Protected Carotid Stenting in High‐Risk Patients: Results of the SpideRX Arm of the Carotid Revascularization with ev3 Arterial Technology Evolution Trial |
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| Authors: | ROBERT D SAFIAN MD MICHAEL R JAFF DO JOHN F BRESNAHAN MD MALCOLM FOSTER MD J MICHAEL BACHARACH MD JAY YADAV MD JAMES JOYE DO SUBBARAO MYLA MD ELIAS KASSAB MD J TIFT MANN MD GARY M ANSEL MD |
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| Institution: | 1. William Beaumont Hospital, Royal Oak, Michigan;2. Mayo Clinic, Rochester, Minnesota;3. Massachusetts General Hospital, Boston Massachusetts;4. Baptist Heart Institute, Nashville, Tennessee;5. North Central Heart Hospital of South Dakota, Sioux Falls, South Dakota;6. Cleveland Clinic Foundation, Cleveland, Ohio;7. El Camino Hospital, Mountainview, California;8. Hoag Memorial Hospital, Newport Beach, California;9. Oakwood Hospital, Dearborn, Michigan;10. Wake Heart Associates, Raleigh, North Carolina;11. Riverside Methodist Hospital, Columbus, Ohio |
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| Abstract: | Purpose: A prospective nonrandomized multicenter registry of 160 patients with severe carotid stenosis and high‐risk features for carotid endarterectomy was conducted during the 3‐month period from March to May 2005. Methods: Carotid artery stenting (CAS) was performed with the SpideRX? Embolic Protection System (ev3, Inc., Plymouth, MN, USA) as part of an investigational device exemption from the Food and Drug Administration. Results: The primary end‐point of major adverse cardiac and cerebrovascular events at 30 days after CAS was observed in nine patients (5.6%), including death in four patients (2.5%), nonfatal stroke in five patients (3.1%), and nonfatal myocardial infarction in one patient (0.6%). A secondary end‐point of technical success (defined as successful deployment of all devices, filter retrieval, and final diameter stenosis <50%) was achieved in 156 of 160 patients (97.5%). The only independent predictor of death or stroke at 30 days was baseline stenosis severity (P < 0.05). Conclusion: CAS with distal embolic protection using the SpideRX? Embolic Protection System is a reasonable alternative for revascularization of some high‐risk patients with severe carotid stenosis. (J Interven Cardiol 2010;23:491–498) |
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