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ROOBY Trial Follow-up Extension
Not Recruiting
Trial ID: NCT01924442
Purpose
The Department of Veterans Affairs "Randomized On/Off Bypass" (ROOBY) Trial (CSP #517) was
funded in 2001. ROOBY was designed to compare the short-term (30-day) and intermediate-term
(1-year) outcomes for patients undergoing off-pump versus on-pump coronary artery bypass
graft (CABG) procedures. The ROOBY trial reported a significantly higher 1-year adverse
composite outcome rate (i.e., all-cause death, non-fatal myocardial infarction (MI) and/or
repeat revascularization) for off-pump versus on-pump patients. ROOBY documented that a
higher percentage of off-pump patients received fewer grafts than originally planned (i.e.,
off-pump patients were less completely revascularized) as compared to on-pump patients.
Across all anatomic regions of the heart, the 1-year graft patency rates were significantly
lower for off-pump CABG patients. Based on these ROOBY trial initial findings, critically
important clinical questions related to the long-term efficacy, stability and durability of
the off-pump versus on-pump techniques have been raised. Extending the original ROOBY trial,
this CSP #517 follow-up study (CSP 517-FS) will evaluate the longer-term impact of off-pump
versus on-pump surgical approaches upon the future occurrence of major adverse cardiovascular
events (MACE).
Official Title
CSP #517-FS - ROOBY Trial Extension (Randomized on Pump and Off Pump Bypass Surgery: Long Term Follow-up)
Stanford Investigator(s)
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305