Igor Kolos1, Alexandr Troitskiy2, Tatiana Balakhonova3, Merab Shariya4, Denis Skrypnik5, Tatiana Tvorogova6, Alexandr Deev7, Sergey Boytsov8. 1. Department of Clinical Cardiology and Molecular Genetics, National Research Center for Preventive Medicine, Moscow, Russian Federation. Electronic address: docsn173@yandex.ru. 2. Department of Vascular Surgery, Federal Medical and Biological Agency, Moscow, Russian Federation. 3. Department of Vascular Ultrasound, Russian Cardiology Research and Production Center, Moscow, Russian Federation. 4. Department of Tomography, Russian Cardiology Research and Production Center, Moscow, Russian Federation. 5. Department of Vascular Surgery, Regional Clinical Hospital No. 1, Krasnodar, Russian Federation. 6. Neurology Department, National Research Center for Preventive Medicine, Moscow, Russian Federation. 7. Laboratory of Biostatistics, National Research Center for Preventive Medicine, Moscow, Russian Federation. 8. Department of Clinical Cardiology and Molecular Genetics, National Research Center for Preventive Medicine, Moscow, Russian Federation.
Abstract
OBJECTIVE: This study assessed the value of modern medical treatment (MMT) with and without carotid endarterectomy (CEA) in patients with asymptomatic severe carotid artery stenosis. METHODS: 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. RESULTS: 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). CONCLUSIONS:CEA as an initial management strategy could reduce the risk of death and major cerebrovascular events when added to MMT.
RCT Entities:
OBJECTIVE: This study assessed the value of modern medical treatment (MMT) with and without carotid endarterectomy (CEA) in patients with asymptomatic severe carotid artery stenosis. METHODS: 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. RESULTS: 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). CONCLUSIONS: CEA as an initial management strategy could reduce the risk of death and major cerebrovascular events when added to MMT.
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