NCT00463294

Brief Summary

I. Main Research Question:

  • To compare the risks and benefits of Off-pump Coronary artery bypass surgery (CABG) to On-pump CABG and to determine if one is better than the other.
  • The purpose of this pilot study is also to see the rate of recruitment with expertise-based randomization across different hospital settings. II. Small RCT studies and meta-analyses done so far have not been able to conclusively say which of the procedure is better. A large randomized study is required to establish the risks and benefits associated with both the off-pump and on-pump CABG surgical procedures. III. The study will look at which of the two techniques reduce major risks associated with CABG.

Trial Health

98
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,752

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Oct 2007

Longer than P75 for phase_3

Geographic Reach
13 countries

52 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 18, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 20, 2007

Completed
5 months until next milestone

Study Start

First participant enrolled

October 1, 2007

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
4.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

September 16, 2016

Status Verified

September 1, 2016

Enrollment Period

4.4 years

First QC Date

April 18, 2007

Last Update Submit

September 15, 2016

Conditions

the Efficacy and Safety of Off-pump CABG

Keywords

CABGOn-pumpOff-pump

Outcome Measures

Primary Outcomes (2)

  • First Co-Primary Outcome

    The occurrence of the composite of total mortality, stroke, nonfatal MI, or new renal failure at 30 days post CABG surgery

    30 days post CABG surgery

  • Second co-primary outcome

    The occurrence of the composite of total mortality, stroke, nonfatal MI, new renal failure, or repeat coronary revascularization (i.e. coronary artery bypass surgery or percutaneous coronary intervention) over 5 years after randomization.

    5 years after CABG

Secondary Outcomes (2)

  • The assessment of total costs and resources consumption at 30 days after CABG surgery

    30 days after CABG surgery

  • The assessment of total costs and resources consumption at 5 years after CABG surgery

    5 years after CABG surgery

Study Arms (2)

On Pump Arm

ACTIVE COMPARATOR
Procedure: Coronary Artery Bypass Graft with the use of CPB

Off Pump Arm

EXPERIMENTAL
Procedure: Coronary Artery Bypass Graft without the use of CPB

Interventions

Coronary Artery Bypass Graft with the use of CPBPROCEDURE

Coronary Artery Bypass Graft (CABG) using median sternotomy, CPB, cardioplegia and complete cross-clamp and no associated or concomitant surgical procedures

Also known as: ON Pump CABG
On Pump Arm
Coronary Artery Bypass Graft without the use of CPBPROCEDURE

Coronary Artery Bypass Graft (CABG) with no associated or concomitant surgical procedures, using median sternotomy and without CPB and cardioplegia

Also known as: OFF Pump
Off Pump Arm

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who have been diagnosed with coronary artery disease (single, double or triple disease) will be eligible if they:
  • require isolated CABG with median sternotomy
  • are able to give their informed written consent
  • are\> 21 years of age and
  • have one or more of the following risk factors:
  • ≥ 70 years
  • peripheral vascular disease (previous peripheral bypass or amputation or ABI \<0.80)
  • Cerebrovascular disease (history of stroke, TIA)
  • Renal insufficiency (creatinine above upper limit of normal)
  • \>60 years of age and one of the following:
  • diabetes (oral hypoglycemic agent and/or insulin)
  • urgent revascularization (waiting in hospital)
  • LV ejection fraction \<35%
  • current or recent smoker.
  • years of age and two of the following:
  • +4 more criteria

You may not qualify if:

  • Patients will be excluded if they have one of the following:
  • concomitant cardiac procedure associated with CABG,
  • contra-indications to off-pump CABG or on-pump CABG (calcified aorta, intramuscular LAD, calcified coronaries, small target vessels)
  • concomitant life-threatening disease likely to limit life expectancy to less than 2 years,
  • prior enrollment in this trial
  • emergency CABG surgery (immediate revascularization for hemodynamic instability) OR
  • redo CABG.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (52)

