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

Matthew Lee, Mark Petrie, Paul Rocchiccioli, Joanne Simpson, Collette Jackson, David Corcoran, Kenneth Mangion, Ammani Brown , Pio Cialdella, Novalia Sidik, Margaret McEntegart, Aadil Shaukat, Alan Rae, Stuart Hood, Eileen Peat, Iain Findlay, Clare Murphy, Alistair Cormack, Nikolay Bukov, Kanarath Balachandran & 6 others Keith Oldroyd, Ian Ford, Olivia Wu, Alex McConnachie, Sarah J.E. Barry, Colin Berry

Research output: Contribution to journalArticle

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.
LanguageEnglish
JournalCirculation: Cardiovascular Interventions
Publication statusAccepted/In press - 14 Jun 2019

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Acute Coronary Syndrome
Coronary Artery Bypass
Randomized Controlled Trials
Transplants
Safety
Health Status
Multicenter Studies
Hospitalization
Ischemia
Stroke
Clinical Trials
Hemorrhage
Kidney
Mortality
Health
Population

Cite this

Lee, Matthew ; Petrie, Mark ; Rocchiccioli, Paul ; Simpson, Joanne ; Jackson, Collette ; Corcoran, David ; Mangion, Kenneth ; Brown , Ammani ; Cialdella, Pio ; Sidik, Novalia ; McEntegart, Margaret ; Shaukat, Aadil ; Rae, Alan ; Hood, Stuart ; Peat, Eileen ; Findlay, Iain ; Murphy, Clare ; Cormack, Alistair ; Bukov, Nikolay ; Balachandran, Kanarath ; Oldroyd, Keith ; Ford, Ian ; Wu, Olivia ; McConnachie, Alex ; Barry, Sarah J.E. ; Berry, Colin. / 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. 2019.
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title = "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",
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.",
author = "Matthew Lee and Mark Petrie and Paul Rocchiccioli and Joanne Simpson and Collette Jackson and David Corcoran and Kenneth Mangion and Ammani Brown and Pio Cialdella and Novalia Sidik and Margaret McEntegart and Aadil Shaukat and Alan Rae and Stuart Hood and Eileen Peat and Iain Findlay and Clare Murphy and Alistair Cormack and Nikolay Bukov and Kanarath Balachandran and Keith Oldroyd and Ian Ford and Olivia Wu and Alex McConnachie and Barry, {Sarah J.E.} and Colin Berry",
year = "2019",
month = "6",
day = "14",
language = "English",

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Lee, M, Petrie, M, Rocchiccioli, P, Simpson, J, Jackson, C, Corcoran, D, Mangion, K, Brown , A, Cialdella, P, Sidik, N, McEntegart, M, Shaukat, A, Rae, A, Hood, S, Peat, E, Findlay, I, Murphy, C, Cormack, A, Bukov, N, Balachandran, K, Oldroyd, K, Ford, I, Wu, O, McConnachie, A, Barry, SJE & Berry, C 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'.

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; Petrie, Mark; Rocchiccioli, Paul; Simpson, Joanne; Jackson, Collette ; Corcoran, David; Mangion, Kenneth; Brown , Ammani; Cialdella, Pio; Sidik, Novalia; McEntegart, Margaret; Shaukat, Aadil; Rae, Alan; Hood, Stuart ; Peat, Eileen; Findlay, Iain; Murphy, Clare ; Cormack, Alistair; Bukov, Nikolay; Balachandran, Kanarath; Oldroyd, Keith; Ford, Ian; Wu, Olivia; McConnachie, Alex; Barry, Sarah J.E.; Berry, Colin.

14.06.2019.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Invasive versus medical management in patients with prior coronary artery bypass surgery with a non-ST segment elevation acute coronary syndrome (CABG-ACS)

T2 - a randomized controlled trial

AU - Lee, Matthew

AU - Petrie, Mark

AU - Rocchiccioli, Paul

AU - Simpson, Joanne

AU - Jackson, Collette

AU - Corcoran, David

AU - Mangion, Kenneth

AU - Brown , Ammani

AU - Cialdella, Pio

AU - Sidik, Novalia

AU - McEntegart, Margaret

AU - Shaukat, Aadil

AU - Rae, Alan

AU - Hood, Stuart

AU - Peat, Eileen

AU - Findlay, Iain

AU - Murphy, Clare

AU - Cormack, Alistair

AU - Bukov, Nikolay

AU - Balachandran, Kanarath

AU - Oldroyd, Keith

AU - Ford, Ian

AU - Wu, Olivia

AU - McConnachie, Alex

AU - Barry, Sarah J.E.

AU - Berry, Colin

PY - 2019/6/14

Y1 - 2019/6/14

N2 - 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.

AB - 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.

UR - https://www.ahajournals.org/loi/circinterventions/content/by/year

M3 - Article

ER -