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Three-year follow-up in a subset of high-risk patients randomly assigned to off-pump versus on-pump coronary artery bypass surgery: the Best Bypass Surgery Trial
  1. Christian H Møller1,2,
  2. Mario J Perko1,
  3. Jens T Lund1,
  4. Lars W Andersen3,
  5. Henning Kelbæk4,
  6. Jan K Madsen5,
  7. Per Winkel2,
  8. Christian Gluud2,
  9. Daniel A Steinbrüchel1
  1. 1Department of Cardio-Thoracic Surgery, Rigshospitalet, Copenhagen University Hospital, Denmark
  2. 2Copenhagen Trial Unit, Center for Clinical Intervention Research, Rigshospitalet, Copenhagen University Hospital, Denmark
  3. 3Department of Cardio-Thoracic Anesthesiology, Rigshospitalet, Copenhagen University Hospital, Denmark
  4. 4Department of Cardiology, Rigshospitalet, Copenhagen University Hospital, Denmark
  5. 5Department of Cardiology, Gentofte Hospital, Copenhagen University Hospital, Denmark
  1. Correspondence to Dr Christian H Møller, Department of Cardio-Thoracic Surgery, 2152, Rigshospitalet, Blegdamsvej 9, Copenhagen 2100, Denmark; chm{at}ctu.rh.dk

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Objective To evaluate off-pump versus on-pump coronary artery bypass grafting (CABG) in patients with three-vessel disease and a high-risk operative profile.

Design A randomised clinical trial.

Setting Rigshospitalet, University Hospital, Copenhagen, Denmark.

Participants 341 patients with three-vessel disease and a EuroSCORE of 5 or greater. Main exclusion criteria were previous heart surgery, poor left ventricular function (ejection fraction <30%), or unstable preoperative condition.

Intervention CABG performed with versus without cardiopulmonary bypass.

Main outcome measure The primary outcome was a composite of major adverse cardiac and cerebrovascular events (MACCE) including all-cause mortality, acute myocardial infarction, cardiac arrest with successful resuscitation, low cardiac output syndrome/cardiogenic shock, stroke and coronary reintervention.

Results MACCE occurred in 69 (40%) patients allocated to off-pump versus 54 (33%) patients allocated to on-pump CABG during the median 3.7 years of follow-up (HR 1.22; 95% CI 0.86 to 1.75; p=0.26). All-cause mortality was significantly increased in the off-pump group (24% vs 15%; HR 1.66, 95% CI 1.02 to 2.73; p=0.04), but cardiac-related death was not significantly different (10% vs 7%; HR 1.30, 95% CI 0.64 to 2.66; p=0.47). An insignificant trend towards a reduction in myocardial infarction after off-pump CABG was observed (7% vs 14%; HR 0.53, 95% CI: 0.27 to 1.04; p=0.06).

Conclusions No significant difference in the primary outcome of MACCE was found between off-pump and on-pump CABG. However, mortality seemed higher after off-pump CABG.

Trial registration http://clinicaltrials.gov/ number, NCT00120991.

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Footnotes

  • Funding The work was performed at the Department of Cardio-Thoracic Surgery, Rigshospitalet, Denmark. The Danish Heart Foundation (08-4-R64-A2029-B948-22480), the Danish Medical Research Council, the Copenhagen Hospital Corporations Medical Research Council, the Rigshospitalet Research Council, Aase and Ejnar Danielsens Foundation, the Gangsted Foundation and Danish Agency for Science, Technology and Innovation provided funding for the study.

  • Competing interests None.

  • Patient consent Obtained.

  • Ethics approval This study was conducted with the approval of the Danish Regional Committee on Biomedical Ethics and the Danish Data Protection Agency.

  • Provenance and peer review Not commissioned; externally peer reviewed.

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