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

Lee, Matthew M Y and Petrie, Mark C and Rocchiccioli, Paul and Simpson, Joanne and Jackson, Colette E and Corcoran, David S and Mangion, Kenneth and Brown, Ammani and Cialdella, Pio and Sidik, Novalia P and McEntegart, Margaret B and Shaukat, Aadil and Rae, Alan P and Hood, Stuart H M and Peat, Eileen E and Findlay, Iain N and Murphy, Clare L and Cormack, Alistair J and Bukov, Nikolay B and Balachandran, Kanarath P and Ford, Ian and Wu, Olivia and McConnachie, Alex and Barry, Sarah J E and Berry, Colin (2021) Invasive versus medically managed acute coronary syndromes with prior bypass (CABG-ACS) : insights into the registry versus randomised trial populations. BMJ Open Heart, 8 (1). e001453. ISSN 2053-3624 (https://doi.org/10.1136/openhrt-2020-001453)

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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.

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