An international multi-centre open randomised controlled trial of isolated off-pump CABG (OPCABG) versus on-pump CABG (ONCABG) in high risk patients
Aim of study
To test the hypothesis that OPCABG reduces mortality and morbidity in high-risk patients without causing a higher risk of re-intervention
Design
An open multicenter study
Study population
5420 adult, consenting patients having isolated, non emergency CABG surgery
Outcome measures
Primary
- Composite endpoint of death or serious morbidity (CRISPSw)
Secondary
- Duration of intensive care unit stay during index hospital admission
- Duration of hospital stay during index hospital admission
- Survival free from death, stroke, MI, re-intervention, renal failure and sternal wound infection at 1 year
- Resource utilisation
- Quality of life assessment at 1 year
- Cost-effectiveness
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Inclusion criteria
- Euroscore ≥5
- Non-emergency surgery
- Operation to be carried out via a median sternotomy
- Written informed patient consent
Exclusion criteria
- Euroscore <5
- Emergency operation (immediate revascularisation for haemodynamic instability)
- Concomitant cardiac procedure with CABG
- Operation to be carried out via an incision other than a median sternotomy (e.g. anterolateral left thoracotomy)
- Contraindication to ONCABG or OPCABG (e.g. calcified aorta, intramuscular LAD, calcified coronaries, small target vessels)
Contact
Chris Rogers
Email: chris.rogers@bristol.ac.uk
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