Design of the stenting and aggressive medical management for preventing recurrent stroke in intracranial stenosis trial.
Design of the stenting and aggressive medical management for preventing recurrent stroke in intracranial stenosis trial.
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DOI：
10.1016/j.jstrokecerebrovasdis.2011.05.001
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发表时间：
2011-07
影响因子：
2.5
通讯作者：
Derdeyn, Colin P.
中科院分区：
文献类型：
--
作者：
Chimowitz, Marc I.;Lynn, Michael J.;Turan, Tanya N.;Fiorella, David;Lane, Bethany F.;Janis, Scott;Derdeyn, Colin P.
近期发生短暂性脑缺血发作或由颅内主要动脉狭窄70-99%引起的卒中的患者在常规医疗管理中复发卒中的风险较高，这表明需要对这种疾病进行替代治疗。支架植入术和积极的医疗管理预防颅内狭窄患者复发性卒中试验是一项正在进行的随机、多中心、两组试验，旨在确定颅内血管成形术和支架植入术是否增加了单独积极的医疗管理预防主要终点的获益（入组后30天内或随访期间合格病变的任何血运重建手术后发生任何卒中或死亡，或症状性颅内动脉区域内卒中超过30天）。两组的积极药物管理包括阿司匹林325 mg/天，氯吡格雷75 mg/天，入组后90天，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< 70 mg / dl的强化风险因素管理，以及生活方式调整计划。基于对数秩检验，检测血管成形术和支架植入术的主要终点发生率降低35%所需的样本量为每组382例患者，α为0.05，把握度为80%，并调整了2%的失访和5%的从医疗组到支架植入组的交叉。这是第一个比较颅内血管成形术和支架植入术与药物治疗的随机试验，并在研究设计中纳入了多种风险因素的强化管理和生活方式改变计划。希望试验结果能够为这种高危疾病提供更有效的治疗方法。
Patients with recent transient ischemic attack or stroke caused by 70–99% 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. The Stenting and Aggressive Medical Management for Preventing Recurrent stroke in Intracranial Stenosis trial is an ongoing, randomized, multicenter, two-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 70–99% stenosis of a major intracranial artery. Aggressive medical management in both arms consists of aspirin 325 mg per day, clopidogrel 75mg 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 lifetsyle modification program. The sample size required todetect 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. This is the first randomized trial to compare intracranial angioplasty and stenting with medical therapy 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.
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影响因子：
168.9
作者：
Diener, HC;Bogousslavsky, J;Rupprecht, HJ
通讯作者：
Rupprecht, HJ
影响因子：
4.8
作者：
Fiorella, D.;Turan, T. N.;Chimowitz, M. I.
通讯作者：
Chimowitz, M. I.
影响因子：
4.8
作者：
Meyers, PM;Higashida, RT;Halbach, VV
通讯作者：
Halbach, VV
影响因子：
1.9
作者：
OBRIEN, PC;FLEMING, TR
通讯作者：
FLEMING, TR
影响因子：
8.3
作者：
Gorelick, Philip B.;Wong, Ka Sing;Pandey, Dilip K.
通讯作者：
Pandey, Dilip K.