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Leo H Bonati - One of the best experts on this subject based on the ideXlab platform.
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carotid artery stenting versus Endarterectomy for treatment of carotid artery stenosis
Cochrane Database of Systematic Reviews, 2020Co-Authors: Mandy D Muller, Martin M Brown, Philippe Lyrer, Leo H BonatiAbstract:BACKGROUND Carotid artery stenting is an alternative to carotid Endarterectomy for the treatment of atherosclerotic carotid artery stenosis. This review updates a previous version first published in 1997 and subsequently updated in 2004, 2007, and 2012. OBJECTIVES To assess the benefits and risks of stenting compared with Endarterectomy in people with symptomatic or asymptomatic carotid stenosis. SEARCH METHODS We searched the Cochrane Stroke Group Trials Register (last searched August 2018) and the following databases: CENTRAL, MEDLINE, Embase, and Science Citation Index to August 2018. We also searched ongoing trials registers (August 2018) and reference lists, and contacted researchers in the field. SELECTION CRITERIA Randomised controlled trials (RCTs) comparing stenting with Endarterectomy for symptomatic or asymptomatic atherosclerotic carotid stenosis. In addition, we included RCTs comparing carotid artery stenting with medical therapy alone. DATA COLLECTION AND ANALYSIS One review author selected trials for inclusion, assessed trial quality and risk of bias, and extracted data. A second review author independently validated trial selection and a third review author independently validated data extraction. We calculated treatment effects as odds ratios (OR) and 95% confidence intervals (CI), with Endarterectomy as the reference group. We quantified heterogeneity using the I² statistic and used GRADE to assess the overall certainty of evidence. MAIN RESULTS We included 22 trials involving 9753 participants. In participants with symptomatic carotid stenosis, compared with Endarterectomy stenting was associated with a higher risk of periprocedural death or stroke (the primary safety outcome; OR 1.70, 95% CI 1.31 to 2.19; P < 0.0001, I² = 5%; 10 trials, 5396 participants; high-certainty evidence); and periprocedural death, stroke, or myocardial infarction (OR 1.43, 95% CI 1.14 to 1.80; P = 0.002, I² = 0%; 6 trials, 4861 participants; high-certainty evidence). The OR for the primary safety outcome was 1.11 (95% CI 0.74 to 1.64) in participants under 70 years old and 2.23 (95% CI 1.61 to 3.08) in participants 70 years old or more (interaction P = 0.007). There was a non-significant increase in periprocedural death or major or disabling stroke with stenting (OR 1.36, 95% CI 0.97 to 1.91; P = 0.08, I² = 0%; 7 trials, 4983 participants; high-certainty evidence). Compared with Endarterectomy, stenting was associated with lower risks of myocardial infarction (OR 0.47, 95% CI 0.24 to 0.94; P = 0.03, I² = 0%), cranial nerve palsy (OR 0.09, 95% CI 0.06 to 0.16; P < 0.00001, I² = 0%), and access site haematoma (OR 0.32, 95% CI 0.15 to 0.68; P = 0.003, I² = 27%). The combination of periprocedural death or stroke or ipsilateral stroke during follow-up (the primary combined safety and efficacy outcome) favoured Endarterectomy (OR 1.51, 95% CI 1.24 to 1.85; P < 0.0001, I² = 0%; 8 trials, 5080 participants; high-certainty evidence). The rate of ipsilateral stroke after the periprocedural period did not differ between treatments (OR 1.05, 95% CI 0.75 to 1.47; P = 0.77, I² = 0%). In participants with asymptomatic carotid stenosis, there was a non-significant increase in periprocedural death or stroke with stenting compared with Endarterectomy (OR 1.72, 95% CI 1.00 to 2.97; P = 0.05, I² = 0%; 7 trials, 3378 participants; moderate-certainty evidence). The risk of periprocedural death or stroke or ipsilateral stroke during follow-up did not differ significantly between treatments (OR 1.27, 95% CI 0.87 to 1.84; P = 0.22, I² = 0%; 6 trials, 3315 participants; moderate-certainty evidence). Moderate or higher carotid artery restenosis (50% or greater) or occlusion during follow-up was more common after stenting (OR 2.00, 95% CI 1.12 to 3.60; P = 0.02, I² = 44%), but the difference in risk of severe restenosis was not significant (70% or greater; OR 1.26, 95% CI 0.79 to 2.00; P = 0.33, I² = 58%; low-certainty evidence). AUTHORS' CONCLUSIONS Stenting for symptomatic carotid stenosis is associated with a higher risk of periprocedural stroke or death than Endarterectomy. This extra risk is mostly attributed to an increase in minor, non-disabling strokes occurring in people older than 70 years. Beyond the periprocedural period, carotid stenting is as effective in preventing recurrent stroke as Endarterectomy. However, combining procedural safety and long-term efficacy in preventing recurrent stroke still favours Endarterectomy. In people with asymptomatic carotid stenosis, there may be a small increase in the risk of periprocedural stroke or death with stenting compared with Endarterectomy. However, CIs of treatment effects were wide and further data from randomised trials in people with asymptomatic stenosis are needed.
