Coronary Artery Bypass Surgery (CABG) Off or On Pump Revascularization Study
NCT ID: NCT00463294
Last Updated: 2016-09-16
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE3
Total Enrollment
4752 participants
Study Classification
INTERVENTIONAL
Study Start Date
2007-10-31
Study Completion Date
2016-09-30
Brief Summary
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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.
* 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.
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Detailed Description
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Rationale and purpose of the study:
Coronary artery bypass grafting (CABG) surgery prolongs life-expectancy in patients with severe ischemic heart disease, especially those with left main, triple vessel disease or single/double vessel disease with stenosis of the proximal left anterior descending (LAD) artery. The perioperative mortality is about 2% with an additional 5% to 7% suffering complications such as myocardial infarction, stroke, renal failure, etc. The technique of operating on a beating heart (off-pump) for coronary artery bypass grafting surgery has been recently developed in the past few years in an effort to decrease the above perioperative complications typically related to cardiopulmonary bypass associated with on-pump CABG. While registries suggest that off-pump CABG may be superior, these data cannot fully control for differences in patient characteristics, which influence patient selection for specific procedures. The benefits of off-pump CABG compared with conventional on-pump CABG are unclear. The investigators therefore propose a large simple, international multicentre randomized controlled trial to definitively evaluate the efficacy and safety of off-pump CABG in the treatment of patients undergoing coronary artery surgery funded by CIHR, this pilot study will be a preliminary step towards a full trial.
Sample size:
The investigators examined the outcomes in the Canadian off-pump CABG Registry to identify a group of patients who represent a higher risk of cardiovascular events. Utilizing the inclusion criteria described below, this group of patients has accumulated the vast majority of outcomes in the Registry and represent more than 50% of patients in the Registry, therefore minimizing the sample size but still being representative. The cumulative event rate at 30 days (first co-primary outcome) for on-pump CABG is estimated as being 8.6% and the investigators expect a 33% relative risk reduction (RRR) for the off-pump CABG group. The sample calculated for the whole trial is 4700 patients.
Design/Methodology:
Trial design: This is a pilot randomized controlled trial comparing off-pump CABG versus on-pump CABG in 60 patients who will be undergoing isolated CABG.
Interventions: Patients eligible for CABG will be randomized to receive either an Off-pump CABG surgery or On-pump CABG surgery.
Randomization: After obtaining informed written consent patients will be allocated to either off-pump CABG or on-pump CABG by calling a 24-hour randomization telephone number. An expertise-based randomization will be used wherein a surgeon who is an expert in Off-pump surgery will operate on patients randomized to receive Off-pump surgery. Patients randomized to receive On-pump CABG will be operated on by a surgeon who is an expert in on-pump CABG surgery. To minimize bias stratified block randomization will used. For this pilot study randomization will be stratified to 3 centres and random block of 4 or 6.
The data adjudicators will be blinded to the study. Due to the nature of intervention, the operating surgeon, anesthetist, perfusionist, other operation room staff, intensive-care unit staff will not be blinded in this study.
Setting:
Patients will have either been seen in the emergency, outpatient or ICU and diagnosed with having single, double or triple coronary artery occlusion requiring an isolated CABG.
Study interventions:
Interventions: Patients eligible for CABG will be randomized to receive either an Off-pump CABG surgery or On-pump CABG surgery. A surgeon who is an expert in the assigned technique will perform the procedure.
Primary outcomes:
* The occurrence of the composite of total mortality, stroke, nonfatal MI, or new renal failure at 30 days post CABG surgery AND
* 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.
The secondary outcomes
* The assessment of total costs and resources consumption at 30 days after CABG surgery AND
* The assessment of total costs and resources consumption at 5 years after CABG surgery
Measurements:
The investigators will ascertain all events of interest through periodic and regular follow-up utilizing standardized definitions for all events, appropriate supporting documents will be obtained centrally.
* CV death: all deaths are considered cardiovascular unless a specific non-cardiovascular cause is evident (e.g. malignancy).
* Stroke: new acute focal neurological deficit (except for subarachnoid hemorrhage which may not be focal) thought to be of vascular origin with signs or symptoms lasting greater than 24 hours.
