CAROTID REVASCULARIZATION ENDARTERECTOMY VS STENTING

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EXCEED THE SPACE PROVIDED. Stent assisted carotid percutaneous transluminal angioplasty (SACPTA) is a relatively new procedure that has been used increasingly in recent years. Its growth is due, at least in part, to the perceived advantages of a less invasive treatment for extracranial carotid occlusive disease. However, data contrasting the efficacy of SACPTA and carotid endarterectomy (CEA), the gold standard treatment for carotid atherosclerosis, are not available. Current reports are either non-randomizec comparisons, or retrospective clinical studies. The Carotid RevascularizationEndarterectomy versus Stent Trial (CREST) contrasts the-rtSlfe-flVte^fficacyof SACPTA with CEA in preventing stroke, myocardial infarction or death during a 30-day peri-procedural period, or ipsilateral stroke ove the follow-up period extending up to four years. Stroke events will be verified by an Adjudication Committee masked to the assigned treatment. Secondary outcomes include:(1) describe differential efficacy of SACPTA and CEA in men and women, (2) contrast peri-procedural (30-day) morbidity and post-procedural (after 30-days) morbidity and mortality (3 estimate and contrast the restenosis rates of the two procedures, (4) evaluate differences in measures of health related quality of life andcost effectiveness , and (5) identify subgroups of participants at differential risk for SACPTA and CEA The primary eligibility criterion is a high grade U70%) stenosis of the carotid artery in patients with transient ischemic attack or ipsilateral non-disabling stroke. Men and women will be eligible for the trial, but patients with medical conditions ikely to limit their participation during the follow-up or to interfere with outcome evaluation will be excluded. After a credentialing and training phase, 2,200 patients will be randomizedto 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% in event rates of the primary outcomes. PERFORMANCE SITE ========================================Section End===========================================