David Hildick-Smith1, Mohaned Egred2, Adrian Banning3, Philippe Brunel4, Miroslaw Ferenc5, Thomas Hovasse6, Adrian Wlodarczak7, Manuel Pan8, Thomas Schmitz9, Marc Silvestri10, Andreis Erglis11, Evgeny Kretov12, Jens Flensted Lassen13, Alaide Chieffo14, Thierry Lefèvre6, Francesco Burzotta15, James Cockburn1, Olivier Darremont16, Goran Stankovic17, Marie-Claude Morice6, Yves Louvard6. 1. Sussex Cardiac Centre, Brighton and Sussex University Hospitals, Brighton, UK. 2. Freeman Hospital, Newcastle upon Tyne, UK. 3. John Radcliffe Hospital, Oxford, UK. 4. Hôpital Privé, Dijon, France. 5. Universitäts-Herzzentrum Bad Krozingem, Bad Krozingen, Germany. 6. Institute Cardiovasculaire Paris Sud, Massy, France. 7. Poland Miedziowe Centrum Zdrowia Lubin, Lubin, Poland. 8. Department of Cardiology, Reina Sofia Hospital, University of Cordoba, Cordoba, Spain. 9. Elisabeth Hospital Essen, Essen, Germany. 10. Hopital Marseille, Marseille, France. 11. Paul Stradins University Hospital, Riga, Latvia. 12. Sibirskiy Fеdеrаl Biomedical Research Center Novosibirsk, Novosibirsk, Russia. 13. Rigshospitalet University of Copenhagen, Copenhagen, Denmark. 14. San Raffaele Scientific Institute, Milan, Italy. 15. Fondazione Policlinico Universitario A. Gemelli, Università Cattolica del Sacro Cuore, Rome, Italy. 16. Clinique Saint-Augustin-Elsan, 114 Avenue d'Arès, Bordeaux 33200, France. 17. Department of Cardiology, Clinical Centre of Serbia, University of Belgrade, Belgrade, Serbia.
Abstract
BACKGROUND: Patients with non-left-main coronary bifurcation lesions are usually best treated with a stepwise provisional approach. However, patients with true left main stem bifurcation lesions have been shown in one dedicated randomized study to benefit from systematic dual stent implantation. METHODS AND RESULTS: Four hundred and sixty-seven patients with true left main stem bifurcation lesions requiring intervention were recruited to the EBC MAIN study in 11 European countries. Patients were aged 71 ± 10 years; 77% were male. Patients were randomly allocated to a stepwise layered provisional strategy (n = 230) or a systematic dual stent approach (n = 237). The primary endpoint (a composite of death, myocardial infarction, and target lesion revascularization at 12 months) occurred in 14.7% of the stepwise provisional group vs. 17.7% of the systematic dual stent group (hazard ratio 0.8, 95% confidence interval 0.5-1.3; P = 0.34). Secondary endpoints were death (3.0% vs. 4.2%, P = 0.48), myocardial infarction (10.0% vs. 10.1%, P = 0.91), target lesion revascularization (6.1% vs. 9.3%, P = 0.16), and stent thrombosis (1.7% vs. 1.3%, P = 0.90), respectively. Procedure time, X-ray dose and consumables favoured the stepwise provisional approach. Symptomatic improvement was excellent and equal in each group. CONCLUSIONS: Among patients with true bifurcation left main stem stenosis requiring intervention, fewer major adverse cardiac events occurred with a stepwise layered provisional approach than with planned dual stenting, although the difference was not statistically significant. The stepwise provisional strategy should remain the default for distal left main stem bifurcation intervention. STUDY REGISTRATION: http://clinicaltrials.gov NCT02497014. Published on behalf of the European Society of Cardiology. All rights reserved.
BACKGROUND: Patients with non-left-main coronary bifurcation lesions are usually best treated with a stepwise provisional approach. However, patients with true left main stem bifurcation lesions have been shown in one dedicated randomized study to benefit from systematic dual stent implantation. METHODS AND RESULTS: Four hundred and sixty-seven patients with true left main stem bifurcation lesions requiring intervention were recruited to the EBC MAIN study in 11 European countries. Patients were aged 71 ± 10 years; 77% were male. Patients were randomly allocated to a stepwise layered provisional strategy (n = 230) or a systematic dual stent approach (n = 237). The primary endpoint (a composite of death, myocardial infarction, and target lesion revascularization at 12 months) occurred in 14.7% of the stepwise provisional group vs. 17.7% of the systematic dual stent group (hazard ratio 0.8, 95% confidence interval 0.5-1.3; P = 0.34). Secondary endpoints were death (3.0% vs. 4.2%, P = 0.48), myocardial infarction (10.0% vs. 10.1%, P = 0.91), target lesion revascularization (6.1% vs. 9.3%, P = 0.16), and stent thrombosis (1.7% vs. 1.3%, P = 0.90), respectively. Procedure time, X-ray dose and consumables favoured the stepwise provisional approach. Symptomatic improvement was excellent and equal in each group. CONCLUSIONS: Among patients with true bifurcation left main stem stenosis requiring intervention, fewer major adverse cardiac events occurred with a stepwise layered provisional approach than with planned dual stenting, although the difference was not statistically significant. The stepwise provisional strategy should remain the default for distal left main stem bifurcation intervention. STUDY REGISTRATION: http://clinicaltrials.gov NCT02497014. Published on behalf of the European Society of Cardiology. All rights reserved.
Authors: Wojciech Jan Skorupski; Marta Kałużna-Oleksy; Maciej Lesiak; Aleksander Araszkiewicz; Włodzimierz Skorupski; Stefan Grajek; Przemysław Mitkowski; Małgorzata Pyda; Marek Grygier Journal: J Pers Med Date: 2022-02-25