* MI perioperative (within 24 hours of surgery): new pathologic Q waves with documented new wall motion abnormalities other than septal OR cardiac markers ³ 10 x ULN.
* MI non-perioperative (later than 24 hours after surgery): ECG changes consistent with infarction (new significant Q waves in two contiguous leads in the absence of previous LVH or conduction abnormalities) or evolving ST-segment to T-wave changes in two contiguous leads or new left bundle branch block or ST segment elevation requiring thrombolysis or PCI AND cardiac markers (troponins or CKMB) in the necrosis range. Post-PCI MI are included into non-perioperative MI group but are defined as new pathologic Q waves with documented new wall motion abnormalities other than septal OR cardiac markers ³ 3 x ULN within 24 hours of PCI.
* Renal failure: doubling of serum creatinine from pre-op baseline or requirement for renal replacement therapy (eg, dialysis, continuous hemofiltration, renal transplant). Hemofiltration or dialysis only during cardio-pulmonary bypass does not constitute a requirement for renal replacement therapy. Patients who receive dialysis within 1 month of the surgery are not eligible for this endpoint.
* Repeated coronary revascularization: new CABG procedure or PCI associated with documented ischemia by stress testing (ECG, ECHO, or nuclear) AND graft failure or new culprit lesion (³ 70% luminal stenosis).
For other endpoints, the investigators have defined:
* Recurrence of angina: new or chronic onset of typical chest pain with documented ischemia by stress testing (ECG, ECHO, or nuclear).
* Blood transfusions: all blood bank products transfused within 24 hours of the CABG surgery.
* Total mortality: all causes of mortality
Plan for data analysis:
The intention to treat principle, in which all participants will be included in their assigned treatment groups regardless of adherence, will guide all analyses. In the principle analysis, the time to the first occurrence of one of the components of the cluster of (cardiac death, stroke, nonfatal MI, new renal failure) will be presented by Kaplan-Meier survival curves and the comparisons between the two treatment groups will be performed by a log-rank test. The treatment effect as measured by the hazard ratio and 95% confidence interval will be derived by the Cox proportional hazards model. The investigators will also calculate the absolute risk reductions and the associated 95% confidence intervals, as well as the number needed to treat (NNT) with off-pump CABG to prevent one major cardiovascular event. Participants who prematurely discontinue follow-up before a major cardiovascular event will be censored as to their last follow-up data; this number is expected to be \<1% given the relatively short period of follow-up after surgery.
In secondary analyses the investigators will determine and compare the incidence of major cardiovascular events (cardiac death, stroke, nonfatal MI, new renal dialysis) and revascularization procedures (i.e. coronary artery bypass surgery and percutaneous coronary intervention) using the same strategy. The effect of the two operative techniques on different sub-groups (i.e. patients with diabetes, renal failure, congestive heart failure, cerebrovascular disease, as well as patient left ventricular function, gender and ages will be conducted by stratified analysis through a Cox proportional hazards model. The test of interaction between each subgroup factor and the treatment group will be done by including a product term in the model already containing treatment and the subgroup factor. The length of hospital stay and length of ICU/CCU stay will be compared using a student's t-test. An events adjudication committee (blind to surgical allocation) will centrally review all suspected major outcomes listed above.
The investigators will also do subgroup analysis on different sub-groups (i.e. patients with diabetes, renal failure, congestive heart failure, cerebrovascular disease, as well as patient left ventricular function, gender and ages will be examined for consistency and coherence)
Coronary artery bypass grafting (CABG) surgery prolongs life-expectancy in patients with severe ischemic heart disease, especially those with left main, triple vessel disease or single/double vessel disease with stenosis of the proximal left anterior descending (LAD) artery. The perioperative mortality is about 2% with an additional 5% to 7% suffering complications such as myocardial infarction, stroke, renal failure, etc. The technique of operating on a beating heart (off-pump) for coronary artery bypass grafting surgery has been recently developed in the past few years in an effort to decrease the above perioperative complications typically related to cardiopulmonary bypass associated with on-pump CABG. While registries suggest that off-pump CABG may be superior, these data cannot fully control for differences in patient characteristics, which influence patient selection for specific procedures. The benefits of off-pump CABG compared with conventional on-pump CABG are unclear. The investigators therefore propose a large simple, international multicentre randomized controlled trial to definitively evaluate the efficacy and safety of off-pump CABG in the treatment of patients undergoing coronary artery surgery funded by CIHR, this pilot study will be a preliminary step towards a full trial.