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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
Lancet Neurology, 2018Co-Authors: Joanna Dobson, Leo H Bonati, Gert J De Borst, Dominick J H Mccabe, Paul J Nederkoorn, Bart H Van Der Worp, John Gregson, Toby RichardsAbstract:Summary 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 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-Synthelabo, and the European Union.
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long term outcomes after stenting versus Endarterectomy for treatment of symptomatic carotid stenosis the international carotid stenting study icss randomised trial
The Lancet, 2015Co-Authors: Jorg Ederle, Joanna Dobson, Leo H Bonati, Gert J De Borst, R L Featherstone, Willem Th P M Mali, J D Beard, Bart H Van Der Worp, Trevor J ClevelandAbstract:Summary 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 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-Synthelabo, European Union.
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short term outcome after stenting versus Endarterectomy for symptomatic carotid stenosis a preplanned meta analysis of individual patient data
The Lancet, 2010Co-Authors: Leo H Bonati, Gilles Chatellier, Alain Branchereau, Joanna Dobson, Martin M Brown, A Algra, Gustav Fraedrich, Willem Th P M Mali, Hermann Zeumer, Jean-louis MasAbstract:BACKGROUND: Results from randomised controlled trials have shown a higher short-term risk of stroke associated with carotid stenting than with carotid Endarterectomy for the treatment of symptomatic carotid stenosis. However, these trials were underpowered for investigation of whether carotid artery stenting might be a safe alternative to Endarterectomy in specific patient subgroups. We therefore did a preplanned meta-analysis of individual patient data from three randomised controlled trials. METHODS: Data from all 3433 patients with symptomatic carotid stenosis who were randomly assigned and analysed in the Endarterectomy versus Angioplasty in Patients with Symptomatic Severe Carotid Stenosis (EVA-3S) trial, the Stent-Protected Angioplasty versus Carotid Endarterectomy (SPACE) trial, and the International Carotid Stenting Study (ICSS) were pooled and analysed with fixed-effect binomial regression models adjusted for source trial. The primary outcome event was any stroke or death. The intention-to-treat (ITT) analysis included all patients and outcome events occurring between randomisation and 120 days thereafter. The per-protocol (PP) analysis was restricted to patients receiving the allocated treatment and events occurring within 30 days after treatment. FINDINGS: In the first 120 days after randomisation (ITT analysis), any stroke or death occurred significantly more often in the carotid stenting group (153 [8·9%] of 1725) than in the carotid Endarterectomy group (99 [5·8%] of 1708, risk ratio [RR] 1·53, [95% CI 1·20-1·95], p=0·0006; absolute risk difference 3·2 [1·4-4·9]). Of all subgroup variables assessed, only age significantly modified the treatment effect: in patients younger than 70 years (median age), the estimated 120-day risk of stroke or death was 50 (5·8%) of 869 patients in the carotid stenting group and 48 (5·7%) of 843 in the carotid Endarterectomy group (RR 1·00 [0·68-1·47]); in patients 70 years or older, the estimated risk with carotid stenting was twice that with carotid Endarterectomy (103 [12·0%] of 856 vs 51 [5·9%] of 865, 2·04 [1·48-2·82], interaction p=0·0053, p=0·0014 for trend). In the PP analysis, risk estimates of stroke or death within 30 days of treatment among patients younger than 70 years were 43 (5·1%) of 851 patients in the stenting group and 37 (4·5%) of 821 in the Endarterectomy group (1·11 [0·73-1·71]); in patients 70 years or older, the estimates were 87 (10·5%) of 828 patients and 36 (4·4%) of 824, respectively (2·41 [1·65-3·51]; categorical interaction p=0·0078, trend interaction p=0·0013]. INTERPRETATION: Stenting for symptomatic carotid stenosis should be avoided in older patients (age>=70 years), but might be as safe as Endarterectomy in younger patients. FUNDING: The Stroke Association.
