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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...
Autores principales: | , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
MDPI
2023
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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. |
format | Online Article Text |
id | pubmed-10051351 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | MDPI |
record_format | MEDLINE/PubMed |
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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