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)

Matthew M Y Lee, Mark C Petrie, Paul Rocchiccioli, Joanne Simpson, Colette Jackson, Ammani Brown, David Corcoran, Kenneth Mangion, Margaret McEntegart, Aadil Shaukat, Alan Rae, Stuart Hood, Eileen Peat, Iain Findlay, Clare Murphy, Alistair Cormack, Nikolay Bukov, Kanarath Balachandran, Richard Papworth, Ian Ford, Andrew Briggs, Colin Berry, Matthew M Y Lee, Mark C Petrie, Paul Rocchiccioli, Joanne Simpson, Colette Jackson, Ammani Brown, David Corcoran, Kenneth Mangion, Margaret McEntegart, Aadil Shaukat, Alan Rae, Stuart Hood, Eileen Peat, Iain Findlay, Clare Murphy, Alistair Cormack, Nikolay Bukov, Kanarath Balachandran, Richard Papworth, Ian Ford, Andrew Briggs, Colin Berry

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).

Keywords: CABG; Invasive; NSTE-ACS; RCT; Registry.

Figures

Figure 1
Figure 1
Flow diagram of Coronary Artery Bypass Graft-Acute Coronary Syndrome (CABG-ACS) trial. Patients who provide consent will enter either the (1) randomised trial or (2) registry (ie, based on the presence of exclusion criteria, or physician or patient preference). Patients who do not provide consent and/or are ineligible will enter the (3) screen failure group. A change in the treatment strategy (eg, from non-invasive to invasive management, or vice versa) within the first 30 days from randomisation is a cross-over.

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