NCT01290952

On Versus Off Pump Myocardial Revascularization Study

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 411 (actual)
• Sponsor: Medtronic Italia · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
PROCEDURE	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.
PROCEDURE	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.

Timeline

• Start date: 2006-09-01
• Primary completion: 2010-06-01
• Completion: 2011-06-01
• First posted: 2011-02-07
• Last updated: 2016-11-21
• Results posted: 2016-11-21

Locations

8 sites across 2 countries: Italy, Switzerland