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

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 Oldroyd, Keith G. 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 : a pilot randomized controlled trial. Circulation: Cardiovascular Interventions, 12 (8). e007830. (https://doi.org/10.1161/CIRCINTERVENTIONS.119.0078...)

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Abstract

Background: The benefits of routine invasive management in patients with prior coronary artery bypass grafts presenting with non-ST elevation acute coronary syndromes are uncertain because these patients were excluded from pivotal trials. Methods: In a multicenter trial, non-ST elevation acute coronary syndromes patients with prior coronary artery bypass graft were prospectively screened in 4 acute hospitals. Medically stabilized patients were randomized to invasive management (invasive group) or noninvasive management (medical group). The primary outcome was adherence with the randomized strategy by 30 days. A blinded, independent Clinical Event Committee adjudicated predefined composite outcomes for efficacy (all-cause mortality, rehospitalization for refractory ischemia/angina, myocardial infarction, hospitalization because of heart failure) and safety (major bleeding, stroke, procedure-related myocardial infarction, and worsening renal function). Results: Two hundred 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 percutaneous coronary intervention. In the medical group, 1 participant crossed over to invasive management on day 30 but percutaneous coronary intervention was not performed. During 2-years' follow-up (median [interquartile range], 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 (EuroQol 5 Dimensions) 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 noninvasive management strategy is feasible. A substantive health outcomes trial of invasive versus noninvasive management in non-ST elevation acute coronary syndromes patients with prior coronary artery bypass grafts appears warranted. Clinical Trial Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01895751.

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