Clinical Alert: Bypass Over Angioplasty for Patients with Diabetes
The trial has been closely monitored by both the study chairman (Dr. Robert Frye, Mayo Clinic Foundation), the Clinical Coordinating Center (Dr. Katherine Detre, University of Pittsburgh), and the independent Data and Safety Monitoring Board (chaired by Dr. J. David Bristow, Oregon Health Sciences University). The Data and Safety Monitoring Board is composed of PTCA experts, cardiovascular surgeons, clinical cardiologists, and experts in biostatistics and ethics. The Board regularly reviews the monitoring reports. ECG analyses are being done by the Central ECG Laboratory (Dr. Bernard R. Chaitman, director) at the St. Louis University Medical Center. An independent Mortality and Morbidity Classification Committee (chaired by Dr. Ronald Prineas, University of Miami) categorizes fatal events in the trial.
On September 13, 1995, the Data and Safety Monitoring Board held an urgent session to review the 5-year mortality data. The Board concluded that the unfavorable mortality results for the patients on drug treatment for diabetes and first treated with PTCA were unlikely to be due to chance. The Board recommended to the National Institutes of Health that physicians and other health care professionals and the public be promptly informed of the results.
BARI's findings should not be applied to all persons with diabetes. They apply only to those on oral hypoglycemic agents or insulin for diabetes and who have multivessel coronary artery disease and are undergoing an initial revascularization procedure. The data offer the following guidelines for such patients: They will probably fare better with CABG than PTCA as an initial treatment. For patients who have already had a PTCA and are asymptomatic -- experiencing no ischemia, angina, or other symptom -- they should take no special action but continue their regular care. Alternatively, if they have already had a PTCA and had their ischemia return (e.g., reappearance of angina), they should consult their physicians to assess their current health status and review optimal strategies for further care. Close physician monitoring is particularly important for patients with diabetes who have coronary artery disease, since they may not experience symptoms during periods of ischemia.
Finally, all patients who have evidence of coronary artery disease, with or without a prior PTCA or CABG, should receive an aggressive approach to medical management of known risk factors for coronary artery disease, including smoking cessation for smokers, appropriate control of elevated blood pressure or serum cholesterol, and optimal control of diabetes.
The full text of this alert has been mailed to all libraries that are members of the National Network of Libraries of Medicine.