This is a Competing Continuation Application for the ongoing Bypass Angioplasty Revascularization Investigation (BARI) clinical center at the University of Alabama Medical Center. BARI is a collaborative clinical trial comparing the efficacy of coronary artery bypass surgery (CABG) with percutaneous transluminal coronary angioplasty (PTCA) in patients with multivessel coronary artery disease requiring revascularization. A variety of endpoints are being assessed including long-term survival, functional status and quality of life. BARI is presently underway at 14 primary and 4 satellite centers in the United States and Canada. From August 1, 1988, through August 31, 1991, 1829 patients were randomized study-wide between PTCA and CABG. Additionally, two registry populations were defined for follow-up: (1) 2013 patients eligible for randomization but not randomized; and (2) 422 patients angiographically unsuitable for randomization. The University of Alabama at Birmingham randomized 202 patients and enrolled 30 patients in the registries. The number of patients randomized at our center was the highest number of any U.S. center and the second highest study-wide. Protocol adherence and timeliness of data transmission has been excellent at our site. The present application is part of a package of one lead application prepared by the BARI Coordinating Center, 13 site applications and 2 Core Laboratory applications proposing to extend the duration of follow-up of the BARI randomized and registry patients to 10 years post-entry. BARI randomized patients will undergo a 5-year clinic evaluation including medical history, physical examination, blood lipid screen, graded exercise test and radionuclide ejection fraction assessment. Randomized and registry patients will then be followed annually by telephone questionnaire for a minimum of 10 years post-entry. If BARI can demonstrate that PTCA is an effective as CABG in favorably modifying the endpoints listed above, the impact on current medical practice, as well as the impact on cost-containment in the treatment of coronary artery disease will be highly significant.
