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UB cardiologist publishes NEJM editorial
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“Some may legitimately question, based on the BARI-2D trial results, why we continue to do so many PCI procedures in patients, especially diabetic patients with extensive multi-vessel coronary disease, whose clinical outcomes would appear to be significantly enhanced by CABG surgery.”
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A UB faculty member has published an editorial in the current issue of the New England Journal of Medicine (NEJM) responding to the results of a study published in that issue.
The editorial by William E. Boden, professor of medicine, titled “Diabetes with Coronary Disease—A Moving Target Amid Evolving Therapies?” addresses the results of the BARI-2D Trial, which were presented June 7 at the American Diabetes Association’s annual meeting and published simultaneously online. The paper and editorial are appearing in print in the June 11 issue of NEJM.
The BARI-2D trial set out to test two heart management strategies and scientific hypotheses: that prompt revascularization with either PCI [percutaneous coronary intervention—stenting and/or balloon angioplasty] or coronary-artery bypass grafting (CABG) 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 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 provides no incremental clinical benefit over intensive medical therapy, including in patients with both diabetes and coronary disease,” Boden states in the editorial.
Boden is clinical chief of the Division of Cardiovascular Medicine in the 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.
He was the lead investigator and study chairman of the COURAGE trial, a landmark clinical trial, published in the NEJM in 2007, that 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.
Boden recommends that the results of the BARI-2D Trial be interpreted with “considerable caution” based 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 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 CABG surgery for treating diabetic patients with coronary artery disease.
“The important findings of the BARI-2D trial, combined with a recent authoritative review of 10 randomized trials comparing PCI with CABG surgery, show that diabetics derive an important survival advantage and a reduced rate of subsequent heart attack with CABG surgery, while PCI was not associated with any such benefit,” he says.
The continued high rate of use of PCI (1.24 million procedures per year in the U.S.) and the high rate of drug-eluting stent usage “strongly suggests that we critically reassess our approach to revascularization, if needed, in diabetics with coronary disease,” he says.
“Some may legitimately question, based on the BARI-2D trial results, why we continue to do so many PCI procedures in patients, especially diabetic patients with extensive multi-vessel coronary disease, whose clinical outcomes would appear to be significantly enhanced by CABG surgery,” he adds.
Boden speculates that in this era of mounting health care reform, physicians, payers and health economists will begin to scrutinize more carefully the level of clinical evidence that supports and guides clinical treatment decisions.
“The interventional community will continue to support PCI because it does result in symptom improvement,” he said. “But, if faced with a decision of needing revascularization, it would seem logical, if not preferable, that patients and referring physicians would increasingly base treatment decisions on the scientific evidence that supports clinical superiority and on approaches that improve hard outcomes (i.e., death, MI, etc.), and not just a relief of angina symptoms, especially in diabetic patients with more extensive coronary disease who may require revascularization.”
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