TY - JOUR T1 - 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) JF - Open Heart JO - Open Heart DO - 10.1136/openhrt-2015-000371 VL - 3 IS - 1 SP - e000371 AU - Matthew M Y Lee AU - Mark C Petrie AU - Paul Rocchiccioli AU - Joanne Simpson AU - Colette Jackson AU - Ammani Brown AU - David Corcoran AU - Kenneth Mangion AU - Margaret McEntegart AU - Aadil Shaukat AU - Alan Rae AU - Stuart Hood AU - Eileen Peat AU - Iain Findlay AU - Clare Murphy AU - Alistair Cormack AU - Nikolay Bukov AU - Kanarath Balachandran AU - Richard Papworth AU - Ian Ford AU - Andrew Briggs AU - Colin Berry Y1 - 2016/04/01 UR - http://openheart.bmj.com/content/3/1/e000371.abstract N2 - 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). ER -