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new ischaemic brain lesions on mri after stenting or Endarterectomy for symptomatic carotid stenosis a substudy of the international carotid stenting study icss
Lancet Neurology, 2010Co-Authors: Leo H Bonati, Joanna Dobson, Peter Gaines, Lisa M Jongen, Sven Haller, Zwenneke H Flach, Paul J Nederkoorn, Sumaira Macdonald, A Waaijer, Peter StierliAbstract:Summary Background The International Carotid Stenting Study (ICSS) of stenting and Endarterectomy for symptomatic carotid stenosis found a higher incidence of stroke within 30 days of stenting compared with Endarterectomy. We aimed to compare the rate of ischaemic brain injury detectable on MRI between the two groups. Methods Patients with recently symptomatic carotid artery stenosis enrolled in ICSS were randomly assigned in a 1:1 ratio to receive carotid artery stenting or Endarterectomy. Of 50 centres in ICSS, seven took part in the MRI substudy. The protocol specified that MRI was done 1–7 days before treatment, 1–3 days after treatment (post-treatment scan), and 27–33 days after treatment. Scans were analysed by two or three investigators who were masked to treatment. The primary endpoint was the presence of at least one new ischaemic brain lesion on diffusion-weighted imaging (DWI) on the post-treatment scan. Analysis was per protocol. This is a substudy of a registered trial, ISRCTN 25337470. Findings 231 patients (124 in the stenting group and 107 in the Endarterectomy group) had MRI before and after treatment. 62 (50%) of 124 patients in the stenting group and 18 (17%) of 107 patients in the Endarterectomy group had at least one new DWI lesion detected on post-treatment scans done a median of 1 day after treatment (adjusted odds ratio [OR] 5·21, 95% CI 2·78–9·79; p Interpretation About three times more patients in the stenting group than in the Endarterectomy group had new ischaemic lesions on DWI on post-treatment scans. The difference in clinical stroke risk in ICSS is therefore unlikely to have been caused by ascertainment bias. Protection devices did not seem to be effective in preventing cerebral ischaemia during stenting. DWI might serve as a surrogate outcome measure in future trials of carotid interventions. Funding UK Medical Research Council, the Stroke Association, Sanofi-Synthelabo, European Union, Netherlands Heart Foundation, and Mach-Gaensslen Foundation.
Thomas G. Brott - One of the best experts on this subject based on the ideXlab platform.
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carotid Endarterectomy and carotid artery stenting in the us medicare population 1999 2014
JAMA, 2017Co-Authors: Judith H Lichtman, George Howard, Michael R Jones, Erica C Leifheit, Alice J Sheffet, Virginia J Howard, Yun Wang, Jeptha P Curtis, Thomas G. BrottAbstract:Importance Carotid Endarterectomy and carotid artery stenting are the leading approaches to revascularization for carotid stenosis, yet contemporary data on trends in rates and outcomes are limited. Objective To describe US national trends in performance and outcomes of carotid Endarterectomy and stenting among Medicare beneficiaries from 1999 to 2014. Design, Setting, and Participants Serial cross-sectional analysis of Medicare fee-for-service beneficiaries aged 65 years or older from 1999 to 2014 using the Medicare Inpatient and Denominator files. Spatial mixed models adjusted for age, sex, and race were fit to calculate county-specific risk-standardized revascularization rates. Mixed models were fit to assess trends in outcomes after adjustment for demographics, comorbidities, and symptomatic status. Exposures Carotid Endarterectomy and carotid artery stenting. Main Outcomes and Measures Revascularization rates per 100 000 beneficiary-years of fee-for-service enrollment, in-hospital mortality, 30-day stroke or death, 30-day stroke, myocardial infarction, or death, 30-day all-cause mortality, and 1-year stroke. Results During the study, 937 111 unique patients underwent carotid Endarterectomy (mean age, 75.8 years; 43% women) and 231 077 underwent carotid artery stenting (mean age, 75.4 years; 49% women). There were 81 306 patients who underwent Endarterectomy in 1999 and 36 325 in 2014; national rates per 100 000 beneficiary-years decreased from 298 in 1999-2000 to 128 in 2013-2014 ( P P P P Conclusions and Relevance Among fee-for-service Medicare beneficiaries, the performance of carotid Endarterectomy declined from 1999 to 2014, whereas the performance of carotid artery stenting increased until 2006 and then declined from 2007 to 2014. Outcomes improved despite increases in vascular risk factors.
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long term results of stenting versus Endarterectomy for carotid artery stenosis
The New England Journal of Medicine, 2016Co-Authors: Thomas G. Brott, George Howard, Gary S RoubinAbstract:BackgroundIn the Carotid Revascularization Endarterectomy versus Stenting Trial, we found no significant difference between the stenting group and the Endarterectomy group with respect to the primary composite end point of stroke, myocardial infarction, or death during the periprocedural period or any subsequent ipsilateral stroke during 4 years of follow-up. We now extend the results to 10 years. MethodsAmong patients with carotid-artery stenosis who had been randomly assigned to stenting or Endarterectomy, we evaluated outcomes every 6 months for up to 10 years at 117 centers. In addition to assessing the primary composite end point, we assessed the primary end point for the long-term extension study, which was ipsilateral stroke after the periprocedural period. ResultsAmong 2502 patients, there was no significant difference in the rate of the primary composite end point between the stenting group (11.8%; 95% confidence interval [CI], 9.1 to 14.8) and the Endarterectomy group (9.9%; 95% CI, 7.9 to 12.2)...
