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
| Autor: | 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 |
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| Přispěvatelé: | Graduate School, ACS - Atherosclerosis & ischemic syndromes, ACS - Heart failure & arrhythmias, ACS - Microcirculation |
| Rok vydání: | 2020 |
| Předmět: |
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 |
| Zdroj: | EuroIntervention, 16(8), 654-662. EuroPCR |
| ISSN: | 1774-024X |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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