Sandeep Arunothayaraj1, MBBS; Miles Behan2, FRCP, DM; Thierry Lefèvre3, MD; Jens Flensted Lassen4, MD; Alaide Chieffo5, MD; Goran Stankovic6, MD; Francesco Burzotta7, MD; Manuel Pan8, MD; Miroslaw Ferenc9, MD; Thomas Hovasse3, MD; Mark Spence10, MD; Philippe Brunel11, MD; James Cotton12, MD; James Cockburn1, MD; Didier Carrié13, PhD; Andreas Baumbach14, MD; Michael Maeng15, MD; Yves Louvard3, MD; David Hildick-Smith1, MD
1. Sussex Cardiac Centre, University Hospitals Sussex NHS Trust, Brighton, UK; 2. Edinburgh Heart Centre, Edinburgh, UK; 3. Institut Cardiovasculaire Paris Sud, Hôpital privé Jacques Cartier, Ramsay Santé, Massy, France; 4. Department of Cardiology B, Odense University Hospital, Odense, Denmark and University of Southern Denmark, Odense, Denmark; 5. Interventional Cardiology Unit, San Raffaele Scientific Institute, Milan, Italy; 6. Department of Cardiology, University Clinical Centre of Serbia, Belgrade, Serbia and Faculty of Medicine, University of Belgrade, Belgrade, Serbia; 7. Fondazione Policlinico A. Gemelli IRCCS, Università Cattolica del Sacro Cuore, Rome, Italy; 8. Department of Cardiology, Reina Sofia Hospital, University of Cordoba, (IMIBIC), Cordoba, Spain; 9. University Heart Center Freiburg – Bad Krozingen, Bad Krozingen, Germany; 10. Department of Cardiology, Royal Victoria Hospital, Belfast, UK; 11. Hôpital privé Dijon Bourgogne, Clinique Valmy, Dijon, France; 12. Royal Wolverhampton University Hospital NHS Trust, Wolverhampton, UK; 13. Department of Cardiology, Toulouse University, Rangueil Hospital, Toulouse, France; 14. Centre for Cardiovascular Medicine and Devices, William Harvey Research Institute, Queen Mary University of London and Barts Heart Centre, London, UK; 15. Department of Cardiology, Aarhus University Hospital & Aarhus University, Aarhus, Denmark
Background: The multicentre European Bifurcation Club Trial (EBC TWO) showed no significant differences in 12-month clinical outcomes between patients randomised to a provisional stenting strategy or systematic culotte stenting in true non-left main bifurcations.
Aims: This study aimed to investigate the 5-year clinical results of the EBC TWO Trial.
Methods: A total of 200 patients undergoing stent implantation for non-left main bifurcation lesions were recruited into EBC TWO. Inclusion criteria required a side branch diameter ≥2.5 mm and side branch lesion length >5 mm. Five-year follow-up was completed for 197 patients. The primary endpoint was the composite of all-cause mortality, myocardial infarction, or target vessel revascularisation.
Results: The mean side branch stent diameter was 2.7±0.3 mm and mean side branch lesion length was 10.3±7.2 mm. At 5-year follow-up, the primary endpoint occurred in 18.4% of provisional and 23.7% of systematic culotte patients (hazard ratio [HR] 0.75, 95% confidence interval [CI]: 0.41-1.38). No significant differences were identified individually for all-cause mortality (7.8% vs 7.2%, HR 1.11, 95% CI: 0.40-3.05), myocardial infarction (8.7% vs 13.4%, HR 0.64, 95% CI: 0.27-1.50) or target vessel revascularisation (6.8% vs 9.3%, HR 1.12, 95% CI: 0.37-3.34). Stent thrombosis rates were also similar (1.9% vs 3.1%, HR 0.63, 95% CI: 0.11-3.75). There was no significant interaction between the extent of side branch disease and the primary outcome (p=0.34).
Conclusions: In large non-left main true bifurcation lesions, the use of a systematic culotte strategy showed no benefit over provisional stenting for the composite outcome of all-cause mortality, myocardial infarction, or target vessel revascularisation at 5 years. The stepwise provisional approach may be considered preferable for the majority of true coronary bifurcation lesions. ClinicalTrials.gov: NCT01560455.
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