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)

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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 Kanarath 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 > Institute of Cardiovascular and Medical Sciences
College of Medical Veterinary and Life Sciences > Institute of Health and Wellbeing > Health Economics and Health Technology Assessment
College of Medical Veterinary and Life Sciences > Institute of Health and 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

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