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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.
Primary Hypotheses: The study has two primary hypotheses to evaluate the impact of using an off-pump versus an on-pump surgical technique for CABG procedures. One is a short term objective to assess the immediate impact of the two surgical techniques while the second assesses the long-term impact of the two techniques: 1) Short-Term Null Hypothesis: For patients having CABG-only procedures performed, there will be no difference in the short-term composite clinical outcome (30 day death or major morbidity) between patients randomized to the on-pump and off-pump procedures, 2) Long-Term Null Hypothesis: For patients undergoing CABG-only procedures, there will be no difference in long-term clinical outcome as measured by one year mortality and/or acute myocardial infarction prior to one year and/or a subsequent revascularization procedure within one year between patients randomized to the on-pump and off-pump procedures.
Secondary Hypotheses: Major secondary objectives are to determine if there are differences in patients undergoing CABG-only procedures using the on-pump and off-pump techniques for 1) long-term completeness of revascularization, 2) one year graft patency and stenosis rates as determined by angiography at one year, and 3) short-term completeness of revascularization. Other secondary objectives are to evaluate the two surgical techniques on 1) changes in neuropsychological function, 2) traditional clinical outcomes, 3) general and disease specific quality of life, and 4) use of system resources.
Intervention: Patients requiring an elective or urgent CABG-only (no other procedures to be done) surgical procedure will be randomized to either the off-pump procedure or to the on-pump procedure.
Primary Outcomes: The short-term primary outcome measure is a composite measure of death, repeat cardiac surgery, new technical support, cardiac arrest, coma, prolonged stroke and/or renal failure requiring dialyses occurring within 30 days of surgery or prior to discharge, whichever is latest. The long-term primary outcome measure is a composite of death, acute myocardial infarction, and/or subsequent revascularization procedure prior to one year post-surgery.
Study Abstract: 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 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Other | Coronary artery bypass - on-pump |
|
| Arm 2 | Other | Coronary artery bypass - off-pump |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Coronary artery bypass - on-pump | Procedure | CABG procedure performed on heart lung machine |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Short-term End Point | Short-term end point was a composite of death or major complications (reoperation, new mechanical support, cardiac arrest, coma, stroke, or renal failure requiring dialysis) occuring within 30 days after surgery or before discharge, whichever was later. | 30 day |
| Long-term Composite | Long-term composite endpoint was death from any cause within 1 year, nonfatal myocardial infarction between 30 days and 1 year, or repeat revascularization between 30 days and 1 year. | one-year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Frederick Grover, MD | VA Eastern Colorado Health Care System, Denver | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Palo Alto Health Care System | Palo Alto | California | 94304-1290 | United States | ||
| VA Medical Center, San Francisco |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19890125 | Result | Shroyer AL, Grover FL, Hattler B, Collins JF, McDonald GO, Kozora E, Lucke JC, Baltz JH, Novitzky D; Veterans Affairs Randomized On/Off Bypass (ROOBY) Study Group. On-pump versus off-pump coronary-artery bypass surgery. N Engl J Med. 2009 Nov 5;361(19):1827-37. doi: 10.1056/NEJMoa0902905. | |