Sample size:
The investigators examined the outcomes in the Canadian off-pump CABG Registry to identify a group of patients who represent a higher risk of cardiovascular events. Utilizing the inclusion criteria described below, this group of patients has accumulated the vast majority of outcomes in the Registry and represent more than 50% of patients in the Registry, therefore minimizing the sample size but still being representative. The cumulative event rate at 30 days (first co-primary outcome) for on-pump CABG is estimated as being 8.6% and the investigators expect a 33% relative risk reduction (RRR) for the off-pump CABG group. The sample calculated for the whole trial is 4700 patients.
Design/Methodology:
Trial design: This is a pilot randomized controlled trial comparing off-pump CABG versus on-pump CABG in 60 patients who will be undergoing isolated CABG.
Interventions: Patients eligible for CABG will be randomized to receive either an Off-pump CABG surgery or On-pump CABG surgery.
Randomization: After obtaining informed written consent patients will be allocated to either off-pump CABG or on-pump CABG by calling a 24-hour randomization telephone number. An expertise-based randomization will be used wherein a surgeon who is an expert in Off-pump surgery will operate on patients randomized to receive Off-pump surgery. Patients randomized to receive On-pump CABG will be operated on by a surgeon who is an expert in on-pump CABG surgery. To minimize bias stratified block randomization will used. For this pilot study randomization will be stratified to 3 centres and random block of 4 or 6.
The data adjudicators will be blinded to the study. Due to the nature of intervention, the operating surgeon, anesthetist, perfusionist, other operation room staff, intensive-care unit staff will not be blinded in this study.
Setting:
Patients will have either been seen in the emergency, outpatient or ICU and diagnosed with having single, double or triple coronary artery occlusion requiring an isolated CABG.
Study interventions:
Interventions: Patients eligible for CABG will be randomized to receive either an Off-pump CABG surgery or On-pump CABG surgery. A surgeon who is an expert in the assigned technique will perform the procedure.
Primary outcomes:
* The occurrence of the composite of total mortality, stroke, nonfatal MI, or new renal failure at 30 days post CABG surgery AND
* 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.
The secondary outcomes
* The assessment of total costs and resources consumption at 30 days after CABG surgery AND
* The assessment of total costs and resources consumption at 5 years after CABG surgery
Measurements:
The investigators will ascertain all events of interest through periodic and regular follow-up utilizing standardized definitions for all events, appropriate supporting documents will be obtained centrally.
* CV death: all deaths are considered cardiovascular unless a specific non-cardiovascular cause is evident (e.g. malignancy).
* Stroke: new acute focal neurological deficit (except for subarachnoid hemorrhage which may not be focal) thought to be of vascular origin with signs or symptoms lasting greater than 24 hours.
* MI perioperative (within 24 hours of surgery): new pathologic Q waves with documented new wall motion abnormalities other than septal OR cardiac markers ³ 10 x ULN.
* MI non-perioperative (later than 24 hours after surgery): ECG changes consistent with infarction (new significant Q waves in two contiguous leads in the absence of previous LVH or conduction abnormalities) or evolving ST-segment to T-wave changes in two contiguous leads or new left bundle branch block or ST segment elevation requiring thrombolysis or PCI AND cardiac markers (troponins or CKMB) in the necrosis range. Post-PCI MI are included into non-perioperative MI group but are defined as new pathologic Q waves with documented new wall motion abnormalities other than septal OR cardiac markers ³ 3 x ULN within 24 hours of PCI.
