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

Lee, M. M.Y. et al. (2021) Invasive versus medically managed acute coronary syndromes with prior bypass (CABG-ACS): insights into the registry versus randomised trial populations. Open Heart, 8(1), e001453. (doi: 10.1136/openhrt-2020-001453) (PMID:33637568) (PMCID:PMC7919592)

Abstract

Background: Coronary artery bypass graft (CABG) patients are under-represented in acute coronary syndrome (ACS) trials. We compared characteristics and outcomes for patients who did and did not participate in a randomised trial of invasive versus non-invasive management (CABG-ACS). Methods: ACS patients with prior CABG in four hospitals were randomised to invasive or non-invasive management. Non-randomised patients entered a registry. Primary efficacy (composite of all-cause mortality, rehospitalisation for refractory ischaemia/angina, myocardial infarction (MI), heart failure) and safety outcomes (composite of bleeding, stroke, procedure-related MI, worsening renal function) were independently adjudicated. Results: Of 217 patients screened, 84 (39%) screenfailed, of whom 24 (29%) did not consent and 60 (71%) were ineligible. Of 133 (61%) eligible, 60 (mean±SD age, 71±9 years, 72% male) entered the trial and 73 (age, 72±10 years, 73% male) entered a registry (preferences: physician (79%), patient (38%), both (21%)). Compared with trial participants, registry patients had more valve disease, lower haemoglobin, worse New York Heart Association class and higher frailty. At baseline, invasive management was performed in 52% and 49% trial and registry patients, respectively, of whom 32% and 36% had percutaneous coronary intervention at baseline, respectively (p=0.800). After 2 years follow-up (694 (median, IQR 558–841) days), primary efficacy (43% trial vs 49% registry (HR 1.14, 95% CI 0.69 to 1.89)) and safety outcomes (28% trial vs 22% registry (HR 0.74, 95% CI 0.37 to 1.46)) were similar. EuroQol was lower in registry patients at 1 year. Conclusions: Compared with trial participants, registry participants had excess morbidity, but longer-term outcomes were similar. Trial registration number: NCT01895751.

• Item Type: Articles
• Additional Information: CB has received research support from the British Heart Foundation (PG/17/2532884, FS/17/26/32744, and RE/18/6134217) and the Medical Research Council (MR/S005714/1). KM and NS were supported by BHF Clinical Training Fellowships (FS/15/54/31639; FS/17/26/32744). This research received no specific grant from any funding agency in the public, commercial or not-for-profit sectors.
• Status: Published
• Refereed: Yes
• Glasgow Author(s) Enlighten ID: Simpson, Dr Joanne and Rocchiccioli, Dr John and McEntegart, Dr Margaret and Corcoran, Dr David and Mangion, Dr Kenneth and Cormack, Dr Alistair and Jackson, Dr Colette and Hood, Dr Stuart and Rae, Dr Alan and Findlay, Dr Iain and Balachandran, Dr Bala and Wu, Professor Olivia and McConnachie, Professor Alex and Shaukat, Dr Aadil and Lee, Matthew and Petrie, Professor Mark and Brown, Mrs Ammani and Murphy, Dr Clare and Barry, Dr Sarah and Ford, Professor Ian and Berry, Professor Colin and Sidik, Ms Novalia
• Authors: Lee, M. M.Y., Petrie, M. C., Rocchiccioli, P., Simpson, J., Jackson, C. E., Corcoran, D. S., Mangion, K., Brown, A., Cialdella, P., Sidik, N. P., McEntegart, M. B., Shaukat, A., Rae, A. P., Hood, S. H.M., Peat, E. E., Findlay, I. N., Murphy, C. L., Cormack, A., Bukov, N. B., Balachandran, K. P., Ford, I., Wu, O., McConnachie, A., Barry, S. J.E., and Berry, C.
• College/School: College of Medical Veterinary and Life Sciences > School of Cardiovascular & Metabolic Health; College of Medical Veterinary and Life Sciences > School of Health & Wellbeing > Health Economics and Health Technology Assessment; College of Medical Veterinary and Life Sciences > School of Health & Wellbeing > Robertson Centre; College of Medical Veterinary and Life Sciences > School of Medicine, Dentistry & Nursing
• Journal Name: Open Heart
• Publisher: BMJ Publishing Group
• ISSN: 2053-3624
• ISSN (Online): 2053-3624
• Copyright Holders: Copyright © 2021 The Authors
• First Published: First published in Open Heart 8(1):e001453
• Publisher Policy: Reproduced under a Creative Commons License

Project Code	Award No	Project Name	Principal Investigator	Funder's Name	Funder Ref	Lead Dept
174109		The conundrum of angina in patients without obstructive coronary disease: a randomised controlled pilot trial of routine testing of coronary function.	Colin Berry	British Heart Foundation (BHF)	FS/17/26/32744	Institute of Cardiovascular & Medical Sciences
172173		Myocardial strain measurements in survivors of acute ST-elevation myocardial infarction: implementation and prognostic significance of novel magnetic resonance imaging methods.	Colin Berry	British Heart Foundation (BHF)	FS/15/54/31639	Institute of Cardiovascular & Medical Sciences
174109		The conundrum of angina in patients without obstructive coronary disease: a randomised controlled pilot trial of routine testing of coronary function.	Colin Berry	British Heart Foundation (BHF)	FS/17/26/32744	Institute of Cardiovascular & Medical Sciences
303684		A randomized, double-blind, placebo-controlled Phase 2A cross-over trial of oral zibotentan in patients with angina due to small vessel disease: a proof-of-concept, developmental trial for safety, efficacy and biomarkers development	Colin Berry	Medical Research Council (MRC)	MR/S018905/1	CAMS - Cardiovascular Science