Document Detail


Carotid revascularization using endarterectomy or stenting systems (CaRESS): 4-year outcomes.
MedLine Citation:
PMID:  19702339     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
PURPOSE: To examine the 4-year outcomes from Carotid Revascularization using Endarterectomy or Stenting Systems (CaRESS) in light of the current reimbursement guidelines for carotid artery stenting (CAS) from the Centers for Medicare and Medicaid Services (CMS). METHODS:CaRESS was designed as a prospective, nonrandomized comparative cohort study of a broad-risk population of symptomatic and asymptomatic patients with carotid stenosis. In all, 397 patients (247 men; mean age 71 years, range 43-89) were enrolled and underwent carotid endarterectomy (CEA; n = 254) or protected CAS (n = 143). More than 90% of patients had >75% stenosis; two thirds were asymptomatic. The primary endpoints included (1) all-cause mortality, (2) any stroke, and (3) myocardial infarction (MI), as well as the composite endpoints of (4) death and any nonfatal stroke and (5) death, nonfatal stroke, and MI. The secondary endpoints were restenosis, repeat angiography, and carotid revascularization. All patients were classified with respect to surgical risk, symptom status, and stenosis grade based on criteria published by the CMS. In addition, separate analyses were performed comparing genders and octogenarians to those <80 years old. RESULTS:No significant differences in the primary outcome measures were found between the CEA and CAS groups in the 4-year analysis. The incidences of any stroke at 4 years were 9.6% for CEA and 8.6% for CAS (p = 0.444); when combined with death, the composite death/nonfatal stroke rates were 26.5% for CEA versus 21.8% for CAS (p = 0.361). The composite endpoint of death, nonfatal stroke, and MI at 4 years was 27.0% in CEA versus 21.7% in CAS (p = 0.273) patients. The secondary endpoints of restenosis (p = 0.014) and repeat angiography (p = 0.052) were higher in the CAS arm. There were no differences in any of the subgroups stratified according the CMS guidelines or in the gender comparison. Four-year incidences of death/nonfatal stroke and death/nonfatal stroke/MI were higher in the CEA arm among patients <80 years of age (p = 0.049 and p = 0.030, respectively). There were no significant differences between these incidences in the octogenarian subgroup. CONCLUSION:The risk of death or nonfatal stroke 4 years following CAS with distal protection is equivalent to CEA in a broad category of patients with carotid stenosis. There were no significant differences in stroke or mortality rates between high-risk and non-high-risk patients and no differences in outcomes between symptomatic and asymptomatic patients. After 4 years, CAS had a 2-fold higher restenosis rate compared to CEA. The risk of death/stroke or death/stroke/MI appears to be higher following CEA than CAS among patients <80 years of age, yet there is no statistically significant relationship between death, stroke, or MI among octogenarians.
Authors:
Christopher K Zarins; Rodney A White; Edward B Diethrich; Rebecca J Shackelton; Flora S Siami;
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Publication Detail:
Type:  Clinical Trial; Comparative Study; Journal Article; Multicenter Study; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Journal of endovascular therapy : an official journal of the International Society of Endovascular Specialists     Volume:  16     ISSN:  1545-1550     ISO Abbreviation:  J. Endovasc. Ther.     Publication Date:  2009 Aug 
Date Detail:
Created Date:  2009-08-25     Completed Date:  2009-11-02     Revised Date:  2010-04-29    
Medline Journal Info:
Nlm Unique ID:  100896915     Medline TA:  J Endovasc Ther     Country:  United States    
Other Details:
Languages:  eng     Pagination:  397-409     Citation Subset:  IM    
Affiliation:
Stanford University, Stanford, Torrance, California, USA.
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MeSH Terms
Descriptor/Qualifier:
Adult
Age Factors
Aged
Aged, 80 and over
Angioplasty / adverse effects,  instrumentation*,  mortality
Carotid Stenosis / mortality,  radiography,  surgery,  therapy*
Centers for Medicare and Medicaid Services (U.S.)
Endarterectomy, Carotid* / adverse effects,  mortality
Female
Humans
Kaplan-Meiers Estimate
Male
Middle Aged
Myocardial Infarction / etiology
Patient Selection
Practice Guidelines as Topic
Proportional Hazards Models
Prospective Studies
Recurrence
Risk Assessment
Risk Factors
Severity of Illness Index
Sex Factors
Stents*
Stroke / etiology
Time Factors
Treatment Outcome
United States
Investigator
Investigator/Affiliation:
Edward B Diethrich / ; Lawrence Wechsler / ; Carlo Dall'Olmo / ; Subbarao Myla / ; Lowell Satler / ; Louis N Hopkins / ; Carl Jacobs / ; Daniel McCormick / ; J Michael Bacharach / ; Sriram Iyer / ; Mark Langsfeld / ; Barry Katzen / ; Zvonimir Krajcer /
Comments/Corrections
Comment In:
J Endovasc Ther. 2010 Apr;17(2):271-2   [PMID:  20426655 ]
J Endovasc Ther. 2009 Dec;16(6):755; author reply 755-7   [PMID:  19995124 ]

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


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