Kolos Igor, Loukianov Mikhail, Dupik Nikolay, Boytsov Sergey, Deev Alexandr
National Research Center for Preventive Medicine, Moscow, Russian Federation.
Int J Stroke. 2015 Feb;10(2):269-74. doi: 10.1111/ijs.12019. Epub 2013 Mar 15.
Carotid endarterectomy and medical therapy (aspirin) were shown superior to medical therapy alone for asymptomatic (≥ 60%) carotid stenosis. The role of modern medical therapy (statins, antihypertensive treatment, and aspirin) in the treatment of such patients is undefined. Establishing the safety, efficacy, and durability of optimal medical therapy and lifestyle modification requires rigorous comparison with carotid endarterectomy in asymptomatic patients.
The objective is to compare the efficacy of carotid endarterectomy + optimal medical therapy versus optimal medical therapy alone in patients with asymptomatic (70-79%) extracranial carotid stenosis.
The Aggressive Medical Treatment Evaluation for Asymptomatic Carotid Artery Stenosis study is a prospective, randomized, parallel, two-arm, multicenter trial. Primary end-points will be analyzed using standard time-to-event statistical modeling with adjustment for major baseline covariates. The primary analysis is on an intent-to-treat basis.
The primary outcome is nonfatal stroke, nonfatal myocardial infarction, and death during follow-up of up to five-years, and the secondary outcome includes death from any cause and stroke.
对于无症状（≥60%）颈动脉狭窄患者，颈动脉内膜切除术和药物治疗（阿司匹林）已被证明优于单纯药物治疗。现代药物治疗（他汀类药物、抗高血压治疗和阿司匹林）在此类患者治疗中的作用尚不明确。确定最佳药物治疗和生活方式改变的安全性、有效性和持久性需要与无症状患者的颈动脉内膜切除术进行严格比较。
目的是比较颈动脉内膜切除术+最佳药物治疗与单纯最佳药物治疗对无症状（70 - 79%）颅外颈动脉狭窄患者的疗效。
无症状颈动脉狭窄积极药物治疗评估研究是一项前瞻性、随机、平行、双臂、多中心试验。主要终点将使用标准的事件发生时间统计模型进行分析，并对主要基线协变量进行调整。主要分析基于意向性治疗原则。
主要结局是随访长达五年期间的非致命性卒中、非致命性心肌梗死和死亡，次要结局包括任何原因导致的死亡和卒中。
