title: Feasibility trial of carotid stenting with and without an embolus protection device.
abstract: OBJECTIVE
  To evaluate the feasibility of stenting and cerebral protection in patients with carotid bifurcation disease.
  
  
  METHODS
  Carotid stenting with self-expanding nitinol stents was evaluated in 261 patients (157 men; mean age 70.9+/-9.7 years, range 41-90) treated at 33 clinical sites. Among these patients, 141 (54.3%) were symptomatic, and 71 (27.2%) had postendarterectomy restenotic lesions. An embolus protection device became available in the latter third of the study. The primary endpoint of the study was the 30-day composite occurrence of major adverse clinical events (all deaths, strokes, or myocardial infarctions [MI]). At 1 year, the endpoint included all deaths, strokes, or MIs at 30 days, plus all deaths or ipsilateral strokes between 31 days and 1 year.
  
  
  RESULTS
  SMART stents were placed in 147 (56%) patients and Precise stents in 107 (41%); 7 (3%) patients were treated with non-study stents. Lesion success, defined as <30% postprocedural residual stenosis, was achieved in 249 (95%). An AngioGuard filter was used in 85 patients; of 90 filters employed, 78 (87%) were successfully deployed and retrieved. Visible material was noted in 42 (54%) retrieved filters. One (0.4%) stent thrombosis occurred at <30 days, and no restenotic lesions >80% were noted in up to 1 year of follow-up. At 30 days, stroke occurred in 16 (6.1%) patients, MI in 1 (0.4%), and 2 (0.8%) patients died. The 30-day rate of stroke, MI, or death was 6.9%. Major ipsilateral stroke occurred in 4 (1.5%) patients between 0 and 30 days; no new major ipsilateral strokes were noted up to 1 year. By Kaplan-Meier analysis, the 1-year risk of stroke, MI, or death was 10.9%+/-2.0%. The 1-year risk of major ipsilateral stroke was significantly lower in patients treated with embolus protection devices (0.0% versus 2.3%, p=0.05).
  
  
  CONCLUSIONS
  The use of nitinol self-expanding stents in the carotid position appears to be a safe and efficacious alternative for the treatment of carotid bifurcation disease. The addition of embolus protection devices may diminish the risk of postprocedural major ipsilateral strokes.
authors.affiliation: Department of Surgery, The Cleveland Foundation, OH 44195, USA. ourielk@ccf.org
authors.forename: Kenneth
authors.initials: K
authors.lastname: Ouriel
authors.forename: Mark H
authors.initials: MH
authors.lastname: Wholey
authors.forename: Pierre
authors.initials: P
authors.lastname: Fayad
authors.forename: Barry T
authors.initials: BT
authors.lastname: Katzen
authors.forename: Patrick
authors.initials: P
authors.lastname: Whitlow
authors.forename: Michael
authors.initials: M
authors.lastname: Frentzko
authors.forename: Richard E
authors.initials: RE
authors.lastname: Kuntz
authors.forename: Lawrence
authors.initials: L
authors.lastname: Wechsler
authors.forename: Nelson
authors.initials: N
authors.lastname: Hopkins
authors.forename: Lowell
authors.initials: L
authors.lastname: Satler
authors.forename: Greg
authors.initials: G
authors.lastname: Mishkel
authors.forename: Jay S
authors.initials: JS
authors.lastname: Yadav
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001241:Aspirin / Q000627:therapeutic use; D019917:Blood Vessel Prosthesis Implantation / Q000009:adverse effects / Q000295:instrumentation; D017536:Carotid Artery, Common / Q000000981:diagnostic imaging / Q000473:pathology*; D016893:Carotid Stenosis / Q000628:therapy*; D000077144:Clopidogrel; D005240:Feasibility Studies; D005260:Female; D006083:Graft Occlusion, Vascular / Q000209:etiology / Q000401:mortality / Q000517:prevention & control; D006801:Humans; D020766:Intracranial Embolism / Q000209:etiology / Q000401:mortality / Q000517:prevention & control*; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000209:etiology / Q000401:mortality / Q000517:prevention & control; D010975:Platelet Aggregation Inhibitors / Q000627:therapeutic use; D011859:Radiography; D015607:Stents; D020521:Stroke / Q000209:etiology / Q000401:mortality / Q000517:prevention & control; D015996:Survival Rate; D013988:Ticlopidine / Q000031:analogs & derivatives / Q000627:therapeutic use; D016896:Treatment Outcome
chemical_list: D010975:Platelet Aggregation Inhibitors; D000077144:Clopidogrel; D013988:Ticlopidine; D001241:Aspirin