* Renal failure: doubling of serum creatinine from pre-op baseline or requirement for renal replacement therapy (eg, dialysis, continuous hemofiltration, renal transplant). Hemofiltration or dialysis only during cardio-pulmonary bypass does not constitute a requirement for renal replacement therapy. Patients who receive dialysis within 1 month of the surgery are not eligible for this endpoint.
* Repeated coronary revascularization: new CABG procedure or PCI associated with documented ischemia by stress testing (ECG, ECHO, or nuclear) AND graft failure or new culprit lesion (³ 70% luminal stenosis).
For other endpoints, the investigators have defined:
* Recurrence of angina: new or chronic onset of typical chest pain with documented ischemia by stress testing (ECG, ECHO, or nuclear).
* Blood transfusions: all blood bank products transfused within 24 hours of the CABG surgery.
* Total mortality: all causes of mortality
Plan for data analysis:
The intention to treat principle, in which all participants will be included in their assigned treatment groups regardless of adherence, will guide all analyses. In the principle analysis, the time to the first occurrence of one of the components of the cluster of (cardiac death, stroke, nonfatal MI, new renal failure) will be presented by Kaplan-Meier survival curves and the comparisons between the two treatment groups will be performed by a log-rank test. The treatment effect as measured by the hazard ratio and 95% confidence interval will be derived by the Cox proportional hazards model. The investigators will also calculate the absolute risk reductions and the associated 95% confidence intervals, as well as the number needed to treat (NNT) with off-pump CABG to prevent one major cardiovascular event. Participants who prematurely discontinue follow-up before a major cardiovascular event will be censored as to their last follow-up data; this number is expected to be \<1% given the relatively short period of follow-up after surgery.
In secondary analyses the investigators will determine and compare the incidence of major cardiovascular events (cardiac death, stroke, nonfatal MI, new renal dialysis) and revascularization procedures (i.e. coronary artery bypass surgery and percutaneous coronary intervention) using the same strategy. The effect of the two operative techniques on different sub-groups (i.e. patients with diabetes, renal failure, congestive heart failure, cerebrovascular disease, as well as patient left ventricular function, gender and ages will be conducted by stratified analysis through a Cox proportional hazards model. The test of interaction between each subgroup factor and the treatment group will be done by including a product term in the model already containing treatment and the subgroup factor. The length of hospital stay and length of ICU/CCU stay will be compared using a student's t-test. An events adjudication committee (blind to surgical allocation) will centrally review all suspected major outcomes listed above.
The investigators will also do subgroup analysis on different sub-groups (i.e. patients with diabetes, renal failure, congestive heart failure, cerebrovascular disease, as well as patient left ventricular function, gender and ages will be examined for consistency and coherence)
Conditions
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the Efficacy and Safety of Off-pump CABG
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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On Pump Arm
Group Type
ACTIVE_COMPARATOR
Coronary Artery Bypass Graft with the use of CPB
Intervention Type
PROCEDURE
Coronary Artery Bypass Graft (CABG) using median sternotomy, CPB, cardioplegia and complete cross-clamp and no associated or concomitant surgical procedures
Off Pump Arm
Group Type
EXPERIMENTAL
Coronary Artery Bypass Graft without the use of CPB
Intervention Type
PROCEDURE
Coronary Artery Bypass Graft (CABG) with no associated or concomitant surgical procedures, using median sternotomy and without CPB and cardioplegia
Interventions
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Coronary Artery Bypass Graft with the use of CPB
Coronary Artery Bypass Graft (CABG) using median sternotomy, CPB, cardioplegia and complete cross-clamp and no associated or concomitant surgical procedures
Intervention Type
PROCEDURE
Coronary Artery Bypass Graft without the use of CPB
Coronary Artery Bypass Graft (CABG) with no associated or concomitant surgical procedures, using median sternotomy and without CPB and cardioplegia
Intervention Type
PROCEDURE
Other Intervention Names
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ON Pump CABG
OFF Pump
Eligibility Criteria
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Inclusion Criteria
Patients who have been diagnosed with coronary artery disease (single, double or triple disease) will be eligible if they:
1. require isolated CABG with median sternotomy
2. are able to give their informed written consent
3. are\> 21 years of age and
4. 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.
