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).
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.



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.



NCT01895751 (ClinicalTrials.gov).
West of Scotland Heart and Lung Centre, Golden Jubilee National Hospital, Glasgow, UK; Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, UK; Western Infirmary, Glasgow, UK; Royal Alexandra Hospital, Paisley, UK; Glasgow Royal Infirmary, Glasgow, UK.
Matthew M Y
MM
Lee
West of Scotland Heart and Lung Centre, Golden Jubilee National Hospital, Glasgow, UK; Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, UK; Glasgow Royal Infirmary, Glasgow, UK.
Mark C
MC
Petrie
West of Scotland Heart and Lung Centre, Golden Jubilee National Hospital, Glasgow, UK; Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, UK; Glasgow Royal Infirmary, Glasgow, UK.
Paul
P
Rocchiccioli
West of Scotland Heart and Lung Centre, Golden Jubilee National Hospital, Glasgow, UK; Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, UK.
Joanne
J
Simpson
West of Scotland Heart and Lung Centre, Golden Jubilee National Hospital, Glasgow, UK; Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, UK.
Colette
C
Jackson
Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, UK; Western Infirmary, Glasgow, UK.
Ammani
A
Brown
West of Scotland Heart and Lung Centre, Golden Jubilee National Hospital, Glasgow, UK; Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, UK.
David
D
Corcoran
West of Scotland Heart and Lung Centre, Golden Jubilee National Hospital, Glasgow, UK; Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, UK.
Kenneth
K
Mangion
West of Scotland Heart and Lung Centre, Golden Jubilee National Hospital, Glasgow, UK; Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, UK; Western Infirmary, Glasgow, UK.
Margaret
M
McEntegart
West of Scotland Heart and Lung Centre, Golden Jubilee National Hospital, Glasgow, UK; Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, UK; Glasgow Royal Infirmary, Glasgow, UK.
Aadil
A
Shaukat
West of Scotland Heart and Lung Centre, Golden Jubilee National Hospital, Glasgow, UK; Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, UK; Glasgow Royal Infirmary, Glasgow, UK.
Alan
A
Rae
West of Scotland Heart and Lung Centre, Golden Jubilee National Hospital, Glasgow, UK; Royal Alexandra Hospital, Paisley, UK.
Stuart
S
Hood
West of Scotland Heart and Lung Centre, Golden Jubilee National Hospital, Glasgow, UK; Royal Alexandra Hospital, Paisley, UK.
Eileen
E
Peat
Royal Alexandra Hospital , Paisley , UK.
Iain
I
Findlay
Royal Alexandra Hospital , Paisley , UK.
Clare
C
Murphy
Royal Alexandra Hospital , Paisley , UK.
Alistair
A
Cormack
Royal Blackburn Hospital , Blackburn , UK.
Nikolay
N
Bukov
Royal Blackburn Hospital , Blackburn , UK.
Kanarath
K
Balachandran
Robertson Centre for Biostatistics, University of Glasgow , Glasgow , UK.
Richard
R
Papworth
Robertson Centre for Biostatistics, University of Glasgow , Glasgow , UK.
Ian
I
Ford
Department of Health Economics and Health Technology Assessment , University of Glasgow , Glasgow , UK.
Andrew
A
Briggs
West of Scotland Heart and Lung Centre, Golden Jubilee National Hospital, Glasgow, UK; Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, UK; Western Infirmary, Glasgow, UK.
Colin
C
Berry
CABG; Invasive; NSTE-ACS; RCT; Registry