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long term results of stenting versus Endarterectomy for carotid artery stenosis
The New England Journal of Medicine, 2016Co-Authors: Thomas G. Brott, Ariane Mackey, William Brooks, James F Meschia, Wesley S Moore, George Howard, Gary S Roubin, Michael D Hill, Vito A Mantese, Wayne M ClarkAbstract:BackgroundIn the Carotid Revascularization Endarterectomy versus Stenting Trial, we found no significant difference between the stenting group and the Endarterectomy group with respect to the primary composite end point of stroke, myocardial infarction, or death during the periprocedural period or any subsequent ipsilateral stroke during 4 years of follow-up. We now extend the results to 10 years. MethodsAmong patients with carotid-artery stenosis who had been randomly assigned to stenting or Endarterectomy, we evaluated outcomes every 6 months for up to 10 years at 117 centers. In addition to assessing the primary composite end point, we assessed the primary end point for the long-term extension study, which was ipsilateral stroke after the periprocedural period. ResultsAmong 2502 patients, there was no significant difference in the rate of the primary composite end point between the stenting group (11.8%; 95% confidence interval [CI], 9.1 to 14.8) and the Endarterectomy group (9.9%; 95% CI, 7.9 to 12.2)...
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influence of sex on outcomes of stenting versus Endarterectomy a subgroup analysis of the carotid revascularization Endarterectomy versus stenting trial crest
Lancet Neurology, 2011Co-Authors: Virginia J Howard, Ariane Mackey, James F Meschia, Alice J Sheffet, Helmi L Lutsep, Bart M Demaerschalk, Albert D Sam, Nicole R Gonzales, Jenifer H Voeks, Thomas G. BrottAbstract:Summary Background In the randomised Carotid Revascularization Endarterectomy versus Stenting Trial (CREST), the primary endpoint did not differ between carotid artery stenting and carotid Endarterectomy in patients with symptomatic and asymptomatic stenosis. A prespecified secondary aim was to examine differences by sex. Methods Patients who were asymptomatic or had had a stroke or transient ischaemic attack within 180 days before random allocation were enrolled in CREST at 117 clinical centres in the USA and Canada. The primary outcome was the composite of stroke, myocardial infarction, or death during the periprocedural period or ipsilateral stroke within 4 years. We used standard survival methods including Kaplan-Meier survival curves and sex-by-treatment interaction term to assess the relation between patient factors and risk of reaching the primary outcome. Analyses were by intention to treat. CREST is registered with ClinicalTrials.gov, NCT00004732. Findings Between Dec 21, 2000, and July 18, 2008, 2502 patients were randomly assigned to carotid Endarterectomy (n=1240) or carotid artery stenting (n=1262), 872 (34·9%) of whom were women. Rates of the primary endpoint for carotid artery stenting compared with carotid Endarterectomy were 6·2% versus 6·8% in men (hazard ratio [HR] 0·99, 95% CI 0·66–1·46) and 8·9% versus 6·7% in women (1·35, 0·82–2·23). There was no significant interaction in the primary endpoint between sexes (interaction p=0·34). Periprocedural events occurred in 35 (4·3%) of 807 men assigned to carotid artery stenting compared with 40 (4·9%) of 823 assigned to carotid Endarterectomy (HR 0·90, 95% CI 0·57–1·41) and 31 (6·8%) of 455 women assigned to carotid artery stenting compared with 16 (3·8%) of 417 assigned to carotid Endarterectomy (1·84, 1·01–3·37; interaction p=0·064). Interpretation Periprocedural risk of events seems to be higher in women who have carotid artery stenting than those who have carotid Endarterectomy whereas there is little difference in men. Additional data are needed to confirm whether this differential risk should be taken into account in decisions for treatment of carotid disease in women. Funding National Institute of Neurological Disorders and Stroke and Abbott Vascular Solutions (formerly Guidant).
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Management of Stenosis of the Extracranial Internal Carotid Artery: Endarterectomy Versus Angioplasty and Stenting
Current Treatment Options in Neurology, 2010Co-Authors: Kevin M. Barrett, Thomas G. BrottAbstract:Recent randomized clinical trial data support the safety and efficacy of carotid artery stenting and carotid Endarterectomy for treatment of symptomatic and asymptomatic carotid occlusive disease. Endarterectomy is more effective in preventing stroke, but this may be countered by a higher risk of perioperative myocardial infarction. Age is an important determinant in selecting patients for either carotid Endarterectomy or stenting. Patients older than 70 years achieve better outcomes with Endarterectomy, and younger patients achieve better outcomes with stenting. Comparative clinical and anatomic durability of Endarterectomy and stenting will require additional follow-up from recently completed trials. The efficacy of carotid revascularization compared with modern medical therapy in asymptomatic patients remains an important and unanswered clinical question.
Dominick J H Mccabe - One of the best experts on this subject based on the ideXlab platform.
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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
Lancet Neurology, 2018Co-Authors: Joanna Dobson, Leo H Bonati, Gert J De Borst, Dominick J H Mccabe, Paul J Nederkoorn, Bart H Van Der Worp, John Gregson, Toby RichardsAbstract:Summary 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 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-Synthelabo, and the European Union.
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long term risk of carotid restenosis in patients randomly assigned to endovascular treatment or Endarterectomy in the carotid and vertebral artery transluminal angioplasty study cavatas long term follow up of a randomised trial
Lancet Neurology, 2009Co-Authors: Leo H Bonati, Jorg Ederle, Joanna Dobson, Roland L Featherstone, Peter Gaines, Dominick J H Mccabe, J D Beard, Graham S Venables, Hugh S Markus, Andrew CliftonAbstract:Summary Background In the Carotid and Vertebral Artery Transluminal Angioplasty Study (CAVATAS), early recurrent carotid stenosis was more common in patients assigned to endovascular treatment than it was in patients assigned to Endarterectomy (CEA), raising concerns about the long-term effectiveness of endovascular treatment. We aimed to investigate the long-term risks of restenosis in patients included in CAVATAS. Methods 413 patients who were randomly assigned in CAVATAS and completed treatment for carotid stenosis (200 patients had endovascular treatment and 213 patients had Endarterectomy) had prospective clinical follow-up at a median of 5 years and carotid duplex ultrasound at a median of 4 years. We investigated the cumulative long-term incidence of carotid restenosis after endovascular treatment and Endarterectomy, the effect of the use of stents on restenosis after endovascular treatment, risk factors for the development of restenosis, and the effect of carotid restenosis on the risk of recurrent cerebrovascular events. Analysis was by intention to treat. This study is registered, number ISRCTN01425573. Findings Severe carotid restenosis (≥70%) or occlusion occurred significantly more often in patients in the endovascular arm than in patients in the Endarterectomy arm (adjusted hazard ratio [HR] 3·17, 95% CI 1·89–5·32; p vs 11%; HR 2·18, 1·04–4·54; p=0·04), but the increase in ipsilateral stroke alone was not significant (10% vs 5%; 1·67, 0·54–5·11). Interpretation Restenosis is about three times more common after endovascular treatment than after Endarterectomy and is associated with recurrent ipsilateral cerebrovascular symptoms; however, the risk of recurrent ipsilateral stroke is low. Further data are required from on-going trials of stenting versus Endarterectomy to ascertain whether long-term ultrasound follow-up is necessary after carotid revascularisation. Funding British Heart Foundation; UK National Health Service Management Executive; UK Stroke Association.
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restenosis after carotid angioplasty stenting or Endarterectomy in the carotid and vertebral artery transluminal angioplasty study cavatas
Stroke, 2005Co-Authors: Dominick J H Mccabe, Andrew Clifton, Anthony Pereira, Martin Bland, Martin M BrownAbstract:Background and Purpose— Carotid and Vertebral Artery Transluminal Angioplasty Study (CAVATAS) patients with carotid stenosis were randomized between endovascular treatment and Endarterectomy. The rates of residual severe stenosis and restenosis and their contribution to recurrent symptoms was unclear. Methods— Endovascular patients were treated by balloon angioplasty alone (88%) or stenting (22%). Patches were used in 63% of Endarterectomy patients. Carotid stenosis was categorized as mild (0% to 49%), moderate (50% to 69%), severe (70% to 99%), or occluded, using standardized Doppler ultrasound criteria at the examination closest to 1 month (n=283) and 1 year (n=347) after treatment. Recurrent cerebrovascular symptoms during follow-up were analyzed. Results— More patients had ≥70% stenosis of the ipsilateral carotid artery 1 year after endovascular treatment than after Endarterectomy (18.5% versus 5.2%, P=0.0001). Residual severe stenosis was present in 6.5% of patients at 1 month after endovascular trea...
Martin M Brown - One of the best experts on this subject based on the ideXlab platform.