* 55-59 years of age and two of the following:
* diabetes (oral hypoglycemic agent and/or insulin)
* urgent revascularization (waiting in hospital)
* LV ejection fraction \<35%
* current or recent smoker.
1. require isolated CABG with median sternotomy
2. are able to give their informed written consent
3. are\> 21 years of age and
4. 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.
* 55-59 years of age and two of the following:
* diabetes (oral hypoglycemic agent and/or insulin)
* urgent revascularization (waiting in hospital)
* LV ejection fraction \<35%
* current or recent smoker.
Exclusion Criteria
Patients will be excluded if they have one of the following:
1. concomitant cardiac procedure associated with CABG,
2. contra-indications to off-pump CABG or on-pump CABG (calcified aorta, intramuscular LAD, calcified coronaries, small target vessels)
3. concomitant life-threatening disease likely to limit life expectancy to less than 2 years,
4. prior enrollment in this trial
5. emergency CABG surgery (immediate revascularization for hemodynamic instability) OR
6. redo CABG.
1. concomitant cardiac procedure associated with CABG,
2. contra-indications to off-pump CABG or on-pump CABG (calcified aorta, intramuscular LAD, calcified coronaries, small target vessels)
3. concomitant life-threatening disease likely to limit life expectancy to less than 2 years,
4. prior enrollment in this trial
5. emergency CABG surgery (immediate revascularization for hemodynamic instability) OR
6. redo CABG.
Minimum Eligible Age
21 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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McMaster University
OTHER
Sponsor Role
collaborator
University of Oxford
OTHER
Sponsor Role
collaborator
Instituto Dante Pazzanese de Cardiologia
OTHER
Sponsor Role
collaborator
Fu Wai Hospital, Beijing, China
OTHER
Sponsor Role
collaborator
Universidad de La Frontera
OTHER
Sponsor Role
collaborator
Fundación Cardiovascular de Colombia
OTHER
Sponsor Role
collaborator
Charles University, Czech Republic
OTHER
Sponsor Role
collaborator
Hopital Jean Minjoz
OTHER
Sponsor Role
collaborator
Centre for Chronic Disease Control, India
OTHER
Sponsor Role
collaborator
Ospedale Santa Croce-Carle Cuneo
OTHER
Sponsor Role
collaborator
Medical University of Gdansk
OTHER
Sponsor Role
collaborator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
OTHER
Sponsor Role
collaborator
Ankara University
OTHER
Sponsor Role
collaborator
Hotel Dieu Hospital
OTHER
Sponsor Role
collaborator
Centre hospitalier de l'Université de Montréal (CHUM)
OTHER
Sponsor Role
collaborator
SAL Hospital, Ahmedabad, India
UNKNOWN
Sponsor Role
collaborator
Population Health Research Institute
OTHER
Sponsor Role
lead
Responsible Party
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Andre Lamy
Cardiac Surgeon
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Lamy Andre, MD, MSc
Role: PRINCIPAL_INVESTIGATOR
McMaster University
Salim Yusuf, MD, DPhil
Role: PRINCIPAL_INVESTIGATOR
Population Health Research Institute
David Taggart, MD
Role: PRINCIPAL_INVESTIGATOR
University of Oxford
Locations
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Fundacion Medica de rio negro y neuquen
Rio Negro, , Argentina
Site Status
Beneficencia Portuguesa de Sao Paulo
São Paulo, CEP, Brazil
Site Status
Instituto Dante Pazzanese de Cardiologia
São Paulo, CEP, Brazil
Site Status
Hospital Sao Francisco Complexo Hospitalar Santa Casa
Porto Alegre, Rio Grande do Sul, Brazil
Site Status
Irmande Santa Casa De Misericordia De Curtiba
Curitiba Parana, , Brazil
Site Status
Braile Clinica de Servicos de Assistencia Medico
São José do Rio Preto, , Brazil
Site Status
Irmandade da Santa Casa de Misericordia de Sao Paulo
São Paulo, , Brazil
Site Status
Federal University of Sao Paulo School of Medicine
São Paulo, , Brazil
Site Status
Associação do Sanátorio Sírio
São Paulo, , Brazil
Site Status
