title: Endarterectomy Versus Angioplasty in Patients with Symptomatic Severe Carotid Stenosis (EVA-3S) trial: results up to 4 years from a randomised, multicentre trial.
abstract: BACKGROUND
  Carotid stenting is a potential alternative to carotid endarterectomy but whether this technique is as safe as surgery and whether the long-term protection against stroke is similar to that of surgery are unclear. We previously reported that in patients in the Endarterectomy Versus Angioplasty in Patients with Symptomatic Severe Carotid Stenosis (EVA-3S) trial, the rate of any stroke or death within 30 days after the procedure was higher with stenting than with endarterectomy. We now report the results up to 4 years.
  
  
  METHODS
  In this follow-up study of a multicentre, randomised, open, assessor-blinded, non-inferiority trial, we compared outcome after stenting with outcome after endarterectomy in 527 patients who had carotid stenosis of at least 60% that had recently become symptomatic. The primary endpoint of the EVA-3S trial was the rate of any periprocedural stroke or death (ie, within 30 days after the procedure). The prespecified main secondary endpoint was a composite of any periprocedural stroke or death and any non-procedural ipsilateral stroke during up to 4 years of follow-up. Other trial outcomes were any stroke or periprocedural death, any stroke or death, and the above endpoints restricted to disabling or fatal strokes. This trial is registered with ClinicalTrials.gov, number NCT00190398.
  
  
  RESULTS
  262 patients were randomly assigned to endarterectomy and 265 to stenting. The cumulative probability of periprocedural stroke or death and non-procedural ipsilateral stroke after 4 years of follow-up was higher with stenting than with endarterectomy (11.1%vs 6.2%, hazard ratio [HR] 1.97, 95% CI 1.06-3.67; p=0.03). The HR for periprocedural disabling stroke or death and non-procedural fatal or disabling ipsilateral stroke was 2.00 (0.75-5.33; p=0.17). A hazard function analysis showed the 4-year differences in the cumulative probabilities of outcomes between stenting and endarterectomy were largely accounted for by the higher periprocedural (within 30 days of the procedure) risk of stenting compared with endarterectomy. After the periprocedural period, the risk of ipsilateral stroke was low and similar in both treatment groups. For any stroke or periprocedural death, the HR was 1.77 (1.03-3.02; p=0.04). For any stroke or death, the HR was 1.39 (0.96-2.00; p=0.08).
  
  
  CONCLUSIONS
  The results of this study suggest that carotid stenting is as effective as carotid endarterectomy for middle-term prevention of ipsilateral stroke, but the safety of carotid stenting needs to be improved before it can be used as an alternative to carotid endarterectomy in patients with symptomatic carotid stenosis.
authors.affiliation: Hôpitaux Sainte-Anne, Université Paris Descartes, Paris, France. jl.mas@ch-sainte-anne.fr
authors.forename: Jean-Louis
authors.initials: JL
authors.lastname: Mas
authors.forename: Ludovic
authors.initials: L
authors.lastname: Trinquart
authors.forename: Didier
authors.initials: D
authors.lastname: Leys
authors.forename: Jean-François
authors.initials: JF
authors.lastname: Albucher
authors.forename: Hervé
authors.initials: H
authors.lastname: Rousseau
authors.forename: Alain
authors.initials: A
authors.lastname: Viguier
authors.forename: Jean-Pierre
authors.initials: JP
authors.lastname: Bossavy
authors.forename: Béatrice
authors.initials: B
authors.lastname: Denis
authors.forename: Philippe
authors.initials: P
authors.lastname: Piquet
authors.forename: Pierre
authors.initials: P
authors.lastname: Garnier
authors.forename: Fausto
authors.initials: F
authors.lastname: Viader
authors.forename: Emmanuel
authors.initials: E
authors.lastname: Touzé
authors.forename: Pierre
authors.initials: P
authors.lastname: Julia
authors.forename: Maurice
authors.initials: M
authors.lastname: Giroud
authors.forename: Denis
authors.initials: D
authors.lastname: Krause
authors.forename: Hassan
authors.initials: H
authors.lastname: Hosseini
authors.forename: Jean-Pierre
authors.initials: JP
authors.lastname: Becquemin
authors.forename: Grégoire
authors.initials: G
authors.lastname: Hinzelin
authors.forename: Emmanuel
authors.initials: E
authors.lastname: Houdart
authors.forename: Hilde
authors.initials: H
authors.lastname: Hénon
authors.forename: Jean-Philippe
authors.initials: JP
authors.lastname: Neau
authors.forename: Serge
authors.initials: S
authors.lastname: Bracard
authors.forename: Yannick
authors.initials: Y
authors.lastname: Onnient
authors.forename: Raymond
authors.initials: R
authors.lastname: Padovani
authors.forename: Gilles
authors.initials: G
authors.lastname: Chatellier
mesh_terms: D000328:Adult; D000368:Aged; D017130:Angioplasty; D016893:Carotid Stenosis / Q000150:complications* / Q000401:mortality / Q000601:surgery*; D016001:Confidence Intervals; D004311:Double-Blind Method; D016894:Endarterectomy, Carotid; D005260:Female; D007839:Functional Laterality; D006801:Humans; D015993:Life Tables; D008137:Longitudinal Studies; D008297:Male; D008875:Middle Aged; D016016:Proportional Hazards Models; D012189:Retrospective Studies; D018570:Risk Assessment; D012307:Risk Factors; D012720:Severity of Illness Index; D020521:Stroke / Q000209:etiology / Q000517:prevention & control*; D013997:Time Factors; D016896:Treatment Outcome