Clinical trial NCT00032630: Outcomes Following Myocardial Revascularization: On and Off Cardiopulmonary Bypass
Official title: CSP #517 - Outcomes Following Myocardial Revascularization: On and Off Cardiopulmonary Bypass
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Ischemic Heart Disease
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2002-03-28
Enrollment: 2203
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

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

Primary outcomes:
measure: Short-term End Point
timeFrame: 30 day
measure: Long-term Composite
timeFrame: one-year
Secondary outcomes:
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: VA Palo Alto Health Care System
state: California
city: San Francisco
country: United States
facility: VA Medical Center, San Francisco
state: California
city: Sepulveda
country: United States
facility: VA Greater Los Angeles HCS, Sepulveda
state: California
city: Denver
country: United States
facility: VA Eastern Colorado Health Care System, Denver
state: Colorado
city: Washington
country: United States
facility: VA Medical Center, DC
state: District of Columbia
city: Gainesville
country: United States
facility: North Florida/South Georgia Veterans Health System
state: Florida
city: Miami
country: United States
facility: VA Medical Center, Miami
state: Florida
city: Tampa
country: United States
facility: James A. Haley Veterans Hospital, Tampa
state: Florida
city: Albuquerque
country: United States
facility: New Mexico VA Health Care System, Albuquerque
state: New Mexico
city: Asheville
country: United States
facility: VA Medical Center, Asheville
state: North Carolina
city: Durham
country: United States
facility: VA Medical Center, Durham
state: North Carolina
city: Cleveland
country: United States
facility: VA Medical Center, Cleveland
state: Ohio
city: Portland
country: United States
facility: VA Medical Center, Portland
state: Oregon
city: Pittsburgh
country: United States
facility: VA Pittsburgh Health Care System
state: Pennsylvania
city: Dallas
country: United States
facility: VA North Texas Health Care System, Dallas
state: Texas
city: San Antonio
country: United States
facility: VA South Texas Health Care System, San Antonio
state: Texas
city: Milwaukee
country: United States
facility: Zablocki VA Medical Center, Milwaukee
state: Wisconsin
Study officials:
affiliation: VA Eastern Colorado Health Care System, Denver
name: Frederick Grover, MD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.