On Versus Off Pump Myocardial Revascularization Study

NCT01290952 | Completed Phase 4 Results

• 1 other identifier: 030211
• Study Type: interventional
• Target: 411
• Locations: 2 countries
• Sites: 8

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).

Conditions

Coronary Artery Disease

Keywords

off-pump; bypass; coronary artery surgery

Outcome Measures

Primary Outcomes (1)

• 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

  30 days

Secondary Outcomes (1)

• Number of Patients With Secondary Combined Endpoint (i.e. With One or More of the Following)

  30 days

Study Arms (2)

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

Procedure: Off-pump bypass surgery

On-pump bypass surgery

ACTIVE COMPARATOR

coronary artery bypass graft with cardiopulmonary bypass (CPB/CAB)

Procedure: On-pump bypass surgery

Interventions

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.

Off-pump bypass surgery

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.

On-pump bypass surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients in cardiogenic shock requiring emergency surgery or preoperative intra-aortic balloon pump
• Patients requiring additional surgical procedures
• Porcelain Aorta
• Lack of informed consent

Sponsors & Collaborators

• Medtronic Italia: lead

Study Sites (8)

Policlinico

Bari, Italy

Location

S. Anna e S. Sebastiano

Caserta, Italy

Location

Ospedale Luigi Sacco

Milan, 20100, Italy

Location

European Hospital

Roma, Italy

Location

Ospedale S. Camillo

Roma, Italy

Location

Ospedale S. Giovanni di Dio e Ruggi d'Aragona

Salerno, Italy

Location

Ospedale Molinette

Torino, Italy

Location

University Hospital

Zurich, Switzerland

Location

Related Publications (19)

• 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.

  PMID: 1677884 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.

  PMID: 11093485 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.

  PMID: 10750747 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.

  PMID: 11276485 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.

  PMID: 10386418 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.

  PMID: 11178301 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.

  PMID: 10649196 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.

  PMID: 10554854 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.

  PMID: 11789787 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.

  PMID: 11789773 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.

  PMID: 11515882 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.

  PMID: 12493504 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.

  PMID: 11544627 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.

  PMID: 11251259 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.

  PMID: 10773562 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.

  PMID: 10456395 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.

  PMID: 19890125 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.

  PMID: 14702424 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.

  PMID: 19766798 BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Results Point of Contact

• Title: Dr. Massimo Lemma
• Organization: Azienda Ospedaliera Luigi Sacco

lemma.massimo@hsacco.it

0039 0239042876

Study Officials

• Massimo Lemma, Dr.

  Ospedale Sacco-Milano

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2011
• First Posted: February 7, 2011
• Study Start: September 1, 2006
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2011
• Last Updated: November 21, 2016
• Results First Posted: November 21, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will not share

Locations

IT (7); CH (1)