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J Interv Cardiol. 2010 Oct;23(5):491-8. doi: 10.1111/j.1540-8183.2010.00578.x.

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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1
William Beaumont Hospital, Royal Oak, Michigan 48073, USA. rsafian@beaumont.edu

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.

[Indexed for MEDLINE]

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