logo

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


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

Randomisation service provided by: Sealed Envelope™.com