血发作或脑卒中的患者（70% - 99%）。主要终点为30天内卒中或死亡，或30天以上符合条件的动脉区域卒中。其他次要结果包括符合条件的动脉区域中风，以及入组后致残性中风或死亡。结果：从2014年3月5日起共招募358例患者（支架置入176例，MT置入182例），随访至2024年1月22日。中位随访时间为7.4年（四分位数范围为6.0-8.0）。主要结局无显著差异(支架置入14.8% vs MT 14.3%；风险比，1.02 [95% CI, 0.58-1.77]；P = 0.97)。次要结局组间无显著差异：合格动脉区域卒中(14.8% vs 14.3%；风险比，1.02 [95% CI, 0.58-1.77]；P=0.97)，致残性中风或死亡(16.5%比14.3%；风险比，1.12 [95% CI, 0.66-1.91]；P=0.70)和死亡(9.1%对7.1%；风险比，1.22 [95% CI, 0.58-2.58]；P = 0.60)。结论：这项研究提供了令人信服的证据，即使经过长时间的观察，在有症状的严重颅内动脉狭窄的患者中，MT的支架置入并不会给MT带来额外的益处。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。注册：网址：https://www.clinicaltrials.gov；唯一标识符：NCT01763320。

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来源期刊

Stroke 医学-临床神经学

CiteScore

13.40

自引率

6.00%

发文量

2021

审稿时长

3 months

期刊介绍： Stroke is a monthly publication that collates reports of clinical and basic investigation of any aspect of the cerebral circulation and its diseases. The publication covers a wide range of disciplines including anesthesiology, critical care medicine, epidemiology, internal medicine, neurology, neuro-ophthalmology, neuropathology, neuropsychology, neurosurgery, nuclear medicine, nursing, radiology, rehabilitation, speech pathology, vascular physiology, and vascular surgery. The audience of Stroke includes neurologists, basic scientists, cardiologists, vascular surgeons, internists, interventionalists, neurosurgeons, nurses, and physiatrists. Stroke is indexed in Biological Abstracts, BIOSIS, CAB Abstracts, Chemical Abstracts, CINAHL, Current Contents, Embase, MEDLINE, and Science Citation Index Expanded.