Protected Carotid Stenting in High-Risk Patients With Severe Carotid Artery Stenosis

Protected Carotid Stenting in High-Risk Patients With Severe Carotid Artery Stenosis Robert D. Safian, John F. Bresnahan, Michael R. Jaff, Malcolm Foster, J. Michael Bacharach, Brijeshwar Maini, Mark Turco, Subbarao Myla, Gustav Eles, Gary M. Ansel, on behalf of the CREATE Pivotal Trial Investigator...

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Bibliographic Details
Published in:Journal of the American College of Cardiology 2006-06, Vol.47 (12), p.2384-2389
Main Authors: Safian, Robert D., Bresnahan, John F., Jaff, Michael R., Foster, Malcolm, Bacharach, J. Michael, Maini, Brijeshwar, Turco, Mark, Myla, Subbarao, Eles, Gustav, Ansel, Gary M.
Format: Article
Language:English
Subjects:
Aged
Cardiology
Cardiovascular disease
Carotid Stenosis - complications
Carotid Stenosis - surgery
Confidence intervals
Female
Heart attacks
Humans
Kinases
Male
Medical imaging
Postoperative Complications - epidemiology
Prospective Studies
Risk Factors
Severity of Illness Index
Statistical methods
Stents
Ultrasonic imaging
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Summary:Protected Carotid Stenting in High-Risk Patients With Severe Carotid Artery Stenosis Robert D. Safian, John F. Bresnahan, Michael R. Jaff, Malcolm Foster, J. Michael Bacharach, Brijeshwar Maini, Mark Turco, Subbarao Myla, Gustav Eles, Gary M. Ansel, on behalf of the CREATE Pivotal Trial Investigators A prospective non-randomized multicenter registry of 419 patients with severe carotid stenosis and one or more high-risk features for carotid endarterectomy was conducted in the U.S. Technical success was achieved in 97.4%, and major adverse events at 30 days were observed in 6.2%, including death in 1.9%, nonfatal stroke in 3.3%, and nonfatal myocardial infarction in 1%. Independent predictors of death or stroke at 30 days included duration of filter deployment, symptomatic carotid stenosis, and baseline renal insufficiency. Some patients with severe carotid stenosis and high-risk features for carotid endarterectomy may be treated with carotid artery stenting with distal embolic protection. 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. 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. 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
ISSN:0735-1097
1558-3597
DOI:10.1016/j.jacc.2005.12.076