Kolos Igor, Troitskiy Alexandr, Balakhonova Tatiana, Shariya Merab, Skrypnik Denis, Tvorogova Tatiana, Deev Alexandr, Boytsov Sergey
Department of Clinical Cardiology and Molecular Genetics, National Research Center for Preventive Medicine, Moscow, Russian Federation.
Department of Vascular Surgery, Federal Medical and Biological Agency, Moscow, Russian Federation.
J Vasc Surg. 2015 Oct;62(4):914-22. doi: 10.1016/j.jvs.2015.05.005.
This study assessed the value of modern medical treatment (MMT) with and without carotid endarterectomy (CEA) in patients with asymptomatic severe carotid artery stenosis.
We conducted a randomized trial involving 55 patients with 70% to 79% carotid stenosis at three Russian centers. Between 2009 and 2013, 31 patients were randomized to undergo CEA with MMT (CEA group) and 24 to receive MMT alone. The primary end point was nonfatal ipsilateral stroke or death from any cause during a follow-up period of 5.0 years. The secondary end point was any nonfatal stroke, carotid revascularization, or death from any cause during follow-up.
The trial was stopped after a median follow-up of 3.3 years (maximum, 5.0 years). There were two primary events in the CEA group and nine events in the MMT group. The 3.3-year cumulative primary event rates were 6.5% in the CEA group and 37.5% in the MMT group (hazard ratio for the MMT group, 5.06; 95% confidence interval, 1.53-16.79; P = .008). The 3.3-year cumulative secondary end point was 12.9% in the CEA group and 50.0% in the MMT group (hazard ratio for the MMT group, 4.23; 95% confidence interval, 1.55-11.53; P = .0048).
CEA as an initial management strategy could reduce the risk of death and major cerebrovascular events when added to MMT.
本研究评估了有无颈动脉内膜切除术（CEA）的现代医学治疗（MMT）对无症状重度颈动脉狭窄患者的价值。
我们在俄罗斯的三个中心进行了一项随机试验，纳入了55例颈动脉狭窄70%至79%的患者。2009年至2013年期间，31例患者被随机分配接受CEA联合MMT（CEA组），24例患者仅接受MMT。主要终点是在5.0年的随访期内发生非致命性同侧卒中或任何原因导致的死亡。次要终点是随访期间发生的任何非致命性卒中、颈动脉血运重建或任何原因导致的死亡。
中位随访3.3年（最长5.0年）后试验停止。CEA组有2例主要事件，MMT组有9例。CEA组3.3年累积主要事件发生率为6.5%，MMT组为37.5%（MMT组的风险比为5.06；95%置信区间为1.53 - 16.79；P = 0.008）。CEA组3.3年累积次要终点为12.9%，MMT组为50.0%（MMT组的风险比为4.23；95%置信区间为1.55 - 11.53；P = 0.0048）。
CEA作为初始治疗策略，联合MMT时可降低死亡和重大脑血管事件的风险。
