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

This study has been completed.
Information provided by (Responsible Party):
Medtronic Italia Identifier:
First received: February 4, 2011
Last updated: September 29, 2016
Last verified: September 2016
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 Intervention Phase
Coronary Artery Disease
Procedure: Off-pump bypass surgery
Procedure: On-pump bypass surgery
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: ON Pump vs OFF Pump Myocardial Revascularization in High Risk Patients: a Randomized Study

Further study details as provided by Medtronic Italia:

Primary Outcome Measures:
  • 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:
  • 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

Enrollment: 411
Study Start Date: September 2006
Study Completion Date: June 2011
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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).


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01290952

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
Principal Investigator: Massimo Lemma, Dr. Ospedale Sacco-Milano
  More Information


Responsible Party: Medtronic Italia Identifier: NCT01290952     History of Changes
Other Study ID Numbers: 030211
Study First Received: February 4, 2011
Results First Received: March 16, 2016
Last Updated: September 29, 2016
Individual Participant Data  
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:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases processed this record on April 26, 2017