BYPASS ANGIOPLASTY REVASCULARIZATION INVESTIGATION

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The objective of this investigation is to compare the effectiveness of percutaneous transluminal coronary angioplasty (PTCA) and coronary bypass surgery (CABG) as means of achieving relief of myocardial ischemia in patients with symptomatic multivessel coronary artery disease. Specific aims include: 1) to determine whether PTCA is as effective as CABG in relieving exercise induced myocardial ischemia; 2) to determine whether the incidence of coronary events such as death and myocardial infarction differ among patients treated with PTCA or CABG; 3) to determine whether PTCA results in a lower incidence of morbid events than CABG; 4) to assess the lasting effect of PTCA in relieving myocardial ischemia; 5) to assess the impact of CABG and PTCA on employment; 6) to assess the economic costs associated with each intervention, both short and long term. Patients with disabling chronic angina pectoris, unstable angina pectoris, angina pectoris following myocardial infarction associated with electrocardiographic evidence of exercise induced ischemia or patients with mild angina and evidence of marked myocardial ischemia who undergo cardiac catheterization at Rhode Island Hospital will be considered potential candidates for randomization to PTCA or coronary bypass surgery. Catheterized patients who do have primary myocardial or valvular heart disease or no evidence of coronary disease or who do not meet one of the functional criteria will be considered for enrollment in an observational Registry. Patients who consent to randomization will undergo a thorough baseline assessment including graded exercise tests if appropriate, prior to performance of either PTCA or CABG. Randomized patients will be followed with periodic questionnaires, graded exercise stress tests at 12 and 48 months and as supplement to the protocol, cardiac catheterization at 12 and 60 months. The clinical outcome of patients entering the Registry will be assessed by means of a questionnaire. The primary endpoint of this investigation will be the proportion of patients demonstrating evidence of exercise induced ischemia assessed at 12 and 48 months. Multiple secondary end points will also be monitored in accordance with the specific aims of the investigation.