Key result
Registry patients with ACS and prior CABG show similar major event rates to trial participants.
Why the study?
Coronary artery bypass graft patients are under-represented in acute coronary syndrome trials, limiting understanding of invasive versus non-invasive management outcomes in this group.
Do baseline characteristics and clinical outcomes differ between ACS patients with prior CABG who participate in a randomized trial versus those who enter a registry?
Observational (n=133)
Yes
Do baseline characteristics and clinical outcomes differ between ACS patients with prior CABG who participate in a randomized trial versus those who enter a registry?
Despite registry patients having excess baseline morbidity compared to trial participants, long-term clinical outcomes were similar between the two groups in ACS patients with prior CABG.
Registry patients had similar outcomes despite greater frailty; leaves open generalizability of CABG-ACS trial results to frailer ACS 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 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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Lee et al. (2021) conducted an observational in Acute coronary syndrome with prior CABG (n=133). Registry participation vs. Trial participation was evaluated on Composite of all-cause mortality, rehospitalisation for refractory ischaemia/angina, MI, or heart failure (HR 1.14, 95% CI 0.69 to 1.89). Registry patients with acute coronary syndrome and prior bypass surgery had similar rates of the primary efficacy composite outcome compared to trial participants (49% vs 43%; HR 1.14).
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