Rationale, design, and implementation of aggressive risk factor management in the Stenting and Aggressive Medical Management for Prevention of Recurrent Stroke in Intracranial Stenosis (SAMMPRIS) trial.
Rationale, design, and implementation of aggressive risk factor management in the Stenting and Aggressive Medical Management for Prevention of Recurrent Stroke in Intracranial Stenosis (SAMMPRIS) trial.
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DOI：
10.1161/circoutcomes.112.966911
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发表时间：
2012-09-01
期刊：
影响因子：
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通讯作者：
SAMMPRIS Investigators
中科院分区：
文献类型：
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作者：
Turan TN;Lynn MJ;Nizam A;Lane B;Egan BM;Le NA;Lopes-Virella MF;Hermayer KL;Benavente O;White CL;Brown WV;Caskey MF;Steiner MR;Vilardo N;Stufflebean A;Derdeyn CP;Fiorella D;Janis S;Chimowitz MI;SAMMPRIS Investigators
e52 Circuitvasc Qual Outcomes 2012年9月，由美国国家神经疾病和卒中研究所资助的由患者发起和设计的III期随机、多中心试验，其中合格患者在50个研究中心随机接受单独的积极药物治疗或使用Wingspan支架系统的经皮腔内血管成形术和支架植入术加积极药物治疗。主要合格性标准为入组前30天内TIA或非致残性卒中，由颅内主要动脉（大脑中动脉、颈动脉、椎动脉或基底动脉）狭窄70%至99%引起。主要结局是入组后30天内或随访期间对合格病变进行血运重建手术后发生卒中或死亡，或超过30天在合格动脉范围内发生卒中。积极的药物治疗包括在整个随访期间（估计平均随访时间约32个月）服用阿司匹林325 mg/天，入组后每天服用氯吡格雷75 mg，持续90天，以及积极的风险因素管理，主要针对收缩压（SBP）< 140 mm Hg（如果患有糖尿病，则< 130）和低密度脂蛋白胆固醇（LDLc）< 70 mg/dL。主要和次要目标的风险因素管理（见表1）由每个研究中心的研究神经科医生和协调员进行，并由创新的、循证的、教育性的生活方式改变计划（INTERxVENT）辅助，该计划在整个研究期间定期对所有患者进行。SAMMPRIS的目标样本量为764例患者，但国家神经疾病和卒中研究所根据独立数据安全监测委员会的建议于2011年4月5日提前停止招募，主要原因是经皮腔内血管成形术和支架植入术组围手术期卒中和死亡风险的安全性问题。17在停止入组时，已入组451例患者，医疗组的主要事件发生率显著低于预期。17对所有入组患者的积极医疗管理随访将持续到2013年3月，之后将获得最终结局和风险因素数据以供分析。
e52 Circ Cardiovasc Qual Outcomes September 2012 investigator-initiated and designed Phase III randomized, multicenter trial funded by the National Institute of Neurological Disorders and Stroke in which eligible patients were randomized at 50 sites to aggressive medical therapy alone or percutaneous transluminal angioplasty and stenting using the Wingspan stent system plus aggressive medical therapy. The main eligibility criteria were TIA or nondisabling stroke within 30 days prior to enrollment caused by 70% to 99% stenosis of a major intracranial artery (middle cerebral artery, carotid, vertebral, or basilar). The primary outcome is stroke or death within 30 days after enrollment or after a revascularization procedure for the qualifying lesion performed during the follow-up period or stroke in the territory of the qualifying artery beyond 30 days. Aggressive medical therapy includes aspirin 325 mg/day during the entire follow-up period (estimated mean follow-up of≈ 32 months), clopidogrel 75 mg per day for 90 days after enrollment, and aggressive risk factor management primarily targeting systolic blood pressure (SBP)< 140 mm Hg (< 130 if diabetic) and low-density lipoprotein cholesterol (LDLc)< 70 mg/dL. Risk factor management of both primary and secondary targets (see Table 1) is performed by the study neurologist and coordinator at each site, assisted by an innovative, evidence-based, educational, lifestyle modification program (INTERxVENT) that is administered at regularly scheduled times to all patients throughout the study. The target sample size in SAMMPRIS was 764 patients, but enrollment was stopped early by National Institute of Neurological Disorders and Stroke on the basis of recommendation by the independent Data Safety Monitoring Board on April 5, 2011 due primarily to safety concerns regarding the periprocedural stroke and death risk in the percutaneous transluminal angioplasty and stenting group. 17 At the time when enrollment was stopped, 451 patients had been enrolled and the primary event rate in the medical arm was substantially lower than anticipated. 17 Follow-up with aggressive medical management of all enrolled patients will continue until March 2013, after which the final outcome and risk factor data will be available for analysis.