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carotid artery stenting versus Endarterectomy for treatment of carotid artery stenosis
Cochrane Database of Systematic Reviews, 2020Co-Authors: Mandy D Muller, Martin M Brown, Philippe Lyrer, Leo H BonatiAbstract:BACKGROUND Carotid artery stenting is an alternative to carotid Endarterectomy for the treatment of atherosclerotic carotid artery stenosis. This review updates a previous version first published in 1997 and subsequently updated in 2004, 2007, and 2012. OBJECTIVES To assess the benefits and risks of stenting compared with Endarterectomy in people with symptomatic or asymptomatic carotid stenosis. SEARCH METHODS We searched the Cochrane Stroke Group Trials Register (last searched August 2018) and the following databases: CENTRAL, MEDLINE, Embase, and Science Citation Index to August 2018. We also searched ongoing trials registers (August 2018) and reference lists, and contacted researchers in the field. SELECTION CRITERIA Randomised controlled trials (RCTs) comparing stenting with Endarterectomy for symptomatic or asymptomatic atherosclerotic carotid stenosis. In addition, we included RCTs comparing carotid artery stenting with medical therapy alone. DATA COLLECTION AND ANALYSIS One review author selected trials for inclusion, assessed trial quality and risk of bias, and extracted data. A second review author independently validated trial selection and a third review author independently validated data extraction. We calculated treatment effects as odds ratios (OR) and 95% confidence intervals (CI), with Endarterectomy as the reference group. We quantified heterogeneity using the I² statistic and used GRADE to assess the overall certainty of evidence. MAIN RESULTS We included 22 trials involving 9753 participants. In participants with symptomatic carotid stenosis, compared with Endarterectomy stenting was associated with a higher risk of periprocedural death or stroke (the primary safety outcome; OR 1.70, 95% CI 1.31 to 2.19; P < 0.0001, I² = 5%; 10 trials, 5396 participants; high-certainty evidence); and periprocedural death, stroke, or myocardial infarction (OR 1.43, 95% CI 1.14 to 1.80; P = 0.002, I² = 0%; 6 trials, 4861 participants; high-certainty evidence). The OR for the primary safety outcome was 1.11 (95% CI 0.74 to 1.64) in participants under 70 years old and 2.23 (95% CI 1.61 to 3.08) in participants 70 years old or more (interaction P = 0.007). There was a non-significant increase in periprocedural death or major or disabling stroke with stenting (OR 1.36, 95% CI 0.97 to 1.91; P = 0.08, I² = 0%; 7 trials, 4983 participants; high-certainty evidence). Compared with Endarterectomy, stenting was associated with lower risks of myocardial infarction (OR 0.47, 95% CI 0.24 to 0.94; P = 0.03, I² = 0%), cranial nerve palsy (OR 0.09, 95% CI 0.06 to 0.16; P < 0.00001, I² = 0%), and access site haematoma (OR 0.32, 95% CI 0.15 to 0.68; P = 0.003, I² = 27%). The combination of periprocedural death or stroke or ipsilateral stroke during follow-up (the primary combined safety and efficacy outcome) favoured Endarterectomy (OR 1.51, 95% CI 1.24 to 1.85; P < 0.0001, I² = 0%; 8 trials, 5080 participants; high-certainty evidence). The rate of ipsilateral stroke after the periprocedural period did not differ between treatments (OR 1.05, 95% CI 0.75 to 1.47; P = 0.77, I² = 0%). In participants with asymptomatic carotid stenosis, there was a non-significant increase in periprocedural death or stroke with stenting compared with Endarterectomy (OR 1.72, 95% CI 1.00 to 2.97; P = 0.05, I² = 0%; 7 trials, 3378 participants; moderate-certainty evidence). The risk of periprocedural death or stroke or ipsilateral stroke during follow-up did not differ significantly between treatments (OR 1.27, 95% CI 0.87 to 1.84; P = 0.22, I² = 0%; 6 trials, 3315 participants; moderate-certainty evidence). Moderate or higher carotid artery restenosis (50% or greater) or occlusion during follow-up was more common after stenting (OR 2.00, 95% CI 1.12 to 3.60; P = 0.02, I² = 44%), but the difference in risk of severe restenosis was not significant (70% or greater; OR 1.26, 95% CI 0.79 to 2.00; P = 0.33, I² = 58%; low-certainty evidence). AUTHORS' CONCLUSIONS Stenting for symptomatic carotid stenosis is associated with a higher risk of periprocedural stroke or death than Endarterectomy. This extra risk is mostly attributed to an increase in minor, non-disabling strokes occurring in people older than 70 years. Beyond the periprocedural period, carotid stenting is as effective in preventing recurrent stroke as Endarterectomy. However, combining procedural safety and long-term efficacy in preventing recurrent stroke still favours Endarterectomy. In people with asymptomatic carotid stenosis, there may be a small increase in the risk of periprocedural stroke or death with stenting compared with Endarterectomy. However, CIs of treatment effects were wide and further data from randomised trials in people with asymptomatic stenosis are needed.
