On Versus Off Pump Myocardial Revascularization Study

Study Overview
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Brief Summary
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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
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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).

Official Title
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ON Pump vs OFF Pump Myocardial Revascularization in High Risk Patients: a Randomized Study

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Procedure: Off-pump bypass surgery
* Procedure: On-pump bypass surgery


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Off-pump bypass surgery<br>Off-pump coronary artery bypass graft (OPCAB) using mandatory a stabilization device and advisable, but not mandatory, a heart positioner | Procedure: Off-pump bypass surgery<br>* 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.<br>|
| Active Comparator: On-pump bypass surgery<br>coronary artery bypass graft with cardiopulmonary bypass (CPB/CAB) | Procedure: On-pump bypass surgery<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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off-pump, bypass, coronary artery surgery