Document Detail


Influence of a randomized clinical trial on practice by participating investigators: lessons from the Coronary Angioplasty Versus Excisional Atherectomy Trial (CAVEAT). CAVEAT I and II Investigators.
MedLine Citation:
PMID:  9462565     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
OBJECTIVES: We sought to determine whether the results of the first Coronary Angioplasty Versus Excisional Atherectomy Trial (CAVEAT-I) influenced subsequent practice patterns among the investigators. BACKGROUND: CAVEAT-I demonstrated that directional coronary atherectomy (DCA) resulted in higher rates of early complications at a higher cost and with no clinical benefit. We sought to determine whether these results influenced subsequent use of procedures among CAVEAT-I investigators. METHODS: We compared the results of a week-long registry of all coronary interventions performed at 35 CAVEAT-I sites in 1994 with those of a similar registry obtained in 1992 before the trial, the results of which were published in 1993. For control purposes, the use of procedures was studied at 24 additional sites to provide insight into practice at hospitals not participating in the trial. A total of 1,465 interventions were analyzed. RESULTS: Ninety-four percent of CAVEAT-I sites responded. Utilization rates differed between CAVEAT-I and CAVEAT-I follow-up (p < 0.001). Balloon angioplasty decreased from 83.8% to 68.5%, DCA increased slightly from 10.7% to 14.1%, and the use of other devices increased from 5.4% to 17.5%. Stand-alone balloon use was more prevalent at nonparticipating control sites than at sites that took part in CAVEAT-I (p < 0.001). CONCLUSIONS: Paradoxically, despite the negative findings of CAVEAT-I, there was a noteworthy trend toward an increase in the use of DCA and other devices at CAVEAT-I sites. Our findings suggest that among investigators in the trial, there may have been a lack of influence of trial data on clinical practice patterns 1 year after publication of the results. Ethics of protocol: Both CAVEAT I and II were approved by the Institutional Review Board at each study site.
Authors:
N A Omoigui; M J Silver; L A Rybicki; M Rosenthal; L G Berdan; K Pieper; S V King; R M Califf; E J Topol
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Publication Detail:
Type:  Clinical Trial; Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial    
Journal Detail:
Title:  Journal of the American College of Cardiology     Volume:  31     ISSN:  0735-1097     ISO Abbreviation:  J. Am. Coll. Cardiol.     Publication Date:  1998 Feb 
Date Detail:
Created Date:  1998-02-26     Completed Date:  1998-02-26     Revised Date:  2007-11-15    
Medline Journal Info:
Nlm Unique ID:  8301365     Medline TA:  J Am Coll Cardiol     Country:  UNITED STATES    
Other Details:
Languages:  eng     Pagination:  265-72     Citation Subset:  AIM; IM    
Affiliation:
Department of Medicine, University of South Carolina, Columbia 29203, USA. nowa@richmed.medpark.sc.edu
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MeSH Terms
Descriptor/Qualifier:
Adult
Aged
Aged, 80 and over
Analysis of Variance
Angioplasty, Transluminal, Percutaneous Coronary* / utilization
Atherectomy, Coronary* / adverse effects,  economics,  utilization
Chi-Square Distribution
Coronary Disease / surgery,  therapy
Coronary Vessels / pathology,  surgery
Costs and Cost Analysis
Female
Follow-Up Studies
Humans
Logistic Models
Male
Middle Aged
Physician's Practice Patterns*
Prevalence
Randomized Controlled Trials as Topic*
Registries
Retreatment
Saphenous Vein / transplantation
Sex Factors
Treatment Outcome
Comments/Corrections
Comment In:
J Am Coll Cardiol. 1998 Feb;31(2):273-4   [PMID:  9462566 ]

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


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