1. 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
- Author
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Norihiro Kogame, Franck Digne, Thierry Lefèvre, Robert J. Gil, Ply Chichareon, Yoshinobu Onuma, Patrick W. Serruys, Jacek Legutko, Taku Asano, Rodrigo Modolo, Marie-Angèle Morel, Graduate School, ACS - Atherosclerosis & ischemic syndromes, ACS - Heart failure & arrhythmias, and ACS - Microcirculation
- Subjects
Chromium ,medicine.medical_specialty ,medicine.medical_treatment ,Coronary Artery Disease ,030204 cardiovascular system & hematology ,Coronary Angiography ,Prosthesis Design ,03 medical and health sciences ,Percutaneous Coronary Intervention ,0302 clinical medicine ,Intravascular ultrasound ,Left main ,Clinical endpoint ,medicine ,Humans ,Prospective Studies ,cardiovascular diseases ,030212 general & internal medicine ,Myocardial infarction ,Prospective cohort study ,Stroke ,Sirolimus ,medicine.diagnostic_test ,business.industry ,Coronary Stenosis ,Percutaneous coronary intervention ,Stent ,Drug-Eluting Stents ,Cobalt ,medicine.disease ,Treatment Outcome ,Conventional PCI ,Stents ,Bifurcation ,Radiology ,Drug-eluting stent ,Cardiology and Cardiovascular Medicine ,business - Abstract
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.
- Published
- 2020