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 i nclude: 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.

Agency
National Institute of Health (NIH)
Institute
National Heart, Lung, and Blood Institute (NHLBI)
Type
Research Project--Cooperative Agreements (U01)
Project #
5U01HL038532-02
Application #
3553069
Study Section
(SRC)
Project Start
1987-06-01
Project End
1994-11-30
Budget Start
1987-12-01
Budget End
1988-11-30
Support Year
2
Fiscal Year
1988
Total Cost
Indirect Cost
Name
Rhode Island Hospital (Providence, RI)
Department
Type
DUNS #
161202122
City
Providence
State
RI
Country
United States
Zip Code
02903
Holmes Jr, David R; Kim, Lauren J; Brooks, Maria Mori et al. (2007) The effect of coronary artery bypass grafting on specific causes of long-term mortality in the Bypass Angioplasty Revascularization Investigation. J Thorac Cardiovasc Surg 134:38-46, 46.e1
BARI Investigators (2007) The final 10-year follow-up results from the BARI randomized trial. J Am Coll Cardiol 49:1600-6
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
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
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
Vander Salm, Thomas J; Kip, Kevin E; Jones, Robert H et al. (2002) What constitutes optimal surgical revascularization? Answers from the Bypass Angioplasty Revascularization Investigation (BARI). J Am Coll Cardiol 39:565-72
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
Gurm, Hitinder S; Whitlow, Patrick L; Kip, Kevin E et al. (2002) The impact of body mass index on short- and long-term outcomes inpatients undergoing coronary revascularization. Insights from the bypass angioplasty revascularization investigation (BARI). J Am Coll Cardiol 39:834-40
Yokoyama, Y; Chaitman, B R; Hardison, R M et al. (2000) Association between new electrocardiographic abnormalities after coronary revascularization and five-year cardiac mortality in BARI randomized and registry patients. Am J Cardiol 86:819-24
Williams, D O; Baim, D S; Bates, E et al. (1995) Coronary anatomic and procedural characteristics of patients randomized to coronary angioplasty in the Bypass Angioplasty Revascularization Investigation (BARI). Am J Cardiol 75:27C-33C