CLINICAL RESEARCH: INTERVENTIONAL CARDIOLOGY
Protected Carotid Stenting in High-Risk Patients With Severe Carotid Artery Stenosis
Robert D. Safian, MD*,*,
John F. Bresnahan, MD ,
Michael R. Jaff, DO ,
Malcolm Foster, MD ,
J. Michael Bacharach, MD||,
Brijeshwar Maini, MD¶,
Mark Turco, MD#,
Subbarao Myla, MD**,
Gustav Eles, MD,
Gary M. Ansel, MD on behalf of the CREATE Pivotal Trial Investigators
* William Beaumont Hospital, Royal Oak, Michigan
Mayo Clinic, Rochester, Minnesota
Cardiovascular Research Foundation, New York, New York
Baptist Heart Institute, Nashville, Tennessee
|| North Central Heart Hospital of South Dakota, Sioux Falls, South Dakota
¶ Pinnacle Health at Harrisburg Hospital, Harrisburg, Pennsylvania
# Washington Adventist Hospital, Washington, DC
** Hoag Memorial Hospital, Newport Beach, California
Allegheny General Hospital, Pittsburgh, Pennsylvania
Riverside Methodist Hospital, Columbus, Ohio
Manuscript received October 18, 2005;
revised manuscript received November 29, 2005,
accepted December 5, 2005.
* Reprint requests and correspondence: Dr. Robert D. Safian, Cardiac and Vascular Intervention, William Beaumont Hospital, Heart Center-3rd Floor, Royal Oak, Michigan 48073. (Email: rsafian{at}beaumont.edu).
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.
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Abbreviations and Acronyms
| | ACAS = Asymptomatic Carotid Atherosclerosis Study | | ACST = Asymptomatic Carotid Surgery Trial | | ARCHeR = Acculink for Revascularization of Carotids in High-Risk Patients trial | | CAS = carotid artery stenting | | CEA = carotid endarterectomy | | CI = confidence interval | | CREATE = Carotid Revascularization with ev3 Arterial Technology Evolution trial | | ECST = European Carotid Surgery Trial | | MACCE = major adverse cardiac and cerebrovascular events | | MI = myocardial infarction | | NASCET = North American Symptomatic Carotid Endarterectomy Trial | | OR = odds ratio | | SAPPHIRE = Stenting and Angioplasty with Protection in Patients at High Risk for Endarterectomy Investigation trial | | SECURITY = Registry Study to Evaluate the Neuroshield Bare Wire Cerebral Protection System and X-Act Stent in Patients at High Risk for Carotid Endarterectomy |
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