Randomized clinical trials: how will results influence clinical practice in the management of symptomatic and asymptomatic extracranial carotid occlusive disease?

Abstract

Evaluation of the efficacy of carotid endarterectomy and stenting requires careful consideration of clinical trial methodology as applied to the primary clinical end points of the specific trial. Although publication of observational data including registries is helpful in selecting options for further study, these reports are not considered replacements for the randomized clinical trial. This article reviews methodology and results of registries and randomized clinical trials. Pending publication of larger clinical trials on the management of symptomatic and asymptomatic carotid stenosis within the next 1 to 3 years, carotid endarterectomy remains the preferred technique for cerebral revascularization. The only exceptions to this recommendation come from higher risk categories of patients; however, their identification is frequently difficult and controversial.