Invasive versus medically managed acute coronary syndromes with prior bypass (CABG-ACS): insights into the registry versus randomised trial 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 patient...
Saved in:
| Main Authors: | , , , , , , , , , , , , , , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
BMJ Publishing Group
2021-02-01
|
| Series: | Open Heart |
| Online Access: | https://openheart.bmj.com/content/8/1/e001453.full |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1846170658820587520 |
|---|---|
| author | Mark C Petrie Colin Berry Kenneth Mangion Alex McConnachie Ian Ford Olivia Wu Paul Rocchiccioli Aadil Shaukat Matthew M Y Lee Joanne Simpson Colette E Jackson David S Corcoran Ammani Brown Pio Cialdella Novalia P Sidik Margaret B McEntegart Alan P Rae Stuart H M Hood Eileen E Peat Iain N Findlay Clare L Murphy Alistair J Cormack Nikolay B Bukov Kanarath P Balachandran Sarah J E Barry |
| author_facet | Mark C Petrie Colin Berry Kenneth Mangion Alex McConnachie Ian Ford Olivia Wu Paul Rocchiccioli Aadil Shaukat Matthew M Y Lee Joanne Simpson Colette E Jackson David S Corcoran Ammani Brown Pio Cialdella Novalia P Sidik Margaret B McEntegart Alan P Rae Stuart H M Hood Eileen E Peat Iain N Findlay Clare L Murphy Alistair J Cormack Nikolay B Bukov Kanarath P Balachandran Sarah J E Barry |
| author_sort | Mark C Petrie |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-a30408dbdabd43f096f53dc0fae821a9 |
| institution | Kabale University |
| issn | 2053-3624 |
| language | English |
| publishDate | 2021-02-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | Open Heart |
| spelling | doaj-art-a30408dbdabd43f096f53dc0fae821a92024-11-11T13:10:08ZengBMJ Publishing GroupOpen Heart2053-36242021-02-018110.1136/openhrt-2020-001453Invasive versus medically managed acute coronary syndromes with prior bypass (CABG-ACS): insights into the registry versus randomised trial populationsMark C Petrie0Colin Berry1Kenneth Mangion2Alex McConnachie3Ian Ford4Olivia Wu5Paul Rocchiccioli6Aadil Shaukat7Matthew M Y Lee8Joanne Simpson9Colette E Jackson10David S Corcoran11Ammani Brown12Pio Cialdella13Novalia P Sidik14Margaret B McEntegart15Alan P Rae16Stuart H M Hood17Eileen E Peat18Iain N Findlay19Clare L Murphy20Alistair J Cormack21Nikolay B Bukov22Kanarath P Balachandran23Sarah J E Barry24School of Cardiovascular and Metabolic Health, University of Glasgow, Glasgow, UK27 BHF Glasgow Cardiovascular Research Centre, University of Glasgow, Glasgow, UKSchool of Cardiovascular and Metabolic Health, University of Glasgow, Glasgow, UKRobertson Centre for Biostatistics, University of Glasgow, Glasgow, UK2University of GlasgowHealth Economics and Health Technology Assessment (HEHTA), School of Health and Wellbeing, University of Glasgow, Glasgow, UK1Golden Jubilee National Hospital, Golden Jubilee National Hospital, Agamemnon St, Clydebank, Glasgow, GLG G81 4DY, UK1Golden Jubilee National Hospital, Golden Jubilee National Hospital, Agamemnon St, Clydebank, Glasgow, GLG G81 4DY, UK1 Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, UK1 Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, UK1 Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, UK1 Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, UK4 Cardiology, Western Infirmary, Glasgow, UK2 West of Scotland Heart and Lung Centre, Golden Jubilee National Hospital, Clydebank, UK1 Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, UK1 Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, UK1 Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, UK1 Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, UK2 West of Scotland Heart and Lung Centre, Golden Jubilee National Hospital, Clydebank, UK5 Cardiology, Royal Alexandra Hospital, Paisley, UK5 Cardiology, Royal Alexandra Hospital, Paisley, UK5 Cardiology, Royal Alexandra Hospital, Paisley, UK6 Cardiology, Royal Blackburn Hospital, Blackburn, UK6 Cardiology, Royal Blackburn Hospital, Blackburn, UK9 Department of Mathematics and Statistics, University of Strathclyde, Glasgow, UKBackground 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.https://openheart.bmj.com/content/8/1/e001453.full |
| spellingShingle | Mark C Petrie Colin Berry Kenneth Mangion Alex McConnachie Ian Ford Olivia Wu Paul Rocchiccioli Aadil Shaukat Matthew M Y Lee Joanne Simpson Colette E Jackson David S Corcoran Ammani Brown Pio Cialdella Novalia P Sidik Margaret B McEntegart Alan P Rae Stuart H M Hood Eileen E Peat Iain N Findlay Clare L Murphy Alistair J Cormack Nikolay B Bukov Kanarath P Balachandran Sarah J E Barry Invasive versus medically managed acute coronary syndromes with prior bypass (CABG-ACS): insights into the registry versus randomised trial populations Open Heart |
