%0 Journal Article %A Matthew M Y Lee %A Mark C Petrie %A Paul Rocchiccioli %A Joanne Simpson %A Colette Jackson %A Ammani Brown %A David Corcoran %A Kenneth Mangion %A Margaret McEntegart %A Aadil Shaukat %A Alan Rae %A Stuart Hood %A Eileen Peat %A Iain Findlay %A Clare Murphy %A Alistair Cormack %A Nikolay Bukov %A Kanarath Balachandran %A Richard Papworth %A Ian Ford %A Andrew Briggs %A Colin Berry %T 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) %D 2016 %R 10.1136/openhrt-2015-000371 %J Open Heart %P e000371 %V 3 %N 1 %X 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). %U https://openheart.bmj.com/content/openhrt/3/1/e000371.full.pdf