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cost utility analysis of stenting versus Endarterectomy in the international carotid stenting study
International Journal of Stroke, 2016Co-Authors: Stephen Morris, Joanna Dobson, Nishma Patel, R L Featherstone, Toby Richards, Ramon Luengofernandez, Peter M Rothwell, Martin M BrownAbstract:BACKGROUND: The International Carotid Stenting Study was a multicenter randomized trial in which patients with symptomatic carotid artery stenosis were randomly allocated to treatment by carotid stenting or Endarterectomy. Economic evidence comparing these treatments is limited and inconsistent. AIMS: We compared the cost-effectiveness of stenting versus Endarterectomy using International Carotid Stenting Study data. METHODS: We performed a cost-utility analysis estimating mean costs and quality-adjusted life years per patient for both treatments over a five-year time horizon based on resource use data and utility values collected in the trial. Costs of managing stroke events were estimated using individual patient data from a UK population-based study (Oxford Vascular Study). RESULTS: Mean costs per patient (95% CI) were US$10,477 ($9669 to $11,285) in the stenting group (N = 853) and $9669 ($8835 to $10,504) in the Endarterectomy group (N = 857). There were no differences in mean quality-adjusted life years per patient (3.247 (3.160 to 3.333) and 3.228 (3.150 to 3.306), respectively). There were no differences in adjusted costs between groups (mean incremental costs for stenting versus Endarterectomy $736 (95% CI -$353 to $1826)) or adjusted outcomes (mean quality-adjusted life years gained -0.010 (95% CI -0.117 to 0.097)). The incremental net monetary benefit for stenting versus Endarterectomy was not significantly different from zero at the maximum willingness to pay for a quality-adjusted life year commonly used in the UK. Sensitivity analyses showed little uncertainty in these findings. CONCLUSIONS: Economic considerations should not affect whether patients with symptomatic carotid stenosis undergo stenting or Endarterectomy.
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short term outcome after stenting versus Endarterectomy for symptomatic carotid stenosis a preplanned meta analysis of individual patient data
The Lancet, 2010Co-Authors: Leo H Bonati, Gilles Chatellier, Alain Branchereau, Joanna Dobson, Martin M Brown, A Algra, Gustav Fraedrich, Willem Th P M Mali, Hermann Zeumer, Jean-louis MasAbstract:BACKGROUND: Results from randomised controlled trials have shown a higher short-term risk of stroke associated with carotid stenting than with carotid Endarterectomy for the treatment of symptomatic carotid stenosis. However, these trials were underpowered for investigation of whether carotid artery stenting might be a safe alternative to Endarterectomy in specific patient subgroups. We therefore did a preplanned meta-analysis of individual patient data from three randomised controlled trials. METHODS: Data from all 3433 patients with symptomatic carotid stenosis who were randomly assigned and analysed in the Endarterectomy versus Angioplasty in Patients with Symptomatic Severe Carotid Stenosis (EVA-3S) trial, the Stent-Protected Angioplasty versus Carotid Endarterectomy (SPACE) trial, and the International Carotid Stenting Study (ICSS) were pooled and analysed with fixed-effect binomial regression models adjusted for source trial. The primary outcome event was any stroke or death. The intention-to-treat (ITT) analysis included all patients and outcome events occurring between randomisation and 120 days thereafter. The per-protocol (PP) analysis was restricted to patients receiving the allocated treatment and events occurring within 30 days after treatment. FINDINGS: In the first 120 days after randomisation (ITT analysis), any stroke or death occurred significantly more often in the carotid stenting group (153 [8·9%] of 1725) than in the carotid Endarterectomy group (99 [5·8%] of 1708, risk ratio [RR] 1·53, [95% CI 1·20-1·95], p=0·0006; absolute risk difference 3·2 [1·4-4·9]). Of all subgroup variables assessed, only age significantly modified the treatment effect: in patients younger than 70 years (median age), the estimated 120-day risk of stroke or death was 50 (5·8%) of 869 patients in the carotid stenting group and 48 (5·7%) of 843 in the carotid Endarterectomy group (RR 1·00 [0·68-1·47]); in patients 70 years or older, the estimated risk with carotid stenting was twice that with carotid Endarterectomy (103 [12·0%] of 856 vs 51 [5·9%] of 865, 2·04 [1·48-2·82], interaction p=0·0053, p=0·0014 for trend). In the PP analysis, risk estimates of stroke or death within 30 days of treatment among patients younger than 70 years were 43 (5·1%) of 851 patients in the stenting group and 37 (4·5%) of 821 in the Endarterectomy group (1·11 [0·73-1·71]); in patients 70 years or older, the estimates were 87 (10·5%) of 828 patients and 36 (4·4%) of 824, respectively (2·41 [1·65-3·51]; categorical interaction p=0·0078, trend interaction p=0·0013]. INTERPRETATION: Stenting for symptomatic carotid stenosis should be avoided in older patients (age>=70 years), but might be as safe as Endarterectomy in younger patients. FUNDING: The Stroke Association.
