title: Protected carotid stenting in high-risk patients: results of the SpideRX arm of the carotid revascularization with ev3 arterial technology evolution trial.
abstract: 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.
authors.affiliation: William Beaumont Hospital, Royal Oak, Michigan 48073, USA. rsafian@beaumont.edu
authors.forename: Robert D
authors.initials: RD
authors.lastname: Safian
authors.forename: Michael R
authors.initials: MR
authors.lastname: Jaff
authors.forename: John F
authors.initials: JF
authors.lastname: Bresnahan
authors.forename: Malcolm
authors.initials: M
authors.lastname: Foster
authors.forename: J Michael
authors.initials: JM
authors.lastname: Bacharach
authors.forename: Jay
authors.initials: J
authors.lastname: Yadav
authors.forename: James
authors.initials: J
authors.lastname: Joye
authors.forename: Subbarao
authors.initials: S
authors.lastname: Myla
authors.forename: Elias
authors.initials: E
authors.lastname: Kassab
authors.forename: J Tift
authors.initials: JT
authors.lastname: Mann
authors.forename: Gary M
authors.initials: GM
authors.lastname: Ansel
mesh_terms: 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