Clinical and Angiographic Risk Stratification and Differential Impact on Treatment Outcomes in the BARI 2D Trial
Background—The BARI 2D trial assigned patients with type 2 diabetes to prompt coronary revascularization (REV) plus intensive medical therapy versus intensive medical therapy (MED) alone and reported no significant difference in mortality. Among patients selected for CABG, REV was associated with a significant reduction in death/MI/stroke compared with MED. We hypothesized that clinical and angiographic risk stratification would impact the effectiveness of the treatments overall and within revascularization strata.
Methods and Results—An angiographic risk score was developed from variables assessed at randomization; independent prognostic factors were myocardial jeopardy index, total number of coronary lesions, prior coronary revascularization, and left ventricular ejection fraction. The Framingham risk score for patients with coronary disease was used to summarize clinical risk. Cardiovascular event rates were compared by assigned treatment within high-risk and low-risk subgroups. No overall MED versus REV outcome differences were seen in any risk stratum. The five-year risk of death/MI/stroke was 36.8% for MED compared with 24.8% for REV among the 381 CABG-selected patients in the highest angiographic risk tertile (p=0.005); this treatment effect was amplified in patients with both high angiographic and high Framingham risk (47.3% MED versus 27.1% REV, p=0.010; Hazard Ratio=2.10, p=0.009). Treatment group differences were not significant in other clinical-angiographic risk groups within the CABG stratum nor any subgroups within the PCI stratum.
Conclusions—Among patients with diabetes and stable ischemic heart disease, a strategy of prompt CABG significantly reduces the rate of death/MI/stroke in those with extensive coronary artery disease or impaired left ventricular function.
Clinical Trial Registration Information—ClinicalTrials.gov; Identifier: NCT00006305.
- Received January 12, 2012.
- Accepted August 24, 2012.
- Copyright © 2012, American Heart Association, Inc. All rights reserved. Unauthorized use prohibited