title: Long-term outcomes after stenting versus endarterectomy for treatment of symptomatic carotid stenosis: the International Carotid Stenting Study (ICSS) randomised trial.
abstract: BACKGROUND
  Stenting is an alternative to endarterectomy for treatment of carotid artery stenosis, but long-term efficacy is uncertain. We report long-term data from the randomised International Carotid Stenting Study comparison of these treatments.
  
  
  METHODS
  Patients with symptomatic carotid stenosis were randomly assigned 1:1 to open treatment with stenting or endarterectomy at 50 centres worldwide. Randomisation was computer generated centrally and allocated by telephone call or fax. Major outcomes were assessed by an independent endpoint committee unaware of treatment assignment. The primary endpoint was fatal or disabling stroke in any territory after randomisation to the end of follow-up. Analysis was by intention to treat ([ITT] all patients) and per protocol from 31 days after treatment (all patients in whom assigned treatment was completed). Functional ability was rated with the modified Rankin scale. This study is registered, number ISRCTN25337470.
  
  
  RESULTS
  1713 patients were assigned to stenting (n=855) or endarterectomy (n=858) and followed up for a median of 4·2 years (IQR 3·0-5·2, maximum 10·0). Three patients withdrew immediately and, therefore, the ITT population comprised 1710 patients. The number of fatal or disabling strokes (52 vs 49) and cumulative 5-year risk did not differ significantly between the stenting and endarterectomy groups (6·4% vs 6·5%; hazard ratio [HR] 1·06, 95% CI 0·72-1·57, p=0·77). Any stroke was more frequent in the stenting group than in the endarterectomy group (119 vs 72 events; ITT population, 5-year cumulative risk 15·2% vs 9·4%, HR 1·71, 95% CI 1·28-2·30, p<0·001; per-protocol population, 5-year cumulative risk 8·9% vs 5·8%, 1·53, 1·02-2·31, p=0·04), but were mainly non-disabling strokes. The distribution of modified Rankin scale scores at 1 year, 5 years, or final follow-up did not differ significantly between treatment groups.
  
  
  CONCLUSIONS
  Long-term functional outcome and risk of fatal or disabling stroke are similar for stenting and endarterectomy for symptomatic carotid stenosis.
  
  
  BACKGROUND
  Medical Research Council, Stroke Association, Sanofi-Synthélabo, European Union.
authors.affiliation: Department of Brain Repair and Rehabilitation, UCL Institute of Neurology, University College London, London, UK; Department of Neurology and Stroke Unit, University Hospital Basel, Basel University, Basel, Switzerland.
authors.forename: Leo H
authors.initials: LH
authors.lastname: Bonati
authors.affiliation: Department of Medical Statistics, London School of Hygiene & Tropical Medicine, London, UK.
authors.forename: Joanna
authors.initials: J
authors.lastname: Dobson
authors.affiliation: Department of Brain Repair and Rehabilitation, UCL Institute of Neurology, University College London, London, UK.
authors.forename: Roland L
authors.initials: RL
authors.lastname: Featherstone
authors.affiliation: Department of Brain Repair and Rehabilitation, UCL Institute of Neurology, University College London, London, UK.
authors.forename: Jörg
authors.initials: J
authors.lastname: Ederle
authors.affiliation: Department of Neurology and Neurosurgery, Brain Center Rudolf Magnus, University Medical Center Utrecht, Utrecht, Netherlands.
authors.forename: H Bart
authors.initials: HB
authors.lastname: van der Worp
authors.affiliation: Department of Vascular Surgery, University Medical Center Utrecht, Utrecht, Netherlands.
authors.forename: Gert J
authors.initials: GJ
authors.lastname: de Borst
authors.affiliation: Department of Radiology, University Medical Center Utrecht, Utrecht, Netherlands.
authors.forename: Willem P Th M
authors.initials: WP
authors.lastname: Mali
authors.affiliation: Sheffield Vascular Institute, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UK.
authors.forename: Jonathan D
authors.initials: JD
authors.lastname: Beard
authors.affiliation: Sheffield Vascular Institute, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UK.
authors.forename: Trevor
authors.initials: T
authors.lastname: Cleveland
authors.affiliation: Department of Neurology and Stroke Unit, University Hospital Basel, Basel University, Basel, Switzerland.
authors.forename: Stefan T
authors.initials: ST
authors.lastname: Engelter
authors.affiliation: Department of Neurology and Stroke Unit, University Hospital Basel, Basel University, Basel, Switzerland.
authors.forename: Philippe A
authors.initials: PA
authors.lastname: Lyrer
authors.affiliation: Stroke Research Group, Newcastle University, Newcastle upon Tyne, UK.
authors.forename: Gary A
authors.initials: GA
authors.lastname: Ford
authors.affiliation: Department of Neurology, Royal Victoria Infirmary, Newcastle upon Tyne, UK.
authors.forename: Paul J
authors.initials: PJ
authors.lastname: Dorman
authors.affiliation: Department of Brain Repair and Rehabilitation, UCL Institute of Neurology, University College London, London, UK. Electronic address: martin.brown@ucl.ac.uk.
authors.forename: Martin M
authors.initials: MM
authors.lastname: Brown
mesh_terms: D000368:Aged; D016893:Carotid Stenosis / Q000150:complications / Q000401:mortality / Q000628:therapy*; D016894:Endarterectomy, Carotid; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D020127:Recovery of Function; D015607:Stents; D020521:Stroke / Q000209:etiology / Q000401:mortality / Q000517:prevention & control; D013997:Time Factors; D016896:Treatment Outcome