title: Long-term results of carotid stenting versus endarterectomy in high-risk patients.
abstract: BACKGROUND
  We previously reported that, in a randomized trial, carotid stenting with the use of an emboli-protection device is not inferior to carotid endarterectomy for the treatment of carotid artery disease at 30 days and at 1 year. We now report the 3-year results.
  
  
  METHODS
  The trial evaluated carotid artery stenting with the use of an emboli-protection device as compared with endarterectomy in 334 patients at increased risk for complications from endarterectomy who had either a symptomatic carotid artery stenosis of at least 50% of the luminal diameter or an asymptomatic stenosis of at least 80%. The prespecified major secondary end point at 3 years was a composite of death, stroke, or myocardial infarction within 30 days after the procedure or death or ipsilateral stroke between 31 days and 1080 days (3 years).
  
  
  RESULTS
  At 3 years, data were available for 260 patients (77.8%), including 85.6% of patients in the stenting group and 70.1% of those in the endarterectomy group. The prespecified major secondary end point occurred in 41 patients in the stenting group (cumulative incidence, 24.6%; Kaplan-Meier estimate, 26.2%) and 45 patients in the endarterectomy group (cumulative incidence, 26.9%; Kaplan-Meier estimate, 30.3%) (absolute difference in cumulative incidence for the stenting group, -2.3%; 95% confidence interval, -11.8 to 7.0). There were 15 strokes in each of the two groups, of which 11 in the stenting group and 9 in the endarterectomy group were ipsilateral.
  
  
  CONCLUSIONS
  In our trial of patients with severe carotid artery stenosis and increased surgical risk, no significant difference could be shown in long-term outcomes between patients who underwent carotid artery stenting with an emboli-protection device and those who underwent endarterectomy. (ClinicalTrials.gov number, NCT00231270 [ClinicalTrials.gov].).
authors.affiliation: University of Michigan School of Medicine, Ann Arbor, USA.
authors.forename: Hitinder S
authors.initials: HS
authors.lastname: Gurm
authors.forename: Jay S
authors.initials: JS
authors.lastname: Yadav
authors.forename: Pierre
authors.initials: P
authors.lastname: Fayad
authors.forename: Barry T
authors.initials: BT
authors.lastname: Katzen
authors.forename: Gregory J
authors.initials: GJ
authors.lastname: Mishkel
authors.forename: Tanvir K
authors.initials: TK
authors.lastname: Bajwa
authors.forename: Gary
authors.initials: G
authors.lastname: Ansel
authors.forename: Neil E
authors.initials: NE
authors.lastname: Strickman
authors.forename: Hong
authors.initials: H
authors.lastname: Wang
authors.forename: Sidney A
authors.initials: SA
authors.lastname: Cohen
authors.forename: Joseph M
authors.initials: JM
authors.lastname: Massaro
authors.forename: Donald E
authors.initials: DE
authors.lastname: Cutlip
mesh_terms: D000328:Adult; D000800:Angioplasty, Balloon; D016893:Carotid Stenosis / Q000401:mortality / Q000601:surgery / Q000628:therapy*; D016894:Endarterectomy, Carotid; D005500:Follow-Up Studies; D006801:Humans; D053208:Kaplan-Meier Estimate; D009203:Myocardial Infarction / Q000453:epidemiology / Q000517:prevention & control; D012307:Risk Factors; D015607:Stents; D020521:Stroke / Q000453:epidemiology / Q000517:prevention & control*