ROOBY Trial Follow-up Extension

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ClinicalTrials.gov Identifier: NCT01924442

Recruitment Status : Completed

First Posted : August 16, 2013

Results First Posted : June 7, 2019

Last Update Posted : June 7, 2019

View this study on Beta.ClinicalTrials.gov

Sponsor:

Information provided by (Responsible Party):

VA Office of Research and Development

Study Type	Observational
Study Design	Observational Model: Cohort; Time Perspective: Prospective
Conditions	All Cause Mortality MACE
Enrollment	2203

Participant Flow

Recruitment Details
Pre-assignment Details


Arm/Group Title	On-Pump	Off-Pump
Arm/Group Description	Cardiac bypass using Heart Lung Mac...	Cardiac bypass surgery on beating h...
Arm/Group Description	Cardiac bypass using Heart Lung Machine	Cardiac bypass surgery on beating heart
Period Title: Overall Study
Started	1099	1104
Completed	1059	967
Not Completed	40	137

Baseline Characteristics

Arm/Group Title		On-Pump	Off-Pump	Total
Arm/Group Description		Cardiac bypass using Heart Lung Mac...	Cardiac bypass surgery on beating h...	Total of all reporting groups
Arm/Group Description		Cardiac bypass using Heart Lung Machine	Cardiac bypass surgery on beating heart	Total of all reporting groups
Overall Number of Baseline Participants		1099	1104	2203
Baseline Analysis Population Description		[Not Specified]
Baseline Analysis Population Description		[Not Specified]
Age, Categorical Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	1099 participants	1104 participants	2203 participants
	<=18 years	0 0.0%	0 0.0%	0 0.0%
	Between 18 and 65 years	699 63.6%	671 60.8%	1370 62.2%
	>=65 years	400 36.4%	433 39.2%	833 37.8%
Age, Continuous Mean (Standard Deviation) Unit of measure: Years
	Number Analyzed	1099 participants	1104 participants	2203 participants
		62.5 (8.5)	63.0 (8.5)	62.74 (8.49)
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	1099 participants	1104 participants	2203 participants
	Female	6 0.5%	7 0.6%	13 0.6%
	Male	1093 99.5%	1097 99.4%	2190 99.4%
Race/Ethnicity, Customized Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	1099 participants	1104 participants	2203 participants
	Black	93 8.5%	77 7.0%	170 7.7%
	Hispanic	52 4.7%	71 6.4%	123 5.6%
	White	926 84.3%	931 84.3%	1857 84.3%
	Other	27 2.5%	25 2.3%	52 2.4%
	Unknown	1 0.1%	0 0.0%	1 0.0%
Urgent Status requiring surgery within 12 to 72 hours Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	1099 participants	1104 participants	2203 participants
		146 13.3%	146 13.2%	292 13.3%
Chronic obstructive pulmonary disease (COPD) Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	1099 participants	1104 participants	2203 participants
		238 21.7%	220 19.9%	458 20.8%
Peripheral vascular disease Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	1099 participants	1104 participants	2203 participants
		163 14.8%	179 16.2%	342 15.5%
Diabetes Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	1099 participants	1104 participants	2203 participants
		491 44.7%	470 42.6%	961 43.6%
Hypertension Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	1099 participants	1104 participants	2203 participants
		952 86.6%	948 85.9%	1900 86.2%
History of Depression Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	1099 participants	1104 participants	2203 participants
		120 10.9%	146 13.2%	266 12.1%

Outcome Measures

1.Primary Outcome


Title	Long-term All Cause Mortality Between On-pump and Off-pump Patients.
Description	Five-year mortality was initially assessed by matching the participant...
Description	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.
Time Frame	5 Years

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	On-Pump	Off-Pump
Arm/Group Description:	Cardiac bypass using Heart Lung Mac...	Cardiac bypass surgery on beating h...
Arm/Group Description:	Cardiac bypass using Heart Lung Machine	Cardiac bypass surgery on beating heart
Overall Number of Participants Analyzed	1099	1104
Measure Type: Count of Participants Unit of Measure: Participants
All cause death	131 11.9%	168 15.2%
Composite MACE outcome with death	298 27.1%	342 31.0%
No MACE outcome	670 61.0%	594 53.8%

2.Secondary Outcome


Title	Long-term Major Adverse Cardiovascular Event (MACE) Between On-pump and Off-pump Patients
Description	Secondary outcomes included the 5-year rates of death from cardiac cau...
Description	Secondary outcomes included the 5-year rates of death from cardiac causes, repeat revascularization and nonfatal myocardial infarction.
Time Frame	5 years

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	On-Pump	Off-Pump
Arm/Group Description:	Cardiac bypass using Heart Lung Mac...	Cardiac bypass surgery on beating h...
Arm/Group Description:	Cardiac bypass using Heart Lung Machine	Cardiac bypass surgery on beating heart
Overall Number of Participants Analyzed	1099	1104
Measure Type: Count of Participants Unit of Measure: Participants
Death from cardiac causes	58 5.3%	70 6.3%
Acute myocardial infarction	105 9.6%	134 12.1%
Repeat revascularization procedure	131 11.9%	145 13.1%
Percutaneous coronary intrevention	127 11.6%	131 11.9%
Repeat Coronary artery bypass grafting (CABG)	5 0.5%	16 1.4%
No MACE outcome (non cardiac deaths included)	673 61.2%	608 55.1%

Adverse Events

Time Frame	5 Years
Adverse Event Reporting Description	[Not Specified]

Arm/Group Title	On-Pump		Off-Pump
Arm/Group Description	Cardiac bypass using Heart Lung Mac...		Cardiac bypass surgery on beating h...
Arm/Group Description	Cardiac bypass using Heart Lung Machine		Cardiac bypass surgery on beating heart
All-Cause Mortality
	On-Pump		Off-Pump
	Affected / at Risk (%)		Affected / at Risk (%)
Total	131/1099 (11.92%)		168/1104 (15.22%)
Serious Adverse Events Serious Adverse Events
	On-Pump		Off-Pump
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	426/1099 (38.76%)		496/1104 (44.93%)
Cardiac disorders
Death from cardiac causes ^†	58/1099 (5.28%)	58	70/1104 (6.34%)	70
Acute myocardial infarction ^†	105/1099 (9.55%)	105	134/1104 (12.14%)	134
Repeat revascularization procedure ^†	131/1099 (11.92%)	131	145/1104 (13.13%)	145
Percutaneous coronary intervention ^†	127/1099 (11.56%)	127	131/1104 (11.87%)	131
Repeat Coronary artery bypass grafting (CABG) ^†	5/1099 (0.45%)	5	16/1104 (1.45%)	16
† Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	On-Pump		Off-Pump
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/1099 (0.00%)		0/1104 (0.00%)

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact

Layout table for Results Point of Contact information

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Layout table for additonal information

Responsible Party:	VA Office of Research and Development
ClinicalTrials.gov Identifier:	NCT01924442
Other Study ID Numbers:	517-FS
First Submitted:	July 18, 2013
First Posted:	August 16, 2013
Results First Submitted:	September 1, 2017
Results First Posted:	June 7, 2019
Last Update Posted:	June 7, 2019

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