This proposal for selected clinical sites participating in the Bypass Angioplasty Revascularization Investigation (BARI) clinical trial is to obtain five year follow-up angiography in at least 80% of each center's randomized patient population. The purpose is to assess the relationship of the coronary anatomical characteristics five years after initial treatment with either percutaneous transluminal coronary angioplasty (PTCA) or coronary artery bypass graft (CABG) surgery to clinical status, and radionuclide left ventricular ejection fraction (RLVEF). Issues such as long term success of coronary bypass grafts and revascularization after initial treatment to the clinical course can also be addressed. Questions such as whether or not morphologic features of coronary lesions entered into BARI and ventricular function can be addressed with angiographic follow-up. Only coronary arteriography can provide information regarding patency of dilated vessels and surgical conduits. As part of a pilot trial attempting to obtain one year angiography, the Cleveland Clinic accomplished this goal with a success rate of 80%. The RLVEF has been added as a five year endpoint in all BARI patients, with a subset of patients having LV angiography as well to support conclusions derived from the entire patient pool. Studies have documented the accuracy and reproducibility of radionuclide ejection fractions but the relationship of the revascularization result can only be known through angiography. Cleveland Clinic Foundation has already demonstrated its ability to achieve a high success rate in obtaining follow-up angiograms. We have kept close contact with our patient population, supplying patient and family education, communication with the referring physician, cost defrayment to relieve patient financial concerns and constancy in personnel to help achieve a close rapport with individual patients have helped foster a commitment to the study and a willingness to return for five year angiography. We fully expect more than 90% compliance with the 5 year catheterization and we believe that the data generated will be invaluable in judging the outcome of surgery versus/angioplasty in patients with multivessel coronary disease.
