On Versus Off Pump Myocardial Revascularization Study (On-Off)
Primary Purpose
Coronary Artery Disease
Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Off-pump bypass surgery
On-pump bypass surgery
Sponsored by

About this trial
This is an interventional treatment trial for Coronary Artery Disease focused on measuring off-pump, bypass, coronary artery surgery
Eligibility Criteria
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
Sites / Locations
- Policlinico
- S. Anna e S. Sebastiano
- Ospedale Luigi Sacco
- European Hospital
- Ospedale S. Camillo
- Ospedale S. Giovanni di Dio e Ruggi d'Aragona
- Ospedale Molinette
- University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Off-pump bypass surgery
On-pump bypass surgery
Arm Description
Off-pump coronary artery bypass graft (OPCAB) using mandatory a stabilization device and advisable, but not mandatory, a heart positioner
coronary artery bypass graft with cardiopulmonary bypass (CPB/CAB)
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01290952
Brief Title
On Versus Off Pump Myocardial Revascularization Study
Acronym
On-Off
Official Title
ON Pump vs OFF Pump Myocardial Revascularization in High Risk Patients: a Randomized Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
June 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic Italia
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
off-pump, bypass, coronary artery surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
411 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Off-pump bypass surgery
Arm Type
Experimental
Arm Description
Off-pump coronary artery bypass graft (OPCAB) using mandatory a stabilization device and advisable, but not mandatory, a heart positioner
Arm Title
On-pump bypass surgery
Arm Type
Active Comparator
Arm Description
coronary artery bypass graft with cardiopulmonary bypass (CPB/CAB)
Intervention Type
Procedure
Intervention Name(s)
Off-pump bypass surgery
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
On-pump bypass surgery
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Patients With Post-operative Combined Endpoint (i.e. With One or More of the Following)
Description
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
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Number of Patients With Secondary Combined Endpoint (i.e. With One or More of the Following)
Description
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
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Massimo Lemma, Dr.
Organizational Affiliation
Ospedale Sacco-Milano
Official's Role
Principal Investigator
Facility Information:
Facility Name
Policlinico
City
Bari
Country
Italy
Facility Name
S. Anna e S. Sebastiano
City
Caserta
Country
Italy
Facility Name
Ospedale Luigi Sacco
City
Milano
ZIP/Postal Code
20100
Country
Italy
Facility Name
European Hospital
City
Roma
Country
Italy
Facility Name
Ospedale S. Camillo
City
Roma
Country
Italy
Facility Name
Ospedale S. Giovanni di Dio e Ruggi d'Aragona
City
Salerno
Country
Italy
Facility Name
Ospedale Molinette
City
Torino
Country
Italy
Facility Name
University Hospital
City
Zurich
Country
Switzerland
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
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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On Versus Off Pump Myocardial Revascularization Study
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