Does the Stenting Versus Aggressive Medical Therapy Trial Support Stenting for Subgroups With Intracranial Stenosis?
Does the Stenting Versus Aggressive Medical Therapy Trial Support Stenting for Subgroups With Intracranial Stenosis?
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DOI：
10.1161/strokeaha.115.009846
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发表时间：
2015-11-01
期刊：
影响因子：
8.3
通讯作者：
Chimowitz, Marc I.
中科院分区：
文献类型：
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作者：
Lutsep, Helmi L.;Lynn, Michael J.;Chimowitz, Marc I.
背景与目的虽然颅内动脉狭窄的支架置入术与积极的药物治疗（SAMMPRIS）试验显示，在预防症状性颅内动脉狭窄患者复发性卒中方面，单纯药物治疗上级支架植入加药物治疗，我们确定SAMMPRIS是否支持在症状性颅内动脉狭窄患者的任何亚群中使用支架植入术。比较了2个治疗组（经皮腔内血管成形术和支架植入术（PTAS）+积极药物治疗与单纯积极药物治疗）中有和无基线因素的患者的30天卒中和死亡以及合格动脉区域内的晚期卒中。基线因素包括性别、年龄、种族、糖尿病、高血压、血脂紊乱、吸烟状况、合格事件类型、合格事件低灌注症状、基线时使用抗血栓或质子泵抑制剂、入组天数、同一区域的陈旧性梗死、狭窄百分比、其他动脉狭窄和症状性动脉的位置。227例随机接受积极药物治疗，224例接受PTAS治疗。在所有评估的变量中，观察到的2年事件发生率在绝大多数情况下PTAS高于积极的药物治疗，并且与治疗的相互作用对于任何factor.ConclusionsThe SAMMPRIS结果都没有提供证据来支持使用Wingspan支架系统的PTAS与任何检查的症状性颅内狭窄患者亚群中的药物治疗相比，临床试验注册URL：http://www.clinicaltrials.gov。唯一标识符：NCT 00576693。
Background and PurposeAlthough the Stenting Versus Aggressive Medical Therapy for Intracranial Arterial Stenosis (SAMMPRIS) trial showed that medical therapy alone was superior to stenting plus medical therapy for preventing recurrent strokes in patients with symptomatic intracranial stenosis, we determined whether SAMMPRIS supported the use of stenting in any subpopulations of patients with symptomatic intracranial arterial stenosis.MethodsThe primary outcome, 30-day stroke and death and later strokes in the territory of the qualifying artery, was compared in those with and without baseline factors in the 2 treatment arms, percutaneous transluminal angioplasty and stenting (PTAS) plus aggressive medical therapy versus aggressive medical therapy alone. Baseline factors included sex, age, race, diabetes mellitus, hypertension, lipid disorder, smoking status, type of qualifying event, qualifying event hypoperfusion symptoms, use of antithrombotic or proton pump inhibitor at baseline, days to enrollment, old infarcts in the same territory, percent stenosis, other artery stenosis, and location of the symptomatic artery.ResultsA total of 451 patients were enrolled, 227 randomized to aggressive medical therapy and 224 to PTAS. Of all variables evaluated, the observed 2-year event rates were higher with PTAS than with aggressive medical therapy in the vast majority and the interaction with treatment was not statistically significant for any of the factors.ConclusionsThe SAMMPRIS results do not provide evidence to support the use of PTAS using the Wingspan stent system compared with medical treatment in any examined subpopulation of patients with symptomatic intracranial stenosis, including those with qualifying event hypoperfusion symptoms.Clinical Trial RegistrationURL: http://www.clinicaltrials.gov. Unique identifier: NCT00576693.