Health status after treatment for coronary artery disease and type 2 diabetes mellitus in the Bypass Angioplasty Revascularization Investigation 2 Diabetes trial.

Health status after treatment for coronary artery disease and type 2 diabetes mellitus in the Bypass Angioplasty Revascularization Investigation 2 Diabetes trial.

MedLine Citation:	PMID: 20937978 Owner: NLM Status: MEDLINE
Abstract/OtherAbstract:	BACKGROUND: Health status is a key outcome for comparing treatments, particularly when mortality does not differ significantly. METHODS AND RESULTS: Bypass Angioplasty Revascularization Investigation 2 Diabetes (BARI 2D) randomized 2368 patients with type 2 diabetes mellitus and stable ischemic heart disease to (1) prompt revascularization versus medical therapy and (2) insulin sensitization versus insulin provision. Randomization was stratified by the intended method of revascularization, coronary artery bypass graft surgery or percutaneous coronary intervention. The Duke Activity Status Index and RAND Energy, Health Distress, and Self-Rated Health scales were assessed at study entry and annually thereafter; linear mixed models were used to evaluate the effect of randomized treatment on these measures. Health status improved significantly from baseline to 1 year (P<0.001) in each randomized treatment group. Compared with medical therapy, prompt revascularization was associated with significantly greater improvements in Duke Activity Status Index (1.32 points; P<0.001), Energy (1.36 points; P=0.02), and Self-rated Health (1.77 points; P=0.007) but not Health Distress (-0.47; P=0.46). These treatment effects were largely maintained over 4 years of follow-up. The effect of revascularization on the Duke Activity Status Index was significantly larger in the subgroup of patients intended for coronary artery bypass graft surgery compared with the subgroup intended for percutaneous coronary intervention. Health status did not differ significantly on any of the 4 measures between the insulin provision and insulin sensitization strategies. CONCLUSIONS: Prompt coronary revascularization was associated with small yet statistically significant improvements in health status compared with initial medical therapy among patients with diabetes mellitus and stable ischemic heart disease. CLINICAL TRIAL REGISTRATION: http://www.clinicaltrials.gov. Unique identifier: NCT00006305.

Authors:	Maria Mori Brooks; Sheng-Chia Chung; Tarek Helmy; William B Hillegass; Jorge Escobedo; Kathryn A Melsop; Elaine M Massaro; Robert D McBane; Pamela Hyde; Mark A Hlatky;
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Publication Detail:	Type: Journal Article; Randomized Controlled Trial; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't Date: 2010-10-11
Journal Detail:	Title: Circulation Volume: 122 ISSN: 1524-4539 ISO Abbreviation: Circulation Publication Date: 2010 Oct
Date Detail:	Created Date: 2010-10-26 Completed Date: 2010-11-16 Revised Date: 2011-10-26
Medline Journal Info:	Nlm Unique ID: 0147763 Medline TA: Circulation Country: United States
Other Details:	Languages: eng Pagination: 1690-9 Citation Subset: AIM; IM
Affiliation:	Department of Epidemiology, University of Pittsburgh, GSPH, 130 DeSoto St, Pittsburgh, PA 15261, USA. mbrooks@pitt.edu
Data Bank Information
Bank Name/Acc. No.:	ClinicalTrials.gov/NCT00006305
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MeSH Terms
Descriptor/Qualifier:	Angioplasty, Balloon, Coronary* Comorbidity Coronary Artery Bypass* Coronary Artery Disease / epidemiology, therapy* Diabetes Mellitus, Type 2 / blood, drug therapy, epidemiology Follow-Up Studies Health Status Health Surveys Hemoglobin A, Glycosylated / metabolism Humans Hypoglycemic Agents* / therapeutic use Multivariate Analysis Quality of Life Severity of Illness Index
Grant Support
ID/Acronym/Agency:	U01 HL061744/HL/NHLBI NIH HHS; U01 HL061746/HL/NHLBI NIH HHS; U01 HL061748/HL/NHLBI NIH HHS; U01 HL063804/HL/NHLBI NIH HHS
Chemical
Reg. No./Substance:	0/Hemoglobin A, Glycosylated; 0/Hypoglycemic Agents
Comments/Corrections
Comment In:	Circulation. 2010 Oct 26;122(17):1664-6 [PMID: 20937972 ]

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