Document Detail


Results of carotid artery stenting with distal embolic protection with improved systems: Protected Carotid Artery Stenting in Patients at High Risk for Carotid Endarterectomy (PROTECT) trial.
MedLine Citation:
PMID:  22236885     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
OBJECTIVE: The Protected Carotid Artery Stenting in Patients at High Risk for Carotid Endarterectomy (PROTECT) study was performed to evaluate the safety and effectiveness of two devices for carotid artery stenting (CAS) in the treatment of carotid artery stenosis in patients at high risk for carotid endarterectomy (CEA): (1) a new embolic protection device, the Emboshield Pro (Abbott Vascular, Abbott Park, Ill), using the periprocedural composite end point of 30-day death, stroke, and myocardial infarction (DSMI), and (2) a carotid stent in conjunction with an embolic protection device (EPD) using the DSMI periprocedural composite end point plus ipsilateral stroke at up to 3 years for long-term evaluation.
METHODS: This prospective, multicenter clinical trial enrolled 220 consecutive participants between November 29, 2006, and January 14, 2008, followed by a second cohort of 102 participants between January 14 and June 18, 2008. Enrolled participants had carotid stenosis (symptomatic >50% or asymptomatic >80%). The first 220 subjects underwent distal EPD placement with a new large-diameter filter, and the second cohort of 102 underwent placement of an older EPD that is no longer manufactured. All 322 participants were to be treated with a dedicated carotid stent with a tapered, small, closed-cell design (Xact; Abbott Vascular) and were to be included in the long-term evaluation. Independent neurologic assessment was performed before CAS and at 1 day, 30 days, and annually after CAS. All primary end point events were independently adjudicated by a central committee.
RESULTS: The periprocedural composite end point of DSMI (95% confidence interval) in the first 220 participants was 2.3% (0.74%, 5.22%), with a combined death and stroke rate of 1.8% (0.50%, 4.59%) and a rate of death and major stroke of 0.5% (0.01%, 2.51%). As of January 3, 2011, the median follow-up for the entire 322-subject cohort for the long-term evaluation was 2.8 years. Freedom from the periprocedural composite of DSMI plus ipsilateral stroke thereafter was 95.4%, with an annualized ipsilateral stroke rate of 0.4%.
CONCLUSIONS: CAS outcomes in patients at high risk for CEA have improved from earlier carotid stent trials. With periprocedural rates of DSMI of 2.3%, death or stroke at 1.8%, and death or major stroke rate of 0.5%, PROTECT has the lowest rate of periprocedural complications among other comparable single-arm CAS trials in patients at high risk for CEA.
Authors:
Jon S Matsumura; William Gray; Seemant Chaturvedi; Dai Yamanouchi; Lei Peng; Patrick Verta
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Publication Detail:
Type:  Clinical Trial; Comparative Study; Journal Article; Multicenter Study     Date:  2012-01-09
Journal Detail:
Title:  Journal of vascular surgery     Volume:  55     ISSN:  1097-6809     ISO Abbreviation:  J. Vasc. Surg.     Publication Date:  2012 Apr 
Date Detail:
Created Date:  2012-04-02     Completed Date:  2012-05-30     Revised Date:  2012-10-03    
Medline Journal Info:
Nlm Unique ID:  8407742     Medline TA:  J Vasc Surg     Country:  United States    
Other Details:
Languages:  eng     Pagination:  968-976.e5     Citation Subset:  IM    
Copyright Information:
Copyright © 2012 Society for Vascular Surgery. Published by Mosby, Inc. All rights reserved.
Affiliation:
Division of Vascular Surgery, University of Wisconsin, School of Medicine, Public Health, G5/325 Clinical Science Center, 600 Highland Ave, Madison, WI 53792, USA. matsumura@surgery.wisc.edu
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MeSH Terms
Descriptor/Qualifier:
Aged
Aged, 80 and over
Angioplasty / methods*,  mortality
Carotid Stenosis / mortality*,  radiography,  surgery,  therapy*
Cause of Death
Embolic Protection Devices / utilization*
Endarterectomy, Carotid / methods,  mortality
Female
Follow-Up Studies
Hospital Mortality
Humans
Male
Patient Selection
Prospective Studies
Risk Assessment
Stents
Survival Rate
Thromboembolism / prevention & control*
Treatment Outcome
Comments/Corrections
Comment In:
J Vasc Surg. 2012 Apr;55(4):977   [PMID:  22464459 ]

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


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