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)

Lee, M. M.Y. et al. (2016) 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). Open Heart, 3(1), e000371. (doi:10.1136/openhrt-2015-000371) (PMID:27110377) (PMCID:PMC4838768)

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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.

Item Type:Articles
Status:Published
Refereed:Yes
Glasgow Author(s) Enlighten ID:Berry, Professor Colin and Rae, Dr Alan and Simpson, Dr Joanne and Lee, Matthew and Briggs, Professor Andrew and Papworth, Dr Richard and Petrie, Professor Mark and Brown, Mrs Ammani and Corcoran, Dr David and Murphy, Dr Clare and Mangion, Dr Kenneth and Cormack, Dr Alistair and Jackson, Dr Colette and Ford, Professor Ian and Hood, Dr Stuart
Authors: Lee, M. M.Y., Petrie, M. C., Rocchiccioli, P., Simpson, J., Jackson, C., Brown, A., Corcoran, D., Mangion, K., McEntegart, M., Shaukat, A., Rae, A., Hood, S., Peat, E., Findlay, I., Murphy, C., Cormack, A., Bukov, N., Balachandran, K., Papworth, R., Ford, I., Briggs, A., and Berry, C.
College/School:College of Medical Veterinary and Life Sciences > Institute of Cardiovascular and Medical Sciences
College of Medical Veterinary and Life Sciences > Institute of Health and Wellbeing > Health Economics and Health Technology Assessment
College of Medical Veterinary and Life Sciences > Institute of Health and Wellbeing > Robertson Centre
Journal Name:Open Heart
Publisher:BMJ Publishing Group
ISSN:2053-3624
ISSN (Online):2053-3624
Copyright Holders:Copyright © 2016 The Authors
First Published:First published in Open Heart 3(1):e000371
Publisher Policy:Reproduced under a Creative Commons License
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Project CodeAward NoProject NamePrincipal InvestigatorFunder's NameFunder RefLead Dept
628691Microvascular Dysfunction in Patients with Angina: The CE-MARC2 Microvascular SubstudyColin BerryBritish Heart Foundation (BHF)FS/14/15/30661RI CARDIOVASCULAR & MEDICAL SCIENCES
699321Myocardial strain measurements in survivors of acute ST-elevation myocardial infarction: implementation and prognostic significance of novel magnetic resonance imaging methods.Colin BerryBritish Heart Foundation (BHF)FS/15/54/31639RI CARDIOVASCULAR & MEDICAL SCIENCES