Document Detail


Influence of site and operator characteristics on carotid artery stent outcomes: analysis of the CAPTURE 2 (Carotid ACCULINK/ACCUNET Post Approval Trial to Uncover Rare Events) clinical study.
MedLine Citation:
PMID:  21349464     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
OBJECTIVES: The aim of this study was to analyze the CAPTURE 2 (Carotid ACCULINK/ACCUNET Post Approval Trial to Uncover Rare Events) study for physician- or site-related variables associated with differential outcomes for carotid artery stenting (CAS).
BACKGROUND: The CAPTURE 2 trial is an ongoing, prospective, nonrandomized, independently adjudicated, multicenter clinical study enrolling high-surgical-risk patients undergoing CAS.
METHODS: In this assessment of the CAPTURE 2 study, the American Heart Association carotid endarterectomy guideline limits were used to define acceptable site and physician CAS outcomes; therefore, the resulting population of nonoctogenarian, asymptomatic subjects in this analysis is confined to 3,388 (of the total 5,297) subjects treated at 180 U.S. hospitals by 459 operators between March 2006 and January 2009.
RESULTS: The rates of death, stroke, and myocardial infarction and death and stroke (DS) at 30 days were 3.5% and 3.3%, respectively, for the full CAPTURE 2 study cohort and 2.9% and 2.7%, respectively, for the asymptomatic, nonoctogenarian subgroup. In this subgroup, two-thirds of sites (118 of 180, 66%) had no DS events. Within the remaining sites, an inverse relationship between event rates and hospital patient volume as well as between event rates and individual operator volume was observed. The DS rates trended lower for interventional cardiologists compared with other specialties.
CONCLUSIONS: Outcomes from the largest prospectively gathered, independently adjudicated, multicenter CAS study indicate that CAS can be safely performed in a variety of hospital settings by physicians with various specialties. The most important determinant of perioperative CAS outcomes was both site and operator CAS volume. A threshold of 72 cases was found to be necessary for consistently achieving a DS rate below 3% in this later-phase single arm study; background era and non-study operator experience will affect this determination. (Second Phase of "Carotid RX ACCULINK/RX ACCUNET Post-Approval Trial to Uncover Unanticipated or Rare Events"; NCT00302237).
Authors:
William A Gray; Kenneth A Rosenfield; Michael R Jaff; Seemant Chaturvedi; Lei Peng; Patrick Verta;
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Publication Detail:
Type:  Journal Article; Multicenter Study    
Journal Detail:
Title:  JACC. Cardiovascular interventions     Volume:  4     ISSN:  1876-7605     ISO Abbreviation:  JACC Cardiovasc Interv     Publication Date:  2011 Feb 
Date Detail:
Created Date:  2011-02-25     Completed Date:  2011-06-28     Revised Date:  2012-08-29    
Medline Journal Info:
Nlm Unique ID:  101467004     Medline TA:  JACC Cardiovasc Interv     Country:  United States    
Other Details:
Languages:  eng     Pagination:  235-46     Citation Subset:  IM    
Copyright Information:
Copyright © 2011 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
Affiliation:
Department of Medicine, Center for Interventional Vascular Therapy, Columbia University, New York, New York 10032, USA. wg2131@columbia.edu
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT00302237
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MeSH Terms
Descriptor/Qualifier:
Adult
Aged
Aged, 80 and over
Angioplasty / adverse effects,  instrumentation*,  mortality
Carotid Artery Diseases / complications,  mortality,  therapy*
Clinical Competence* / statistics & numerical data
Device Approval
Female
Hospitals* / statistics & numerical data
Humans
Linear Models
Male
Middle Aged
Myocardial Infarction / etiology
Product Surveillance, Postmarketing
Prospective Studies
Risk Assessment
Risk Factors
Stents*
Stroke / etiology
Time Factors
Treatment Outcome
United States

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


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