Invasive versus medical management in patients with prior coronary artery bypass surgery with a non-ST segment elevation acute coronary syndrome: a pilot randomized controlled trial

Lee, M. M.Y. et al. (2019) Invasive versus medical management in patients with prior coronary artery bypass surgery with a non-ST segment elevation acute coronary syndrome: a pilot randomized controlled trial. Circulation: Cardiovascular Interventions, 12(8), e007830. (doi:10.1161/CIRCINTERVENTIONS.119.007830) (PMID:31362541)

[img]
Preview
Text
189522.pdf - Published Version
Available under License Creative Commons Attribution.

800kB

Abstract

Background: The benefits of routine invasive management in patients with prior coronary artery bypass grafts presenting with non-ST elevation acute coronary syndromes are uncertain because these patients were excluded from pivotal trials. Methods: In a multicenter trial, non-ST elevation acute coronary syndromes patients with prior coronary artery bypass graft were prospectively screened in 4 acute hospitals. Medically stabilized patients were randomized to invasive management (invasive group) or noninvasive management (medical group). The primary outcome was adherence with the randomized strategy by 30 days. A blinded, independent Clinical Event Committee adjudicated predefined composite outcomes for efficacy (all-cause mortality, rehospitalization for refractory ischemia/angina, myocardial infarction, hospitalization because of heart failure) and safety (major bleeding, stroke, procedure-related myocardial infarction, and worsening renal function). Results: Two hundred seventeen patients were screened and 60 (mean±SD age, 71±9 years, 72% male) were randomized (invasive group, n=31; medical group, n=29). One-third (n=10) of the participants in the invasive group initially received percutaneous coronary intervention. In the medical group, 1 participant crossed over to invasive management on day 30 but percutaneous coronary intervention was not performed. During 2-years’ follow-up (median [interquartile range], 744 [570–853] days), the composite outcome for efficacy occurred in 13 (42%) subjects in the invasive group and 13 (45%) subjects in the medical group. The composite safety outcome occurred in 8 (26%) subjects in the invasive group and 9 (31%) subjects in the medical group. An efficacy or safety outcome occurred in 17 (55%) subjects in the invasive group and 16 (55%) subjects in the medical group. Health status (EuroQol 5 Dimensions) and angina class in each group were similar at 12 months. Conclusions: More than half of the population experienced a serious adverse event. An initial noninvasive management strategy is feasible. A substantive health outcomes trial of invasive versus noninvasive management in non-ST elevation acute coronary syndromes patients with prior coronary artery bypass grafts appears warranted. Clinical Trial Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01895751.

Item Type:Articles
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 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 Oldroyd, Dr Keith and Murphy, Dr Clare 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., Corcoran, D., 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. J., Bukov, N. B., Balachandran, K. P., Oldroyd, K. G., 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:Circulation: Cardiovascular Interventions
Publisher:American Heart Assocation
ISSN:1941-7640
ISSN (Online):1941-7632
Published Online:31 July 2019
Copyright Holders:Copyright © 2019 The Authors
First Published:First published in Circulation: Cardiovascular Interventions 12(8): e007830
Publisher Policy:Reproduced under a Creative Commons License

University Staff: Request a correction | Enlighten Editors: Update this record

Project CodeAward NoProject NamePrincipal InvestigatorFunder's NameFunder RefLead Dept
617771BHF centre of excellenceRhian TouyzBritish Heart Foundation (BHF)RE/13/5/30177RI CARDIOVASCULAR & MEDICAL SCIENCES
699321Myocardial strain measurements in survivors of acute ST-elevation myocardial infarction: implementation and prognostic significance of novel magnetic resonance imaging methods.Colin BerryBritish Heart Foundation (BHF)FS/15/54/31639RI CARDIOVASCULAR & MEDICAL SCIENCES
327441E-CultureNetSeamus RossEuropean Commission (EC)IST-2001-37491HU - INFORMATION STUDIES

Downloads per month over past year

View more statistics