Trial Outcomes & Findings for On Versus Off Pump Myocardial Revascularization Study (NCT NCT01290952)
NCT ID: NCT01290952
Last Updated: 2016-11-21
Results Overview
Number of patients with one or more of the following: * Operative Mortality * Myocardial Infarction * Postoperative neurological complications * Renal failure * ARDS (Acute Respiratory Distress Syndrome) * Bleeding
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
411 participants
Primary outcome timeframe
30 days
Results posted on
2016-11-21
Participant Flow
630 patients was the planned estimated sample size needed to test the null hypothesis. An interim analysis was scheduled at 400 enrolled patients, to verify the null hypothesis used for the sample size calculation. A p\<0.0294 was considered statistically significant to reject the null hypothesis, thus study enrollment was stopped at 411 patients.
Participant milestones
| Measure |
Off Pump
Off-pump coronary artery bypass graft (OPCAB) using mandatory a stabilization device and advisable, but not mandatory, a heart positioner
Off-pump bypass surgery: is a method of performing a coronary bypass operation for the purpose of treating advanced coronary heart disease while the heart is still beating normally.
|
On-pump
coronary artery bypass graft with cardiopulmonary bypass (CPB/CAB)
On-pump bypass surgery: is a technique that temporarily takes over the function of the heart and lungs during surgery, maintaining the circulation of blood and the oxygen content of the body.
|
|---|---|---|
|
Overall Study
STARTED
|
204
|
207
|
|
Overall Study
COMPLETED
|
192
|
193
|
|
Overall Study
NOT COMPLETED
|
12
|
14
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
On Versus Off Pump Myocardial Revascularization Study
Baseline characteristics by cohort
| Measure |
Off Pump
n=204 Participants
Off-pump coronary artery bypass graft (OPCAB) using mandatory a stabilization device and advisable, but not mandatory, a heart positioner
Off-pump bypass surgery: is a method of performing a coronary bypass operation for the purpose of treating advanced coronary heart disease while the heart is still beating normally.
|
On-pump
n=207 Participants
coronary artery bypass graft with cardiopulmonary bypass (CPB/CAB)
On-pump bypass surgery: is a technique that temporarily takes over the function of the heart and lungs during surgery, maintaining the circulation of blood and the oxygen content of the body.
|
Total
n=411 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
204 Participants
n=5 Participants
|
207 Participants
n=7 Participants
|
411 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
59 Participants
n=5 Participants
|
67 Participants
n=7 Participants
|
126 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
145 Participants
n=5 Participants
|
140 Participants
n=7 Participants
|
285 Participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
189 participants
n=5 Participants
|
196 participants
n=7 Participants
|
385 participants
n=5 Participants
|
|
Region of Enrollment
Switzerland
|
15 participants
n=5 Participants
|
11 participants
n=7 Participants
|
26 participants
n=5 Participants
|
|
Euroscore > 6 (high risk for early mortality for cardiac surgery)
|
204 participants
n=5 Participants
|
207 participants
n=7 Participants
|
411 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 30 daysNumber of patients with one or more of the following: * Operative Mortality * Myocardial Infarction * Postoperative neurological complications * Renal failure * ARDS (Acute Respiratory Distress Syndrome) * Bleeding
Outcome measures
| Measure |
Off Pump
n=204 Participants
Off-pump coronary artery bypass graft (OPCAB) using mandatory a stabilization device and advisable, but not mandatory, a heart positioner
Off-pump bypass surgery: is a method of performing a coronary bypass operation for the purpose of treating advanced coronary heart disease while the heart is still beating normally.
|
On-pump
n=207 Participants
coronary artery bypass graft with cardiopulmonary bypass (CPB/CAB)
On-pump bypass surgery: is a technique that temporarily takes over the function of the heart and lungs during surgery, maintaining the circulation of blood and the oxygen content of the body.
