NCT01924442

Brief Summary

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,203

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 18, 2013

Completed
29 days until next milestone

First Posted

Study publicly available on registry

August 16, 2013

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2013

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2018

Completed
8 months until next milestone

Results Posted

Study results publicly available

June 7, 2019

Completed
Last Updated

June 7, 2019

Status Verified

March 1, 2019

Enrollment Period

2.9 years

First QC Date

July 18, 2013

Results QC Date

September 1, 2017

Last Update Submit

March 6, 2019

Conditions

All Cause MortalityMACE

Keywords

Coronary Artery DiseaseOff-PumpMyocardial IschemiaHeart Disease

Outcome Measures

Primary Outcomes (1)

  • Long-term All Cause Mortality Between On-pump and Off-pump Patients.

    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.

    5 Years

Secondary Outcomes (1)

  • Long-term Major Adverse Cardiovascular Event (MACE) Between On-pump and Off-pump Patients

    5 years

Study Arms (2)

On-Pump

Cardiac bypass using Heart Lung Machine

Off-Pump

Cardiac bypass surgery on beating heart

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northport VA Medical Center, Northport, NY

Northport, New York, 11768, United States

Location

Related Publications (2)

  • 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.

    PMID: 35171210DERIVED

  • 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.

    PMID: 28813218DERIVED

MeSH Terms

Conditions

Coronary Artery DiseaseMyocardial IschemiaHeart Diseases

Condition Hierarchy (Ancestors)

Coronary DiseaseCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Results Point of Contact

Title
Frederick Grover, MD
Organization
VA Medical Center, Denver, Colorado
Frederic.Grover@ucdenver.edu
303-724-2798

Study Officials

  • Annie Laurie Shroyer, PhD MHSA

    Northport VA Medical Center, Northport, NY

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 18, 2013

First Posted

August 16, 2013

Study Start

October 1, 2013

Primary Completion

September 1, 2016

Study Completion

September 30, 2018

Last Updated

June 7, 2019

Results First Posted

June 7, 2019

Record last verified: 2019-03

Locations

US(1)