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Coronary artery grafting in High RISk patients randomised to Off Pump or On Pump


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

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


Bristol Clinical Trials and Evaluation Unit Medical Research Council UK Clinical Research Collaboration University of Bristol University of Oxford

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