NCT01924442

ROOBY Trial Follow-up Extension

Completed Results posted Last updated 7 June 2019

What this trial tests

trial in All Cause Mortality in 2,203 participants. Completed in 30 September 2018.

Timeline

1 October 2013

Primary endpoint
1 September 2016

30 September 2018

Quick facts

Lead sponsor	VA Office of Research and Development
Status	Completed
Study type	OBSERVATIONAL
Enrollment	2,203
Start date	1 October 2013
Primary completion	1 September 2016
Estimated completion	30 September 2018
Sites	1 location across United States

Conditions studied

• All Cause Mortality — all drugs for All Cause Mortality →
• MACE — all drugs for MACE →

Sponsor

VA Office of Research and Development — full company profile →

Who can join

18 and older, any sex, with All Cause Mortality or MACE. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Long-term All Cause Mortality Between On-pump and Off-pump Patients. Primary · 5 Years

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.

Group	Value	95% CI
On-Pump	131
Off-Pump	168
On-Pump	298
Off-Pump	342
On-Pump	670
Off-Pump	594

Long-term Major Adverse Cardiovascular Event (MACE) Between On-pump and Off-pump Patients Secondary · 5 years

Secondary outcomes included the 5-year rates of death from cardiac causes, repeat revascularization and nonfatal myocardial infarction.

Death from cardiac causes

Group	Value	95% CI
On-Pump	58
Off-Pump	70

Acute myocardial infarction

Group	Value	95% CI
On-Pump	105
Off-Pump	134

Repeat revascularization procedure

Group	Value	95% CI
On-Pump	131
Off-Pump	145

Percutaneous coronary intrevention

Group	Value	95% CI
On-Pump	127
Off-Pump	131

Repeat Coronary artery bypass grafting (CABG)

Group	Value	95% CI
On-Pump	5
Off-Pump	16

No MACE outcome (non cardiac deaths included)

Group	Value	95% CI
On-Pump	673
Off-Pump	608

Adverse events — posted to ClinicalTrials.gov

Time frame: 5 Years. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

On-Pump

Serious: 426/1099 (39%)

Deaths: 131/1099

Off-Pump

Serious: 496/1104 (45%)

Deaths: 168/1104

Serious adverse events (5 terms)

Reaction	System	On-Pump	Off-Pump
Repeat revascularization procedure	Cardiac disorders	—	—
Acute myocardial infarction	Cardiac disorders	—	—
Percutaneous coronary intervention	Cardiac disorders	—	—
Death from cardiac causes	Cardiac disorders	—	—
Repeat Coronary artery bypass grafting (CABG)	Cardiac disorders	—	—

Most-reported serious reactions: Repeat revascularization procedure, Acute myocardial infarction, Percutaneous coronary intervention, Death from cardiac causes, Repeat Coronary artery bypass grafting (CABG).

Data from ClinicalTrials.gov NCT01924442 adverse events section.

Sponsor's own description

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).

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Five-Year Outcomes after On-Pump and Off-Pump Coronary-Artery Bypass.
   Shroyer AL, Hattler B, Wagner TH, Collins JF, et al · · 2017 · cited 182× · PMID 28813218 · DOI 10.1056/nejmoa1614341
2. Ten-Year Outcomes of Off-Pump vs On-Pump Coronary Artery Bypass Grafting in the Department of Veterans Affairs: A Randomized Clinical Trial.
   Quin JA, Wagner TH, Hattler B, Carr BM, et al · · 2022 · cited 46× · PMID 35171210 · DOI 10.1001/jamasurg.2021.7578