Instituto do Coracao do Hospital das Clinicas da
São Paulo, , Brazil
Site Status
Hospital Mario Covas
São Paulo, , Brazil
Site Status
Santa Casa de Misericordia de Marilia
São Paulo, , Brazil
Site Status
Foothills Medical Centre
Calgary, Alberta, Canada
Site Status
Hamilton General Hospital
Hamilton, Ontario, Canada
Site Status
London Health Sciences Centre
London, Ontario, Canada
Site Status
Toronto General Hospital
Toronto, Ontario, Canada
Site Status
Montreal Heart Institute
Montreal, Quebec, Canada
Site Status
Hotel-Dieu du CHUM
Montreal, Quebec, Canada
Site Status
Hospital Regional Temuco
Temuco, Región de la Araucanía, Chile
Site Status
Instituto Nacional del Torax
Santiago, , Chile
Site Status
ChaoYang Hospital
Beijing, , China
Site Status
FuWai Hospital
Beijing, , China
Site Status
Nanjing First Hospital
Nanjing, , China
Site Status
Fundacion Cardioinfantil
Bogotá, , Colombia
Site Status
Fundacion Valle Del Lili
Cali, , Colombia
Site Status
Charles University Hospital
Hradec Králové, , Czechia
Site Status
Kardiochirurgicke centrum
Ostrava-Poruba, , Czechia
Site Status
University Hospital Pilsen
Pilsen, , Czechia
Site Status
Fakultni nemocnice Kralovske Vinohrady (FNKV)
Prague, , Czechia
Site Status
University Hospital Motol
Prague, , Czechia
Site Status
Nemocnice Podlesi
Třinec, , Czechia
Site Status
Service de chirurgie thoracique et cardio-vasculaire
Besançon, , France
Site Status
Nizam's Institute of Medical Sciences
Hyderabad, Andhra Pradesh, India
Site Status
SAL Hospital and Medical Institute
Ahmedabad, Gujarat, India
Site Status
Amrita Institute of Medical Sciences and Research Center
Kochi, Kerala, India
Site Status
G.Kuppuswamy Naidu Memorial Hospital
Coimbatore, Tamil Nadu, India
Site Status
SAL Hospital
Ahmedabad, , India
Site Status
International Center of Cardiovascular and Thoracic Diseases
Chennai Tamil Nadu, , India
Site Status
Sanjay Gandhi PGIMS
Lucknow, , India
Site Status
All India Institute of Medical Sciences
New Delhi, , India
Site Status
Escorts Heart Institute and Research Centre
Noida, , India
Site Status
Ospedale S. Croce
Cuneo, , Italy
Site Status
Ospedale Niguarda - Ca Granda
Milan, , Italy
Site Status
Jagiellonian University
Krakow, , Poland
Site Status
Alp Aslan
Ankara, , Turkey (Türkiye)
Site Status
Erol Senor
Ankara, , Turkey (Türkiye)
Site Status
Ruchan Akar
Ankara, , Turkey (Türkiye)
Site Status
Sertap Aykut Aka
Ankara, , Turkey (Türkiye)
Site Status
Volkan Sinci
Ankara, , Turkey (Türkiye)
Site Status
Basildon and Thurrock University Hospital NHS FT
Basildon, Essex, United Kingdom
Site Status
Royal Infirmary of Edinburgh
Edinburgh, EU, United Kingdom
Site Status
The John Radcliffe Hospital
Oxford, , United Kingdom
Site Status
Countries
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Argentina
Brazil
Canada
Chile
China
Colombia
Czechia
France
India
Italy
Poland
Turkey (Türkiye)
United Kingdom
References
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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.
Reference Type
DERIVED
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.
Reference Type
DERIVED
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.
Reference Type
DERIVED
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.
Reference Type
DERIVED
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.
Reference Type
DERIVED
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.
Reference Type
DERIVED
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.
Reference Type
DERIVED
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.
Reference Type
DERIVED
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.
Reference Type
DERIVED
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.
Reference Type
DERIVED
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
PHRI-065
Identifier Type: -
Identifier Source: org_study_id
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