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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| Format: | Article |
| Language: | English |
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MDPI AG
2023-03-01
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| Series: | Journal of Cardiovascular Development and Disease |
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| Online Access: | https://www.mdpi.com/2308-3425/10/3/126 |
| _version_ | 1797611067139948544 |
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| author | Michael Piorkowski Thomas Zeller Christos Rammos Koen Deloose Klaus Hertting Volker Sesselmann Gunnar Tepe Peter Gaines Michael Lichtenberg |
| author_facet | Michael Piorkowski Thomas Zeller Christos Rammos Koen Deloose Klaus Hertting Volker Sesselmann Gunnar Tepe Peter Gaines Michael Lichtenberg |
| author_sort | Michael Piorkowski |
| collection | DOAJ |
| 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. |
| first_indexed | 2024-03-11T06:23:36Z |
| format | Article |
| id | doaj.art-f4bb613f4a5944eab8514311b440ef0d |
| institution | Directory Open Access Journal |
| issn | 2308-3425 |
| language | English |
| last_indexed | 2024-03-11T06:23:36Z |
| publishDate | 2023-03-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Journal of Cardiovascular Development and Disease |
| spelling | doaj.art-f4bb613f4a5944eab8514311b440ef0d2023-11-17T11:47:46ZengMDPI AGJournal of Cardiovascular Development and Disease2308-34252023-03-0110312610.3390/jcdd10030126BioMimics 3D Stent in Femoropopliteal Lesions: 3-Year Outcomes with Propensity Matching for Drug-Coated BalloonsMichael Piorkowski0Thomas Zeller1Christos Rammos2Koen Deloose3Klaus Hertting4Volker Sesselmann5Gunnar Tepe6Peter Gaines7Michael Lichtenberg8Department of Vascular Medicine, Cardioangiologic Center Bethanien, 60389 Frankfurt, GermanyDepartment of Angiology, Universitätsklinikum Freiburg Herzzentrum, 79189 Bad Krozingen, GermanyDepartment of Cardiology and Vascular Medicine, West German Heart and Vascular Center Essen, University Hospital Essen, 45147 Essen, GermanyDepartment Vascular Surgery, AZ Sint-Blasius Dendermonde, Kroonveldlaan 50, 9200 Dendermonde, BelgiumDepartment of Cardiology and Angiology, Krankenhaus Buchholz und Winsen gGmbH, 21423 Buchholz, GermanyDepartment of Angiology, SRH Zentralklinikum Suhl GmbH, 98527 Suhl, GermanyDepartment of Diagnostic and Interventional Radiology, RoMed Klinikum Rosenheim, 83022 Rosenheim, GermanyCollege of Health, Wellbeing and Life Sciences, Sheffield Hallam University, Sheffield S1 1WB, UKVascular Center, Klinikum Hochsauerland, 59821 Arnsberg, GermanyBackground: 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.https://www.mdpi.com/2308-3425/10/3/126peripheral artery diseasestentdrug-coated balloon |
| spellingShingle | Michael Piorkowski Thomas Zeller Christos Rammos Koen Deloose Klaus Hertting Volker Sesselmann Gunnar Tepe Peter Gaines Michael Lichtenberg BioMimics 3D Stent in Femoropopliteal Lesions: 3-Year Outcomes with Propensity Matching for Drug-Coated Balloons Journal of Cardiovascular Development and Disease peripheral artery disease stent drug-coated balloon |
| 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 | peripheral artery disease stent drug-coated balloon |
| url | https://www.mdpi.com/2308-3425/10/3/126 |
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