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
  Purpose

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).


Condition
All Cause Mortality
MACE

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: CSP #517-FS - ROOBY Trial Extension (Randomized on Pump and Off Pump Bypass Surgery: Long Term Follow-up)

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Long-term all cause mortality between on-pump and off-pump patients. [ Time Frame: 7 Years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Long-term major adverse cardiovascular event (MACE) between on-pump and off-pump patients [ Time Frame: 7 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 2130
Study Start Date: October 2013
Estimated Study Completion Date: October 2016
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
All of the patients that survived to 1 year in the ROOBY Trial

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, 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • None
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01924442

Locations
United States, New York
Northport VA Medical Center, Northport, NY
Northport, New York, United States, 11768
Sponsors and Collaborators
Investigators
Study Chair: Annie Laurie Shroyer, PhD MHSA Northport VA Medical Center, Northport, NY
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT01924442     History of Changes
Other Study ID Numbers: 517-FS
Study First Received: July 18, 2013
Last Updated: June 26, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Coronary Artery Disease
Off-Pump
Myocardial Ischemia
Heart Disease

ClinicalTrials.gov processed this record on October 19, 2014