用于股腘病变的生物模拟3D支架：药物涂层球囊倾向匹配的3年结果

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

作者信息

Piorkowski Michael, Zeller Thomas, Rammos Christos, Deloose Koen, Hertting Klaus, Sesselmann Volker, Tepe Gunnar, Gaines Peter, Lichtenberg Michael

机构信息

Department of Vascular Medicine, Cardioangiologic Center Bethanien, 60389 Frankfurt, Germany.

Department of Angiology, Universitätsklinikum Freiburg Herzzentrum, 79189 Bad Krozingen, Germany.

出版信息

J Cardiovasc Dev Dis. 2023 Mar 16;10(3):126. doi: 10.3390/jcdd10030126.

DOI:10.3390/jcdd10030126

PMID:36975890

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10051351/

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.

摘要

背景

通过其螺旋中心线几何结构，BioMimics 3D血管支架系统专为活动的股腘区域设计，旨在提高长期通畅率并降低支架骨折风险。

方法

MIMICS 3D是一项前瞻性、欧洲多中心观察性注册研究，旨在通过3年时间评估BioMimics 3D支架在真实世界人群中的情况。进行倾向匹配比较以研究额外使用药物涂层球囊（DCB）的效果。

结果

MIMICS 3D注册研究纳入了507例患者（518处病变，长度为125.9±91.0毫米）。3年时，总生存率为85.2%，免于大截肢率为98.5%，免于临床驱动的靶病变血运重建率为78.0%，主要通畅率为70.2%。倾向匹配队列每组包括195例患者。在3年随访时，临床结局无统计学显著差异，如总生存率（DCB组为87.9%，无DCB组为85.1%）、免于大截肢率（99.4%对97.2%）、临床驱动的靶病变血运重建率（76.4%对80.3%）和主要通畅率（68.5%对74.4%）。