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"Meschia, James F"
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Long-Term Results of Stenting versus Endarterectomy for Carotid-Artery Stenosis
2016
In this long-term follow-up of a randomized trial comparing endarterectomy with stenting for carotid-artery stenosis, the risks of periprocedural stroke, myocardial infarction, or death and subsequent ipsilateral stroke did not differ between groups over a 10-year period.
We previously reported the outcomes up to 4 years in the Carotid Revascularization Endarterectomy versus Stenting Trial (CREST).
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No significant difference was shown between patients assigned to stenting and those assigned to endarterectomy with respect to the composite primary end point of periprocedural stroke, myocardial infarction, or death and subsequent ipsilateral stroke. At baseline, the mean age of the patients was 69 years, and at that age the average life expectancy is 15 years for men and 17 years for women.
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As such, long-term treatment differences should be central to treatment decisions. We now report whether the outcomes after stenting . . .
Journal Article
Restenosis after carotid artery stenting and endarterectomy: a secondary analysis of CREST, a randomised controlled trial
2012
In the Carotid Revascularization Endarterectomy versus Stenting Trial (CREST), the composite primary endpoint of stroke, myocardial infarction, or death during the periprocedural period or ipsilateral stroke thereafter did not differ between carotid artery stenting and carotid endarterectomy for symptomatic or asymptomatic carotid stenosis. A secondary aim of this randomised trial was to compare the composite endpoint of restenosis or occlusion.
Patients with stenosis of the carotid artery who were asymptomatic or had had a transient ischaemic attack, amaurosis fugax, or a minor stroke were eligible for CREST and were enrolled at 117 clinical centres in the USA and Canada between Dec 21, 2000, and July 18, 2008. In this secondary analysis, the main endpoint was a composite of restenosis or occlusion at 2 years. Restenosis and occlusion were assessed by duplex ultrasonography at 1, 6, 12, 24, and 48 months and were defined as a reduction in diameter of the target artery of at least 70%, diagnosed by a peak systolic velocity of at least 3·0 m/s. Studies were done in CREST-certified laboratories and interpreted at the Ultrasound Core Laboratory (University of Washington). The frequency of restenosis was calculated by Kaplan-Meier survival estimates and was compared during a 2-year follow-up period. We used proportional hazards models to assess the association between baseline characteristics and risk of restenosis. Analyses were per protocol. CREST is registered with ClinicalTrials.gov, number NCT00004732.
2191 patients received their assigned treatment within 30 days of randomisation and had eligible ultrasonography (1086 who had carotid artery stenting, 1105 who had carotid endarterectomy). In 2 years, 58 patients who underwent carotid artery stenting (Kaplan-Meier rate 6·0%) and 62 who had carotid endarterectomy (6·3%) had restenosis or occlusion (hazard ratio [HR] 0·90, 95% CI 0·63–1·29; p=0·58). Female sex (1·79, 1·25–2·56), diabetes (2·31, 1·61–3·31), and dyslipidaemia (2·07, 1·01–4·26) were independent predictors of restenosis or occlusion after the two procedures. Smoking predicted an increased rate of restenosis after carotid endarterectomy (2·26, 1·34–3·77) but not after carotid artery stenting (0·77, 0·41–1·42).
Restenosis and occlusion were infrequent and rates were similar up to 2 years after carotid endarterectomy and carotid artery stenting. Subsets of patients could benefit from early and frequent monitoring after revascularisation.
National Institute of Neurological Disorders and Stroke and Abbott Vascular Solutions.
Journal Article
Stenting versus Endarterectomy for Treatment of Carotid-Artery Stenosis
2010
In this randomized comparison of stenting and endarterectomy as treatment for carotid-artery stenosis, there was no significant difference in the rate of the composite primary end point of stroke, myocardial infarction, or death (7.2% and 6.8%, respectively; P=0.51). Stroke was more common with carotid-artery stenting than carotid endarterectomy; myocardial infarction was more common with carotid endarterectomy. The 4-year rate of stroke or death was 6.4% for carotid-artery stenting and 4.7% for carotid endarterectomy (P=0.03).
