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Non-invasive versus invasive management in patients with prior coronary artery bypass surgery with a non-ST segment elevation acute coronary syndrome: study design of the pilot randomised controlled trial and registry (CABG-ACS)
  1. Matthew M Y Lee1,2,3,4,5,
  2. Mark C Petrie1,2,5,
  3. Paul Rocchiccioli1,2,5,
  4. Joanne Simpson1,2,
  5. Colette Jackson1,2,
  6. Ammani Brown2,3,
  7. David Corcoran1,2,
  8. Kenneth Mangion1,2,
  9. Margaret McEntegart1,2,3,
  10. Aadil Shaukat1,2,5,
  11. Alan Rae1,2,5,
  12. Stuart Hood1,4,
  13. Eileen Peat1,4,
  14. Iain Findlay4,
  15. Clare Murphy4,
  16. Alistair Cormack4,
  17. Nikolay Bukov6,
  18. Kanarath Balachandran6,
  19. Richard Papworth7,
  20. Ian Ford7,
  21. Andrew Briggs8 and
  22. Colin Berry1,2,3
  23. on behalf of the CABG-ACS Investigators
  1. 1West of Scotland Heart and Lung Centre, Golden Jubilee National Hospital, Glasgow, UK
  2. 2Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, UK
  3. 3Western Infirmary, Glasgow, UK
  4. 4Royal Alexandra Hospital, Paisley, UK
  5. 5Glasgow Royal Infirmary, Glasgow, UK
  6. 6Royal Blackburn Hospital, Blackburn, UK
  7. 7Robertson Centre for Biostatistics, University of Glasgow, Glasgow, UK
  8. 8Department of Health Economics and Health Technology Assessment, University of Glasgow, Glasgow, UK
  1. Correspondence to Professor Colin Berry; colin.berry{at}glasgow.ac.uk

Abstract

Introduction There is an evidence gap about how to best treat patients with prior coronary artery bypass grafts (CABGs) presenting with non-ST segment elevation acute coronary syndromes (NSTE-ACS) because historically, these patients were excluded from pivotal randomised trials. We aim to undertake a pilot trial of routine non-invasive management versus routine invasive management in patients with NSTE-ACS with prior CABG and optimal medical therapy during routine clinical care. Our trial is a proof-of-concept study for feasibility, safety, potential efficacy and health economic modelling. We hypothesise that a routine invasive approach in patients with NSTE-ACS with prior CABG is not superior to a non-invasive approach with optimal medical therapy.

Methods and analysis 60 patients will be enrolled in a randomised clinical trial in 4 hospitals. A screening log will be prospectively completed. Patients not randomised due to lack of eligibility criteria and/or patient or physician preference and who give consent will be included in a registry. We will gather information about screening, enrolment, eligibility, randomisation, patient characteristics and adverse events (including post-discharge). The primary efficacy outcome is the composite of all-cause mortality, rehospitalisation for refractory ischaemia/angina, myocardial infarction and hospitalisation for heart failure. The primary safety outcome is the composite of bleeding, stroke, procedure-related myocardial infarction and worsening renal function. Health status will be assessed using EuroQol 5 Dimensions (EQ-5D) assessed at baseline and 6 monthly intervals, for at least 18 months.

Trial registration number NCT01895751 (ClinicalTrials.gov).

  • Invasive
  • CABG
  • NSTE-ACS
  • RCT
  • Registry

This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) license, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See: http://creativecommons.org/licenses/by/4.0/

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