CREST (Carotid Revascularization Endarterectomy versus Stent Trial): background, design, and current status

The Carotid Revascularization Endarterectomy versus Stent Trial (CREST) contrasts the relative efficacy of carotid endarterectomy (CEA) and carotid angioplasty-stent (CAS) in preventing primary outcomes of stroke, myocardial infarction, or death during a 30-day periprocedural period, or ipsilateral stroke over the follow-up period extending up to 4 years. Stroke events will be verified by an Adjudication Committee masked to the assigned treatment. The primary eligibility criterion is a significant (> or =50%) stenosis of the carotid artery in patients with transient ischemic attack or ipsilateral nondisabling stroke within the prior 180 days. 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, 2,500 patients will be randomized to the treatments. Statistical analysis of the primary outcome will employ standard survival techniques and will result in 90% power to detect annual differences between groups of 1.2% or higher in event rates of the primary outcomes.