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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01290952
Recruitment Status : Completed
First Posted : February 7, 2011
Results First Posted : November 21, 2016
Last Update Posted : November 21, 2016
Information provided by (Responsible Party):
Medtronic Italia

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).

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Procedure: Off-pump bypass surgery Procedure: On-pump bypass surgery Phase 4

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 411 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: ON Pump vs OFF Pump Myocardial Revascularization in High Risk Patients: a Randomized Study
Study Start Date : September 2006
Actual Primary Completion Date : June 2010
Actual Study Completion Date : June 2011

Arm Intervention/treatment
Experimental: Off-pump bypass surgery
Off-pump coronary artery bypass graft (OPCAB) using mandatory a stabilization device and advisable, but not mandatory, a heart positioner
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.

Active Comparator: On-pump bypass surgery
coronary artery bypass graft with cardiopulmonary bypass (CPB/CAB)
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.

Primary Outcome Measures :
  1. Number of Patients With Post-operative Combined Endpoint (i.e. With One or More of the Following) [ Time Frame: 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 :
  1. Number of Patients With Secondary Combined Endpoint (i.e. With One or More of the Following) [ Time Frame: 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Pts candidate to a myocardial revascularization for any patter of coronary artery disease, ventricular dysfunction or any other co-morbidity
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01290952

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Bari, Italy
S. Anna e S. Sebastiano
Caserta, Italy
Ospedale Luigi Sacco
Milano, Italy, 20100
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
Sponsors and Collaborators
Medtronic Italia
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Principal Investigator: Massimo Lemma, Dr. Ospedale Sacco-Milano

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Responsible Party: Medtronic Italia Identifier: NCT01290952    
Other Study ID Numbers: 030211
First Posted: February 7, 2011    Key Record Dates
Results First Posted: November 21, 2016
Last Update Posted: November 21, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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
Keywords provided by Medtronic Italia:
coronary artery surgery
Additional relevant MeSH terms:
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Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases