The Bypass Angioplasty Revascularization Trial (BARI) is an NHLBI-sponsored multi-centered randomized trial comparing the efficacy of coronary artery bypass sugery (CABG) with percutaneous transluminal coronary angioplasty (PTCA) in patients with stable and unstable manifestations of ischemic heart disease. A variety of endpoints will be assessed including survival, non-fatal myocardial infarction, subjective functional status (angina, heart failure), objective functional status (duration of exercise, ST segment changes, and ejection fraction on rest/exercise radionuclide ventriculogram), and quality of life, including economic status. During a two-year recruitment period, 1800 patients will be enrolled study-wide (approximately 180 from our institution). Eligible patients will be those having angiographic demonstration of at least one major coronary artery with 70% or greater stenosis suitable for both PTCA and CABG plus at least one additional vessel with 50% or more stenosis. A Registry of patients having coronary arteriography for severe or unstable angina will be maintained at each participating institution during the two year enrollment period for the randomized trial. This registry population will provide a valuable documentation of the patient population from which the randomized group were drawn and will help to establish the validity of the observations in the randomized patient population to the broader group of patients undergoing coronary revascularization surgery and PTCA. All patients will be followed for at least four years. The organization of the BARI Trial will include approximately 12 participating clinical units, a Radiographic Core Laboratory, a Data Coordinating Center, possibly a Central Electrocardiographic Laboratory, and possibly a Radionuclide Core Laboratory. The Steering Committee will be composed of principal investigators from the participating clinical units, core laboratories, coordinating center, and NHLBI Project Office. Additionally, a Safety and Data Monitoring Committee composed of experts in relevant statistical and bioethical fields will periodically review the progress of the study and evaluate the results. If BARI can demonstrate that PTCA is as 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 extraordinarily significant.

Agency
National Institute of Health (NIH)
Institute
National Heart, Lung, and Blood Institute (NHLBI)
Type
Research Project--Cooperative Agreements (U01)
Project #
5U01HL038512-03
Application #
3553001
Study Section
(SRC)
Project Start
1987-06-01
Project End
1994-11-30
Budget Start
1988-12-01
Budget End
1989-11-30
Support Year
3
Fiscal Year
1989
Total Cost
Indirect Cost
Name
University of Alabama Birmingham
Department
Type
Schools of Medicine
DUNS #
004514360
City
Birmingham
State
AL
Country
United States
Zip Code
35294
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Holper, Elizabeth M; Brooks, Maria Mori; Kim, Lauren J et al. (2007) Effects of heart failure and diabetes mellitus on long-term mortality after coronary revascularization (from the BARI Trial). Am J Cardiol 100:196-202
Schwartz, Leonard; Kip, Kevin E; Frye, Robert L et al. (2002) Coronary bypass graft patency in patients with diabetes in the Bypass Angioplasty Revascularization Investigation (BARI). Circulation 106:2652-8
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Bittner, Vera; Hardison, Regina; Kelsey, Sheryl F et al. (2002) Non-high-density lipoprotein cholesterol levels predict five-year outcome in the Bypass Angioplasty Revascularization Investigation (BARI). Circulation 106:2537-42
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Kip, Kevin E; Alderman, Edwin L; Bourassa, Martial G et al. (2002) Differential influence of diabetes mellitus on increased jeopardized myocardium after initial angioplasty or bypass surgery: bypass angioplasty revascularization investigation. Circulation 105:1914-20
Berger, P B; Velianou, J L; Aslanidou Vlachos, H et al. (2001) Survival following coronary angioplasty versus coronary artery bypass surgery in anatomic subsets in which coronary artery bypass surgery improves survival compared with medical therapy. Results from the Bypass Angioplasty Revascularization Investigation J Am Coll Cardiol 38:1440-9
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