Design of the Carotid Revascularization Endarterectomy vs. Stenting Trial (CREST).

Design of the Carotid Revascularization Endarterectomy vs. Stenting Trial (CREST).
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DOI:
10.1111/j.1747-4949.2009.00405.x
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发表时间:
2010-02
期刊:
International journal of stroke : official journal of the International Stroke Society
影响因子:
--
通讯作者:
Brott TG
Brott TG
中科院分区:
其他
文献类型:
--
作者:
Sheffet AJ;Roubin G;Howard G;Howard V;Moore W;Meschia JF;Hobson RW 2nd;Brott TG

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对于有症状(≥50%)和无症状(≥60%)狭窄的患者,颈动脉内膜切除术(CEA)和药物治疗优于单纯药物治疗。颈动脉血管成形术支架植入术(CAS)提供了一种侵入性较小的替代方法。建立CAS的安全性、有效性和持久性需要在有症状和无症状患者中与CEA进行严格的比较。目的是比较CAS与CEA在有症状(≥50%)或无症状(≥60%)颅外颈动脉狭窄患者中的疗效。颈动脉血管重建术与支架置入试验(CREST)是一项前瞻性、随机、平行、双臂、多中心试验,采用盲法终点判定。主要终点使用标准的事件时间统计模型进行分析,并对主要基线协变量进行调整。初步分析是基于意向治疗。主要结局是在30天的围手术期发生任何中风、心肌梗死或死亡,以及在长达4年的随访期间发生同侧中风。次要结局包括再狭窄和健康相关生活质量。
Carotid endarterectomy (CEA) and medical therapy were shown superior to medical therapy alone for symptomatic (≥50%) and asymptomatic (≥60%) stenosis. Carotid angioplasty stenting (CAS) offers a less invasive alternative. Establishing safety, efficacy, and durability of CAS requires rigorous comparison with CEA in symptomatic and asymptomatic patients. The objective is to compare the efficacy of CAS versus CEA in patients with symptomatic (≥50%) or asymptomatic (≥60%) extracranial carotid stenosis. The Carotid Revascularization Endarterectomy vs. Stenting Trial (CREST) is a prospective, randomized, parallel, two-arm, multi-center trial with blinded endpoint adjudication. Primary endpoints are analyzed using standard time-to-event statistical modeling with adjustment for major baseline covariates. Primary analysis is on an intent-to-treat basis. The primary outcome is the occurrence of any stroke, myocardial infarction, or death during a 30-day peri-procedural period, and ipsilateral stroke during follow-up of up to four years. Secondary outcomes include restenosis and health-related quality of life.
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