HOME SUBSCRIPTIONS CURRENT ISSUE PAST ISSUES CARDIOSOURCE SEARCH HELP FEEDBACK		QUICK SEARCH:   [advanced] Author: Keyword(s): Year:  Vol:  Page:

This Article Full Text Full Text (PDF) View Online Appendix Alert me when this article is cited Alert me if a correction is posted Services Email this article to a friend Similar articles in this journal Similar articles in ISI Web of Science Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Citing Articles Citing Articles via HighWire Citing Articles via ISI Web of Science (29) Citing Articles via Google Scholar Google Scholar Articles by Safian, R. D. Search for Related Content PubMed PubMed Citation Articles by Safian, R. D. Related Collections Related Article

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.

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

Related Article

New Insights Into Improving Acute and Long-Term Outcomes of Carotid Stenting

Jay S. Yadav
J. Am. Coll. Cardiol. 2006 47: 2397-2398. [Full Text] [PDF]

This article has been cited by other articles:

				S. Schnaudigel, K. Groschel, S. M. Pilgram, and A. Kastrup New Brain Lesions After Carotid Stenting Versus Carotid Endarterectomy: A Systematic Review of the Literature Stroke, June 1, 2008; 39(6): 1911 - 1919. [Abstract] [Full Text] [PDF]

				H. S. Gurm, J. S. Yadav, P. Fayad, B. T. Katzen, G. J. Mishkel, T. K. Bajwa, G. Ansel, N. E. Strickman, H. Wang, S. A. Cohen, et al. Long-Term Results of Carotid Stenting versus Endarterectomy in High-Risk Patients N. Engl. J. Med., April 10, 2008; 358(15): 1572 - 1579. [Abstract] [Full Text] [PDF]

				A. Kastrup, K. Groschel, T. Nagele, A. Riecker, F. Schmidt, S. Schnaudigel, and U. Ernemann Effects of Age and Symptom Status on Silent Ischemic Lesions after Carotid Stenting with and without the Use of Distal Filter Devices AJNR Am. J. Neuroradiol., March 1, 2008; 29(3): 608 - 612. [Abstract] [Full Text] [PDF]

				S. S. Iyer, C. J. White, L. N. Hopkins, B. T. Katzen, R. Safian, M. H. Wholey, W. A. Gray, R. Ciocca, W. B. Bachinsky, G. Ansel, et al. Carotid artery revascularization in high-surgical-risk patients using the Carotid WALLSTENT and FilterWire EX/EZ: 1-year outcomes in the BEACH Pivotal Group. J. Am. Coll. Cardiol., January 29, 2008; 51(4): 427 - 434. [Abstract] [Full Text] [PDF]

				R. M. Samuelson, J. Yamamoto, E. I. Levy, A. H. Siddiqui, and L. N. Hopkins The Argument to Support Broader Application of Extracranial Carotid Artery Stent Technology Circulation, October 2, 2007; 116(14): 1602 - 1610. [Full Text] [PDF]

				T. A. Abbruzzese and R. P. Cambria Contemporary Management of Carotid Stenosis: Carotid Endarterectomy Is Here to Stay Perspectives in Vascular Surgery and Endovascular Therapy, September 1, 2007; 19(3): 248 - 256. [Abstract] [PDF]

				E. R Mohler III Carotid stenting for atherothrombosis Heart, September 1, 2007; 93(9): 1147 - 1151. [Full Text] [PDF]

				E. Mahmud, J. J. Cavendish, and A. Salami Current Treatment of Peripheral Arterial Disease: Role of Percutaneous Interventional Therapies J. Am. Coll. Cardiol., August 7, 2007; 50(6): 473 - 490. [Abstract] [Full Text] [PDF]

				S. R. Dixon, C. L. Grines, and W. W. O'Neill The Year in Interventional Cardiology J. Am. Coll. Cardiol., July 17, 2007; 50(3): 270 - 285. [Full Text] [PDF]

				E. R. Bates, C. J. D. Babb, D. E. Casey, C. U. Cates, G. R. Duckwiler, T. E. Feldman, W. A. Gray, K. Ouriel, E. D. Peterson, K. Rosenfield, et al. ACCF/SCAI/SVMB/SIR/ASITN 2007 Clinical Expert Consensus Document on Carotid Stenting: A Report of the American College of Cardiology Foundation Task Force on Clinical Expert Consensus Documents (ACCF/SCAI/SVMB/SIR/ASITN Clinical Expert Consensus Document Committee on Carotid Stenting) Vascular Medicine, February 1, 2007; 12(1): 35 - 83. [PDF]

				P. Fayad Endarterectomy and Stenting for Asymptomatic Carotid Stenosis: A Race at Breakneck Speed Stroke, February 1, 2007; 38(2): 707 - 714. [Abstract] [Full Text] [PDF]

				A. N. DeMaria, O. Ben-Yehuda, G. K. Feld, G. S. Ginsburg, B. H. Greenberg, W. Y.W. Lew, J. A.C. Lima, A. S. Maisel, J. Narula, D. J. Sahn, et al. Highlights of the Year in JACC 2006 J. Am. Coll. Cardiol., January 30, 2007; 49(4): 509 - 527. [Full Text] [PDF]

				American Society of Interventional & Therapeutic N, Society for Cardiovascular Angiography and Interve, Society for Vascular Medicine and Biology, Society of Interventional Radiology, E. R. Bates, J. D. Babb, D. E. Casey Jr, C. U. Cates, G. R. Duckwiler, T. E. Feldman, et al. ACCF/SCAI/SVMB/SIR/ASITN 2007 Clinical Expert Consensus Document on Carotid Stenting: A Report of the American College of Cardiology Foundation Task Force on Clinical Expert Consensus Documents (ACCF/SCAI/SVMB/SIR/ASITN Clinical Expert Consensus Document Committee on Carotid Stenting) J. Am. Coll. Cardiol., January 2, 2007; 49(1): 126 - 170. [Full Text] [PDF]

				J. S. Yadav New Insights Into Improving Acute and Long-Term Outcomes of Carotid Stenting J. Am. Coll. Cardiol., June 20, 2006; 47(12): 2397 - 2398. [Full Text] [PDF]