Stenting versus medical treatment alone for symptomatic intracranial artery stenosis: a preplanned pooled individual patient data analysis.

IF 4.5 1区 医学 Q1 NEUROIMAGING
Tao Wang, Jichang Luo, Tianhua Li, Eyad Almallouhi, Peng Gao, Haozhi Gong, Xiao Zhang, Jie Wang, Taoyuan Lu, Yifan Yang, Renjie Yang, Zixuan Xing, Haibo Wang, Colin P Derdeyn, Liqun Jiao
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引用次数: 0

Abstract

Background: Whether the safety and efficacy of percutaneous transluminal angioplasty and stenting (PTAS) is significantly different from that of medical treatment alone for symptomatic intracranial arterial stenosis (ICAS) is debatable. A study was undertaken to determine the safety and efficacy of both treatments for symptomatic ICAS.

Methods: This preplanned pooled individual patient data analysis included 400 participants treated with PTAS and 409 treated with medical treatment alone in two large multicenter randomized clinical trials (SAMMPRIS and CASSISS). Patients were treated with PTAS using a self-expanding stent or medical treatment alone. The primary outcome was stroke or death within 30 days, or ischemic stroke in the territory of the qualifying artery more than 30 days after enrollment.

Results: Individual data were obtained for 809 patients, 451 from SAMMPRIS and 358 from CASSISS. 400 participants were randomly assigned to the PTAS group and 409 to the medical group. The risk of the primary outcome was not significant between the PTAS and medical groups (17.5% vs 13.2%; HR 1.37 (95% CI 0.96 to 1.95), P=0.08). However, the risk of stroke or death within 30 days was higher in the PTAS group (10.5% vs 4.2%; HR 2.62 (95% CI 1.49 to 4.61), P<0.001). Patients of white ethnicity (HR 1.97, 95% CI 1.17 to 3.31) and those with hyperlipidemia (HR 2.04, 95% CI 1.27 to 3.26) or a transient ischemic attack (TIA) (HR 2.19, 95% CI 1.08 to 4.45) were at higher risk for PTAS.

Conclusions: PTAS poses an increased risk of short-term stroke/death and therefore is not advised as primary treatment for symptomatic ICAS. A balance exists between stroke risks and revascularization benefits. For patients with asymptomatic ICAS of white ethnicity and those with hyperlipidemia or a history of TIA, a thorough assessment is warranted before considering PTAS.

Trial registration: ClinicalTrials.gov Identifier: NCT00576693, NCT01763320.

无症状颅内动脉狭窄的支架置入术与单纯药物治疗:一项预先计划的个体患者数据汇集分析。
背景:对于有症状的颅内动脉狭窄(ICAS),经皮腔内血管成形术和支架植入术(PTAS)的安全性和有效性是否与单纯药物治疗有显著差异,尚存在争议。本研究旨在确定两种治疗方法治疗无症状颅内动脉狭窄的安全性和有效性:这项预先计划的个体患者数据汇总分析包括在两项大型多中心随机临床试验(SAMMPRIS和CASSISS)中接受PTAS治疗的400名参与者和接受单纯药物治疗的409名参与者。患者接受了使用自膨胀支架的 PTAS 治疗或单纯药物治疗。主要结果是入组 30 天内发生中风或死亡,或入组超过 30 天后在合格动脉区域发生缺血性中风:获得了 809 名患者的个人数据,其中 451 人来自 SAMMPRIS,358 人来自 CASSISS。400名参与者被随机分配到PTAS组,409名参与者被随机分配到医疗组。PTAS 组和医疗组的主要结局风险差异不大(17.5% vs 13.2%;HR 1.37(95% CI 0.96 至 1.95),P=0.08)。然而,PTAS 组在 30 天内发生中风或死亡的风险更高(10.5% vs 4.2%;HR 2.62 (95% CI 1.49 to 4.61),P=0.08):PTAS 增加了短期中风/死亡的风险,因此不建议将其作为无症状 ICAS 的主要治疗方法。中风风险与血管重建获益之间存在平衡。对于无症状的白种ICAS患者以及患有高脂血症或有TIA病史的患者,在考虑使用PTAS前应进行全面评估:试验注册:ClinicalTrials.gov Identifier:NCT00576693、NCT01763320。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
CiteScore
9.50
自引率
14.60%
发文量
291
审稿时长
4-8 weeks
期刊介绍: The Journal of NeuroInterventional Surgery (JNIS) is a leading peer review journal for scientific research and literature pertaining to the field of neurointerventional surgery. The journal launch follows growing professional interest in neurointerventional techniques for the treatment of a range of neurological and vascular problems including stroke, aneurysms, brain tumors, and spinal compression.The journal is owned by SNIS and is also the official journal of the Interventional Chapter of the Australian and New Zealand Society of Neuroradiology (ANZSNR), the Canadian Interventional Neuro Group, the Hong Kong Neurological Society (HKNS) and the Neuroradiological Society of Taiwan.
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