Fundacion Medica de rio negro y neuquen

Rio Negro, Argentina

Location

Beneficencia Portuguesa de Sao Paulo

São Paulo, CEP, 01323.001, Brazil

Location

Instituto Dante Pazzanese de Cardiologia

São Paulo, CEP, 04012-909, Brazil

Location

Hospital Sao Francisco Complexo Hospitalar Santa Casa

Porto Alegre, Rio Grande do Sul, 90020-090, Brazil

Location

Irmande Santa Casa De Misericordia De Curtiba

Curitiba Parana, 80010030, Brazil

Location

Braile Clinica de Servicos de Assistencia Medico

São José do Rio Preto, 15091-450, Brazil

Location

Irmandade da Santa Casa de Misericordia de Sao Paulo

São Paulo, 01221-020, Brazil

Location

Federal University of Sao Paulo School of Medicine

São Paulo, 04024-002, Brazil

Location

Associação do Sanátorio Sírio

São Paulo, 04038-030, Brazil

Location

Instituto do Coracao do Hospital das Clinicas da

São Paulo, 05403-00, Brazil

Location

Hospital Mario Covas

São Paulo, 09190-615, Brazil

Location

Santa Casa de Misericordia de Marilia

São Paulo, 17515-000, Brazil

Location

Foothills Medical Centre

Calgary, Alberta, T2N 2T9, Canada

Location

Hamilton General Hospital

Hamilton, Ontario, L8L 2X2, Canada

Location

London Health Sciences Centre

London, Ontario, N6A 5A5, Canada

Location

Toronto General Hospital

Toronto, Ontario, M5G 2C4, Canada

Location

Montreal Heart Institute

Montreal, Quebec, H1T 1C8, Canada

Location

Hotel-Dieu du CHUM

Montreal, Quebec, H2W 1T8, Canada

Location

Hospital Regional Temuco

Temuco, Región de la Araucanía, Chile

Location

Instituto Nacional del Torax

Santiago, Chile

Location

ChaoYang Hospital

Beijing, China

Location

FuWai Hospital

Beijing, China

Location

Nanjing First Hospital

Nanjing, China

Location

Fundacion Cardioinfantil

Bogotá, Colombia

Location

Fundacion Valle Del Lili

Cali, Colombia

Location

Charles University Hospital

Hradec Králové, 50005, Czechia

Location

Kardiochirurgicke centrum

Ostrava-Poruba, 708 52, Czechia

Location

University Hospital Pilsen

Pilsen, 304 60, Czechia

Location

Fakultni nemocnice Kralovske Vinohrady (FNKV)

Prague, 100 34, Czechia

Location

University Hospital Motol

Prague, 150 00, Czechia

Location

Nemocnice Podlesi

Třinec, 739 61, Czechia

Location

Service de chirurgie thoracique et cardio-vasculaire

Besançon, 25030, France

Location

Nizam's Institute of Medical Sciences

Hyderabad, Andhra Pradesh, 500 082, India

Location

SAL Hospital and Medical Institute

Ahmedabad, Gujarat, 380054, India

Location

Amrita Institute of Medical Sciences and Research Center

Kochi, Kerala, 682 026, India

Location

G.Kuppuswamy Naidu Memorial Hospital

Coimbatore, Tamil Nadu, 641 037, India

Location

SAL Hospital

Ahmedabad, India

Location

International Center of Cardiovascular and Thoracic Diseases

Chennai Tamil Nadu, 600101, India

Location

Sanjay Gandhi PGIMS

Lucknow, 226 014, India

Location

All India Institute of Medical Sciences

New Delhi, 110016, India

Location

Escorts Heart Institute and Research Centre

Noida, 201307, India

Location

Ospedale S. Croce

Cuneo, 12100, Italy

Location

Ospedale Niguarda - Ca Granda

Milan, 20162, Italy

Location

Jagiellonian University

Krakow, 31-202, Poland

Location

Alp Aslan

Ankara, Turkey (Türkiye)

Location

Erol Senor

Ankara, Turkey (Türkiye)

Location

Ruchan Akar

Ankara, Turkey (Türkiye)

Location

Sertap Aykut Aka

Ankara, Turkey (Türkiye)

Location

Volkan Sinci

Ankara, Turkey (Türkiye)

Location

Basildon and Thurrock University Hospital NHS FT

Basildon, Essex, SS16 5NL, United Kingdom

Location

Royal Infirmary of Edinburgh

Edinburgh, EU, 16 4SU, United Kingdom

Location

The John Radcliffe Hospital

Oxford, OX3 9DU, United Kingdom

Location

Related Publications (10)

  • Dimagli A, Gaudino M, An KR, Olaria RP, Soletti GJ, Cancelli G, Harik L, Noiseux N, Stevens LM, Lamy A; CORONARY investigators. Five-Year Hospital Readmission After Coronary Artery Bypass Surgery and the Association With Off-Pump Surgery and Sex. J Am Heart Assoc. 2023 Apr 18;12(8):e028063. doi: 10.1161/JAHA.122.028063. Epub 2023 Apr 7.

    PMID: 37026546DERIVED

  • Hebert M, Lamy A, Noiseux N, Stevens LM; CORONARY Investigators. Impact of early quantitative morbidity on 1-year outcomes in coronary artery bypass graft surgery. Interact Cardiovasc Thorac Surg. 2022 Mar 31;34(4):523-531. doi: 10.1093/icvts/ivab316.

    PMID: 34788466DERIVED

  • Conen D, Wang MK, Devereaux PJ, Whitlock R, McIntyre WF, Healey JS, Yuan F, Yusuf S, Lamy A. New-Onset Perioperative Atrial Fibrillation After Coronary Artery Bypass Grafting and Long-Term Risk of Adverse Events: An Analysis From the CORONARY Trial. J Am Heart Assoc. 2021 Jun 15;10(12):e020426. doi: 10.1161/JAHA.120.020426. Epub 2021 May 29.

    PMID: 34056913DERIVED

  • Lamy A, Devereaux PJ, Prabhakaran D, Taggart DP, Hu S, Straka Z, Piegas LS, Avezum A, Akar AR, Lanas Zanetti F, Jain AR, Noiseux N, Padmanabhan C, Bahamondes JC, Novick RJ, Tao L, Olavegogeascoechea PA, Airan B, Sulling TA, Whitlock RP, Ou Y, Gao P, Pettit S, Yusuf S; CORONARY Investigators. Five-Year Outcomes after Off-Pump or On-Pump Coronary-Artery Bypass Grafting. N Engl J Med. 2016 Dec 15;375(24):2359-2368. doi: 10.1056/NEJMoa1601564. Epub 2016 Oct 23.

