The purpose of this multicenter study is to compare the relative efficacy of percutaneous transluminal coronary angioplasty (PTCA) and coronary artery bypass surgery (CABG) in a prospective randomized trial in patients with multivessel coronary artery disease who have coronary anatomic lesions suitable for revascularization with either procedure. The study will evaluate whether PTCA is associated with similar early and long term results as bypass surgery. End points to be evaluated will include symptomatic (angina) status, incidence of follow up events (non-fatal myocardial infarction, death, need for additional revascularization with PTCA or CABG), status of revascularization determined by late angiography, functional status determined by stress testing and radionuclide imaging, and socioeconomic costs. During a 2-year period of recruitment, 150 patients at the Medical College of Virginia Clinical Unit and 1800 patients overall at the 12 participating centers will be entered into the study. Patients with significant stenoses of 2 or more major coronary arteries suitable for both PTCA and CABG would be randomized to either PTCA or CABGS. This trial would test if in comparable patients with multivessel coronary artery disease PTCA is equal to CABGS in maintaining survival and protecting against disabling angina pectoris and myocardial infarction. A registry of all patients with significant coronary artery disease at the participating clinical centers will be maintained as part of the study during the 2-year enrollment period for the randomized trial. This group of patients will make it possible to determine the validity of observations from the randomized group of patients to a broader group of patients who are candidates for either procedure. All patients will be followed for a 5-year period. The organization of the study will include a Data Coordinating Center, a Central Angiographic Laboratory, and 10-12 clinical units. There will be a Steering Committee composed of investigators from all components of the study. Even if PTCA is proven to be a comparable alternative procedure for only a small proportion of patients with multivessel disease who are now receiving coronary bypass surgery, the potential for health care cost savings would be substantial.
