CSP #517 - Outcomes Following Myocardial Revascularization: On and Off Cardiopulmonary Bypass

A prospective, randomized, single-blinded, controlled VA clinical trial to evaluate the impact of using an off-pump versus on-pump surgical technique for coronary artery bypass grafting only (CABG-only) on 30-day and 1-year mortality and morbidity.

Co-Investigators:

Frederick L. Grover, M.D., VAMC Denver, CO
A. Laurie Shroyer, Ph.D., VAMC Denver, CO
Dimitri Novitzky, M.D., VAMC Tampa, FL

"Exploring better hearts and minds."

Study Description:

Nationwide, myocardial revascularization procedures are being performed using two surgical techniques--with cardiopulmonary bypass (CPB), usually with cardioplegic arrest ("on-pump"), and without CPB on a beating heart ("off-pump"). The growing multi-center observational study literature related to the off-pump approach suggests that this technique holds promise to both improve patient outcomes (e.g., risk-adjusted mortality and morbidity) and reduce patient care resource use (e.g., post-operative length of stay). The CSP #517 ROOBY Trial has two primary objectives:

• first to assess the immediate impact of the two surgical techniques on 30-day morbidity/mortality, and
• second, to asses the longer-term clinical outcomes of 1-year mortality/morbidity, including mental functioning and graft patency at one year.

Begun on April 15, 2002, the study will enroll 2,200 CABG-only patients over a five-year period (ending April 14, 2007). Cardiac surgeons at 17 VA's, who are experienced in off-pump surgical technique, will randomize eligible patients to on-pump or off-pump treatment arms. Patients will be followed for one year after surgery and outcomes will be recorded.

Left to right: Douglas Bradham, Ph.D. (Cost-Analysis P.I.), Janet Baltz, RN (National Nurse Coord)., Fred Grover, M.D. (P.I.), Laurie Shroyer, Ph.D. (Co-P.I.), Dimitry Novitzky, M.D. (Co-P.I.), Liza Kozora, Ph.D. (Neuropsychological Outcomes P.I.), Joe Collins, Sc.D. (Director and Statistician, Perry Point CSP Coordinating Center), Gerry McDonald, M.D. (VACO Consultant)

VAMC Study Sites: