Comprehensive Cardiovascular Risk Factor Control Improves Survival: The BARI 2D Trial.
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.


OBJECTIVE
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. (Bypass Angioplasty Revascularization Investigation in Type 2 Diabetes [BARI 2D]; NCT00006305).
Division of Cardiovascular Disease, Department of Medicine, University of Alabama at Birmingham, Birmingham, Alabama. Electronic address: vbittner@uab.edu.
Vera
V
Bittner
Department of Epidemiology, Graduate School of Public Health, University of Pittsburgh, Pittsburgh, Pennsylvania.
Marnie
M
Bertolet
Mexican Institute of Social Security, Mexico City, Mexico.
Rafael
R
Barraza Felix
Mount Sinai School of Medicine, New York, New York.
Michael E
ME
Farkouh
National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Maryland.
Suzanne
S
Goldberg
VA Medical Center Memphis, Memphis, Tennessee.
Kodangudi B
KB
Ramanathan
Department of Medicine and Urologic Surgery, University of Minnesota, Minneapolis, Minnesota.
J Bruce
JB
Redmon
Emory University, Atlanta, Georgia.
Laurence
L
Sperling
The Endocrinology and Diabetes Research Group, Institute of Human Development, Faculty of Medical and Human Sciences, University of Manchester, Manchester, United Kingdom; Manchester Diabetes Centre, Central Manchester University Hospitals NHS Foundation Trust, Manchester Academic Health Science Centre, Manchester, United Kingdom.
Martin K
MK
Rutter
D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000401:mortality* / Q000639:trends; D002318:Cardiovascular Diseases / Q000175:diagnosis / Q000401:mortality* / Q000628:therapy*; D001026:Coronary Artery Bypass / Q000401:mortality* / Q000639:trends; D003924:Diabetes Mellitus, Type 2 / Q000175:diagnosis / Q000401:mortality* / Q000628:therapy*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D012307:Risk Factors; D015996:Survival Rate / Q000639:trends
blood pressure; cholesterol; coronary heart disease; diabetes mellitus; glycosylated hemoglobin A; smoking