Timo Mäkikallio1, Niels R Holm2, Mitchell Lindsay3, Mark S Spence4, Andrejs Erglis5, Ian B A Menown6, Thor Trovik7, Markku Eskola8, Hannu Romppanen9, Thomas Kellerth10, Jan Ravkilde11, Lisette O Jensen12, Gintaras Kalinauskas13, Rikard B A Linder14, Markku Pentikainen15, Anders Hervold16, Adrian Banning17, Azfar Zaman18, Jamen Cotton19, Erlend Eriksen20, Sulev Margus21, Henrik T Sørensen22, Per H Nielsen23, Matti Niemelä1, Kari Kervinen1, Jens F Lassen2, Michael Maeng2, Keith Oldroyd3, Geoff Berg3, Simon J Walsh4, Colm G Hanratty4, Indulis Kumsars5, Peteris Stradins5, Terje K Steigen7, Ole Fröbert10, Alastair N J Graham4, Petter C Endresen24, Matthias Corbascio25, Olli Kajander8, Uday Trivedi26, Juha Hartikainen9, Vesa Anttila27, David Hildick-Smith26, Leif Thuesen11, Evald H Christiansen28. 1. Department of Cardiology, Oulu University Hospital, Oulu, Finland. 2. Department of Cardiology, Aarhus University Hospital, Skejby, Aarhus, Denmark. 3. Department of Cardiology, Golden Jubilee National Hospital, Clydebank, Scotland. 4. Belfast Heart Centre, Belfast Trust, Belfast, Northern Ireland. 5. Latvia Centre of Cardiology, Paul Stradins Clinical Hospital, Riga, Latvia. 6. Craigavon Cardiac Centre, Craigavon, Northern Ireland. 7. Department of Cardiology, University of Northern Norway, Tromsø, Norway. 8. Heart Hospital, Tampere University Hospital, Tampere, Finland. 9. Heart Center, Kuopio University Hospital, Kuopio, Finland. 10. Department of Cardiology, Örebro University Hospital, Örebro, Sweden. 11. Department of Cardiology, Aalborg University Hospital, Aalborg, Denmark. 12. Department of Cardiology, Odense University Hospital, Odense, Denmark. 13. Department of Cardiology, Vilnius University Hospital, Vilnius, Lithuania. 14. Department of Cardiology, Danderyd Hospital, Stockholm, Sweden. 15. Heart and Lung Center, Helsinki University Hospital, Helsinki, Finland. 16. Department of Cardiology, Oslo University Hospital, Rikshospitalet, Oslo, Norway. 17. Oxford Heart Centre, Oxford, UK. 18. Department of Cardiology, Freeman Hospital and Institute of Cellular Medicine, Newcastle, UK. 19. Heart and Lung Centre, New Cross Hospital, Wolverhampton, UK. 20. Department of Cardiology, Haukeland University Hospital, Bergen, Norway. 21. Department of Cardiology, East Tallinn Hospital, Tallinn, Estonia. 22. Department of Clinical Epidemiology, Aarhus University Hospital, Aarhus, Denmark; Department of Health Research and Policy (Epidemiology), Stanford University, Stanford, CA, USA. 23. Department of Cardiac Surgery, Aarhus University Hospital, Skejby, Aarhus, Denmark. 24. Department of Cardiovascular Surgery, University of Northern Norway, Tromsø, Norway. 25. Department of Cardiology, Karolinska University Hospital, Huddinge, Stockholm, Sweden. 26. Sussex Cardiac Centre, Brighton and Sussex University Hospital, Brighton, UK. 27. Department of Cardiac Surgery, Oulu University Hospital, Finland. 28. Department of Cardiology, Aarhus University Hospital, Skejby, Aarhus, Denmark. Electronic address: evald.christiansen@dadlnet.dk.
