Document Detail


Percutaneous coronary intervention versus coronary bypass surgery in United States veterans with diabetes.
MedLine Citation:
PMID:  23428214     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
OBJECTIVES: This study sought to determine the optimal coronary revascularization strategy in patients with diabetes with severe coronary disease.
BACKGROUND: Although subgroup analyses from large trials, databases, and meta-analyses have found better survival for patients with diabetes with complex coronary artery disease when treated with surgery, a randomized trial comparing interventions exclusively with drug-eluting stents and surgery in patients with diabetes with high-risk coronary artery disease has not yet been reported.
METHODS: In a prospective, multicenter study, 198 eligible patients with diabetes with severe coronary artery disease were randomly assigned to either coronary artery bypass grafting (CABG) (n = 97) or percutaneous coronary intervention (PCI) with drug-eluting stents (n = 101) and followed for at least 2 years. The primary outcome measure was a composite of nonfatal myocardial infarction or death. Secondary outcome measures included all-cause mortality, cardiac mortality, nonfatal myocardial infarction, and stroke.
RESULTS: The study was stopped because of slow recruitment after enrolling only 25% of the intended sample size, leaving it severely underpowered for the primary composite endpoint of death plus nonfatal myocardial infarction (hazard ratio: 0.89; 95% confidence interval: 0.47 to 1.71). However, after a mean follow-up period of 2 years, all-cause mortality was 5.0% for CABG and 21% for PCI (hazard ratio: 0.30; 95% confidence interval: 0.11 to 0.80), while the risk for nonfatal myocardial infarction was 15% for CABG and 6.2% for PCI (hazard ratio: 3.32; 95% confidence interval: 1.07 to 10.30).
CONCLUSIONS: This study was severely underpowered for its primary endpoint, and therefore no firm conclusions about the comparative effectiveness of CABG and PCI are possible. There were interesting differences in the components of the primary endpoint. However, the confidence intervals are very large, and the findings must be viewed as hypothesis generating only. (Coronary Artery Revascularization in Diabetes; NCT00326196).
Authors:
Masoor Kamalesh; Thomas G Sharp; X Charlene Tang; Kendrick Shunk; Herbert B Ward; James Walsh; Spencer King; Cindy Colling; Thomas Moritz; Kevin Stroupe; Domenic Reda;
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Publication Detail:
Type:  Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, U.S. Gov't, Non-P.H.S.    
Journal Detail:
Title:  Journal of the American College of Cardiology     Volume:  61     ISSN:  1558-3597     ISO Abbreviation:  J. Am. Coll. Cardiol.     Publication Date:  2013 Feb 
Date Detail:
Created Date:  2013-02-22     Completed Date:  2013-05-24     Revised Date:  2013-08-06    
Medline Journal Info:
Nlm Unique ID:  8301365     Medline TA:  J Am Coll Cardiol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  808-16     Citation Subset:  AIM; IM    
Copyright Information:
Copyright © 2013 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
Affiliation:
Roudebush VA Medical Center, Indiana University School of Medicine, Indianapolis, Indiana 46202, USA. mkamales@iupui.edu
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT00326196
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MeSH Terms
Descriptor/Qualifier:
Aged
Angioplasty, Balloon, Coronary* / adverse effects,  methods,  mortality
Comparative Effectiveness Research
Coronary Artery Bypass* / adverse effects,  methods,  mortality
Coronary Artery Disease* / complications,  diagnosis,  physiopathology,  therapy
Diabetes Mellitus, Type 2* / blood,  complications,  diagnosis
Drug-Eluting Stents
Early Termination of Clinical Trials
Female
Humans
Male
Middle Aged
Mortality
Myocardial Infarction* / epidemiology,  etiology
Postoperative Complications / epidemiology*
Postoperative Period
Stroke* / epidemiology,  etiology
Survival Analysis
United States
United States Department of Veterans Affairs
Comments/Corrections
Comment In:
J Am Coll Cardiol. 2013 Feb 26;61(8):817-9   [PMID:  23428215 ]
J Am Coll Cardiol. 2013 Jun 18;61(24):2492-3   [PMID:  23542098 ]
J Am Coll Cardiol. 2013 Jun 18;61(24):2492   [PMID:  23542099 ]

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