Background It is unclear whether achieving multiple risk factor (RF) goals through protocol-guided intensive medical therapy is feasible or improves outcomes in type 2 diabetes mellitus. Objectives This study sought to quantify the relationship between achieved RF goals in the BARI 2D (Bypass Angioplasty Investigation Revascularization 2 Diabetes) trial and cardiovascular events/survival. Methods We performed a nonrandomized analysis of survival/cardiovascular events and control of 6 RFs (no smoking, non-high-density lipoprotein cholesterol <130 mg/dl, triglycerides <150 mg/dl, blood pressure [systolic <130 mm Hg; diastolic <80 mm Hg], glycosylated hemoglobin <7%) in BARI 2D. Cox models with time-varying number of RFs in control were adjusted for baseline number of RFs in control, clinical characteristics, and trial randomization assignments. Results In 2,265 patients (mean age 62 years, 29% women) followed up for 5 years, the mean ± SD number of RFs in control improved from 3.5 ± 1.4 at baseline to 4.2 ± 1.3 at 5 years (p < 0.0001). The number of RFs in control during the trial was strongly related to death (global p = 0.0010) and the composite of death, myocardial infarction, and stroke (global p = 0.0035) in fully adjusted models. Participants with 0 to 2 RFs in control during follow-up had a 2-fold higher risk of death (hazard ratio: 2.0; 95% confidence interval: 1.3 to 3.3; p = 0.0031) and a 1.7-fold higher risk of the composite endpoint (hazard ratio: 1.7; 95% confidence interval: 1.2 to 2.5; p = 0.0043), compared with those with 6 RFs in control. Conclusions Simultaneous control of multiple RFs through protocol-guided intensive medical therapy is feasible and relates to cardiovascular morbidity and mortality in patients with coronary disease and type 2 diabetes mellitus.
Bibliographical noteFunding Information:
The BARI 2D (Bypass Angioplasty Revascularization Investigation 2 Diabetes) trial was funded by the National Heart, Lung, and Blood Institute and the National Institute of Diabetes and Digestive and Kidney Diseases ( U01 HL061744 , U01 HL061746 , U01 HL061748 , U01 HL063804 , and R21 HL121495 ). BARI 2D received significant supplemental funding provided by: GlaxoSmithKline, Lantheus Medical Imaging Inc. (formerly Bristol-Myers Squibb Medical Imaging Inc.), Astellas Pharma US Inc., Merck & Co., Inc., Abbott Laboratories Inc., and Pfizer Inc. Generous support was given by Abbott Laboratories Ltd., MediSense Products, Bayer Diagnostics, Becton, Dickinson and Company, J.R. Carlson Labs, Centocor Inc., Eli Lilly and Company, LipoScience Inc., Merck Sante, Novartis Pharmaceuticals Corporation, and Novo Nordisk Inc. Dr. Bittner has received research support from the National Institutes of Health, Amgen, Bayer Healthcare, Janssen Pharmaceuticals, Pfizer, and Sanofi; and has served on advisory panels for Amgen and Eli Lilly. Dr. Farkouh has received research support from Amgen, Boston Scientific, Bristol-Myers Squibb, Cordis, Eli Lilly, and Sanofi. Dr. Rutter has received grant support from GlaxoSmithKline, Eli Lilly and Company, and Novo Nordisk. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
© 2015 American College of Cardiology Foundation.
- blood pressure
- coronary heart disease
- diabetes mellitus
- glycosylated hemoglobin A