The effect of age on clinical outcomes and health status BARI 2D (Bypass Angioplasty Revascularization Investigation in Type 2 Diabetes)

Abstract

Objectives: The purpose of this study was to determine the extent to which effectiveness of cardiac and diabetes treatment strategies varies by patient age.

Background: The impact of age on the effectiveness of revascularization and hyperglycemia treatments has not been thoroughly investigated.

Methods: In the BARI 2D (Bypass Angioplasty Revascularization Investigation in Type 2 Diabetes) trial, 2,368 patients with documented stable heart disease and type 2 diabetes were randomized to receive prompt revascularization versus initial medical therapy with deferred revascularization and insulin sensitization versus insulin provision for hyperglycemia treatment. Patients were followed for an average of 5.3 years. Cox regression and mixed models were used to investigate the effect of age and randomized treatment assignment on clinical and health status outcomes.

Results: The effect of prompt revascularization versus medical therapy did not differ by age for death (interaction p = 0.99), major cardiovascular events (interaction p = 0.081), angina (interaction p = 0.98), or health status outcomes. After intervention, participants of all ages had significant angina and health status improvement. Younger participants experienced a smaller decline in health status during follow-up than older participants (age by time interaction p < 0.01). The effect of the randomized glycemia treatment on clinical and health status outcomes was similar for patients of different ages.

Conclusions: Among patients with stable heart disease and type 2 diabetes, the relative beneficial effects of a strategy of prompt revascularization versus initial medical therapy and insulin-sensitizing versus insulin-providing therapy on clinical endpoints, symptom relief, and perceived health status outcomes do not vary by age. Health status improved significantly after treatment for all ages, and this improvement was sustained longer among younger patients. (Bypass Angioplasty Revascularization Investigation in Type 2 Diabetes [BARI 2D]; NCT00006305).

Copyright © 2011 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Figures

Figure 1

Five-year survival free from major cardiovascular events. Kaplan Meier estimates comparing patients randomized to prompt revascularization (REV: solid red line) versus medical therapy (MED: dashed black line) stratified by baseline age category: age

Figure 2

Classic angina by age group and randomized treatment. The comparison of angina rates for patients randomized to prompt revascularization (REV: blue striped bars) versus medical therapy (MED: red solid bars) within age group at baseline, one-year, and three-years; statistical significance is indicated by * for 0.01≤p

Figure 3

Estimated mean health status by age group and time. Estimates for DASI (upper left panel), Energy (upper right panel), Health Distress (lower left panel), and Self-rated Health (lower right panel) are based on longitudinal mixed models accounting for baseline age group (

Figure 4

DASI by baseline age and follow-up time. Estimates and interpretation of the results from the DASI multivariate longitudinal mixed model which includes an interaction between baseline age and follow-up time.