|
|---|---|---|
|
Number of Patients With Post-operative Combined Endpoint (i.e. With One or More of the Following)
|
13 participants
|
26 participants
|
SECONDARY outcome
Timeframe: 30 daysNumber of patients with one of more of the following: * Post-operative Atrial Fibrillation * IAPB (Intra-Aortic Balloon Pump) insertion and low cardiac output syndrome * Ventilation \> 24h * Sternal wound infection or dehiscence
Outcome measures
| Measure |
Off Pump
n=207 Participants
Off-pump coronary artery bypass graft (OPCAB) using mandatory a stabilization device and advisable, but not mandatory, a heart positioner
Off-pump bypass surgery: is a method of performing a coronary bypass operation for the purpose of treating advanced coronary heart disease while the heart is still beating normally.
|
On-pump
n=204 Participants
coronary artery bypass graft with cardiopulmonary bypass (CPB/CAB)
On-pump bypass surgery: is a technique that temporarily takes over the function of the heart and lungs during surgery, maintaining the circulation of blood and the oxygen content of the body.
|
|---|---|---|
|
Number of Patients With Secondary Combined Endpoint (i.e. With One or More of the Following)
|
73 participants
|
67 participants
|
Adverse Events
Off Pump
Serious events: 16 serious events
Other events: 72 other events
Deaths: 0 deaths
On-pump
Serious events: 30 serious events
Other events: 79 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Off Pump
n=204 participants at risk
Off-pump coronary artery bypass graft (OPCAB) using mandatory a stabilization device and advisable, but not mandatory, a heart positioner
Off-pump bypass surgery: is a method of performing a coronary bypass operation for the purpose of treating advanced coronary heart disease while the heart is still beating normally.
|
On-pump
n=207 participants at risk
coronary artery bypass graft with cardiopulmonary bypass (CPB/CAB)
On-pump bypass surgery: is a technique that temporarily takes over the function of the heart and lungs during surgery, maintaining the circulation of blood and the oxygen content of the body.
|
|---|---|---|
|
Cardiac disorders
Overall mortality
|
5.9%
12/204 • Number of events 12 • 1 year
|
6.8%
14/207 • Number of events 14 • 1 year
|
|
Cardiac disorders
MACE
|
2.0%
4/204 • Number of events 4 • 1 year
|
7.7%
16/207 • Number of events 16 • 1 year
|
Other adverse events
| Measure |
Off Pump
n=204 participants at risk
Off-pump coronary artery bypass graft (OPCAB) using mandatory a stabilization device and advisable, but not mandatory, a heart positioner
Off-pump bypass surgery: is a method of performing a coronary bypass operation for the purpose of treating advanced coronary heart disease while the heart is still beating normally.
|
On-pump
n=207 participants at risk
coronary artery bypass graft with cardiopulmonary bypass (CPB/CAB)
On-pump bypass surgery: is a technique that temporarily takes over the function of the heart and lungs during surgery, maintaining the circulation of blood and the oxygen content of the body.
|
|---|---|---|
|
Cardiac disorders
angina
|
2.5%
5/204 • Number of events 5 • 1 year
|
2.9%
6/207 • Number of events 6 • 1 year
|
|
Cardiac disorders
Post-operative AF
|
21.6%
44/204 • Number of events 44 • 1 year
|
21.3%
44/207 • Number of events 44 • 1 year
|
|
Cardiac disorders
IABP insertion
|
3.4%
7/204 • Number of events 7 • 1 year
|
1.9%
4/207 • Number of events 4 • 1 year
|
|
Injury, poisoning and procedural complications
Ventilation >24 h
|
4.4%
9/204 • Number of events 9 • 1 year
|
7.2%
15/207 • Number of events 15 • 1 year
|
|
Injury, poisoning and procedural complications
Wound infection
|
3.4%
7/204 • Number of events 7 • 1 year
|
4.8%
10/207 • Number of events 10 • 1 year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place