title: Optimal medical treatment versus carotid endarterectomy: the rationale and design of the Aggressive Medical Treatment Evaluation for Asymptomatic Carotid Artery Stenosis (AMTEC) study.
abstract: BACKGROUND
  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.
  
  
  OBJECTIVE
  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.
  
  
  METHODS
  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.
  
  
  RESULTS
  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.
authors.affiliation: National Research Center for Preventive Medicine, Moscow, Russian Federation.
authors.forename: Igor
authors.initials: I
authors.lastname: Kolos
authors.forename: Mikhail
authors.initials: M
authors.lastname: Loukianov
authors.forename: Nikolay
authors.initials: N
authors.lastname: Dupik
authors.forename: Sergey
authors.initials: S
authors.lastname: Boytsov
authors.forename: Alexandr
authors.initials: A
authors.lastname: Deev
mesh_terms: D017311:Amlodipine / Q000627:therapeutic use; D000959:Antihypertensive Agents / Q000627:therapeutic use; D001241:Aspirin / Q000627:therapeutic use; D016893:Carotid Stenosis / Q000150:complications / Q000188:drug therapy* / Q000601:surgery*; D003131:Combined Modality Therapy; D016894:Endarterectomy, Carotid; D005343:Fibrinolytic Agents / Q000627:therapeutic use; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000627:therapeutic use; D019808:Losartan / Q000627:therapeutic use; D009203:Myocardial Infarction / Q000209:etiology / Q000517:prevention & control; D011446:Prospective Studies; D012107:Research Design; D012426:Russia; D020521:Stroke / Q000209:etiology / Q000517:prevention & control
chemical_list: D000959:Antihypertensive Agents; D005343:Fibrinolytic Agents; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D017311:Amlodipine; D019808:Losartan; D001241:Aspirin
keywords: carotid endarterectomy; carotid stenosis; medical treatment; randomized trial; stroke prevention