Percutaneous transluminal coronary angioplasty (PTCA) is now being widely used in the management of patients with multivessel coronary artery disease, but its efficacy in comparison to coronary artery bypass graft surgery (CABG) is unknown. We propose to perform a prospective, randomized trial comparing PTCA and CABG in patients with multivessel disease in whom coronary surgery is clinically indicated. The primary end-points will be revascularization and functional status. These will be measured at 1 year and 3 years using coronary arteriographic studies and stress tomographic thallium-201 imaging. Clinical status, coronary event rate, survival, return to work, and economic comparisons will also be made. The study will be conducted by the divisions of Cardiology, Cardio-Thoracic Surgery and Nuclear Medicine of the Emory University School of Medicine at two Emory University hospitals -Crawford W. Long Memorial Hospital and Emory University Hospital in Atlanta, Georgia. PTCA will be performed by 5 independent operators whose expertise will, on average, approximate that found in experienced centers in the United States. We estimate that approximately 900 patients will be required to be randomized to satisfy the statistical requirements of precision and lost-to-follow-up assumptions. Randomization will be conducted allowing for 2 important baseline characteristics. They are the number of major coronary vessels to be revascularized (2 or 3) and presence of single, discrete or multiple lesions in each vessel. Patient enrollment will be completed within 2 years and clinical follow-up will extend for a minimum of 3 years.

Agency
National Institute of Health (NIH)
Institute
National Heart, Lung, and Blood Institute (NHLBI)
Type
Research Project (R01)
Project #
1R01HL033965-01A1
Application #
3346414
Study Section
Clinical Trials Review Committee (CLTR)
Project Start
1987-06-01
Project End
1992-05-31
Budget Start
1987-06-01
Budget End
1988-05-31
Support Year
1
Fiscal Year
1987
Total Cost
Indirect Cost
Name
Emory University
Department
Type
Schools of Medicine
DUNS #
042250712
City
Atlanta
State
GA
Country
United States
Zip Code
30322
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