| title | Invasive versus medically managed acute coronary syndromes with prior bypass (CABG-ACS): insights into the registry versus randomised trial populations |
| title_full | Invasive versus medically managed acute coronary syndromes with prior bypass (CABG-ACS): insights into the registry versus randomised trial populations |
| title_fullStr | Invasive versus medically managed acute coronary syndromes with prior bypass (CABG-ACS): insights into the registry versus randomised trial populations |
| title_full_unstemmed | Invasive versus medically managed acute coronary syndromes with prior bypass (CABG-ACS): insights into the registry versus randomised trial populations |
| title_short | Invasive versus medically managed acute coronary syndromes with prior bypass (CABG-ACS): insights into the registry versus randomised trial populations |
| title_sort | invasive versus medically managed acute coronary syndromes with prior bypass cabg acs insights into the registry versus randomised trial populations |
| url | https://openheart.bmj.com/content/8/1/e001453.full |
| work_keys_str_mv | AT markcpetrie invasiveversusmedicallymanagedacutecoronarysyndromeswithpriorbypasscabgacsinsightsintotheregistryversusrandomisedtrialpopulations AT colinberry invasiveversusmedicallymanagedacutecoronarysyndromeswithpriorbypasscabgacsinsightsintotheregistryversusrandomisedtrialpopulations AT kennethmangion invasiveversusmedicallymanagedacutecoronarysyndromeswithpriorbypasscabgacsinsightsintotheregistryversusrandomisedtrialpopulations AT alexmcconnachie invasiveversusmedicallymanagedacutecoronarysyndromeswithpriorbypasscabgacsinsightsintotheregistryversusrandomisedtrialpopulations AT ianford invasiveversusmedicallymanagedacutecoronarysyndromeswithpriorbypasscabgacsinsightsintotheregistryversusrandomisedtrialpopulations AT oliviawu invasiveversusmedicallymanagedacutecoronarysyndromeswithpriorbypasscabgacsinsightsintotheregistryversusrandomisedtrialpopulations AT paulrocchiccioli invasiveversusmedicallymanagedacutecoronarysyndromeswithpriorbypasscabgacsinsightsintotheregistryversusrandomisedtrialpopulations AT aadilshaukat invasiveversusmedicallymanagedacutecoronarysyndromeswithpriorbypasscabgacsinsightsintotheregistryversusrandomisedtrialpopulations AT matthewmylee invasiveversusmedicallymanagedacutecoronarysyndromeswithpriorbypasscabgacsinsightsintotheregistryversusrandomisedtrialpopulations AT joannesimpson invasiveversusmedicallymanagedacutecoronarysyndromeswithpriorbypasscabgacsinsightsintotheregistryversusrandomisedtrialpopulations AT coletteejackson invasiveversusmedicallymanagedacutecoronarysyndromeswithpriorbypasscabgacsinsightsintotheregistryversusrandomisedtrialpopulations AT davidscorcoran invasiveversusmedicallymanagedacutecoronarysyndromeswithpriorbypasscabgacsinsightsintotheregistryversusrandomisedtrialpopulations AT ammanibrown invasiveversusmedicallymanagedacutecoronarysyndromeswithpriorbypasscabgacsinsightsintotheregistryversusrandomisedtrialpopulations AT piocialdella invasiveversusmedicallymanagedacutecoronarysyndromeswithpriorbypasscabgacsinsightsintotheregistryversusrandomisedtrialpopulations AT novaliapsidik invasiveversusmedicallymanagedacutecoronarysyndromeswithpriorbypasscabgacsinsightsintotheregistryversusrandomisedtrialpopulations AT margaretbmcentegart invasiveversusmedicallymanagedacutecoronarysyndromeswithpriorbypasscabgacsinsightsintotheregistryversusrandomisedtrialpopulations AT alanprae invasiveversusmedicallymanagedacutecoronarysyndromeswithpriorbypasscabgacsinsightsintotheregistryversusrandomisedtrialpopulations AT stuarthmhood invasiveversusmedicallymanagedacutecoronarysyndromeswithpriorbypasscabgacsinsightsintotheregistryversusrandomisedtrialpopulations AT eileenepeat invasiveversusmedicallymanagedacutecoronarysyndromeswithpriorbypasscabgacsinsightsintotheregistryversusrandomisedtrialpopulations AT iainnfindlay invasiveversusmedicallymanagedacutecoronarysyndromeswithpriorbypasscabgacsinsightsintotheregistryversusrandomisedtrialpopulations AT clarelmurphy invasiveversusmedicallymanagedacutecoronarysyndromeswithpriorbypasscabgacsinsightsintotheregistryversusrandomisedtrialpopulations AT alistairjcormack invasiveversusmedicallymanagedacutecoronarysyndromeswithpriorbypasscabgacsinsightsintotheregistryversusrandomisedtrialpopulations AT nikolaybbukov invasiveversusmedicallymanagedacutecoronarysyndromeswithpriorbypasscabgacsinsightsintotheregistryversusrandomisedtrialpopulations AT kanarathpbalachandran invasiveversusmedicallymanagedacutecoronarysyndromeswithpriorbypasscabgacsinsightsintotheregistryversusrandomisedtrialpopulations AT sarahjebarry invasiveversusmedicallymanagedacutecoronarysyndromeswithpriorbypasscabgacsinsightsintotheregistryversusrandomisedtrialpopulations |