TY - JOUR
T1 - Invasive versus medically managed acute coronary syndromes with prior bypass (CABG-ACS)
T2 - insights into the registry versus randomised trial populations
AU - Lee, Matthew M Y
AU - Petrie, Mark C
AU - Rocchiccioli, Paul
AU - Simpson, Joanne
AU - Jackson, Colette E
AU - Corcoran, David S
AU - Mangion, Kenneth
AU - Brown , Ammani
AU - Cialdella, Pio
AU - Sidik, Novalia P
AU - McEntegart, Margaret B
AU - Shaukat, Aadil
AU - Rae, Alan P
AU - Hood, Stuart H M
AU - Peat, Eileen E
AU - Findlay, Iain N
AU - Murphy, Clare L
AU - Cormack, Alistair J
AU - Bukov, Nikolay B
AU - Balachandran, Kanarath P
AU - Ford, Ian
AU - Wu, Olivia
AU - McConnachie, Alex
AU - Barry, Sarah J E
AU - Berry, Colin
PY - 2021/2/26
Y1 - 2021/2/26
N2 - 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.
AB - 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.
KW - coronary artery bypass grafting (CABG)
KW - obstructive coronary artery disease
KW - angina
KW - ischaemia
U2 - 10.1136/openhrt-2020-001453
DO - 10.1136/openhrt-2020-001453
M3 - Article
SN - 2053-3624
VL - 8
JO - BMJ Open Heart
JF - BMJ Open Heart
IS - 1
M1 - e001453
ER -