Invasive versus medical management in patients with prior coronary artery bypass surgery with a non-ST segment elevation acute coronary syndrome (CABG-ACS) : a randomized controlled trial

Lee, Matthew and Petrie, Mark and Rocchiccioli, Paul and Simpson, Joanne and Jackson, Collette and Corcoran, David and Mangion, Kenneth and Brown, Ammani and Cialdella, Pio and Sidik, Novalia and McEntegart, Margaret and Shaukat, Aadil and Rae, Alan and Hood, Stuart and Peat, Eileen and Findlay, Iain and Murphy, Clare and Cormack, Alistair and Bukov, Nikolay and Balachandran, Kanarath and Oldroyd, Keith and Ford, Ian and Wu, Olivia and McConnachie, Alex and Barry, Sarah J.E. and Berry, Colin (2019) Invasive versus medical management in patients with prior coronary artery bypass surgery with a non-ST segment elevation acute coronary syndrome (CABG-ACS) : a randomized controlled trial. Circulation: Cardiovascular Interventions. (In Press)

[img] Text (Lee-etal-CCI-2019-Invasive-versus-medical-management-in-patients-with-prior-coronary)
Lee_etal_CCI_2019_Invasive_versus_medical_management_in_patients_with_prior_coronary.pdf
Accepted Author Manuscript
Restricted to Repository staff only until 14 December 2019.

Download (5MB) | Request a copy from the Strathclyde author

    Abstract

    Background: The benefits of routine invasive management in patients with prior coronary artery bypass grafts (CABG) presenting with non-ST elevation acute coronary syndromes (NSTE-ACS) are uncertain because these patients were excluded from pivotal trials. Methods and Results: In a multicenter trial, NSTE-ACS patients with prior CABG were prospectively screened in 4 acute hospitals. Medically stabilized patients were randomized to invasive management (Invasive Group) or non-invasive management (Medical Group). The primary outcome was adherence with the randomized strategy by 30-days. A blinded, independent Clinical Event Committee adjudicated pre-defined composite outcomes for efficacy (all-cause mortality, rehospitalization for refractory ischemia/angina, MI, hospitalization due to HF) and safety (major bleeding, stroke, procedure-related MI, and worsening renal function). Two hundred and seventeen patients were screened and 60 (mean±SD age, 71±9 years, 72% male) were randomized (Invasive Group, n=31; Medical Group, n=29). One third (n=10) of the participants in the Invasive Group initially received PCI. In the Medical Group, one participant crossed over to invasive management on day 30 but PCI was not performed. During 2-years’ follow-up (median (IQR) 744 (570-853) days), the composite outcome for efficacy occurred in 13 (42%) subjects in the Invasive Group and 13 (45%) subjects in the Medical Group. The composite safety outcome occurred in 8 (26%) subjects in the Invasive Group and 9 (31%) subjects in the Medical Group. An efficacy or safety outcome occurred in 17 (55%) subjects in the Invasive Group and 16 (55%) subjects in the Medical Group. Health status (EQ-5D) and angina class in each group were similar at 12 months. Conclusions: More than half of the population experienced a serious adverse event. An initial non-invasive management strategy is feasible. A substantive health outcomes trial of invasive versus non-invasive management in NSTE-ACS patients with prior CABG seems warranted. Clinical Trial Registration: NCT01895751.