- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01924442
ROOBY Trial Follow-up Extension
CSP #517-FS - ROOBY Trial Extension (Randomized on Pump and Off Pump Bypass Surgery: Long Term Follow-up)
Study Overview
Status
Conditions
Detailed Description
A debate is ongoing as to the potential longer-term benefits of off-pump versus on-pump treatments. A recent meta-analysis summarized 12 randomized trials with follow-up extending beyond 1-year; with a significant increase documented in the late off-pump repeat revascularization and mortality rates. As a very large single center study with longer-term follow-up, a Beijing hospital study reported that their early minor advantages identified for off-pump surgery (n = 3,266) were offset at 4.5 years by an increased risk for cardiac death, acute MI and repeat revascularization as compared to an on-pump (n = 3,399) approach. The OCTOPUS study (a multi-center randomized trial based in the Netherlands) concluded that there was no difference in off-pump versus on-pump procedures for 5-year cardiac outcomes. However, OCTOPUS critics raised questions as to whether this study of only 281 low-risk patients was adequately powered to detect 5-year clinically relevant differences.
The ROOBY trial represents the only US-based, multi-center trial that will be adequately powered to detect clinically relevant, statistically significant differences in these long-term MACE (i.e., all cause mortality, non-fatal myocardial infarction, and/or repeat revascularization) outcomes. Recognized as a landmark study, ROOBY has resulted in important contributions including 10 manuscripts, 2 letters to the editor, and an invited editorial. As of October 11, 2012, over 182 manuscripts (not including any self-citations) had referenced the ROOBY trial's original 2009 publication. Most recently, the ROOBY trial was identified in the 2012 Almanac of adult cardiac surgery, where the national society journals present selected research that has driven recent clinical care advances. Additionally, ROOBY was judged independently by the March 2012 Cochrane systematic review as one of only three, multi-center trials that had been conducted to-date with a low risk of bias.
The original ROOBY trial's enrollment was initiated in February 2002 and ended in June 2007. Given the passage of time, it is now possible to obtain at least 5 years of follow-up to identify these critically important longer-term MACE endpoints for all ROOBY patients. For the earliest ROOBY patients enrolled, their MACE outcomes for up to (and potentially beyond) 10 years post-CABG may be assessed. These MACE endpoints will be ascertained using a combination of VA and non-VA database extracts as well as by chart reviews. In summary, the CSP 517-FS proposed study represents the first, large scale, US-based, multi-center, randomized, controlled off-pump versus on-pump trial that will have adequate power to assess major adverse cardiovascular events beyond 5 years - comparing the long-term effectiveness of these procedures to guide future adult cardiac surgical clinical decision-making processes.
The Department of Veterans Affairs "Randomized On/off Bypass" (ROOBY) Trial (CSP#517; NCT00032630) was funded in 2001.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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New York
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Northport, New York, United States, 11768
- Northport VA Medical Center, Northport, NY
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- All patients that survived to 1 year enrolled in the ROOBY Trial
Exclusion Criteria:
- None
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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On-Pump
Cardiac bypass using Heart Lung Machine
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Off-Pump
Cardiac bypass surgery on beating heart
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Long-term All Cause Mortality Between On-pump and Off-pump Patients.
Time Frame: 5 Years
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Five-year mortality was initially assessed by matching the participants in the follow-up study to data in the VA Vital Status File and the National Death Index, which provided cause-of-death codes according to the International Classification of Diseases, 10th Revision.
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5 Years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Long-term Major Adverse Cardiovascular Event (MACE) Between On-pump and Off-pump Patients
Time Frame: 5 years
|
Secondary outcomes included the 5-year rates of death from cardiac causes, repeat revascularization and nonfatal myocardial infarction.
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5 years
|
Collaborators and Investigators
Investigators
- Study Chair: Annie Laurie Shroyer, PhD MHSA, Northport VA Medical Center, Northport, NY
Publications and helpful links
General Publications
- Quin JA, Wagner TH, Hattler B, Carr BM, Collins J, Almassi GH, Grover FL, Shroyer AL. Ten-Year Outcomes of Off-Pump vs On-Pump Coronary Artery Bypass Grafting in the Department of Veterans Affairs: A Randomized Clinical Trial. JAMA Surg. 2022 Apr 1;157(4):303-310. doi: 10.1001/jamasurg.2021.7578.
- Shroyer AL, Hattler B, Wagner TH, Collins JF, Baltz JH, Quin JA, Almassi GH, Kozora E, Bakaeen F, Cleveland JC Jr, Bishawi M, Grover FL; Veterans Affairs ROOBY-FS Group. Five-Year Outcomes after On-Pump and Off-Pump Coronary-Artery Bypass. N Engl J Med. 2017 Aug 17;377(7):623-632. doi: 10.1056/NEJMoa1614341.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 517-FS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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