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

Abstract

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.

Figure 1

Health status by randomization to prompt revascularization (square symbol and solid line) versus medical therapy (circle symbol and dashed line). Points indicate mean scores in each group.

Figure 2

Health status by randomization to insulin sensitization (square symbol and solid line and solid line) versus insulin provision (circle symbol and dashed line). Points indicate mean scores in each group.

Figure 3

Effect of randomization to prompt revascularization or medical therapy on health status overall and within subgroups. Estimates and 99% confidence intervals from mixed effects models.

Figure 4

Effect of randomization to insulin sensitization or insulin provision on health status overall and within subgroups. Estimates and 99% confidence intervals from mixed effects models.