In an editorial in the current issue of the New England Journal of Medicine (NEJM), William E. Boden, M.D., professor of medicine and preventive medicine at the University at Buffalo, recommends that the results of the BARI-2D Trial published in that edition must be interpreted with "considerable caution."
The editorial is titled "Diabetes with Coronary Disease -- A Moving Target Amid Evolving Therapies?"
Boden bases his cautionary note on the fact that the trial did not meet its primary end point of long-term mortality reduction with myocardial revascularization, as compared with optimal medical therapy.
In addition, he notes in the editorial that an important trial secondary outcome -- freedom from death, heart attack or stroke -- did reveal new and important information that reaffirms the potential long-term benefit associated with coronary artery bypass graft (CABG) surgery for treating diabetic patients with coronary artery disease.
Boden is clinical chief of the UB Division of Cardiovascular Medicine in the UB schools of Medicine and Biomedical Sciences and Public Health and Health Professions, and Kaleida Health's medical director of cardiovascular services and chief of cardiology at Buffalo General Hospital and Millard Fillmore Hospitals.
In the editorial Boden states: "The BARI-2D results replicate the principal finding of the Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation (COURAGE) trial -- that an initial strategy of PCI [percutaneous coronary intervention -- stenting and/or balloon angioplasty] provides no incremental clinical benefit over intensive medical therapy, including in patients with both diabetes and coronary disease."
The BARI-2D trial set out to test two heart management strategies and scientific hypotheses: that prompt revascularization with either PCI or coronary-artery bypass grafting would be superior to optimal medical therapy alone; and that increasing patients' sensitivity to insulin produced by the pancreas would be superior to insulin injections.
The trial results were presented at the American Diabetes Association annual meeting June 7 in New Orleans and published simultaneously online. The paper and editorial will appear in print in the June 11, 2009, issue of the journal.
Boden was the lead investigator and study chairman of the COURAGE trial, a study of almost 2,300 chronic stable angina patients randomized to optimal medical therapy with or without PCI.
This landmark clinical trial, published in the NEJM in 2007, showed that optimal medical therapy alone was just as effective in preventing death, a heart attack or other major cardiovascular events in patients with stable heart disease as coronary revascularization with stenting or balloon angioplasty combined with optimal medical therapy during an average 4.6 year follow-up period.
The results of COURAGE have reverberated worldwide over the past 2 years, Boden noted, as many physicians increasingly have turned to aggressive medical therapy and lifestyle intervention as an equally effective initial approach to patient management.
"The COURAGE trial results have sparked intense debate within the cardiology community," Boden noted, "particularly among many interventional cardiologists who have suggested that 'clinical practice should not change based on the results of only one research trial.'
"The BARI-2D trial found that there was no incremental benefit of PCI on top of a background of optimal medical therapy in 2,368 patients with coronary disease and established diabetes (average duration: 10 years)," commented Boden.
"BARI-2D likewise replicates the earlier findings of the original BARI trial -- that patients who underwent CABG fared better than those who underwent balloon angioplasty, especially in patients with diabetes and multi-vessel coronary artery disease.