Coronary Artery DiseasePhase 4On-OffNCT01290952
On Versus Off Pump Myocardial Revascularization Study
A Phase 4 study testing Off-pump bypass surgery and On-pump bypass surgery in people with Coronary Artery Disease, run by Medtronic Italia at 8 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Off-pump bypass surgery and On-pump bypass surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 411 participants
- Where
- 8 sitesin 2 countries
- Study dates
- Sep 2006to Jun 2011
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
8 sites in 2 countries.
8 sites in 2 countries
Italy7 sites
Policlinico
Bari
S. Anna e S. Sebastiano
Caserta
Ospedale Luigi Sacco
Milan, 20100
European Hospital
Roma
Ospedale S. Camillo
Roma
Ospedale S. Giovanni di Dio e Ruggi d'Aragona
Salerno
Ospedale Molinette
Torino
About this study
Official title: ON Pump vs OFF Pump Myocardial Revascularization in High Risk Patients: a Randomized Study
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).
Read the 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
- Being tested
- Off-pump bypass surgery, On-pump bypass surgery
- Keywords
- off-pump, bypass, coronary artery surgery
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Off-pump bypass surgeryProcedure or 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.
On-pump bypass surgeryProcedure or 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.
| Study group | Role | What they receive |
|---|---|---|
| Off-pump bypass surgery | Experimental | Off-pump coronary artery bypass graft (OPCAB) using mandatory a stabilization device and advisable, but not mandatory, a heart positioner Receives: Procedure: Off-pump bypass surgery |
| On-pump bypass surgery | Active comparator | coronary artery bypass graft with cardiopulmonary bypass (CPB/CAB) Receives: Procedure: On-pump bypass surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 30 days
Secondary outcomes (1)
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
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2011 (estimated)
- Study startSep 2006
- Primary completionJun 2010
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 411 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Italia
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Massimo Lemma, Dr., Principal investigator, Ospedale Sacco-Milano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01290952
- Sponsor's protocol ID
- 030211
- Acronym
- On-Off
- Status last verified
- Sep 2016
- First submitted
- 4 Feb 2011
- Last updated
- 21 Nov 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No: 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
Publications
Benetti FJ, Naselli G, Wood M, Geffner L. Direct myocardial revascularization without extracorporeal circulation. Experience in 700 patients. Chest. 1991 Aug;100(2):312-6. doi: 10.1378/chest.100.2.312.
PubMed 1677884Yokoyama T, Baumgartner FJ, Gheissari A, Capouya ER, Panagiotides GP, Declusin RJ. Off-pump versus on-pump coronary bypass in high-risk subgroups. Ann Thorac Surg. 2000 Nov;70(5):1546-50. doi: 10.1016/s0003-4975(00)01922-6.
PubMed 11093485Arom KV, Flavin TF, Emery RW, Kshettry VR, Janey PA, Petersen RJ. Safety and efficacy of off-pump coronary artery bypass grafting. Ann Thorac Surg. 2000 Mar;69(3):704-10. doi: 10.1016/s0003-4975(99)01510-6.
PubMed 10750747D'Ancona G, Karamanoukian HL, Soltoski P, Salerno TA, Bergsland J. Changing referral pattern in off-pump coronary artery bypass surgery: a strategy for improving surgical results. Heart Surg Forum. 1999;2(3):246-9.
PubMed 11276485Ascione R, Lloyd CT, Gomes WJ, Caputo M, Bryan AJ, Angelini GD. Beating versus arrested heart revascularization: evaluation of myocardial function in a prospective randomized study. Eur J Cardiothorac Surg. 1999 May;15(5):685-90. doi: 10.1016/s1010-7940(99)00072-x.
PubMed 10386418Vallely MP, Bannon PG, Kritharides L. The systemic inflammatory response syndrome and off-pump cardiac surgery. Heart Surg Forum. 2001;4 Suppl 1:S7-S13. No abstract available.
PubMed 11178301Cartier R, Brann S, Dagenais F, Martineau R, Couturier A. Systematic off-pump coronary artery revascularization in multivessel disease: experience of three hundred cases. J Thorac Cardiovasc Surg. 2000 Feb;119(2):221-9. doi: 10.1016/S0022-5223(00)70176-0.
