Gao P et al.  JAMA. 2022 Aug 9;328(6):534-542. 

先前的随机试验通常表明，对于有症状的严重颅内动脉粥样硬化狭窄患者，在药物治疗的基础上加支架治疗是有害的还是没有好处的，但仍不确定的是，更精细的患者选择和更有经验的外科医生是否可能改善结果。研究旨在比较有症状的严重颅内动脉粥样硬化狭窄患者支架联合药物治疗与单纯药物治疗的差异。

在随机分组的380例患者中，358例符合条件完成试验。支架植入术加药物治疗组与单纯药物治疗组在卒中或死亡风险的主要转归上无显著差异（P = .82），在5个预先设定的次要终点中，没有一个显示出显著差异，包括2年后合格动脉区域卒中（P = .80）。支架植入术加药物治疗组3年死亡率为4.4%，而单纯药物治疗组3年死亡率为1.3%（P = .08）

在症状性严重颅内动脉粥样硬化狭窄导致的短暂性脑缺血发作或缺血性卒中患者中，在药物治疗的基础上加行经皮腔内血管成形术和支架植入术，与单纯药物治疗相比，在30天内发生卒中或死亡的风险，或在30天以上至1年内符合条件的动脉区域发生卒中的风险均无显著差异。

Abstract

Importance: Prior randomized trials have generally shown harm or no benefit of stenting added to medical therapy for patients with symptomatic severe intracranial atherosclerotic stenosis, but it remains uncertain as to whether refined patient selection and more experienced surgeons might result in improved outcomes.

Objective: To compare stenting plus medical therapy vs medical therapy alone in patients with symptomatic severe intracranial atherosclerotic stenosis.

Design, setting, and participants: Multicenter, open-label, randomized, outcome assessor-blinded trial conducted at 8 centers in China. A total of 380 patients with transient ischemic attack or nondisabling, nonperforator (defined as nonbrainstem or non-basal ganglia end artery) territory ischemic stroke attributed to severe intracranial stenosis (70%-99%) and beyond a duration of 3 weeks from the latest ischemic symptom onset were recruited between March 5, 2014, and November 10, 2016, and followed up for 3 years (final follow-up: November 10, 2019).

Interventions: Medical therapy plus stenting (n = 176) or medical therapy alone (n = 182). Medical therapy included dual-antiplatelet therapy for 90 days (single antiplatelet therapy thereafter) and stroke risk factor control.

Main outcomes and measures: The primary outcome was a composite of stroke or death within 30 days or stroke in the qualifying artery territory beyond 30 days through 1 year. There were 5 secondary outcomes, including stroke in the qualifying artery territory at 2 years and 3 years as well as mortality at 3 years.

Results: Among 380 patients who were randomized, 358 were confirmed eligible (mean age, 56.3 years; 263 male [73.5%]) and 343 (95.8%) completed the trial. For the stenting plus medical therapy group vs medical therapy alone, no significant difference was found for the primary outcome of risk of stroke or death (8.0% [14/176] vs 7.2% [13/181]; difference, 0.4% [95% CI, -5.0% to 5.9%]; hazard ratio, 1.10 [95% CI, 0.52-2.35]; P = .82). Of the 5 prespecified secondary end points, none showed a significant difference including stroke in the qualifying artery territory at 2 years (9.9% [17/171] vs 9.0% [16/178]; difference, 0.7% [95% CI, -5.4% to 6.7%]; hazard ratio, 1.10 [95% CI, 0.56-2.16]; P = .80) and 3 years (11.3% [19/168] vs 11.2% [19/170]; difference, -0.2% [95% CI, -7.0% to 6.5%]; hazard ratio, 1.00 [95% CI, 0.53-1.90]; P > .99). Mortality at 3 years was 4.4% (7/160) in the stenting plus medical therapy group vs 1.3% (2/159) in the medical therapy alone group (difference, 3.2% [95% CI, -0.5% to 6.9%]; hazard ratio, 3.75 [95% CI, 0.77-18.13]; P = .08).

Conclusions and relevance: Among patients with transient ischemic attack or ischemic stroke due to symptomatic severe intracranial atherosclerotic stenosis, the addition of percutaneous transluminal angioplasty and stenting to medical therapy, compared with medical therapy alone, resulted in no significant difference in the risk of stroke or death within 30 days or stroke in the qualifying artery territory beyond 30 days through 1 year. The findings do not support the addition of percutaneous transluminal angioplasty and stenting to medical therapy for the treatment of patients with symptomatic severe intracranial atherosclerotic stenosis.

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https://jamanetwork.com/journals/jama/article-abstract/2795028?resultClick=1

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