Optimal medical treatment versus carotid endarterectomy: the rationale and design of the Aggressive Medical Treatment Evaluation for Asymptomatic Carotid Artery Stenosis (AMTEC) study.

Abstract

RATIONALE:

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.

AIMS:

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.

DESIGN:

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.

STUDY OUTCOMES:

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: Igor Kolos, Mikhail Loukianov, Nikolay Dupik, Sergey Boytsov, Alexandr Deev
• Journal: International journal of stroke : official journal of the International Stroke Society (Int J Stroke) Vol. 10 Issue 2 Pg. 269-74 (Feb 2015) ISSN: 1747-4949 [Electronic] United States
• PMID: 23490405 (Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial)
• Copyright: © 2013 The Authors. International Journal of Stroke © 2013 World Stroke Organization.

Chemical References

• Antihypertensive Agents
• Fibrinolytic Agents
• Hydroxymethylglutaryl-CoA Reductase Inhibitors
• Amlodipine
• Losartan
• Aspirin

Topics

• Amlodipine (therapeutic use)
• Antihypertensive Agents (therapeutic use)
• Aspirin (therapeutic use)
• Carotid Stenosis (complications, drug therapy, surgery)
• Combined Modality Therapy
• Endarterectomy, Carotid
• Fibrinolytic Agents (therapeutic use)
• Humans
• Hydroxymethylglutaryl-CoA Reductase Inhibitors (therapeutic use)
• Losartan (therapeutic use)
• Myocardial Infarction (etiology, prevention & control)
• Prospective Studies
• Research Design
• Russia
• Stroke (etiology, prevention & control)