Status report on the carotid revascularization endarterectomy versus stent trial

Abstract

Carotid angioplasty and stenting (CAS) is a relatively new procedure that has been used increasingly in recent years. Its growth is caused, at least in part, by the perceived advantages of a less invasive treatment for extracranial carotid occlusive disease. However, data comparing the efficacy of CAS with carotid endarterectomy (CEA), which is the gold standard for treatment of symptomatic carotid stenosis, are not available. The Carotid Revascularization Endarterectomy versus Stent Trial (CREST) will compare the relative efficacy of CAS with CEA in preventing stroke, myocardial infarction, and death during a 30-day periprocedural period. The efficacy of the 2 procedures in preventing ipsilateral stroke over a follow-up period of up to 4 years will also be assessed. Cerebrovascular events will be verified by an Adjudication Committee masked to the assigned treatment. Secondary outcomes assessment will include the following: (1) differential efficacy of CAS and CEA in men and women, (2) comparison of periprocedural (30-day) morbidity with late postprocedural (after 30-days) morbidity and mortality that is associated with the procedures, (3) estimation and comparison of the restenosis rates associated with the 2 procedures, (4) evaluation of differences in measures of health-related quality of life and cost effectiveness, and (5) identification of subgroups of participants at differential risk for CAS and CEA. The primary eligibility criteria are a significant (greater than 50% as shown by cerebral angiography) stenosis of the carotid artery in a patient with amaurosis fugax (transient monocular blindness), transient ischemic attack, or ipsilateral nondisabling stroke. Men and women will be eligible for the trial, but patients with medical conditions that are likely to limit their participation during the follow-up or to interfere with outcome evaluation will be excluded. After a credentialing and training phase, 2,500 patients will be randomized to the treatment groups. Statistical analysis of the primary outcome will use standard survival methodology.