Twelve-month clinical results from the new cobalt-chromium sirolimus-eluting dedicated bifurcation stent BiOSS LIM C Registry

Introduction Percutaneous coronary interventions (PCI) in bifurcations are still challenging and are associated with higher risks of periprocedural complications as well as restenosis and stent thrombosis. The aim of this paper was to summarize 12 months of clinical results of the prospective, first...

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Main Authors: Robert J. Gil, Adam Kern, Tomasz Pawłowski, Jacek Bil
Format: Article
Language:English
Published: Termedia Publishing House 2020-02-01
Series:Archives of Medical Science
Subjects:
Online Access:https://www.archivesofmedicalscience.com/Twelve-month-clinical-results-from-the-new-cobalt-chromium-sirolimus-eluting-dedicated,111580,0,2.html
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author Robert J. Gil
Adam Kern
Tomasz Pawłowski
Jacek Bil
author_facet Robert J. Gil
Adam Kern
Tomasz Pawłowski
Jacek Bil
author_sort Robert J. Gil
collection DOAJ
description Introduction Percutaneous coronary interventions (PCI) in bifurcations are still challenging and are associated with higher risks of periprocedural complications as well as restenosis and stent thrombosis. The aim of this paper was to summarize 12 months of clinical results of the prospective, first-in-man registry assessing the BiOSS LIM C stent (Balton, Poland). Material and methods In the prospective two-center registry we enrolled patients with non-ST-segment elevation acute coronary syndrome (NSTE-ACS) and stable coronary artery disease. Provisional T-stenting was the default treatment strategy. The primary endpoint was defined as the rate of cardiac death, myocardial infarction (MI) and clinically driven target lesion revascularization (TLR) in 12-month follow-up. Results The study population consisted of 95 patients (mean age: 66.8 ±9.8 years, 17.9% were females). A BiOSS LIM C stent was implanted in the left main (LM) in 53 (55.8%) cases. There were 25.2% of patients with NSTE-ACS, 33.7% with diabetes, 90.5% with hypertension, and 53.7% had previous MI. The device success rate was 100%. An additional regular drug-eluting stent was deployed in the side branch in 18.9% of cases. Proximal optimization technique and final kissing balloon (FKB) technique were used in 53.7% and 30.5% of cases, respectively. MI type 4a was registered in 4 (4.2%) cases. At 12 months the MACE rate was 9.5%, cardiac death 1.1%, MI 2.1% and clinically driven TLR 6.3%. All incidents, apart from one TLR, appeared in the LM subgroup. Conclusions Our registry might suggest that PCI using the BiOSS LIM C in coronary bifurcations is feasible and might be an option for percutaneous revascularization.
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spelling doaj.art-40b775a373fb4d2492e80ae19568d6cf2023-12-01T09:52:58ZengTermedia Publishing HouseArchives of Medical Science1734-19221896-91512020-02-0119232433010.5114/aoms.2020.92974111580Twelve-month clinical results from the new cobalt-chromium sirolimus-eluting dedicated bifurcation stent BiOSS LIM C RegistryRobert J. Gil0Adam Kern1Tomasz Pawłowski2Jacek Bil3Department of Invasive Cardiology, Centre of Postgraduate Medical Education, Central Clinical Hospital of the Ministry of Interior and Administration, Warsaw, PolandDepartment of Cardiology and Cardiosurgery, Faculty of Medical Sciences, University of Warmia and Mazury, Olsztyn, PolandDepartment of Invasive Cardiology, Centre of Postgraduate Medical Education, Central Clinical Hospital of the Ministry of Interior and Administration, Warsaw, PolandDepartment of Invasive Cardiology, Centre of Postgraduate Medical Education, Central Clinical Hospital of the Ministry of Interior and Administration, Warsaw, PolandIntroduction Percutaneous coronary interventions (PCI) in bifurcations are still challenging and are associated with higher risks of periprocedural complications as well as restenosis and stent thrombosis. The aim of this paper was to summarize 12 months of clinical results of the prospective, first-in-man registry assessing the BiOSS LIM C stent (Balton, Poland). Material and methods In the prospective two-center registry we enrolled patients with non-ST-segment elevation acute coronary syndrome (NSTE-ACS) and stable coronary artery disease. Provisional T-stenting was the default treatment strategy. The primary endpoint was defined as the rate of cardiac death, myocardial infarction (MI) and clinically driven target lesion revascularization (TLR) in 12-month follow-up. Results The study population consisted of 95 patients (mean age: 66.8 ±9.8 years, 17.9% were females). A BiOSS LIM C stent was implanted in the left main (LM) in 53 (55.8%) cases. There were 25.2% of patients with NSTE-ACS, 33.7% with diabetes, 90.5% with hypertension, and 53.7% had previous MI. The device success rate was 100%. An additional regular drug-eluting stent was deployed in the side branch in 18.9% of cases. Proximal optimization technique and final kissing balloon (FKB) technique were used in 53.7% and 30.5% of cases, respectively. MI type 4a was registered in 4 (4.2%) cases. At 12 months the MACE rate was 9.5%, cardiac death 1.1%, MI 2.1% and clinically driven TLR 6.3%. All incidents, apart from one TLR, appeared in the LM subgroup. Conclusions Our registry might suggest that PCI using the BiOSS LIM C in coronary bifurcations is feasible and might be an option for percutaneous revascularization.https://www.archivesofmedicalscience.com/Twelve-month-clinical-results-from-the-new-cobalt-chromium-sirolimus-eluting-dedicated,111580,0,2.htmlcoronary bifurcationleft maindedicated bifurcation stentdrug-eluting stentsirolimus-eluting stent
spellingShingle Robert J. Gil
Adam Kern
Tomasz Pawłowski
Jacek Bil
Twelve-month clinical results from the new cobalt-chromium sirolimus-eluting dedicated bifurcation stent BiOSS LIM C Registry
Archives of Medical Science
coronary bifurcation
left main
dedicated bifurcation stent
drug-eluting stent
sirolimus-eluting stent
title Twelve-month clinical results from the new cobalt-chromium sirolimus-eluting dedicated bifurcation stent BiOSS LIM C Registry
title_full Twelve-month clinical results from the new cobalt-chromium sirolimus-eluting dedicated bifurcation stent BiOSS LIM C Registry
title_fullStr Twelve-month clinical results from the new cobalt-chromium sirolimus-eluting dedicated bifurcation stent BiOSS LIM C Registry
title_full_unstemmed Twelve-month clinical results from the new cobalt-chromium sirolimus-eluting dedicated bifurcation stent BiOSS LIM C Registry
title_short Twelve-month clinical results from the new cobalt-chromium sirolimus-eluting dedicated bifurcation stent BiOSS LIM C Registry
title_sort twelve month clinical results from the new cobalt chromium sirolimus eluting dedicated bifurcation stent bioss lim c registry
topic coronary bifurcation
left main
dedicated bifurcation stent
drug-eluting stent
sirolimus-eluting stent
url https://www.archivesofmedicalscience.com/Twelve-month-clinical-results-from-the-new-cobalt-chromium-sirolimus-eluting-dedicated,111580,0,2.html
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AT tomaszpawłowski twelvemonthclinicalresultsfromthenewcobaltchromiumsirolimuselutingdedicatedbifurcationstentbiosslimcregistry
AT jacekbil twelvemonthclinicalresultsfromthenewcobaltchromiumsirolimuselutingdedicatedbifurcationstentbiosslimcregistry