Taku Asano1,2, MD; Norihiro Kogame1,3, MD; Yoshinobu Onuma4,5, MD, PhD; Rodrigo Modolo1,6, MD; Ply Chichareon1,7, MD; Thierry Lefèvre8, MD; Jacek Legutko9, MD, PhD; Franck Digne10, MD; Marie-Angèle Morel5, BSc; Patrick W. Serruys4, MD, PhD; Robert J. Gil11,12, MD, PhD
1. Department of Cardiology, Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands; 2. Department of Cardiology, St. Luke’s International Hospital, Tokyo, Japan; 3. Department of Cardiology, Toho University Medical Center Ohashi Hospital, Tokyo, Japan; 4. Department of Cardiology, National University of Ireland, Galway, Ireland; 5. CORRIB Core Lab, Galway, Ireland; 6. Department of Internal Medicine, Cardiology Division, University of Campinas (UNICAMP), Campinas, Brazil; 7. Division of Cardiology, Department of Internal Medicine, Faculty of Medicine, Prince of Songkla University, Songkhla, Thailand; 8. Ramsay Générale de Santé - Institut Cardiovasculaire Paris Sud, Hopital Privé Jacques Cartier, Massy, France; 9. Institute of Cardiology, Jagiellonian University Medical College, John Paul II Hospital, Krakow, Poland; 10. Cardiology Department, Centre Cardiologique du Nord, Saint Denis, France; 11. Department of Invasive Cardiology, Central Clinical Hospital of the Ministry of Interior, Warsaw, Poland; 12. Mossakowski Medical Research Centre of Polish Academy of Science, Warsaw, Poland
Aims: The aim of this study is to demonstrate the non-inferiority of the BiOSS LIM C sirolimus-eluting cobalt-chromium bifurcation dedicated stent against the XIENCE stent regarding the patient-oriented composite endpoint (POCE) at 12 months among patients with left main coronary artery disease (LMCA).
Methods and results: The POLBOS LM study is a single-arm, prospective, multicentre study enrolling 260 patients (SYNTAX score ≤32) with a pre-specified performance goal based on the results of the EXCEL trial with contemporary percutaneous coronary intervention (PCI) for LMCA disease. Patient enrolment will comply with objective inclusion criteria of diameter stenosis ≥50% in the LMCA based on off-line quantitative coronary angiography (QCA) analysed by an independent core laboratory using dedicated bifurcation QCA software. The BiOSS LIM C is used for the treatment of LMCA disease with the same specific technical classification as for the BiOSS LIM (modified MADS classification) and the stent implantation is optimised by using pre-specified intravascular ultrasound criteria. The primary endpoint is POCE (a composite of all-cause death, stroke, any myocardial infarction, and any revascularisation) at 12 months.
Conclusions: The POLBOS LM study will indicate the efficacy of the BiOSS LIM C stent with contemporary PCI for distal left main bifurcation lesions in comparison with the XIENCE stent from the recent EXCEL trial, as a performance index.