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)

Abstract

IntroductionThere 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 analysis60 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 numberNCT01895751 (ClinicalTrials.gov).

Invasive Versus Medical Management in Patients With Prior Coronary Artery Bypass Surgery With a Non-ST Segment Elevation Acute Coronary Syndrome

“…The design of this pilot trial has been previously described. 12 The participants were enrolled in 4 acute hospitals in the National Health Service (NHS), United Kingdom, including 2 large urban hospitals (Western Infirmary and Royal Infirmary, Glasgow) and 2 regional hospitals (Royal Alexandra Hospital, Paisley and Royal Blackburn Hospital). More details about these hospitals are detailed in the Data Supplement .…”

Clinical Characteristics, Management Strategies and Outcomes of Acute Myocardial Infarction Patients With Prior Coronary Artery Bypass Grafting

“…Patients with prior CABG have been excluded from many important clinical trials including VINO 32 and RITA3 24,[33][34][35][36] and only contributed to small numbers of patients in other ACS clinical trials (in OASIS-5: 1643 of 20,078 patients, in LIPSIA-NSTEMI: 41 of 600 patients, in Italian elderly ACS: 29 of 313, and in After Eighty Study: 76 of 457 patients). [37][38][39][40][41][42] Apart from a recently published pilot study where Lee et al 43 reported 12-month outcome data from 60 prior-CABG patients (invasive group, n¼31; medical group, n¼29), no major clinical trials exclusively examined clinical outcomes of an invasive versus medical approach in patients who presented with acute MI and had prior CABG. 40 In our study, only half of prior CABG patients underwent invasive coronary angiography.…”

“…[37][38][39][40][41][42] Apart from a recently published pilot study where Lee et al 43 reported 12-month outcome data from 60 prior-CABG patients (invasive group, n¼31; medical group, n¼29), no major clinical trials exclusively examined clinical outcomes of an invasive versus medical approach in patients who presented with acute MI and had prior CABG. 40 In our study, only half of prior CABG patients underwent invasive coronary angiography. There are many logistic and clinical factors which affect the selection of a management approach for prior-CABG patients presenting with acute MI.…”

Invasive versus medically managed acute coronary syndromes with prior bypass (CABG-ACS): insights into the registry versus randomised trial populations

“…Concurrently, patients who were ineligible for randomisation and who gave informed consent were entered into an observational registry. The study design, 20 and results of the main trial have been published. 21 …”