Phase 3
Completed N=2,203
Outcomes Following Myocardial Revascularization: On and Off Cardiopulmonary Bypass
Source: ClinicalTrials.gov NCT00032630 ↗Enrolled (actual)
2,203
Serious AEs
19.1%
Results posted
Jan 2014
Primary outcomePrimary: Short-term End Point — 61; 77 participants
Summary
Ischemic heart disease is one of the most frequent diagnoses in the VA system. Moreover, 5,819 coronary artery bypass graft (CABG-only) procedures were performed in the VA in Fiscal Year (FY) 1999. Throughout VA and non-VA cardiac surgery programs nationwide, myocardial revascularization is now being performed using two surgical techniques. One technique is performed with cardiopulmonary bypass (CPB) usually with cardioplegic arrest ("on-pump") and the other without CPB on a beating heart ("off-pump"). The overall purpose of this proposed randomized, controlled, clinical trial is to rigorously evaluate the impact of using an on-pump versus off-pump surgical technique for coronary artery bypass graft (CABG-only) procedures (performed with a traditional median sternotomy incision) upon patient clinical outcomes and resource utilization.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Short-term End Point |
61; 77 | — |
| PRIMARY Long-term Composite |
78; 105 | — |
Eligibility Criteria
Inclusion Criteria
- Elective or Urgent CABG
- CABG only procedure to be performed
Exclusion Criteria
- Patient's surgeon is not a participant that meets study off-pup criteria
- Valve or Valve/CABG procedure
- Emergent, hemodynamically unstable, or in cardiogenic shock preoperatively
- Moderate, moderate, to severe, or severe valvular disease
- Enrolled in another therapeutic or interventional study
- Majority of diffusely diseased distal vessels
- Clinical Care Team has reservations
- History of on-compliance
- Patient preference for treatment arm
- Inability to provide informed consent
Data sourced from ClinicalTrials.gov (NCT00032630). 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. Informational only — not medical advice.