Trial Outcomes & Findings for Outcomes Following Myocardial Revascularization: On and Off Cardiopulmonary Bypass (NCT NCT00032630)

Results Overview

Short-term end point was a composite of death or major complications (reoperation, new mechanical support, cardiac arrest, coma, stroke, or renal failure requiring dialysis) occuring within 30 days after surgery or before discharge, whichever was later.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

2203 participants

Primary outcome timeframe

30 day

Results posted on

2014-05-05

Participant Flow

From February 2002 to May 2007, a total of 9663 patients who were scheduled for urgent or elective Coronary Artery Bypass Graft (CABG) were screened for enrollment. Of these, 7460 patients were excluded, mostly because of diffusely diseased or small coronary arteries. Overall,1099 patients were randomized to on-pump and 1104 randomized to off-pump

Participant milestones

Participant milestones
Measure	On Pump Coronary artery bypass performed on a non beating heart using a heart-lung machine	Off Pump Coronary artery bypass performed on a beating heart with no heart-lung machine
Overall Study STARTED	1099	1104
Overall Study COMPLETED	1050	1061
Overall Study NOT COMPLETED	49	43

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Outcomes Following Myocardial Revascularization: On and Off Cardiopulmonary Bypass

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	On Pump n=1099 Participants Coronary artery bypass performed on a non beating heart using a heart-lung machine	Off Pump n=1104 Participants Coronary artery bypass performed on a beating heart with no heart-lung machine	Total n=2203 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	699 Participants n=5 Participants	671 Participants n=7 Participants	1370 Participants n=5 Participants
Age, Categorical >=65 years	400 Participants n=5 Participants	433 Participants n=7 Participants	833 Participants n=5 Participants
Age, Continuous	62.5 years STANDARD_DEVIATION 8.5 • n=5 Participants	63.0 years STANDARD_DEVIATION 8.5 • n=7 Participants	62.74 years STANDARD_DEVIATION 8.49 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	7 Participants n=7 Participants	13 Participants n=5 Participants
Sex: Female, Male Male	1093 Participants n=5 Participants	1097 Participants n=7 Participants	2190 Participants n=5 Participants
Region of Enrollment United States	1099 participants n=5 Participants	1104 participants n=7 Participants	2203 participants n=5 Participants

PRIMARY outcome

Timeframe: 30 day

Short-term end point was a composite of death or major complications (reoperation, new mechanical support, cardiac arrest, coma, stroke, or renal failure requiring dialysis) occuring within 30 days after surgery or before discharge, whichever was later.

Outcome measures

Outcome measures
Measure	On Pump n=1099 Participants Coronary artery bypass performed on a non beating heart using a heart-lung machine	Off Pump n=1104 Participants Coronary artery bypass performed on a beating heart with no heart-lung machine
Short-term End Point	61 participants Interval 0.1 to 4.9	77 participants Interval 0.1 to 4.9

PRIMARY outcome

Timeframe: one-year

Long-term composite endpoint was death from any cause within 1 year, nonfatal myocardial infarction between 30 days and 1 year, or repeat revascularization between 30 days and 1 year.

Outcome measures

Outcome measures
Measure	On Pump n=1050 Participants Coronary artery bypass performed on a non beating heart using a heart-lung machine	Off Pump n=1061 Participants Coronary artery bypass performed on a beating heart with no heart-lung machine
Long-term Composite	78 Participants	105 Participants

Adverse Events

On Pump

Serious events: 201 serious events

Other events: 0 other events

Deaths: 0 deaths

Off Pump

Serious events: 220 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	On Pump n=1099 participants at risk Coronary artery bypass performed on a non beating heart using a heart-lung machine	Off Pump n=1104 participants at risk Coronary artery bypass performed on a beating heart with no heart-lung machine
Cardiac disorders Chest Pain	5.8% 64/1099 • Number of events 64	6.2% 69/1104 • Number of events 69
Cardiac disorders Congestive Heart Failure	3.0% 33/1099 • Number of events 33	2.7% 30/1104 • Number of events 30
Respiratory, thoracic and mediastinal disorders Pleural Effusion	2.9% 32/1099 • Number of events 32	2.7% 30/1104 • Number of events 30
Cardiac disorders Myocardial Infarction	1.6% 18/1099 • Number of events 18	3.3% 36/1104 • Number of events 36
Nervous system disorders CVA	1.7% 19/1099 • Number of events 19	1.7% 19/1104 • Number of events 19
Cardiac disorders Atrial Fibrillation	1.4% 15/1099 • Number of events 15	2.0% 22/1104 • Number of events 22
Infections and infestations Wound Infection	1.8% 20/1099 • Number of events 20	1.3% 14/1104 • Number of events 14

Other adverse events

Adverse event data not reported

Additional Information

Frederick Grover, MD

VA Medical Center, Denver, Colorado

Phone: 303-393-2863

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place