| 23916805 | Result | Wagner TH, Hattler B, Bishawi M, Baltz JH, Collins JF, Quin JA, Grover FL, Shroyer AL; VA #517 Randomized On/Off Bypass (ROOBY) Study Group. On-pump versus off-pump coronary artery bypass surgery: cost-effectiveness analysis alongside a multisite trial. Ann Thorac Surg. 2013 Sep;96(3):770-7. doi: 10.1016/j.athoracsur.2013.04.074. Epub 2013 Aug 2. |
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From February 2002 to May 2007, a total of 9663 patients who were scheduled for urgent or elective Coronary Artery Bypass Graft (CABG) were screened for enrollment. Of these, 7460 patients were excluded, mostly because of diffusely diseased or small coronary arteries. Overall,1099 patients were randomized to on-pump and 1104 randomized to off-pump
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| ID | Title | Description |
|---|---|---|
| FG000 | On Pump | Coronary artery bypass performed on a non beating heart using a heart-lung machine |
| FG001 | Off Pump | Coronary artery bypass performed on a beating heart with no heart-lung machine |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Coronary artery bypass - off-pump |
| Procedure |
CABG procedure performed without the use of the heart lung machine |
|
| San Francisco |
| California |
| 94121 |
| United States |
| VA Greater Los Angeles HCS, Sepulveda | Sepulveda | California | 91343 | United States |
| VA Eastern Colorado Health Care System, Denver | Denver | Colorado | 80220 | United States |
| VA Medical Center, DC | Washington D.C. | District of Columbia | 20422 | United States |
| North Florida/South Georgia Veterans Health System | Gainesville | Florida | 32608 | United States |
| VA Medical Center, Miami | Miami | Florida | 33125 | United States |
| James A. Haley Veterans Hospital, Tampa | Tampa | Florida | 33612 | United States |
| New Mexico VA Health Care System, Albuquerque | Albuquerque | New Mexico | 87108-5153 | United States |
| VA Medical Center, Asheville | Asheville | North Carolina | 28805 | United States |
| VA Medical Center, Durham | Durham | North Carolina | 27705 | United States |
| VA Medical Center, Cleveland | Cleveland | Ohio | 44106 | United States |
| VA Medical Center, Portland | Portland | Oregon | 97201 | United States |
| VA Pittsburgh Health Care System | Pittsburgh | Pennsylvania | 15240 | United States |
| VA North Texas Health Care System, Dallas | Dallas | Texas | 75216 | United States |
| VA South Texas Health Care System, San Antonio | San Antonio | Texas | 78229 | United States |
| Zablocki VA Medical Center, Milwaukee | Milwaukee | Wisconsin | 53295-1000 | United States |
| 31001997 | Derived | Hattler B, Carr BM, Messenger J, Spertus J, Ebrahimi R, Bishawi M, Quin JA, Almassi GH, Collins JF, Kozora E, Grover FL, Shroyer ALW. Clinical and Angiographic Predictors of Patient-Reported Angina 1 Year After Coronary Artery Bypass Graft Surgery. Circ Cardiovasc Qual Outcomes. 2019 Apr;12(4):e005119. doi: 10.1161/CIRCOUTCOMES.118.005119. |
| 29653645 | Derived | Bishawi M, Hattler B, Almassi GH, Spertus JA, Quin JA, Collins JF, Grover FL, Shroyer AL; VA #517 Randomized On/Off Bypass (ROOBY) Study Group. Preoperative factors associated with worsening in health-related quality of life following coronary artery bypass grafting in the Randomized On/Off Bypass (ROOBY) trial. Am Heart J. 2018 Apr;198:33-38. doi: 10.1016/j.ahj.2017.12.014. Epub 2017 Dec 24. |
| 26470910 | Derived | Almassi GH, Carr BM, Bishawi M, Shroyer AL, Quin JA, Hattler B, Wagner TH, Collins JF, Ravichandran P, Cleveland JC, Grover FL, Bakaeen FG; Veterans Affairs #517 Randomized On/Off Bypass (ROOBY) Study Group. Resident versus attending surgeon graft patency and clinical outcomes in on- versus off-pump coronary artery bypass surgery. J Thorac Cardiovasc Surg. 2015 Dec;150(6):1428-35, 1437.e1; discussion 1435-7. doi: 10.1016/j.jtcvs.2015.08.124. Epub 2015 Sep 18. |