In this randomized comparison of stenting and endarterectomy as treatment for carotid-artery stenosis, there was no significant difference in the rate of the composite primary end point of stroke, myocardial infarction, or death (7.2% and 6.8%, respectively).
Carotid-artery atherosclerosis is an important cause of ischemic stroke.
1
Carotid endarterectomy has been established as effective treatment for both symptomatic patients and asymptomatic patients.
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Carotid-artery stenting is another option for treatment. The results of randomized trials comparing carotid-artery stenting and carotid endarterectomy for use in symptomatic patients are conflicting.
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The primary aim of the Carotid Revascularization Endarterectomy vs. Stenting Trial (CREST) was to compare the outcomes of carotid-artery stenting with those of carotid endarterectomy among patients with symptomatic or asymptomatic extracranial carotid stenosis.
Methods
Study Design
CREST is a randomized, controlled trial with blinded end-point adjudication. Ethics review . . .
Journal Article
Influence of sex on outcomes of stenting versus endarterectomy: a subgroup analysis of the Carotid Revascularization Endarterectomy versus Stenting Trial (CREST)
2011
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.
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.
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).
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.
National Institute of Neurological Disorders and Stroke and Abbott Vascular Solutions (formerly Guidant).
Journal Article
Mesenchymal stem cells for hemorrhagic stroke: status of preclinical and clinical research
2019
SummarySignificant progress has been made during the past few decades in stem cell therapy research for various diseases and injury states; however this has not been overwhelmingly translated into approved therapies, despite much public attention and the rise in unregulated ‘regenerative clinics’. In the last decade, preclinical research focusing on mesenchymal stem/stromal cell (MSC) therapy in experimental animal models of hemorrhagic stroke has gained momentum and has led to the development of a small number of human trials. Here we review the current studies focusing on MSC therapy for hemorrhagic stroke in an effort to summarize the status of preclinical and clinical research. Preliminary evidence indicates that MSCs are both safe and tolerable in patients, however future randomized controlled trials are required to translate the promising preclinical research into an effective therapy for hopeful patients.
Journal Article
High-Sensitivity C-Reactive Protein and Risk of Stroke in Atrial Fibrillation (from the Reasons for Geographic and Racial Differences in Stroke Study)
2016
The relation between inflammation and prothrombotic state in atrial fibrillation (AF) is well recognized. This suggests a potential role for high-sensitivity C-reactive protein (hs-CRP), a marker of systemic inflammation, in improving prediction of stroke in participants with AF. Cox proportional hazard analysis was used to examine the risk of stroke in 25,841 participants (40% black and 55% women) with and without AF who were enrolled in the Reasons for Geographic and Racial Differences in Stroke study from 2003 to 2007. Baseline AF (n = 2,132) was ascertained by electrocardiogram and self-reported history of previous physician diagnosis. Stroke events were identified and adjudicated during 8.3 years of follow-up. A total of 655 incident strokes occurred during follow-up. In a model adjusted for sociodemographics, traditional stroke risk factors, and use of aspirin and warfarin, higher levels of hs-CRP were associated with increased overall stroke risk (hazard ratio [HR] 1.30, 95% confidence interval [CI] 1.10 to 1.54, and HR 1.06, 95% CI 1.01 to 1.12 for hs-CRP >3 mg/L and per 1-SD increase, respectively). Higher levels of hs-CRP continued to be associated with incident stroke in participants without AF (HR 1.31, 95% CI 1.09 to 1.57, and HR 1.06, 95% CI 1.01 to 1.12 for hs-CRP >3 mg/L and per 1-SD increase, respectively) but not in those with AF (HR 1.22, 95% CI 0.78 to 1.91, and HR 1.01, 95% CI 0.82 to 1.23 for hs-CRP >3 mg/L and per 1-SD increase, respectively). In conclusion, although hs-CRP was significantly associated with stroke risk in this population, it seems to be limited to those without AF. These findings suggest a limited value of hs-CRP in improving stroke risk stratification in subjects with AF.
Journal Article