PubMed 10649196Krejca M, Skiba J, Szmagala P, Gburek T, Bochenek A. Cardiac troponin T release during coronary surgery using intermittent cross-clamp with fibrillation, on-pump and off-pump beating heart. Eur J Cardiothorac Surg. 1999 Sep;16(3):337-41. doi: 10.1016/s1010-7940(99)00234-1.
PubMed 10554854Ascione R, Nason G, Al-Ruzzeh S, Ko C, Ciulli F, Angelini GD. Coronary revascularization with or without cardiopulmonary bypass in patients with preoperative nondialysis-dependent renal insufficiency. Ann Thorac Surg. 2001 Dec;72(6):2020-5. doi: 10.1016/s0003-4975(01)03250-7.
PubMed 11789787Kilo J, Czerny M, Gorlitzer M, Zimpfer D, Baumer H, Wolner E, Grimm M. Cardiopulmonary bypass affects cognitive brain function after coronary artery bypass grafting. Ann Thorac Surg. 2001 Dec;72(6):1926-32. doi: 10.1016/s0003-4975(01)03199-x.
PubMed 11789773Calafiore AM, Di Mauro M, Contini M, Di Giammarco G, Pano M, Vitolla G, Bivona A, Carella R, D'Alessandro S. Myocardial revascularization with and without cardiopulmonary bypass in multivessel disease: impact of the strategy on early outcome. Ann Thorac Surg. 2001 Aug;72(2):456-62; discussion 462-3. doi: 10.1016/s0003-4975(01)02810-7.
PubMed 11515882Al-Ruzzeh S, Nakamura K, Athanasiou T, Modine T, George S, Yacoub M, Ilsley C, Amrani M. Does off-pump coronary artery bypass (OPCAB) surgery improve the outcome in high-risk patients?: a comparative study of 1398 high-risk patients. Eur J Cardiothorac Surg. 2003 Jan;23(1):50-5. doi: 10.1016/s1010-7940(02)00654-1.
PubMed 12493504Vlassov GP, Deyneka CS, Travine NO, Timerbaev VH, Ermolov AS. Acute myocardial infarction: OPCAB is an alternative approach for treatment. Heart Surg Forum. 2001;4(2):147-50; discussion 150-1.
PubMed 11544627Yeatman M, Caputo M, Ascione R, Ciulli F, Angelini GD. Off-pump coronary artery bypass surgery for critical left main stem disease: safety, efficacy and outcome. Eur J Cardiothorac Surg. 2001 Mar;19(3):239-44. doi: 10.1016/s1010-7940(01)00572-3.
PubMed 11251259Geissler HJ, Holzl P, Marohl S, Kuhn-Regnier F, Mehlhorn U, Sudkamp M, de Vivie ER. Risk stratification in heart surgery: comparison of six score systems. Eur J Cardiothorac Surg. 2000 Apr;17(4):400-6. doi: 10.1016/s1010-7940(00)00385-7.
PubMed 10773562
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ON Pump vs OFF Pump Myocardial Revascularization in High Risk Patients: a Randomized Study
- ClinicalTrials.gov ID
- NCT01290952
- Acronym / sponsor ID
- On-Off / 030211
- Conditions
- Coronary Artery Disease
- Keywords
- off-pump, bypass, coronary artery surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 411 participants (actual)
- Lead sponsor
- Medtronic ItaliaIndustry (pharma, biotech, devices)
- Study start
- Sep 2006
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 7 Feb 2011 (estimated)
- Results
- Posted 21 Nov 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Off-pump bypass surgery | Experimental | Procedure: Off-pump bypass surgeryOff-pump coronary artery bypass graft (OPCAB) using mandatory a stabilization device and advisable, but not mandatory, a heart positioner |
| On-pump bypass surgery | Active comparator | Procedure: On-pump bypass surgerycoronary artery bypass graft with cardiopulmonary bypass (CPB/CAB) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- Patients in cardiogenic shock requiring emergency surgery or preoperative intra-aortic balloon pump
- Patients requiring additional surgical procedures
- Porcelain Aorta
- Lack of informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Off-pump bypass surgeryis 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 or surgery | Off-pump bypass surgery |
| On-pump bypass surgeryis 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. | Procedure or surgery | On-pump bypass surgery |
Primary outcome
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
1 secondary outcome
Number of Patients With Secondary Combined Endpoint (i.e. With One or More of the Following)
Time frame: 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 1677884Benetti FJ, Naselli G, Wood M, Geffner L. Direct myocardial revascularization without extracorporeal circulation. Experience in 700 patients. Chest. 1991 Aug;100(2):312-6. doi: 10.1378/chest.100.2.312.
