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Restenosis and risk of stroke after stenting or endarterectomy for symptomatic carotid stenosis in the International Carotid Stenting Study (ICSS): secondary analysis of a randomised trial

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 Stenti...

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Autores principales: Bonati, Leo H, Gregson, John, Dobson, Joanna, McCabe, Dominick J H, Nederkoorn, Paul J, van der Worp, H Bart, de Borst, Gert J, Richards, Toby, Cleveland, Trevor, Müller, Mandy D, Wolff, Thomas, Engelter, Stefan T, Lyrer, Philippe A, Brown, Martin M
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Lancet Pub. Group 2018
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6004555/
https://www.ncbi.nlm.nih.gov/pubmed/29861139
http://dx.doi.org/10.1016/S1474-4422(18)30195-9
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author Bonati, Leo H
Gregson, John
Dobson, Joanna
McCabe, Dominick J H
Nederkoorn, Paul J
van der Worp, H Bart
de Borst, Gert J
Richards, Toby
Cleveland, Trevor
Müller, Mandy D
Wolff, Thomas
Engelter, Stefan T
Lyrer, Philippe A
Brown, Martin M
author_facet Bonati, Leo H
Gregson, John
Dobson, Joanna
McCabe, Dominick J H
Nederkoorn, Paul J
van der Worp, H Bart
de Borst, Gert J
Richards, Toby
Cleveland, Trevor
Müller, Mandy D
Wolff, Thomas
Engelter, Stefan T
Lyrer, Philippe A
Brown, Martin M
author_sort Bonati, Leo H
collection PubMed
description 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.
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spelling pubmed-60045552018-07-01 Restenosis and risk of stroke after stenting or endarterectomy for symptomatic carotid stenosis in the International Carotid Stenting Study (ICSS): secondary analysis of a randomised trial Bonati, Leo H Gregson, John Dobson, Joanna McCabe, Dominick J H Nederkoorn, Paul J van der Worp, H Bart de Borst, Gert J Richards, Toby Cleveland, Trevor Müller, Mandy D Wolff, Thomas Engelter, Stefan T Lyrer, Philippe A Brown, Martin M Lancet Neurol Article 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. Lancet Pub. Group 2018-07 /pmc/articles/PMC6004555/ /pubmed/29861139 http://dx.doi.org/10.1016/S1474-4422(18)30195-9 Text en © 2018 The Author(s). Published by Elsevier Ltd. This is an Open Access Article under the CC BY license http://creativecommons.org/licenses/by/4.0/ This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
Bonati, Leo H
Gregson, John
Dobson, Joanna
McCabe, Dominick J H
Nederkoorn, Paul J
van der Worp, H Bart
de Borst, Gert J
Richards, Toby
Cleveland, Trevor
Müller, Mandy D
Wolff, Thomas
Engelter, Stefan T
Lyrer, Philippe A
Brown, Martin M
Restenosis and risk of stroke after stenting or endarterectomy for symptomatic carotid stenosis in the International Carotid Stenting Study (ICSS): secondary analysis of a randomised trial
title Restenosis and risk of stroke after stenting or endarterectomy for symptomatic carotid stenosis in the International Carotid Stenting Study (ICSS): secondary analysis of a randomised trial
title_full Restenosis and risk of stroke after stenting or endarterectomy for symptomatic carotid stenosis in the International Carotid Stenting Study (ICSS): secondary analysis of a randomised trial
title_fullStr Restenosis and risk of stroke after stenting or endarterectomy for symptomatic carotid stenosis in the International Carotid Stenting Study (ICSS): secondary analysis of a randomised trial
title_full_unstemmed Restenosis and risk of stroke after stenting or endarterectomy for symptomatic carotid stenosis in the International Carotid Stenting Study (ICSS): secondary analysis of a randomised trial
title_short Restenosis and risk of stroke after stenting or endarterectomy for symptomatic carotid stenosis in the International Carotid Stenting Study (ICSS): secondary analysis of a randomised trial
title_sort restenosis and risk of stroke after stenting or endarterectomy for symptomatic carotid stenosis in the international carotid stenting study (icss): secondary analysis of a randomised trial
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6004555/
https://www.ncbi.nlm.nih.gov/pubmed/29861139
http://dx.doi.org/10.1016/S1474-4422(18)30195-9
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