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

Medtronic

Status and phase: Completed; Phase 4

Conditions: Coronary Artery Disease

Treatments: Procedure: On-pump bypass surgery; Procedure: Off-pump bypass surgery

Study type: Interventional

Funder types: Industry

Identifiers

NCT01290952

030211

Details and patient eligibility

About

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).

Full 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).

Enrollment: 411 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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411 participants in 2 patient groups

Off-pump bypass surgery

Experimental group

Description:

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

Treatment:

Procedure: Off-pump bypass surgery

On-pump bypass surgery

Active Comparator group

Description:

coronary artery bypass graft with cardiopulmonary bypass (CPB/CAB)

Treatment:

Procedure: On-pump bypass surgery