Coronary artery bypass graft (CABG) off- or on-pump revascularisation study

Not Applicable

Completed

• Conditions: Coronary artery disease requiring isolated coronary artery bypass graft (CABG); Circulatory System; Coronary artery disease

• Registration Number: ISRCTN84724990
• Lead Sponsor: Population Health Research Institute (PHRI) (Canada)

Brief Summary

1. 2012 results in: https://www.ncbi.nlm.nih.gov/pubmed/22172429 2. 2012 results in: https://www.ncbi.nlm.nih.gov/pubmed/22449296 3. 2012 sub-study protocol in: https://www.ncbi.nlm.nih.gov/pubmed/22514244 4. 2013 results in: https://www.ncbi.nlm.nih.gov/pubmed/23477676 5. 2014 results in: https://www.ncbi.nlm.nih.gov/pubmed/24886787 6. 2014 results in: https://www.ncbi.nlm.nih.gov/pubmed/25261272 7. 2016 results in: https://www.ncbi.nlm.nih.gov/pubmed/27771985

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-02-04
• Study Completion: 2014-05-31
• Last Update Posted: 29 April 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 4700

Inclusion Criteria

1. Require isolated CABG with median sternotomy
2. Provide written informed consent
3. 21 years of age and older, either sex
4. Have one risk factor or more:
4.1. Greater than or equal to 70 years age
4.2. Peripheral vascular disease (previous peripheral bypass or amputation or ankle brachial index [ABI] less than 0.80)
4.3. Cerebrovascular disease (history of stroke, transient ischaemic attack [TIA], carotid stenosis greater than 70%)
4.4. Renal insufficiency (creatinine above upper limit of normal)
4.5. Greater than 60 years of age with one of the following:
4.5.1. Diabetes (oral hypoglycaemic agent and/or insulin)
4.5.2. Urgent revascularisation (waiting in hospital)
4.5.3. Left ventricular ejection fraction less than 35%
4.5.4. Current or recent smokers (within 1 year of randomisation)

Exclusion Criteria

1. Concomitant cardiac procedure associated with CABG
2. Contra-indications to off-pump CABG or on-pump CABG (calcified aorta, intramuscular left anterior descending [LAD], calcified coronaries, small target vessels)
3. Concomitant life-threatening disease likely to limit life expectancy to less than 2 years
4. Prior enrolment in this trial
5. Emergency CABG surgery (immediate revascularisation for haemodynamic instability)
6. Redo CABG

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 1. The occurrence of the composite of total mortality, stroke, nonfatal myocardial infarction [MI], or new renal failure at 30 days post CABG surgery<br> 2. The occurrence of the composite of total mortality, stroke, nonfatal MI, new renal failure, or repeat coronary revascularisation (i.e. coronary artery bypass surgery or percutaneous coronary intervention) over 5 years after randomisation<br>

Secondary Outcome Measures

Name	Time	Method
<br> 1. The assessment of total costs and resources consumption at 30 days after CABG surgery<br> 2. The assessment of total costs and resources consumption at 5 years after CABG surgery<br>