BYPASS ANGIOPLASTY REVASCULARIZATION INVESTIGATION

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The Bypass Angioplasty Revascularization Investigation (BARI) was initiated in 1987 in fourteen primary sites and five satellites in order to evaluate the efficacy of PTCA vs. bypass surgery in the treatment of patients with multivessel disease and severe angina or ischemia. 1829 patients were enrolled in the trial and 2013 eligible but not randomized patients are being followed. In addition a sample of 422 patients deemed ineligible based on their angiograms are also being followed. All patients are being followed for a five year period. The primary goal of the trial is to compare the two randomized groups in terms of mortality, myocardial infarction, need for repeat procedures, re-hospitalization, functional status, radionuclide ejection fraction, and quality of life. The Boston University Medical Center Clinical Site randomized 93 patients, 63 male and 30 female. 139 patients are being followed in the registry and 14 patients are being followed in the angiographically excluded subgroup. While the results of the five year outcome will serve as the primary endpoint of this trial, it is well recognized that coronary events continue to occur beyond 5 years particularly in patients with bypass surgery. In order to fully understand the impact of these two revascularization strategies on the long term outcome of patients it is the primary aim of this proposal to provide 10 year follow-up for all BARI eligible patients. To accomplish this, we will use the same methods of data collection that we have used during the first five year follow-up. Our high protocol compliance rate and follow-up in addition to our stable staff will provide high-quality data that will ensure acquisition of important information concerning the long-term effectiveness of PTCA vs. bypass surgery. In addition, we will continue to actively participate in the study conduct and participation inn subcommittees and substudies including the SEQOL quality of life substudy. The results of BARI will have an important impact on the future practice of coronary revascularization and affect hundreds of thousands of patients who are expected to undergo these procedures in the next few years.