The Official Journal of EuroPCR and the European Association of Percutaneous Coronary Interventions (EAPCI)

Treatment with a dedicated bifurcation sirolimus-eluting cobalt-chromium stent for distal left main coronary artery disease: rationale and design of the POLBOS LM study

DOI: 10.4244/EIJ-D-19-00361

1. Department of cardiology, Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands; Department of cardiology, St. Luke’s International Hospital, Tokyo, Japan
2. Department of cardiology, Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands; Department of Cardiology, Toho University medical center Ohashi hospital, Tokyo, Japan
3. ThoraxCenter, Erasmus Medical Center, Rotterdam, the Netherlands; Cardialysis, Rotterdam, the Netherlands
4. Department of cardiology, Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands; Department of Internal Medicine, Cardiology Division. University of Campinas (UNICAMP). Campinas, Brazil
5. Department of cardiology, Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands; Division of Cardiology, Department of Internal Medicine, Faculty of Medicine, Prince of Songkla University, Songkhla, Thailand
6. Ramsay Générale de Santé - Institut Cardiovasculaire Paris Sud, Hopital Privé Jacques Cartier, Massy, France.
7. Institute of Cardiology, Jagiellonian University Medical College, John Paul II Hospital, Krakow, Poland
8. Cardiology Department, Centre Cardiologique du Nord, Saint Denis, France
9. Cardialysis, Rotterdam, the Netherlands
10. NHLI, Imperial College London, London, United Kingdom, United Kingdom
11. Department of Invasive Cardiology, Central Clinical Hospital of the Ministry of Interior, Warsaw, Poland; MOSSAKOWSKI MEDICAL RESEARCH CENTRE of Polish Academy of Science, Warsaw, Poland
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Aims: To demonstrate the noninferiority of the BiOSS LIM C sirolimus-eluting cobalt-chromium bifurcation dedicated stent against the Xience stent regarding patients 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 multi-centre study enrolling 260 patients (SYNTAX score ≤32) with pre-specified performance goal based on the results of the EXCEL trial with contemporary percutaneous coronary intervention (PCI) for LMCA disease. Patient enrollment will comply with objective inclusion criteria of diameter stenosis ≥50% in LMCA based on off-line quantitative coronary angiography (QCA) analyzed by an independent core laboratory using dedicated-bifurcation QCA software. The BiOSS LIM C is used for the treatment of LMCA disease with the specific technical classification for the BiOSS LIM (modified MADS classification) and the stent implantation is optimized by using pre-specified intravascular ultrasound criteria. Primary endpoint is POCE (a composite of all-cause death, stroke, any myocardial infarction, and any revascularization) at 12 months. 

Conclusions: The POLBOS LM study will indicate the efficacy of 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.

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