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首页> 外文期刊>Journal of stroke and cerebrovascular diseases: The official journal of National Stroke Association >Design of the stenting and aggressive medical management for preventing recurrent stroke in intracranial stenosis trial.
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Design of the stenting and aggressive medical management for preventing recurrent stroke in intracranial stenosis trial.

机译：支架设计和积极的医学管理，以防止颅内狭窄试验中复发性中风。

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BACKGROUND: Patients with recent transient ischemic attack (TIA) or stroke caused by 70% to 99% stenosis of a major intracranial artery are at high risk of recurrent stroke on usual medical management, suggesting the need for alternative therapies for this disease. METHODS: The Stenting and Aggressive Medical Management for Preventing Recurrent stroke in Intracranial Stenosis trial is an ongoing, randomized, multicenter, 2-arm trial that will determine whether intracranial angioplasty and stenting adds benefit to aggressive medical management alone for preventing the primary endpoint (any stroke or death within 30 days after enrollment or after any revascularization procedure of the qualifying lesion during follow-up, or stroke in the territory of the symptomatic intracranial artery beyond 30 days) during a mean follow-up of 2 years in patients with recent TIA or stroke caused by 70% to 99% stenosis of a major intracranial artery. Aggressive medical management in both arms consists of aspirin 325 mg per day, clopidogrel 75 mg per day for 90 days after enrollment, intensive risk factor management primarily targeting systolic blood pressure <140 mm Hg (<130 mm Hg in diabetics) and low density cholesterol <70 mg/dL, and a lifestyle modification program. The sample size required to detect a 35% reduction in the rate of the primary endpoint from angioplasty and stenting based on the log-rank test with an alpha of 0.05, 80% power, and adjusting for a 2% loss to follow-up and 5% crossover from the medical to the stenting arm is 382 patients per group. RESULTS: Enrollment began in November 2008 and 451 patients have been enrolled as of March 31, 2011. CONCLUSIONS: This is the first randomized stroke prevention trial to compare angioplasty and stenting with medical therapy in patients with intracranial arterial stenosis and to incorporate intensive management of multiple risk factors and a lifestyle modification program in the study design. Hopefully, the results of the trial will lead to more effective therapy for this high-risk disease.
机译：背景：近期发生短暂性脑缺血发作（TIA）或由颅内大动脉狭窄70％至99％引起的中风的患者在常规医疗管理中极易发生中风复发，这表明需要针对该疾病的替代疗法。方法：预防颅内狭窄的支架和积极的药物治疗预防复发性卒中试验是一项正在进行的，随机，多中心，两臂试验，将确定颅内血管成形术和支架置入是否仅对预防主要终点的积极药物治疗有益处（任何入组后30天内或在随访过程中对合格病变进行任何血运重建手术后30天内发生卒中或死亡，或对最近进行过TIA的患者进行平均2年平均随访（在有症状的颅内动脉区域内卒中超过30天）由颅内主要动脉狭窄70％至99％引起的卒中。双方积极的医疗管理包括入组后90天每天服用325毫克阿司匹林，每天服用75毫克氯吡格雷，主要针对收缩压<140 mm Hg（糖尿病患者<130 mm Hg）和低密度胆固醇的强化危险因素管理<70 mg / dL，以及生活方式改善计划。基于对数秩检验，α为0.05，功效为80％，并根据随访调整2％的损失，以检测血管成形术和支架置入的主要终点比率降低35％所需的样本量从医学到支架臂的5％交叉率为每组382名患者。结果：这项研究于2008年11月开始招募，截至2011年3月31日已有451例患者入选。结论：这是第一项比较卒中预防和颅内动脉狭窄患者的血管成形术和支架置入与药物治疗并纳入强化治疗的随机预防试验研究设计中包含多种风险因素和生活方式改变方案。希望该试验的结果将导致针对这种高危疾病的更有效治疗。

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