On Versus Off Pump Myocardial Revascularization Study

Coronary Artery Disease Clinical Trial

— On-Off  

Official title:

ON Pump vs OFF Pump Myocardial Revascularization in High Risk Patients: a Randomized Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01290952
• Other study ID #: 030211
• Status: Active, not recruiting
• Phase: Phase 4
• First received: February 4, 2011
• Last updated: February 4, 2011
• Start date: September 2006
• Est. completion date: June 2011

Study information

• Verified date: February 2011
• Source: Medtronic Italia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical 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. Patients will be randomized to undergo off-pump coronary artery bypass graft (OPCAB) or coronary artery bypass graft with cardiopulmonary bypass (CPB/CAB).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 630
• Est. completion date: June 2011
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

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.
• 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.

Locations

Country	Name	City	State
Italy	Policlinico	Bari
Italy	S. Anna e S. Sebastiano	Caserta
Italy	Ospedale Luigi Sacco	Milano
Italy	European Hospital	Roma
Italy	Ospedale S. Camillo	Roma
Italy	Ospedale S. Giovanni di Dio e Ruggi d'Aragona	Salerno
Italy	Ospedale Molinette	Torino
Switzerland	University Hospital	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Italia

Countries where clinical trial is conducted

Italy,  Switzerland, 

References & Publications (19)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Geissler HJ, Hölzl P, Marohl S, Kuhn-Régnier F, Mehlhorn U, Südkamp M, de Vivie ER. Risk stratification in heart surgery: comparison of six score systems. Eur J Cardiothorac Surg. 2000 Apr;17(4):400-6. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 19 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	post-operative combined endpoint	Operative Mortality Myocardial Infarction Postoperative neurologicalal complications Renal failure ARDS Bleeding	30 days	Yes
Secondary	secondary combined endpoint	Post-operative Atrial Fibrillation IAPB insertion and low cardiac output syndrome Ventilation > 24h Sternal wound infection or dehiscence Length of stay in the intensive care unit Hospital length of stay One year Mortality One year MACE One year ischemic evidence	12 months	Yes