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Cardiovascular Risk Factor Control Improves Survival
Study Questions:
What is the relationship between achieved risk factor goals in the BARI 2D (Bypass Angioplasty Investigation Revascularization 2 Diabetes) trial and cardiovascular events (CVEs)/survival?
Methods:
In BARI 2D, participants were randomized in a 2 × 2 factorial design simultaneously to cardiac treatment and glycemic control treatment strategies. The randomized glycemic control strategies compared primarily insulin-sensitizing versus primarily insulin-providing treatments. The randomized cardiac treatment strategies entailed intensive medical therapy with revascularization within 4 weeks or intensive medical therapy with revascularization when clinically indicated. A nonrandomized analysis of survival/CVEs in BARI 2D was assessed by control of six risk factors (RFs), including nonsmoker, non–high-density lipoprotein cholesterol <130 mg/dl, triglycerides <150 mg/dl, blood pressure (systolic <130 mm Hg; diastolic <80 mm Hg), and glycated hemoglobin <7%. 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, 34% minorities) followed for 5 years, the mean ± standard deviation number of RFs in control improved from 3.5 ± 1.4 out of 6 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 0-2 RFs in control during follow-up had a twofold higher risk of death (hazard ratio [HR], 2.0; 95% confidence interval [CI], 1.3-3.3; p = 0.0031) and a 1.7-fold higher risk of the composite endpoint (HR, 1.7; 95% CI, 1.2-2.5; p = 0.0043), compared with those with six 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.
Perspective:
The results achieved in BARI 2D would be hard to achieve in clinical practice. Patients had monthly visits with a diabetologist with additional nurse coordinator contact, and quarterly visits thereafter. The incremental use of cardiovascular medication responsible for the results was remarkable: baseline aspirin 88% versus third year 94%, beta-blocker 73% versus 85%, angiotensin-converting enzyme inhibitor/angiotensin-receptor blocker 77% versus 91%, and statin 75% versus 95%.
Keywords: Angioplasty, Blood Glucose, Blood Pressure, Cholesterol, Diabetes Mellitus, Type 2, Glycated Hemoglobin A, Insulin, Lipoproteins, HDL, Metabolic Syndrome, Myocardial Infarction, Primary Prevention, Risk Factors, Stroke, Survival
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