On Versus Off Pump Myocardial Revascularization Study

Phase 4

Completed

Interventions: Procedure: Off-pump bypass surgery
Procedure: On-pump bypass 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).

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Off-pump bypass surgery	Off-pump bypass surgery	Off-pump coronary artery bypass graft (OPCAB) using mandatory a stabilization device and advisable, but not mandatory, a heart positioner
On-pump bypass surgery	On-pump bypass surgery	coronary artery bypass graft with cardiopulmonary bypass (CPB/CAB)

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Locations (8): Policlinico
🇮🇹
Bari, Italy
S. Anna e S. Sebastiano
🇮🇹
Caserta, Italy
Ospedale Luigi Sacco
🇮🇹
Milano, Italy
European Hospital
🇮🇹
Roma, Italy
Ospedale S. Camillo
🇮🇹
Roma, Italy
Ospedale S. Giovanni di Dio e Ruggi d'Aragona
🇮🇹
Salerno, Italy
Ospedale Molinette
🇮🇹
Torino, Italy
University Hospital
🇨🇭
Zurich, Switzerland