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restenosis after carotid angioplasty stenting or Endarterectomy in the carotid and vertebral artery transluminal angioplasty study cavatas
Stroke, 2005Co-Authors: Dominick J H Mccabe, Andrew Clifton, Anthony Pereira, Martin Bland, Martin M BrownAbstract:Background and Purpose— Carotid and Vertebral Artery Transluminal Angioplasty Study (CAVATAS) patients with carotid stenosis were randomized between endovascular treatment and Endarterectomy. The rates of residual severe stenosis and restenosis and their contribution to recurrent symptoms was unclear. Methods— Endovascular patients were treated by balloon angioplasty alone (88%) or stenting (22%). Patches were used in 63% of Endarterectomy patients. Carotid stenosis was categorized as mild (0% to 49%), moderate (50% to 69%), severe (70% to 99%), or occluded, using standardized Doppler ultrasound criteria at the examination closest to 1 month (n=283) and 1 year (n=347) after treatment. Recurrent cerebrovascular symptoms during follow-up were analyzed. Results— More patients had ≥70% stenosis of the ipsilateral carotid artery 1 year after endovascular treatment than after Endarterectomy (18.5% versus 5.2%, P=0.0001). Residual severe stenosis was present in 6.5% of patients at 1 month after endovascular trea...
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long term risk of carotid restenosis in patients randomly assigned to endovascular treatment or Endarterectomy in the carotid and vertebral artery transluminal angioplasty study cavatas long term follow up of a randomised trial
Lancet Neurology, 2009Co-Authors: Leo H Bonati, Jorg Ederle, Joanna Dobson, Roland L Featherstone, Peter Gaines, Dominick J H Mccabe, J D Beard, Graham S Venables, Hugh S Markus, Andrew CliftonAbstract:Summary Background In the Carotid and Vertebral Artery Transluminal Angioplasty Study (CAVATAS), early recurrent carotid stenosis was more common in patients assigned to endovascular treatment than it was in patients assigned to Endarterectomy (CEA), raising concerns about the long-term effectiveness of endovascular treatment. We aimed to investigate the long-term risks of restenosis in patients included in CAVATAS. Methods 413 patients who were randomly assigned in CAVATAS and completed treatment for carotid stenosis (200 patients had endovascular treatment and 213 patients had Endarterectomy) had prospective clinical follow-up at a median of 5 years and carotid duplex ultrasound at a median of 4 years. We investigated the cumulative long-term incidence of carotid restenosis after endovascular treatment and Endarterectomy, the effect of the use of stents on restenosis after endovascular treatment, risk factors for the development of restenosis, and the effect of carotid restenosis on the risk of recurrent cerebrovascular events. Analysis was by intention to treat. This study is registered, number ISRCTN01425573. Findings Severe carotid restenosis (≥70%) or occlusion occurred significantly more often in patients in the endovascular arm than in patients in the Endarterectomy arm (adjusted hazard ratio [HR] 3·17, 95% CI 1·89–5·32; p vs 11%; HR 2·18, 1·04–4·54; p=0·04), but the increase in ipsilateral stroke alone was not significant (10% vs 5%; 1·67, 0·54–5·11). Interpretation Restenosis is about three times more common after endovascular treatment than after Endarterectomy and is associated with recurrent ipsilateral cerebrovascular symptoms; however, the risk of recurrent ipsilateral stroke is low. Further data are required from on-going trials of stenting versus Endarterectomy to ascertain whether long-term ultrasound follow-up is necessary after carotid revascularisation. Funding British Heart Foundation; UK National Health Service Management Executive; UK Stroke Association.
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restenosis after carotid angioplasty stenting or Endarterectomy in the carotid and vertebral artery transluminal angioplasty study cavatas
Stroke, 2005Co-Authors: Dominick J H Mccabe, Andrew Clifton, Anthony Pereira, Martin Bland, Martin M BrownAbstract:Background and Purpose— Carotid and Vertebral Artery Transluminal Angioplasty Study (CAVATAS) patients with carotid stenosis were randomized between endovascular treatment and Endarterectomy. The rates of residual severe stenosis and restenosis and their contribution to recurrent symptoms was unclear. Methods— Endovascular patients were treated by balloon angioplasty alone (88%) or stenting (22%). Patches were used in 63% of Endarterectomy patients. Carotid stenosis was categorized as mild (0% to 49%), moderate (50% to 69%), severe (70% to 99%), or occluded, using standardized Doppler ultrasound criteria at the examination closest to 1 month (n=283) and 1 year (n=347) after treatment. Recurrent cerebrovascular symptoms during follow-up were analyzed. Results— More patients had ≥70% stenosis of the ipsilateral carotid artery 1 year after endovascular treatment than after Endarterectomy (18.5% versus 5.2%, P=0.0001). Residual severe stenosis was present in 6.5% of patients at 1 month after endovascular trea...