ROOBY Trial Follow-up Extension

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01924442
First received: July 18, 2013
Last updated: June 26, 2014
Last verified: June 2014

July 18, 2013
June 26, 2014
October 2013
September 2016   (final data collection date for primary outcome measure)
Long-term all cause mortality between on-pump and off-pump patients. [ Time Frame: 7 Years ] [ Designated as safety issue: No ]
There is no difference in long-term all cause mortality between on-pump and off-pump patients; with all patients having at least five years of follow-up available. [ Time Frame: 7 Years ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01924442 on ClinicalTrials.gov Archive Site
Long-term major adverse cardiovascular event (MACE) between on-pump and off-pump patients [ Time Frame: 7 years ] [ Designated as safety issue: No ]
There is no difference in long-term major adverse cardiovascular event (MACE) between on-pump and off-pump patients; with all patients having at least five years of follow-up available. From the ROOBY trial's CABG procedure date, MACE will be based upon [ Time Frame: 7 years ] [ Designated as safety issue: No ]
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ROOBY Trial Follow-up Extension
CSP #517-FS - ROOBY Trial Extension (Randomized on Pump and Off Pump Bypass Surgery: Long Term Follow-up)

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).

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, our 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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

To be eligible for the ROOBY trial, subjects were elective or urgent Coronary Artery Bypass only procedure candidates

  • All Cause Mortality
  • MACE
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1
All of the patients that survived to 1 year in the ROOBY Trial
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
2130
October 2016
September 2016   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • All patients that survived to 1 year enrolled in the ROOBY Trial

Exclusion Criteria:

  • None
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01924442
517-FS
No
Department of Veterans Affairs
Department of Veterans Affairs
Not Provided
Study Chair: Annie Laurie Shroyer, PhD MHSA Northport VA Medical Center, Northport, NY
Department of Veterans Affairs
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP