N/A
N=2,203
ROOBY Trial Follow-up Extension
All Cause Mortality · MACE
Bottom Line
View on ClinicalTrials.gov: NCT01924442 ↗Enrolled (actual)
2,203
Serious AEs
41.9%
Results posted
Jun 2019
Primary outcome: Primary: Long-term All Cause Mortality Between On-pump and Off-pump Patients. — 131; 168; 298; 342 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Sep 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Long-term All Cause Mortality Between On-pump and Off-pump Patients. |
131; 168; 298; 342; 670; 594 | — |
| SECONDARY Long-term Major Adverse Cardiovascular Event (MACE) Between On-pump and Off-pump Patients |
58; 70; 105; 134; 131; 145 | — |
Summary
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).
Eligibility Criteria
Inclusion Criteria
- All patients that survived to 1 year enrolled in the ROOBY Trial
Exclusion Criteria
- None
Data sourced from ClinicalTrials.gov (NCT01924442). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.