TY - JOUR
T1 - Restenosis and risk of stroke after stenting or endarterectomy for symptomatic carotid stenosis in the International Carotid Stenting Study (ICSS)
T2 - secondary analysis of a randomised trial
AU - International carotid stenting study investigators
AU - Bonati, Leo H.
AU - Gregson, John
AU - Dobson, Joanna
AU - McCabe, Dominick J.H.
AU - Nederkoorn, Paul J.
AU - van der Worp, H. Bart
AU - de Borst, Gert J.
AU - Richards, Toby
AU - Cleveland, Trevor
AU - Müller, Mandy D.
AU - Wolff, Thomas
AU - Engelter, Stefan T.
AU - Lyrer, Philippe A.
AU - Brown, Martin M.
AU - Algra, Ale
AU - Bakke, S. J.
AU - Baldwin, Neil
AU - Beard, Jonathan
AU - Bladin, Christopher
AU - Bland, J. Martin
AU - Boiten, J.
AU - Bosiers, Mark
AU - Bradbury, Andrew W.
AU - Canovas, David
AU - Chambers, Brian
AU - Chamorro, Angel
AU - Chataway, Jonathan
AU - Clifton, Andrew
AU - Collins, Rory
AU - Coward, Lucy
AU - Czlonkowska, Anna
AU - Davis, Stephen
AU - DeJaegher, L.
AU - Doig, David
AU - Dorman, Paul
AU - Ederle, Jörg
AU - Featherstone, Roland F.
AU - Ferro, Jose M.
AU - Gaines, Peter
AU - Gilling-Smith, G.
AU - Goertler, M.
AU - Gottsäter, A.
AU - Hacke, Werne
AU - Halliday, Alison
AU - Hamilton, George
AU - Hendriks, Johanna M.H.
AU - Hill, Michael
AU - Kapelle, L. Jaap
AU - Kaste, Markku
AU - Kennedy, Fiona
AU - Konrad, P.
AU - Kool, L. J.S.
AU - Koudstaal, Peter J.
AU - Malik, I.
AU - Markus, Hugh
AU - Martin, Peter J.
AU - Mas, Jean Louis
AU - McCollum, Charles
AU - McGahan, T.
AU - McGuire, A. J.
AU - Michel, Philippe
AU - Molyneux, Andrew
AU - Moroney, Jane
AU - Mosch, A.
AU - Moss, J.
AU - Naylor, Ross
AU - Peeters, A.
AU - Roy, D.
AU - Schultz, David
AU - Seriki, D. M.
AU - Shinton, R. A.
AU - Sidhu, Paul
AU - Stewart, J.
AU - Subramanian, G.
AU - Sztajzel, R.
AU - Than, P. G.
AU - Thomas, Daffyd
AU - Turner, E.
AU - van den Berg, J. S.P.
AU - Vanhooren, G.
AU - Venables, Graham
AU - Wahlgren, Nils
AU - Walker, Stuart Robert
AU - Warlow, Charles
AU - Zvan, Bojana
N1 - Copyright © 2018 The Author(s). Published by Elsevier Ltd. This is an Open Access Article under the CC BY license.
PY - 2018/7
Y1 - 2018/7
N2 - Background: The risk of stroke associated with carotid artery restenosis after stenting or endarterectomy is unclear. We aimed to compare the long-term risk of restenosis after these treatments and to investigate if restenosis causes stroke in a secondary analysis of the International Carotid Stenting Study (ICSS). Methods: ICSS is a parallel-group randomised trial at 50 tertiary care centres in Europe, Australia, New Zealand, and Canada. Patients aged 40 years or older with symptomatic carotid stenosis measuring 50% or more were randomly assigned either stenting or endarterectomy in a 1:1 ratio. Randomisation was computer-generated and done centrally, with allocation by telephone or fax, stratified by centre, and with minimisation for sex, age, side of stenosis, and occlusion of the contralateral carotid artery. Patients were followed up both clinically and with carotid duplex ultrasound at baseline, 30 days after treatment, 6 months after randomisation, then annually for up to 10 years. We included patients whose assigned treatment was completed and who had at least one ultrasound examination after treatment. Restenosis was defined as any narrowing of the treated artery measuring 50% or more (at least moderate) or 70% or more (severe), or occlusion of the artery. The degree of restenosis based on ultrasound velocities and clinical outcome events were adjudicated centrally; assessors were masked to treatment assignment. Restenosis was analysed using interval-censored models and its association with later ipsilateral stroke using Cox regression. This trial is registered with the ISRCTN registry, number ISRCTN25337470. This report presents a secondary analysis, and follow-up is complete. Findings: Between May, 2001, and October, 2008, 1713 patients were enrolled and randomly allocated treatment (855 were assigned stenting and 858 endarterectomy), of whom 1530 individuals were followed up with ultrasound (737 assigned stenting and 793 endarterectomy) for a median of 4·0 years (IQR 2·3–5·0). At least moderate restenosis (≥50%) occurred in 274 patients after stenting (cumulative 5-year risk 40·7%) and in 217 after endarterectomy (29·6%; unadjusted hazard ratio [HR] 1·43, 95% CI 1·21–1·72; p<0·0001). Patients with at least moderate restenosis (≥50%) had a higher risk of ipsilateral stroke than did individuals without restenosis in the overall patient population (HR 3·18, 95% CI 1·52–6·67; p=0·002) and in the endarterectomy group alone (5·75, 1·80–18·33; p=0·003), but no significant increase in stroke risk after restenosis was recorded in the stenting group (2·03, 0·77–5·37; p=0·154; p=0·10 for interaction with treatment). No difference was noted in the risk of severe restenosis (≥70%) or subsequent stroke between the two treatment groups. Interpretation: At least moderate (≥50%) restenosis occurred more frequently after stenting than after endarterectomy and increased the risk for ipsilateral stroke in the overall population. Whether the restenosis-mediated risk of stroke differs between stenting and endarterectomy requires further research. Funding: Medical Research Council, the Stroke Association, Sanofi-Synthélabo, and the European Union.
AB - Background: The risk of stroke associated with carotid artery restenosis after stenting or endarterectomy is unclear. We aimed to compare the long-term risk of restenosis after these treatments and to investigate if restenosis causes stroke in a secondary analysis of the International Carotid Stenting Study (ICSS). Methods: ICSS is a parallel-group randomised trial at 50 tertiary care centres in Europe, Australia, New Zealand, and Canada. Patients aged 40 years or older with symptomatic carotid stenosis measuring 50% or more were randomly assigned either stenting or endarterectomy in a 1:1 ratio. Randomisation was computer-generated and done centrally, with allocation by telephone or fax, stratified by centre, and with minimisation for sex, age, side of stenosis, and occlusion of the contralateral carotid artery. Patients were followed up both clinically and with carotid duplex ultrasound at baseline, 30 days after treatment, 6 months after randomisation, then annually for up to 10 years. We included patients whose assigned treatment was completed and who had at least one ultrasound examination after treatment. Restenosis was defined as any narrowing of the treated artery measuring 50% or more (at least moderate) or 70% or more (severe), or occlusion of the artery. The degree of restenosis based on ultrasound velocities and clinical outcome events were adjudicated centrally; assessors were masked to treatment assignment. Restenosis was analysed using interval-censored models and its association with later ipsilateral stroke using Cox regression. This trial is registered with the ISRCTN registry, number ISRCTN25337470. This report presents a secondary analysis, and follow-up is complete. Findings: Between May, 2001, and October, 2008, 1713 patients were enrolled and randomly allocated treatment (855 were assigned stenting and 858 endarterectomy), of whom 1530 individuals were followed up with ultrasound (737 assigned stenting and 793 endarterectomy) for a median of 4·0 years (IQR 2·3–5·0). At least moderate restenosis (≥50%) occurred in 274 patients after stenting (cumulative 5-year risk 40·7%) and in 217 after endarterectomy (29·6%; unadjusted hazard ratio [HR] 1·43, 95% CI 1·21–1·72; p<0·0001). Patients with at least moderate restenosis (≥50%) had a higher risk of ipsilateral stroke than did individuals without restenosis in the overall patient population (HR 3·18, 95% CI 1·52–6·67; p=0·002) and in the endarterectomy group alone (5·75, 1·80–18·33; p=0·003), but no significant increase in stroke risk after restenosis was recorded in the stenting group (2·03, 0·77–5·37; p=0·154; p=0·10 for interaction with treatment). No difference was noted in the risk of severe restenosis (≥70%) or subsequent stroke between the two treatment groups. Interpretation: At least moderate (≥50%) restenosis occurred more frequently after stenting than after endarterectomy and increased the risk for ipsilateral stroke in the overall population. Whether the restenosis-mediated risk of stroke differs between stenting and endarterectomy requires further research. Funding: Medical Research Council, the Stroke Association, Sanofi-Synthélabo, and the European Union.
KW - stroke
KW - stenting
KW - carotid artery restenosis
UR - http://www.scopus.com/inward/record.url?scp=85048401548&partnerID=8YFLogxK
U2 - 10.1016/S1474-4422(18)30195-9
DO - 10.1016/S1474-4422(18)30195-9
M3 - Article
C2 - 29861139
AN - SCOPUS:85048401548
SN - 1474-4422
VL - 17
SP - 587
EP - 596
JO - Lancet Neurology
JF - Lancet Neurology
IS - 7
ER -