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.
|Journal||Circulation: Cardiovascular Interventions|
|Publication status||Accepted/In press - 14 Jun 2019|