    PMID: 27771985DERIVED

  • Lamy A, Tong W, Devereaux PJ, Gao P, Gafni A, Singh K, Taggart D, Straka Z, Akar AR, Piegas L, Ou Y, Yusuf S. The cost implications of off-pump versus on-pump coronary artery bypass graft surgery at one year. Ann Thorac Surg. 2014 Nov;98(5):1620-5. doi: 10.1016/j.athoracsur.2014.06.046. Epub 2014 Sep 24.

    PMID: 25261272DERIVED

  • Garg AX, Devereaux PJ, Yusuf S, Cuerden MS, Parikh CR, Coca SG, Walsh M, Novick R, Cook RJ, Jain AR, Pan X, Noiseux N, Vik K, Stolf NA, Ritchie A, Favaloro RR, Parvathaneni S, Whitlock RP, Ou Y, Lawrence M, Lamy A; CORONARY Investigators. Kidney function after off-pump or on-pump coronary artery bypass graft surgery: a randomized clinical trial. JAMA. 2014 Jun 4;311(21):2191-8. doi: 10.1001/jama.2014.4952.

    PMID: 24886787DERIVED

  • Lamy A, Devereaux PJ, Prabhakaran D, Taggart DP, Hu S, Paolasso E, Straka Z, Piegas LS, Akar AR, Jain AR, Noiseux N, Padmanabhan C, Bahamondes JC, Novick RJ, Vaijyanath P, Reddy SK, Tao L, Olavegogeascoechea PA, Airan B, Sulling TA, Whitlock RP, Ou Y, Pogue J, Chrolavicius S, Yusuf S; CORONARY Investigators. Effects of off-pump and on-pump coronary-artery bypass grafting at 1 year. N Engl J Med. 2013 Mar 28;368(13):1179-88. doi: 10.1056/NEJMoa1301228. Epub 2013 Mar 11.

    PMID: 23477676DERIVED

  • Garg AX, Devereaux PJ, Yusuf S, Cuerden MS, Parikh CR, Coca SG, Walsh M, Cook RJ, Whitlock RP, Noiseux N, Novick RJ, Ou Y, Lamy A; CORONARY Investigators. Coronary Artery Bypass Grafting Surgery Off- or On-pump Revascularisation Study (CORONARY): kidney substudy analytic protocol of an international randomised controlled trial. BMJ Open. 2012 Apr 18;2(2):e001080. doi: 10.1136/bmjopen-2012-001080. Print 2012.

    PMID: 22514244DERIVED

  • Lamy A, Devereaux PJ, Prabhakaran D, Taggart DP, Hu S, Paolasso E, Straka Z, Piegas LS, Akar AR, Jain AR, Noiseux N, Padmanabhan C, Bahamondes JC, Novick RJ, Vaijyanath P, Reddy S, Tao L, Olavegogeascoechea PA, Airan B, Sulling TA, Whitlock RP, Ou Y, Ng J, Chrolavicius S, Yusuf S; CORONARY Investigators. Off-pump or on-pump coronary-artery bypass grafting at 30 days. N Engl J Med. 2012 Apr 19;366(16):1489-97. doi: 10.1056/NEJMoa1200388. Epub 2012 Mar 26.

    PMID: 22449296DERIVED

  • Lamy A, Devereaux PJ, Prabhakaran D, Hu S, Piegas LS, Straka Z, Paolasso E, Taggart D, Lanas F, Akar AR, Jain A, Noiseux N, Ou Y, Chrolavicius S, Ng J, Yusuf S. Rationale and design of the coronary artery bypass grafting surgery off or on pump revascularization study: a large international randomized trial in cardiac surgery. Am Heart J. 2012 Jan;163(1):1-6. doi: 10.1016/j.ahj.2011.10.007.

    PMID: 22172429DERIVED

MeSH Terms

Interventions

Coronary Artery BypassCoronary Artery Bypass, Off-Pump

Intervention Hierarchy (Ancestors)

Myocardial RevascularizationCardiac Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeVascular GraftingVascular Surgical ProceduresThoracic Surgical Procedures

Study Officials

  • Lamy Andre, MD, MSc

    McMaster University

    PRINCIPAL INVESTIGATOR

  • Salim Yusuf, MD, DPhil

    Population Health Research Institute

    PRINCIPAL INVESTIGATOR

  • David Taggart, MD

    University of Oxford

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Cardiac Surgeon

Study Record Dates

First Submitted

April 18, 2007

First Posted

April 20, 2007

Study Start

October 1, 2007

Primary Completion

March 1, 2012

Study Completion

September 1, 2016

Last Updated

September 16, 2016

Record last verified: 2016-09

Locations

CZ(6)BR(11)IN(9)PL(1)CO(2)TU(5)GB(3)AR(1)IT(2)CL(2)CA(6)FR(1)CN(3)