Document Detail

Influence of sex on outcomes of stenting versus endarterectomy: a subgroup analysis of the Carotid Revascularization Endarterectomy versus Stenting Trial (CREST).
MedLine Citation:
PMID:  21550314     Owner:  NLM     Status:  MEDLINE    
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, 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).
Virginia J Howard; Helmi L Lutsep; Ariane Mackey; Bart M Demaerschalk; Albert D Sam; Nicole R Gonzales; Alice J Sheffet; Jenifer H Voeks; James F Meschia; Thomas G Brott;
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Publication Detail:
Type:  Journal Article; Randomized Controlled Trial; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't     Date:  2011-05-05
Journal Detail:
Title:  The Lancet. Neurology     Volume:  10     ISSN:  1474-4465     ISO Abbreviation:  Lancet Neurol     Publication Date:  2011 Jun 
Date Detail:
Created Date:  2011-05-23     Completed Date:  2011-07-22     Revised Date:  2014-09-20    
Medline Journal Info:
Nlm Unique ID:  101139309     Medline TA:  Lancet Neurol     Country:  England    
Other Details:
Languages:  eng     Pagination:  530-7     Citation Subset:  IM    
Copyright Information:
Copyright © 2011 Elsevier Ltd. All rights reserved.
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MeSH Terms
Brain Ischemia / surgery
Carotid Stenosis / surgery*
Clinical Trials as Topic*
Endarterectomy, Carotid* / adverse effects,  utilization
Kaplan-Meier Estimate
Middle Aged
Myocardial Infarction / etiology
Risk Factors
Sex Factors
Stents* / adverse effects,  utilization
Stroke / etiology
Treatment Outcome
Grant Support
Comment In:
Lancet Neurol. 2011 Jun;10(6):494-7   [PMID:  21550315 ]

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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