Protected carotid stenting in high-risk patients: results of the SpideRX arm of the carotid revascularization with ev3 arterial technology evolution trial.
OBJECTIVE
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).


CONCLUSIONS
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.
Safian
Robert D
RD
William Beaumont Hospital, Royal Oak, Michigan 48073, USA. rsafian@beaumont.edu
Jaff
Michael R
MR
Bresnahan
John F
JF
Foster
Malcolm
M
Bacharach
J Michael
JM
Yadav
Jay
J
Joye
James
J
Myla
Subbarao
S
Kassab
Elias
E
Mann
J Tift
JT
Ansel
Gary M
GM
D000368:Aged; D000369:Aged, 80 and over; D015906:Angioplasty, Balloon, Coronary / Q000379:methods*; D002339:Carotid Arteries / Q000473:pathology*; D016893:Carotid Stenosis / Q000473:pathology / Q000517:prevention & control / Q000628:therapy*; D016001:Confidence Intervals; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D016017:Odds Ratio; D011446:Prospective Studies; D012042:Registries; D012307:Risk Factors; D015607:Stents