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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).
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| On-pump bypass surgery | Active Comparator | coronary artery bypass graft with cardiopulmonary bypass (CPB/CAB) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Off-pump bypass surgery | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
| 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
| 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Massimo Lemma, Dr. | Ospedale Sacco-Milano | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Policlinico | Bari | Italy | ||||
| S. Anna e S. Sebastiano |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 1677884 | Background | 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. | |
| 11093485 | Background | Yokoyama 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. |
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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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630 patients was the planned estimated sample size needed to test the null hypothesis. An interim analysis was scheduled at 400 enrolled patients, to verify the null hypothesis used for the sample size calculation. A p<0.0294 was considered statistically significant to reject the null hypothesis, thus study enrollment was stopped at 411 patients.
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| ID | Title | Description |
|---|---|---|
| FG000 | Off Pump | Off-pump coronary artery bypass graft (OPCAB) using mandatory a stabilization device and advisable, but not mandatory, a heart positioner 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. |
| FG001 | On-pump | coronary artery bypass graft with cardiopulmonary bypass (CPB/CAB) 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Off Pump | Off-pump coronary artery bypass graft (OPCAB) using mandatory a stabilization device and advisable, but not mandatory, a heart positioner 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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:
| Posted | Number | participants | 30 days |
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Off Pump | Off-pump coronary artery bypass graft (OPCAB) using mandatory a stabilization device and advisable, but not mandatory, a heart positioner 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Overall mortality | Cardiac disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| angina | Cardiac disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Massimo Lemma | Azienda Ospedaliera Luigi Sacco | 0039 0239042876 | lemma.massimo@hsacco.it |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| On-pump bypass surgery | Procedure | 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. |
|
| Caserta |
| Italy |
| Ospedale Luigi Sacco | Milan | 20100 | Italy |
| 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 |
| 10750747 | Background | Arom 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. |
| 11276485 | Background | D'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. |
| 10386418 | Background | Ascione 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. |
| 11178301 | Background | Vallely 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. |
| 10649196 | Background | Cartier 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. |
| 10554854 | Background | Krejca 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. |
| 11789787 | Background | Ascione 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. |
| 11789773 | Background | Kilo 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. |
| 11515882 | Background | Calafiore 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. |
| 12493504 | Background | Al-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. |
| 11544627 | Background | Vlassov 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. |
| 11251259 | Background | Yeatman 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. |
| 10773562 | Background | Geissler 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. |
| 10456395 | Background | Nashef SA, Roques F, Michel P, Gauducheau E, Lemeshow S, Salamon R. European system for cardiac operative risk evaluation (EuroSCORE). Eur J Cardiothorac Surg. 1999 Jul;16(1):9-13. doi: 10.1016/s1010-7940(99)00134-7. |
| 19890125 | Background | Shroyer AL, Grover FL, Hattler B, Collins JF, McDonald GO, Kozora E, Lucke JC, Baltz JH, Novitzky D; Veterans Affairs Randomized On/Off Bypass (ROOBY) Study Group. On-pump versus off-pump coronary-artery bypass surgery. N Engl J Med. 2009 Nov 5;361(19):1827-37. doi: 10.1056/NEJMoa0902905. |
| 14702424 | Background | Khan NE, De Souza A, Mister R, Flather M, Clague J, Davies S, Collins P, Wang D, Sigwart U, Pepper J. A randomized comparison of off-pump and on-pump multivessel coronary-artery bypass surgery. N Engl J Med. 2004 Jan 1;350(1):21-8. doi: 10.1056/NEJMoa031282. |
| 19766798 | Background | Puskas JD, Thourani VH, Kilgo P, Cooper W, Vassiliades T, Vega JD, Morris C, Chen E, Schmotzer BJ, Guyton RA, Lattouf OM. Off-pump coronary artery bypass disproportionately benefits high-risk patients. Ann Thorac Surg. 2009 Oct;88(4):1142-7. doi: 10.1016/j.athoracsur.2009.04.135. |
| On-pump |
coronary artery bypass graft with cardiopulmonary bypass (CPB/CAB) 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Euroscore > 6 (high risk for early mortality for cardiac surgery) | Number | participants |
|
coronary artery bypass graft with cardiopulmonary bypass (CPB/CAB)
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.
|
|
| Secondary | 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:
| Posted | Number | participants | 30 days |
|
|
|
| 16 |
| 204 |
| 72 |
| 204 |
| EG001 | On-pump | coronary artery bypass graft with cardiopulmonary bypass (CPB/CAB) 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. | 30 | 207 | 79 | 207 |
| MACE | Cardiac disorders | Systematic Assessment |
|
| Post-operative AF | Cardiac disorders | Systematic Assessment |
|
| IABP insertion | Cardiac disorders | Systematic Assessment | Intra Aortic Balloon Pump Insertion |
|
| Ventilation >24 h | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Wound infection | Injury, poisoning and procedural complications | Systematic Assessment |
|
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| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |