Coronary Artery Disease
Conditions
Keywords
off-pump, bypass, coronary artery surgery
Brief summary
Compare completeness and modality of revascularization, operative and postoperative results and 1 year clinical outcomes in unselected high risk patients referred for primary coronary artery bypass surgery. Patients will be randomized to undergo off-pump coronary artery bypass graft (OPCAB) or coronary artery bypass graft with cardiopulmonary bypass (CPB/CAB).
Detailed description
The initial application of off-pump coronary artery bypass in the early nineties was mainly directed to highly selected and relatively low risk surgical patients. Since then there has been a growing body of evidence suggesting many potential advantages of the OPCAB technique over the conventional cardiopulmonary bypass (CPB) technique in different groups of high-risk patients. On-off study is a multicentre, prospective, randomized, parallel, trial.Patients indicated for elective or urgent isolated coronary artery bypass graft with additive European System for Cardiac Operative Risk Evaluation ≥ 6 were enrolled. Patients in cardiogenic shock were excluded. Patients were randomly assigned either to coronary artery bypass surgery with cardiopulmonary bypass (ON arm) or to off-pump coronary artery bypass graft (OFF arm). The composite primary end point included operative mortality, myocardial infarction, stroke, renal failure, re-operation for bleeding and adult respiratory distress syndrome, within 30 days after surgery. The total planned sample size was 693 patients; the actual number of enrolled patients was 411,according to the results of the interim analysis scheduled at 400 enrollments (alfa-spending=0.029, Pocock method).
Interventions
PROCEDUREOff-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.
PROCEDUREOn-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.
Sponsors
Medtronic Italia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Pts candidate to a myocardial revascularization for any patter of coronary artery disease, ventricular dysfunction or any other co-morbidity * EUROSCORE ≥ 6 * Pts who signed the Informed Consent * Age ≥ 18 years
Exclusion criteria
* Patients in cardiogenic shock requiring emergency surgery or preoperative intra-aortic balloon pump * Patients requiring additional surgical procedures * Porcelain Aorta * Lack of informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Post-operative Combined Endpoint (i.e. With One or More of the Following) | 30 days | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Secondary Combined Endpoint (i.e. With One or More of the Following) | 30 days | Number 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 |
Countries
Italy, Switzerland
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 204 |
| 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. | 207 |
| Total | 411 |
Baseline characteristics
| Characteristic | Off Pump | On-pump | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 204 Participants | 207 Participants | 411 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Euroscore > 6 (high risk for early mortality for cardiac surgery) | 204 participants | 207 participants | 411 participants |
| Region of Enrollment Italy | 189 participants | 196 participants | 385 participants |
| Region of Enrollment Switzerland | 15 participants | 11 participants | 26 participants |
| Sex: Female, Male Female | 59 Participants | 67 Participants | 126 Participants |
| Sex: Female, Male Male | 145 Participants | 140 Participants | 285 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 72 / 204 | 79 / 207 |
| serious Total, serious adverse events | 16 / 204 | 30 / 207 |
Outcome results
Primary
Number of Patients With Post-operative Combined Endpoint (i.e. With One or More of the Following)
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
Time frame: 30 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Off Pump | Number of Patients With Post-operative Combined Endpoint (i.e. With One or More of the Following) | 13 participants |
| On-pump | Number of Patients With Post-operative Combined Endpoint (i.e. With One or More of the Following) | 26 participants |
Secondary
Number of Patients With Secondary Combined Endpoint (i.e. With One or More of the Following)
Number 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
Time frame: 30 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Off Pump | Number of Patients With Secondary Combined Endpoint (i.e. With One or More of the Following) | 73 participants |
| On-pump | Number of Patients With Secondary Combined Endpoint (i.e. With One or More of the Following) | 67 participants |