On Versus Off Pump Myocardial Revascularization Study (On-Off)

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).

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).

Off-pump coronary artery bypass graft (OPCAB) using mandatory a stabilization device and advisable, but not mandatory, a heart positioner

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.

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 one or more of the following: Operative Mortality Myocardial Infarction Postoperative neurological complications Renal failure ARDS (Acute Respiratory Distress Syndrome) Bleeding

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

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

The main manuscript with the results of the primary endpoint analysis was published in December 2011.There are no plans to make individual partecipant data available

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