| 25442992 | Derived | Almassi GH, Wagner TH, Carr B, Hattler B, Collins JF, Quin JA, Ebrahimi R, Grover FL, Bishawi M, Shroyer AL; VA #517 Randomized On/Off Bypass (ROOBY) Study Group. Postoperative atrial fibrillation impacts on costs and one-year clinical outcomes: the Veterans Affairs Randomized On/Off Bypass Trial. Ann Thorac Surg. 2015 Jan;99(1):109-14. doi: 10.1016/j.athoracsur.2014.07.035. Epub 2014 Nov 6. |
| 22592900 | Derived | Hattler B, Messenger JC, Shroyer AL, Collins JF, Haugen SJ, Garcia JA, Baltz JH, Cleveland JC Jr, Novitzky D, Grover FL; Veterans Affairs Randomized On/Off Bypass (ROOBY) Study Group. Off-Pump coronary artery bypass surgery is associated with worse arterial and saphenous vein graft patency and less effective revascularization: Results from the Veterans Affairs Randomized On/Off Bypass (ROOBY) trial. Circulation. 2012 Jun 12;125(23):2827-35. doi: 10.1161/CIRCULATIONAHA.111.069260. Epub 2012 May 16. |
| 21978872 | Derived | Novitzky D, Baltz JH, Hattler B, Collins JF, Kozora E, Shroyer AL, Grover FL. Outcomes after conversion in the Veterans Affairs randomized on versus off bypass trial. Ann Thorac Surg. 2011 Dec;92(6):2147-54. doi: 10.1016/j.athoracsur.2011.05.122. Epub 2011 Oct 5. |
| 21130476 | Derived | Zenati MA, Shroyer AL, Collins JF, Hattler B, Ota T, Almassi GH, Amidi M, Novitzky D, Grover FL, Sonel AF. Impact of endoscopic versus open saphenous vein harvest technique on late coronary artery bypass grafting patient outcomes in the ROOBY (Randomized On/Off Bypass) Trial. J Thorac Cardiovasc Surg. 2011 Feb;141(2):338-44. doi: 10.1016/j.jtcvs.2010.10.004. Epub 2010 Dec 3. |
| COMPLETED |
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| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | On Pump | Coronary artery bypass performed on a non beating heart using a heart-lung machine |
| BG001 | Off Pump | Coronary artery bypass performed on a beating heart with no heart-lung machine |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Short-term End Point | Short-term end point was a composite of death or major complications (reoperation, new mechanical support, cardiac arrest, coma, stroke, or renal failure requiring dialysis) occuring within 30 days after surgery or before discharge, whichever was later. | Posted | Number | participants | 30 day |
|
|
| ||||||||||||||||||||||||||||||
| Primary | Long-term Composite | Long-term composite endpoint was death from any cause within 1 year, nonfatal myocardial infarction between 30 days and 1 year, or repeat revascularization between 30 days and 1 year. | Posted | Number | Participants | one-year |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | On Pump | Coronary artery bypass performed on a non beating heart using a heart-lung machine | 201 | 1,099 | 0 | 1,099 | ||
| EG001 | Off Pump | Coronary artery bypass performed on a beating heart with no heart-lung machine | 220 | 1,104 | 0 | 1,104 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chest Pain | Cardiac disorders |
| |||
| Congestive Heart Failure | Cardiac disorders |
| |||
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders |
| |||
| Myocardial Infarction | Cardiac disorders |
| |||
| CVA | Nervous system disorders |
| |||
| Atrial Fibrillation | Cardiac disorders |
| |||
| Wound Infection | Infections and infestations |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Frederick Grover, MD | VA Medical Center, Denver, Colorado | 303-393-2863 | Frederick.Grover@ucdenver.edu |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D047549 | Coronary Artery Bypass, Off-Pump |
| ID | Term |
|---|---|
| D001026 | Coronary Artery Bypass |
| D009204 | Myocardial Revascularization |
| D006348 | Cardiac Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D058017 | Vascular Grafting |
| D014656 | Vascular Surgical Procedures |
| D019616 | Thoracic Surgical Procedures |
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| >=65 years |
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| Male |
|
|