Carotid angioplasty-stent: clinical experience and role for clinical trials

Carotid angioplasty-stenting (CAS) is a relatively new endovascular procedure that has been used increasingly in recent years. Its popularity is due to, at least in part, the perceived advantages of a less invasive treatment for extracranial carotid occlusive disease. However, valid data that contrast the efficacy of CAS and carotid endarterectomy (CEA), the gold standard for the treatment of symptomatic carotid stenosis, are not available. The Carotid Revascularization Endarterectomy versus Stent Trial (CREST) will contrast the relative efficacy of CAS with CEA in the prevention of stroke, myocardial infarction, or death during a 30-day periprocedural period or an ipsilateral stroke thereafter during a follow-up period extending up to 4 years. Stroke events will be verified by an adjudication committee masked to the assigned treatment. Secondary outcomes will (1) describe differential efficacy of CAS and CEA in men and women, (2) contrast periprocedural (30-day) morbidity and postprocedural (after 30-days) morbidity and mortality rates, (3) estimate and contrast the restenosis rates of the two procedures, (4) evaluate the differences in measures of health-related quality of life and cost effectiveness, and (5) identify subgroups of participants at differential risk for CAS and CEA. The primary eligibility criterion is a >50% stenosis of the carotid artery in patients with ipsilateral amaurosis fugax (transient monocular blindness), transient ischemic attack, or nondisabling stroke. Men and women will be eligible for the trial, but patients with medical conditions likely to limit their participation during the follow-up or to interfere with outcome evaluation will be excluded. After a credentialing and training phase, 2500 patients will be randomized to the treatments. Statistical analysis of the primary outcome will use standard survival methods.