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Lancet. 2015 Feb 7;385(9967):529-38. doi: 10.1016/S0140-6736(14)61184-3. Epub 2014 Oct 14.

Long-term outcomes after stenting versus endarterectomy for treatment of symptomatic carotid stenosis: the International Carotid Stenting Study (ICSS) randomised trial.

Collaborators (298)

Bamford J, Beard J, Bland M, Bradbury AW, Brown MM, Hacke W, Halliday A, Malik I, Mas JL, McGuire AJ, Sidhu P, Venables G, Brown MM, Clifton A, Gaines P, Collins R, Molyneux A, Naylor R, Warlow C, Ferro JM, Thomas D, Coward L, Dobson J, Doig D, Ederle J, Featherstone RF, Kennedy F, Tindall H, Turner E, McCabe DJ, Wallis A, Brooks M, Chambers B, Chan A, Dewey H, Donnan G, Fell G, Hoare M, Molan M, Roberts A, Roberts N, Beiles B, Bladin C, Clifford C, Grigg M, New G, Bell R, Bower S, Chong W, Holt M, Than PG, Gett S, Quinn J, Ray M, Wong A, Woodruff P, Foreman R, Schultz D, Scroop R, Atkinson N, Cambell W, Davis S, Field P, Milne P, Mitchell P, Tress B, Yan B, Beasley A, Dunbabin D, Stary D, Walker S, Cras P, Hendriks JM, Van P, St AZ, Bosiers M, Deloose K, Brugge-Oostende AZ, Devos V, Ghekiere J, Vanhooren G, Astarci P, Hammer F, Lacroix V, Peeters A, Verhelst R, Ziekenhuis I, DeJaegher L, Daneault N, Lanthier S, Lebrun LH, Oliva V, Raymond J, Roy D, Soulez G, Hill M, Hu W, Hudion M, Wong J, Albäck A, Curtze S, Harno H, Ijäs P, Lappalainen K, Lepäntalo M, Meretoja A, Mustanoja S, Paananen T, Railo M, Sairanen T, Soinne L, Vehmas A, Vikatmaa P, Goertler M, Halloul Z, Brennan P, Kelly C, Leahy A, Moroney J, Thornton J, Koelemay MJ, Nederkoorn PJ, Reekers JA, Roos BW, Pattynama PM, van Dijk LC, van Sambeek HM, van Urk H, Verhagen HJ, de Bruijn SF, Keunen R, Knippenberg B, Mosch A, Treurniet F, van Dijk L, van Overhagen H, Wever J, van Hasselt AA, Zeilstra DJ, Boiten J, Lycklama GJ, Blankensteijn JD, De Leeuw FE, Schultze LJ, de Borst GJ, de Kort GA, Kapelle LJ, Lo TH, Mali WP, Moll F, Barber PA, Bourchier R, Hill A, Holden A, Bakke SJ, Krohg K, Skjelland M, Tennøe B, Bialek P, Biejat Z, Czepiel W, Czlonkowska A, Dowzenko A, Buczek J, Kobayashi A, Lelek M, Polanski J, Kirbis J, Milosevic Z, Zvan B, Blasco J, Chamorro A, Macho J, San L, Branera J, Canovas D, Perendreu J, Björses K, Gottsäter A, Mätzsch T, Sonesson B, Berg B, Delle M, Formgren J, Nyman N, Takolander R, Andersson T, Malmstedt J, Soderman M, Wahlgren C, Wahlgren N, Binaghi S, Hirt L, Michel P, Ruchat P, Bonati LH, Engelter ST, Jacob AL, Kirsch E, Lyrer PA, Bonvin C, Kalangos A, Lovblad K, Sztajzel R, Higgins N, Kirkpatrick PJ, Martin P, Varty K, Adam D, Bell J, Bradbury AW, Crowe P, Gannon M, Henderson MJ, Sandler D, Shinton RA, Scriven JM, Wilmink T, Egun A, Guta R, Punekar S, Seriki DM, Thomson G, Brennan JA, Enevoldson TP, Gilling-Smith G, Gould DA, Harris PL, McWilliams RG, White R, Prakash KG, Serracino-Inglott F, Subramanian G, Walker MG, Clarke M, Davis M, Dixit SA, Dorman P, Dyker A, Ford G, Golkar A, Lambert D, Lees T, Louw S, Macdonald S, Mendelow AD, Rodgers H, Stansby G, Wyatt M, Baker T, Jones L, Mitchell D, Munro E, Thornton M, Baker D, Davis N, Hamilton G, McCabe D, Platts A, Tibballs J, Beard J, Cleveland T, Dodd D, Nair R, Nassef A, Nawaz S, Venables G, Belli A, Clifton A, Halliday A, Markus H, McFarland R, Morgan R, Pereira A, Chataway J, Cheshire N, Gibbs R, Hammady M, Jenkins M, Malik I, Wolfe J, Adiseshiah M, Bishop C, Brew S, Jäger R, Kitchen N, Ashleigh R, Butterfield S, Gamble GE, McCollum C, Nasim A, O'Neill P, Wong J, Edwards RD, Lees KR, MacKay AJ, Moss J, Rogers P.

Author information

1
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.
2
Department of Medical Statistics, London School of Hygiene & Tropical Medicine, London, UK.
3
Department of Brain Repair and Rehabilitation, UCL Institute of Neurology, University College London, London, UK.
4
Department of Neurology and Neurosurgery, Brain Center Rudolf Magnus, University Medical Center Utrecht, Utrecht, Netherlands.
5
Department of Vascular Surgery, University Medical Center Utrecht, Utrecht, Netherlands.
6
Department of Radiology, University Medical Center Utrecht, Utrecht, Netherlands.
7
Sheffield Vascular Institute, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UK.
8
Department of Neurology and Stroke Unit, University Hospital Basel, Basel University, Basel, Switzerland.
9
Stroke Research Group, Newcastle University, Newcastle upon Tyne, UK.
10
Department of Neurology, Royal Victoria Infirmary, Newcastle upon Tyne, UK.
11
Department of Brain Repair and Rehabilitation, UCL Institute of Neurology, University College London, London, UK. Electronic address: martin.brown@ucl.ac.uk.

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.

FINDINGS:

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.

INTERPRETATION:

Long-term functional outcome and risk of fatal or disabling stroke are similar for stenting and endarterectomy for symptomatic carotid stenosis.

FUNDING:

Medical Research Council, Stroke Association, Sanofi-Synthélabo, European Union.

PMID:
25453443
PMCID:
PMC4322188
DOI:
10.1016/S0140-6736(14)61184-3
[Indexed for MEDLINE]
Free PMC Article

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