This article is more than 5 years old. Information may no longer be current.
BARI 2D analyses explore treatment options, quality of life, costs
Results from an analysis of the STICH trial suggested no benefit from adding surgical LV reconstruction to CABG.
Click Here to Manage Email Alerts
American Heart Association Scientific Sessions 2009
Updates on the results from several analyses of the BARI 2D trial results suggested that improvements in outcomes, cost-effectiveness and quality of life were related to the various treatment strategies employed during the trial.
The results of the Bypass Angioplasty Revascularization Investigation in Type 2 Diabetics (BARI 2D) trial suggested that in patients with type 2 diabetes and stable coronary artery disease, no additional clinical benefit was derived from early revascularization with PCI or CABG vs. medical therapy alone after five years of follow-up. Mortality was similar between the early intervention group compared with the medical therapy group (88.3% vs. 87.8%, P=.97).The study results also suggested no additional benefit for freedom from a composite of CV events, including cardiac death or MI (77.2% vs. 75.9%, P=.70). Although no additional benefits on the rate of death or CV events for prompt PCI vs. medical therapy were reported, patients treated with prompt CABG vs. medical therapy had better outcomes when CV events were included in the analysis along with death or MI (22.4% vs. 30.5%, P=.01) . No differences in outcome between patients assigned to insulin-sensitizers and those assigned to insulin-providers was reported (77.7% vs. 75.4%, P=.13).
Treatment of extensive CAD
Results from a five-year analysis of BARI 2D suggested that in patients in whom CAD was more extensive, a strategy of CABG plus insulin sensitization was associated with better outcomes. The results suggested that cardiac death rates were similar at five years in patients receiving intensive medical therapy or initial revascularization (5.7% vs. 5.9%), as were rates of insulin sensitization or insulin provision (5.7% vs. 6.0%). In the 763 patients with extensive CAD selected for CABG, the researchers reported that MI (10.0% vs. 17.6%) and the composite of death or MI (21.1% vs. 29.2%) were reduced following initial surgery compared with intensive medical therapy. The reduction, however, was limited to the insulin-sensitization group.
“In many patients with type 2 diabetes and stable ischemic CAD, similar to those enrolled in the PCI stratum, an initial strategy of intensive medical therapy should be considered and does not require immediate PCI to prevent cardiac death or MI, when angina symptoms are controlled,” Bernard Chaitman, MD, professor of medicine and director of CV research at the St. Louis School of Medicine, said in a presentation. “In patients with more extensive coronary disease, similar to those enrolled in the CABG stratum, a strategy of prompt CABG, intensive medical therapy and insulin sensitivity therapy should be considered the preferred strategy to reduce the incidence of spontaneous MI.”
Quality of life, costs analyses
Another analysis of the BARI 2D results suggested that patients with type 2 diabetes and CAD who underwent prompt revascularization had improved health-related quality of life compared with those who received initial intensive medical therapy.
Using four different scales to measure quality of life, including the Duke Activity Status Index (DASI) and questions from the RAND Medical Outcomes study, the researchers determined that although all study groups reported clinically meaningful improvements in their quality of life, patients undergoing revascularization with either CABG or catheter-based procedures reported greater improvements in energy, physical activity and self-reported health compared with those who received initial intensive medical therapy.
“Compared to initial medical therapy, prompt revascularization led to small, significant benefits for DASI, self-rated health and small marginal benefits for both energy and health distress,” Maria M. Brooks, PhD, associate professor of epidemiology from the University of Pittsburgh, said in a presentation. “The effect of prompt revascularization on DASI was greater among patients selected for CABG than among those selected for PCI.”
Another analysis examined the cost variances of treatment in the BARI2D population. Two-year data suggested that patients on insulin-sensitization therapy had higher costs than those on insulin-production or insulin-provision therapy ($43,295 vs. $41,246). Four-year costs were also higher for insulin-sensitization therapy vs. provision therapy ($71, 300 vs. $70,200). In general, a strategy of initial revascularization was more expensive than a strategy of medical therapies across all strata ($75,900 vs. $65,600, P<.001), with cost differences driven primarily by the costs of the revascularization procedures.
“Our projections strongly favor medical strategy over prompt revascularization strategy in the PCI stratum,” Mark Hlatky, MD, a professor of medicine and professor of health research and policy at Stanford University Medical School in Calif., said in his presentation. “Our results also suggest that coronary revascularization may be cost-effective in the CABG stratum, particularly if the significant reduction in major CV events seen in the CABG stratum ultimately translate into better long-term survival. We found no clear advantage to either insulin sensitization or insulin provision since the clinical and economic outcomes were so close to one another.”
STICH analysis
Results from an analysis of the STICH trial, which attempted to quantify differences in heart muscle perfusion in 2,136 patients with HF, suggested that a comprehensive analysis of left ventricular function could aid physicians in determining which patients would benefit from combining CABG with LV reconstruction.
The analysis included 1,000 patients randomly assigned to either CABG alone (n=499) or CABG plus LV reconstruction (n=501). The researchers reported 292 deaths or hospitalizations in the CABG alone group vs. 289 (58%) in the CABG plus reconstruction group. There were no differences between the two groups for the combined endpoint of all-cause death or CV hospitalization (P=.90), as well as no differences in all-cause death (P=.98).
“Baseline global and regional LV function did not identify a subgroup of patients who benefited from the addition of surgical vascular reconstruction at the time of CABG,” Jae K. Oh, MD, a professor of medicine at the Mayo Clinic in Rochester, Minn., said in his presentation. “Further analyses are needed to determine whether surgical ventricular reconstruction improves clinical outcome in a specific group of patients defined by the extent of the change from baseline to the post-operative follow-up study.” – by Eric Raible
For more information:
- Chaitman B. LB03 #138.
- Brooks M. LB03 #140.
- Hlatky M. LB03 #142.
- Oh J. LB03 #144.
- All presented at: American Heart Association Scientific Sessions; Nov. 14-18; Orlando, Fla.