Abstract
BACKGROUND:Coronary artery bypass grafting (CABG) is the standard treatment for revascularisation in patients with left main coronary artery disease, but use of percutaneous coronary intervention (PCI) for this indication is increasing. We aimed to compare PCI and CABG for treatment of left main coronary artery disease. METHODS: In this prospective, randomised, open-label, non-inferiority trial, patients with left main coronary artery disease were enrolled in 36 centres in northern Europe and randomised 1:1 to treatment with PCI or CABG. Eligible patients had stable angina pectoris, unstable angina pectoris, or non-ST-elevation myocardial infarction. Exclusion criteria were ST-elevation myocardial infarction within 24 h, being considered too high risk for CABG or PCI, or expected survival of less than 1 year. The primary endpoint was major adverse cardiac or cerebrovascular events (MACCE), a composite of all-cause mortality, non-procedural myocardial infarction, any repeat coronary revascularisation, and stroke. Non-inferiority of PCI to CABG required the lower end of the 95% CI not to exceed a hazard ratio (HR) of 1·35 after up to 5 years of follow-up. The intention-to-treat principle was used in the analysis if not specified otherwise. This trial is registered with ClinicalTrials.gov identifier, number NCT01496651. FINDINGS: Between Dec 9, 2008, and Jan 21, 2015, 1201 patients were randomly assigned, 598 to PCI and 603 to CABG, and 592 in each group entered analysis by intention to treat. Kaplan-Meier 5 year estimates of MACCE were 29% for PCI (121 events) and 19% for CABG (81 events), HR 1·48 (95% CI 1·11-1·96), exceeding the limit for non-inferiority, and CABG was significantly better than PCI (p=0·0066). As-treated estimates were 28% versus 19% (1·55, 1·18-2·04, p=0·0015). Comparing PCI with CABG, 5 year estimates were 12% versus 9% (1·07, 0·67-1·72, p=0·77) for all-cause mortality, 7% versus 2% (2·88, 1·40-5·90, p=0·0040) for non-procedural myocardial infarction, 16% versus 10% (1·50, 1·04-2·17, p=0·032) for any revascularisation, and 5% versus 2% (2·25, 0·93-5·48, p=0·073) for stroke. INTERPRETATION: The findings of this study suggest that CABG might be better than PCI for treatment of left main stem coronary artery disease. FUNDING: Biosensors, Aarhus University Hospital, and participating sites.
RCT Entities:
BACKGROUND: Coronary artery bypass grafting (CABG) is the standard treatment for revascularisation in patients with left main coronary artery disease, but use of percutaneous coronary intervention (PCI) for this indication is increasing. We aimed to compare PCI and CABG for treatment of left main coronary artery disease. METHODS: In this prospective, randomised, open-label, non-inferiority trial, patients with left main coronary artery disease were enrolled in 36 centres in northern Europe and randomised 1:1 to treatment with PCI or CABG. Eligible patients had stable angina pectoris, unstable angina pectoris, or non-ST-elevation myocardial infarction. Exclusion criteria were ST-elevation myocardial infarction within 24 h, being considered too high risk for CABG or PCI, or expected survival of less than 1 year. The primary endpoint was major adverse cardiac or cerebrovascular events (MACCE), a composite of all-cause mortality, non-procedural myocardial infarction, any repeat coronary revascularisation, and stroke. Non-inferiority of PCI to CABG required the lower end of the 95% CI not to exceed a hazard ratio (HR) of 1·35 after up to 5 years of follow-up. The intention-to-treat principle was used in the analysis if not specified otherwise. This trial is registered with ClinicalTrials.gov identifier, number NCT01496651. FINDINGS: Between Dec 9, 2008, and Jan 21, 2015, 1201 patients were randomly assigned, 598 to PCI and 603 to CABG, and 592 in each group entered analysis by intention to treat. Kaplan-Meier 5 year estimates of MACCE were 29% for PCI (121 events) and 19% for CABG (81 events), HR 1·48 (95% CI 1·11-1·96), exceeding the limit for non-inferiority, and CABG was significantly better than PCI (p=0·0066). As-treated estimates were 28% versus 19% (1·55, 1·18-2·04, p=0·0015). Comparing PCI with CABG, 5 year estimates were 12% versus 9% (1·07, 0·67-1·72, p=0·77) for all-cause mortality, 7% versus 2% (2·88, 1·40-5·90, p=0·0040) for non-procedural myocardial infarction, 16% versus 10% (1·50, 1·04-2·17, p=0·032) for any revascularisation, and 5% versus 2% (2·25, 0·93-5·48, p=0·073) for stroke. INTERPRETATION: The findings of this study suggest that CABG might be better than PCI for treatment of left main stem coronary artery disease. FUNDING: Biosensors, Aarhus University Hospital, and participating sites.
Authors: Javier A Valle; Hector Tamez; J Dawn Abbott; Issam D Moussa; John C Messenger; Stephen W Waldo; Kevin F Kennedy; Frederick A Masoudi; Robert W Yeh Journal: JAMA Cardiol Date: 2019-02-01 Impact factor: 14.676