A 5 year extension to the Emory Angioplasty Surgery Trial (EAST) is proposed. EAST is a prospective trial of 392 patients with multivessel coronary artery disease randomized to percutaneous transluminal coronary angioplasty or coronary artery bypass surgery to study the relative long- term efficacy of these procedures. From 842 eligible patients, 392 were randomized between 7/15/87 and 4/15/90. The patients were randomized within the four strata of 1) two vessel disease with one lesion per vessel, 2) two vessel disease with multiple lesions per vessel, 3) three disease vessel with one lesion per vessel and 4) three vessel disease with multiple lesions per vessel. The primary end point of the original EAST grant is the composite of death, new Q wave myocardial infarction, or large reversible thallium defect. Secondary end points are coronary arteriographic status, additional revascularization, symptoms, ability to exercise, quality of life, and cost. Coronary artery disease is a chronic disease. While a lot will be learned from the first three years of EAST, more will be learned by following these patients out to 8 years. Follow-up events including death, myocardial infarction and additional revascularization procedures will be followed. The cause of death, whether cardiac or not, will be determined by the investigators. Myocardial infarctions will be characterized as non-Q or Q-wave. Additional revascularization procedures will be characterized as either coronary angioplasty or coronary surgery and will be analyzed as to whether the additional procedure is performed for an initially unsuccessful procedure, graft failure or restenosis, incomplete original revascularization or progression of disease. The presence of angina will be assessed yearly, as will use of antianginal medications. Similar data will be gathered on the randomized and eligible but not randomized patients. The data will be stored in the EAST database maintained at Emory University in the biostatistical coordinating center for EAST. The long-term outcome will be compared in the two treatment arms for each of the noted end points, as well as combined end points, using standard statistical methods. These data will be analyzed for the randomized patients and separately for the eligible patients. These detailed analyses will also be performed for each strata. For time dependent end points, Cox model analysis and for nontime dependent analyses stepwise logistic regression will be used to determine correlates of outcome. Thus, the EAST extension will offer the opportunity to provide an in- depth and long-term comparison of the two methods of revascularization for coronary artery disease in an extremely well characterized group of patients randomly assigned to coronary angioplasty or coronary surgery.
Showing the most recent 10 out of 12 publications
