Document Detail


Carotid artery stenting with emboli protection surveillance study: outcomes at 1 year.
MedLine Citation:
PMID:  20620717     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
OBJECTIVES: The CASES-PMS (Carotid Artery Stenting With Emboli Protection Surveillance-Post-Marketing Study) multicenter, prospective, single-arm, surveillance study was designed to assess the safety and efficacy of carotid artery stenting (CAS) when performed by physicians with varied experience in CAS utilizing a formal training program. Whether the excellent results achieved at 30 days would be sustained to 1 year was the subject of the current investigation. BACKGROUND: Previously, the pivotal SAPPHIRE (Stenting and Angioplasty with Protection of Patients with High Risk for Endarterectomy) trial demonstrated that CAS was not inferior to carotid endarterectomy (CEA) when performed by physicians experienced in carotid stenting. METHODS: High surgical-risk patients with de novo atherosclerotic or post-endarterectomy restenotic lesions in native carotid arteries were enrolled at participating centers. Inclusion and exclusion criteria matched those of the SAPPHIRE trial. The primary end point was a composite of 30-day major adverse events (MAE) including death, any stroke, or myocardial infarction. RESULTS: A total of 1,492 patients were enrolled at 73 sites. The primary end point of 30-day MAE was 5.0%, meeting criteria for noninferiority to the prespecified objective performance criteria (OPC) established by the SAPPHIRE trial. The 1-year cumulative percentage of MAE was 12.5% by Kaplan-Meier analysis. All strokes to 30 days plus ipsilateral stroke between 31 and 360 days with CASES-PMS (5.4%) was similar to the rate seen with the SAPPHIRE trial stent cohort (4.9%). There were no significant differences in outcomes at 1 year by symptom status and high-risk status. CONCLUSIONS: With the formalized training program utilized in this study, physicians with varied experience in carotid stenting can achieve similar short- and longer-term results to the highly experienced SAPPHIRE Investigators. (Carotid Artery Stenting With Emboli Protection Surveillance-Post-Marketing Study [CASES-PMS]; NCT00231231).
Authors:
Theodore L Schreiber; Neil Strickman; Thomas Davis; Vinay Kumar; Greg Mishkel; Malcolm Foster; Dennis Donohoe; Suzanne Britto; Gary Ansel;
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Publication Detail:
Type:  Journal Article; Multicenter Study    
Journal Detail:
Title:  Journal of the American College of Cardiology     Volume:  56     ISSN:  1558-3597     ISO Abbreviation:  J. Am. Coll. Cardiol.     Publication Date:  2010 Jun 
Date Detail:
Created Date:  2010-07-12     Completed Date:  2010-08-06     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  8301365     Medline TA:  J Am Coll Cardiol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  49-57     Citation Subset:  AIM; IM    
Copyright Information:
Copyright (c) 2010 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
Affiliation:
Harper University Hospital, Detroit, Michigan, USA. tschreib@dmc.org
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT00231231
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MeSH Terms
Descriptor/Qualifier:
Aged
Aged, 80 and over
Carotid Arteries*
Carotid Artery Diseases / prevention & control*
Carotid Stenosis / therapy
Clinical Competence
Embolism / prevention & control*
Endarterectomy, Carotid
Female
Humans
Male
Outcome and Process Assessment (Health Care)
Product Surveillance, Postmarketing
Prospective Studies
Stents*
Treatment Outcome

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


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