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

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

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 patient...

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Main Authors: Mark C Petrie, Colin Berry, Kenneth Mangion, Alex McConnachie, Ian Ford, Olivia Wu, Paul Rocchiccioli, Aadil Shaukat, Matthew M Y Lee, Joanne Simpson, Colette E Jackson, David S Corcoran, Ammani Brown, Pio Cialdella, Novalia P Sidik, Margaret B McEntegart, Alan P Rae, Stuart H M Hood, Eileen E Peat, Iain N Findlay, Clare L Murphy, Alistair J Cormack, Nikolay B Bukov, Kanarath P Balachandran, Sarah J E Barry
Format: Article
Language:English
Published: BMJ Publishing Group 2021-02-01
Series:Open Heart
Online Access:https://openheart.bmj.com/content/8/1/e001453.full
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Summary: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.
ISSN:2053-3624

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