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

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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.

ORCID iDs

Lee, Matthew M Y, Petrie, Mark C, Rocchiccioli, Paul, Simpson, Joanne, Jackson, Colette E, Corcoran, David S, Mangion, Kenneth, Brown, Ammani, Cialdella, Pio, Sidik, Novalia P, McEntegart, Margaret B, Shaukat, Aadil, Rae, Alan P, Hood, Stuart H M, Peat, Eileen E, Findlay, Iain N, Murphy, Clare L, Cormack, Alistair J, Bukov, Nikolay B, Balachandran, Kanarath P, Ford, Ian, Wu, Olivia, McConnachie, Alex, Barry, Sarah J E ORCID logoORCID: https://orcid.org/0000-0003-3039-8729 and Berry, Colin;
CORE (COnnecting REpositories)