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 and LICHTENBERG, Michael (2023). BioMimics 3D Stent in Femoropopliteal Lesions: 3-Year Outcomes with Propensity Matching for Drug-Coated Balloons. Journal of Cardiovascular Development and Disease, 10 (3): 126.

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Abstract

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.

Item Type:	Article
Additional Information:	** Article version: VoR ** From MDPI via Jisc Publications Router ** Licence for VoR version of this article: https://creativecommons.org/licenses/by/4.0/ ** Peer reviewed: TRUE ** Acknowledgements: Acknowledgments: We thank Beatrix Doerr, consultant medical writer, and Helen Parise, consultant statistician, for their help in preparing this manuscript, reimbursed by Veryan Medical Ltd. **Journal IDs: eissn 2308-3425 **Article IDs: publisher-id: jcdd-10-00126 **History: published_online 16-03-2023; accepted 14-03-2023; rev-recd 10-03-2023; collection 03-2023; submitted 28-02-2023
Uncontrolled Keywords:	Article, peripheral artery disease, stent, drug-coated balloon
Identification Number:	https://doi.org/10.3390/jcdd10030126
SWORD Depositor:	Colin Knott
Depositing User:	Colin Knott
Date Deposited:	06 Apr 2023 11:10
Last Modified:	06 Apr 2023 11:10
URI:	https://shura.shu.ac.uk/id/eprint/31745

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