Department of Surgery, UMDNJ-New Jersey Medical School, Newark, NJ, USA.
Int J Stroke. 2010 Feb;5(1):40-6. doi: 10.1111/j.1747-4949.2009.00405.x.
Carotid endarterectomy (CEA) and medical therapy were shown superior to medical therapy alone for symptomatic (> or =50%) and asymptomatic (> or =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 (> or =50%) or asymptomatic (> or =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.
颈动脉内膜切除术(CEA)和药物治疗在治疗有症状(≥50%)和无症状(≥60%)狭窄患者中优于单纯药物治疗。颈动脉血管成形术支架置入术(CAS)提供了一种侵袭性较小的选择。为了确立 CAS 的安全性、有效性和耐久性,需要在有症状和无症状患者中与 CEA 进行严格比较。
比较有症状(≥50%)或无症状(≥60%)颅外颈动脉狭窄患者中 CAS 与 CEA 的疗效。
颈动脉再血管化内膜切除术与支架置入术试验(CREST)是一项前瞻性、随机、平行、双臂、多中心试验,采用盲法终点评估。主要终点采用标准时间事件统计模型进行分析,并对主要基线协变量进行调整。主要分析采用意向治疗原则。
主要结果是 30 天围手术期内任何卒中和死亡的发生,以及随访 4 年内同侧卒中和死亡的发生。次要结果包括再狭窄和健康相关生活质量。