Protected carotid stenting in high-risk patients with severe carotid artery stenosis.

OBJECTIVES The purpose of this study was to determine the safety of carotid artery stenting with a unique distal embolic protection system in high-risk patients with severe carotid stenosis. BACKGROUND Previous studies suggest that some patients with carotid stenosis and serious comorbid conditions are at high risk for carotid endarterectomy, and may be safely treated by carotid artery stenting. METHODS A prospective non-randomized multicenter registry of 419 patients with severe carotid stenosis and high-risk features for carotid endarterectomy was conducted between April 2004 and October 2004. Carotid artery stenting was performed with the Protégé Self-Expanding Nitinol Stent and the SPIDER Embolic Protection System (ev3 Inc., Plymouth, Minnesota). Aspirin and clopidogrel were prescribed at least 24 h before and three months after revascularization. The primary outcome was the combined incidence of major adverse cardiac and cerebrovascular events at 30 days after intervention, including death, stroke, and myocardial infarction. A secondary outcome was the technical success, defined as successful deployment of all devices, filter retrieval, and final diameter stenosis <50%. RESULTS Technical success was achieved in 408 of 419 patients (97.4%). The primary end point was observed in 26 patients (6.2%), including death in 8 (1.9%), nonfatal stroke in 14 (3.3%), and nonfatal myocardial infarction in 4 (1%). Independent predictors of death or stroke at 30 days included duration of filter deployment, symptomatic carotid stenosis, and baseline renal insufficiency. CONCLUSIONS For some patients with severe carotid stenosis and high-risk features for carotid endarterectomy, carotid artery stenting with distal embolic protection is a reasonable alternative for revascularization.