- Background: PubMed 11093485Yokoyama T, Baumgartner FJ, Gheissari A, Capouya ER, Panagiotides GP, Declusin RJ. Off-pump versus on-pump coronary bypass in high-risk subgroups. Ann Thorac Surg. 2000 Nov;70(5):1546-50. doi: 10.1016/s0003-4975(00)01922-6.
- Background: PubMed 10750747Arom KV, Flavin TF, Emery RW, Kshettry VR, Janey PA, Petersen RJ. Safety and efficacy of off-pump coronary artery bypass grafting. Ann Thorac Surg. 2000 Mar;69(3):704-10. doi: 10.1016/s0003-4975(99)01510-6.
- Background: PubMed 11276485D'Ancona G, Karamanoukian HL, Soltoski P, Salerno TA, Bergsland J. Changing referral pattern in off-pump coronary artery bypass surgery: a strategy for improving surgical results. Heart Surg Forum. 1999;2(3):246-9.
- Background: PubMed 10386418Ascione R, Lloyd CT, Gomes WJ, Caputo M, Bryan AJ, Angelini GD. Beating versus arrested heart revascularization: evaluation of myocardial function in a prospective randomized study. Eur J Cardiothorac Surg. 1999 May;15(5):685-90. doi: 10.1016/s1010-7940(99)00072-x.
- Background: PubMed 11178301Vallely MP, Bannon PG, Kritharides L. The systemic inflammatory response syndrome and off-pump cardiac surgery. Heart Surg Forum. 2001;4 Suppl 1:S7-S13. No abstract available.
- Background: PubMed 10649196Cartier R, Brann S, Dagenais F, Martineau R, Couturier A. Systematic off-pump coronary artery revascularization in multivessel disease: experience of three hundred cases. J Thorac Cardiovasc Surg. 2000 Feb;119(2):221-9. doi: 10.1016/S0022-5223(00)70176-0.
- Background: PubMed 10554854Krejca M, Skiba J, Szmagala P, Gburek T, Bochenek A. Cardiac troponin T release during coronary surgery using intermittent cross-clamp with fibrillation, on-pump and off-pump beating heart. Eur J Cardiothorac Surg. 1999 Sep;16(3):337-41. doi: 10.1016/s1010-7940(99)00234-1.
- Background: PubMed 11789787Ascione R, Nason G, Al-Ruzzeh S, Ko C, Ciulli F, Angelini GD. Coronary revascularization with or without cardiopulmonary bypass in patients with preoperative nondialysis-dependent renal insufficiency. Ann Thorac Surg. 2001 Dec;72(6):2020-5. doi: 10.1016/s0003-4975(01)03250-7.
- Background: PubMed 11789773Kilo J, Czerny M, Gorlitzer M, Zimpfer D, Baumer H, Wolner E, Grimm M. Cardiopulmonary bypass affects cognitive brain function after coronary artery bypass grafting. Ann Thorac Surg. 2001 Dec;72(6):1926-32. doi: 10.1016/s0003-4975(01)03199-x.
- Background: PubMed 11515882Calafiore AM, Di Mauro M, Contini M, Di Giammarco G, Pano M, Vitolla G, Bivona A, Carella R, D'Alessandro S. Myocardial revascularization with and without cardiopulmonary bypass in multivessel disease: impact of the strategy on early outcome. Ann Thorac Surg. 2001 Aug;72(2):456-62; discussion 462-3. doi: 10.1016/s0003-4975(01)02810-7.
- Background: PubMed 12493504Al-Ruzzeh S, Nakamura K, Athanasiou T, Modine T, George S, Yacoub M, Ilsley C, Amrani M. Does off-pump coronary artery bypass (OPCAB) surgery improve the outcome in high-risk patients?: a comparative study of 1398 high-risk patients. Eur J Cardiothorac Surg. 2003 Jan;23(1):50-5. doi: 10.1016/s1010-7940(02)00654-1.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Massimo Lemma, Dr. principal investigator
Ospedale Sacco-Milano
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Off-pump bypass surgery and On-pump bypass surgery in people with Coronary Artery Disease, run by Medtronic Italia at 8 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Italy, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Nov 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Patients With Post-operative Combined Endpoint (i.e. With One or More of the Following) (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01290952, which also lists 19 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2016.