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BioMimics 3D Stent in Femoropopliteal Lesions: 3-Year Outcomes with Propensity Matching for Drug-Coated Balloons

Background: Through its helical centreline geometry, the BioMimics 3D vascular stent system is designed for the mobile femoropopliteal region, aiming to improve long-term patency and the risk of stent fractures. Methods: MIMICS 3D is a prospective, European, multi-centre, observational registry to e...

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Autores principales: Piorkowski, Michael, Zeller, Thomas, Rammos, Christos, Deloose, Koen, Hertting, Klaus, Sesselmann, Volker, Tepe, Gunnar, Gaines, Peter, Lichtenberg, Michael
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10051351/
https://www.ncbi.nlm.nih.gov/pubmed/36975890
http://dx.doi.org/10.3390/jcdd10030126
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author Piorkowski, Michael
Zeller, Thomas
Rammos, Christos
Deloose, Koen
Hertting, Klaus
Sesselmann, Volker
Tepe, Gunnar
Gaines, Peter
Lichtenberg, Michael
author_facet Piorkowski, Michael
Zeller, Thomas
Rammos, Christos
Deloose, Koen
Hertting, Klaus
Sesselmann, Volker
Tepe, Gunnar
Gaines, Peter
Lichtenberg, Michael
author_sort Piorkowski, Michael
collection PubMed
description Background: Through its helical centreline geometry, the BioMimics 3D vascular stent system is designed for the mobile femoropopliteal region, aiming to improve long-term patency and the risk of stent fractures. Methods: MIMICS 3D is a prospective, European, multi-centre, observational registry to evaluate the BioMimics 3D stent in a real-world population through 3 years. A propensity-matched comparison was performed to investigate the effect of the additional use of drug-coated balloons (DCB). Results: The MIMICS 3D registry enrolled 507 patients (518 lesion, length 125.9 ± 91.0 mm). At 3 years, the overall survival was 85.2%, freedom from major amputation 98.5%, freedom from clinically driven target lesion revascularisation 78.0%, and primary patency 70.2%. The propensity-matched cohort included 195 patients in each cohort. At 3-year follow-up, there was no statistically significant difference in clinical outcomes, such as overall survival (87.9% in the DCB vs. 85.1% in the no DCB group), freedom from major amputation (99.4% vs. 97.2%), clinically driven TLR (76.4% vs. 80.3%), and primary patency (68.5% vs. 74.4%). Conclusion: The MIMICS 3D registry showed good 3-year outcomes of the BioMimics 3D stent in femoropopliteal lesions, demonstrating the safety and performance of this device under real-world conditions, whether used alone or in combination with a DCB.
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spelling pubmed-100513512023-03-30 BioMimics 3D Stent in Femoropopliteal Lesions: 3-Year Outcomes with Propensity Matching for Drug-Coated Balloons Piorkowski, Michael Zeller, Thomas Rammos, Christos Deloose, Koen Hertting, Klaus Sesselmann, Volker Tepe, Gunnar Gaines, Peter Lichtenberg, Michael J Cardiovasc Dev Dis Article Background: Through its helical centreline geometry, the BioMimics 3D vascular stent system is designed for the mobile femoropopliteal region, aiming to improve long-term patency and the risk of stent fractures. Methods: MIMICS 3D is a prospective, European, multi-centre, observational registry to evaluate the BioMimics 3D stent in a real-world population through 3 years. A propensity-matched comparison was performed to investigate the effect of the additional use of drug-coated balloons (DCB). Results: The MIMICS 3D registry enrolled 507 patients (518 lesion, length 125.9 ± 91.0 mm). At 3 years, the overall survival was 85.2%, freedom from major amputation 98.5%, freedom from clinically driven target lesion revascularisation 78.0%, and primary patency 70.2%. The propensity-matched cohort included 195 patients in each cohort. At 3-year follow-up, there was no statistically significant difference in clinical outcomes, such as overall survival (87.9% in the DCB vs. 85.1% in the no DCB group), freedom from major amputation (99.4% vs. 97.2%), clinically driven TLR (76.4% vs. 80.3%), and primary patency (68.5% vs. 74.4%). Conclusion: The MIMICS 3D registry showed good 3-year outcomes of the BioMimics 3D stent in femoropopliteal lesions, demonstrating the safety and performance of this device under real-world conditions, whether used alone or in combination with a DCB. MDPI 2023-03-16 /pmc/articles/PMC10051351/ /pubmed/36975890 http://dx.doi.org/10.3390/jcdd10030126 Text en © 2023 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
Piorkowski, Michael
Zeller, Thomas
Rammos, Christos
Deloose, Koen
Hertting, Klaus
Sesselmann, Volker
Tepe, Gunnar
Gaines, Peter
Lichtenberg, Michael
BioMimics 3D Stent in Femoropopliteal Lesions: 3-Year Outcomes with Propensity Matching for Drug-Coated Balloons
title BioMimics 3D Stent in Femoropopliteal Lesions: 3-Year Outcomes with Propensity Matching for Drug-Coated Balloons
title_full BioMimics 3D Stent in Femoropopliteal Lesions: 3-Year Outcomes with Propensity Matching for Drug-Coated Balloons
title_fullStr BioMimics 3D Stent in Femoropopliteal Lesions: 3-Year Outcomes with Propensity Matching for Drug-Coated Balloons
title_full_unstemmed BioMimics 3D Stent in Femoropopliteal Lesions: 3-Year Outcomes with Propensity Matching for Drug-Coated Balloons
title_short BioMimics 3D Stent in Femoropopliteal Lesions: 3-Year Outcomes with Propensity Matching for Drug-Coated Balloons
title_sort biomimics 3d stent in femoropopliteal lesions: 3-year outcomes with propensity matching for drug-coated balloons
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10051351/
https://www.ncbi.nlm.nih.gov/pubmed/36975890
http://dx.doi.org/10.3390/jcdd10030126
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