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Polymer Free Amphilimus Drug Eluting Stent for Infrapopliteal Arterial Disease in Patients with Critical Limb Ischemia: A New Device in the Armamentarium

Background and Objectives: Endovascular technologies have significantly improved the outcome of patients with critical limb ischemia (CLI). Drug eluting stents (DES) have documented their efficacy against percutaneous transluminal angioplasty (PTA) and bare metal stents (BMS) in infrapopliteal arter...

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Autores principales: Tigkiropoulos, Konstantinos, Abatzis-Papadopoulos, Manolis, Sidiropoulou, Katerina, Stavridis, Kyriakos, Karamanos, Dimitrios, Lazaridis, Ioannis, Saratzis, Nikolaos
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9866247/
https://www.ncbi.nlm.nih.gov/pubmed/36676663
http://dx.doi.org/10.3390/medicina59010039
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author Tigkiropoulos, Konstantinos
Abatzis-Papadopoulos, Manolis
Sidiropoulou, Katerina
Stavridis, Kyriakos
Karamanos, Dimitrios
Lazaridis, Ioannis
Saratzis, Nikolaos
author_facet Tigkiropoulos, Konstantinos
Abatzis-Papadopoulos, Manolis
Sidiropoulou, Katerina
Stavridis, Kyriakos
Karamanos, Dimitrios
Lazaridis, Ioannis
Saratzis, Nikolaos
author_sort Tigkiropoulos, Konstantinos
collection PubMed
description Background and Objectives: Endovascular technologies have significantly improved the outcome of patients with critical limb ischemia (CLI). Drug eluting stents (DES) have documented their efficacy against percutaneous transluminal angioplasty (PTA) and bare metal stents (BMS) in infrapopliteal arterial occlusive disease. However, late in-stent neoatherosclerosis may lead to vascular lumen loss and eventually thrombosis. Polymer free DES constitute a new technology aiming to improve long term patency which their action is still under investigation. The purpose of this study is to report the mechanism of action and to provide a literature review of a novel polymer free amphilimus eluting stent (Cre8, Alvimedica, Instabul, Turkey) in infrapopliteal arterial disease. Methods: Publications listed in electronic databases, European Union Drug Regulating Authorities Clinical Trials Database, as well as scientific programmes of recent interventional vascular conferences were searched. Three studies were included. We analyzed primary and secondary patency, major amputation rate, freedom from CD-TLR, and mortality. Results: Cre8 was implanted in 79 patients with CLI. Most of the patients (n = 65) were Rutherford class 5–6 (82.3%), and diabetes mellitus (DM) was present in 66 patients (83.5%). Mean primary patency was 82.5% at 12 months. Mean lesion stented length was 20 mm and 35 mm in two studies. Mean limb salvage was 91.3% at 12 months. Freedom from CD-TLR was reported in two out of the three studies and was 96% and 83.8%. Mortality was 15% and 23.8% in the same studies, whilst it was not reported in one study. Conclusion: Stenting of infrapopliteal arteries with Cre8 is safe and feasible in patients with CLI and diabetes. All studies have shown very good primary patency and freedom from CD-TLR at 12 and 24 months. Larger observational prospective studies and randomized trials are necessary to establish long term effectiveness and clinical outcomes using the non-polymer Cre8 DES.
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spelling pubmed-98662472023-01-22 Polymer Free Amphilimus Drug Eluting Stent for Infrapopliteal Arterial Disease in Patients with Critical Limb Ischemia: A New Device in the Armamentarium Tigkiropoulos, Konstantinos Abatzis-Papadopoulos, Manolis Sidiropoulou, Katerina Stavridis, Kyriakos Karamanos, Dimitrios Lazaridis, Ioannis Saratzis, Nikolaos Medicina (Kaunas) Review Background and Objectives: Endovascular technologies have significantly improved the outcome of patients with critical limb ischemia (CLI). Drug eluting stents (DES) have documented their efficacy against percutaneous transluminal angioplasty (PTA) and bare metal stents (BMS) in infrapopliteal arterial occlusive disease. However, late in-stent neoatherosclerosis may lead to vascular lumen loss and eventually thrombosis. Polymer free DES constitute a new technology aiming to improve long term patency which their action is still under investigation. The purpose of this study is to report the mechanism of action and to provide a literature review of a novel polymer free amphilimus eluting stent (Cre8, Alvimedica, Instabul, Turkey) in infrapopliteal arterial disease. Methods: Publications listed in electronic databases, European Union Drug Regulating Authorities Clinical Trials Database, as well as scientific programmes of recent interventional vascular conferences were searched. Three studies were included. We analyzed primary and secondary patency, major amputation rate, freedom from CD-TLR, and mortality. Results: Cre8 was implanted in 79 patients with CLI. Most of the patients (n = 65) were Rutherford class 5–6 (82.3%), and diabetes mellitus (DM) was present in 66 patients (83.5%). Mean primary patency was 82.5% at 12 months. Mean lesion stented length was 20 mm and 35 mm in two studies. Mean limb salvage was 91.3% at 12 months. Freedom from CD-TLR was reported in two out of the three studies and was 96% and 83.8%. Mortality was 15% and 23.8% in the same studies, whilst it was not reported in one study. Conclusion: Stenting of infrapopliteal arteries with Cre8 is safe and feasible in patients with CLI and diabetes. All studies have shown very good primary patency and freedom from CD-TLR at 12 and 24 months. Larger observational prospective studies and randomized trials are necessary to establish long term effectiveness and clinical outcomes using the non-polymer Cre8 DES. MDPI 2022-12-24 /pmc/articles/PMC9866247/ /pubmed/36676663 http://dx.doi.org/10.3390/medicina59010039 Text en © 2022 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 Review
Tigkiropoulos, Konstantinos
Abatzis-Papadopoulos, Manolis
Sidiropoulou, Katerina
Stavridis, Kyriakos
Karamanos, Dimitrios
Lazaridis, Ioannis
Saratzis, Nikolaos
Polymer Free Amphilimus Drug Eluting Stent for Infrapopliteal Arterial Disease in Patients with Critical Limb Ischemia: A New Device in the Armamentarium
title Polymer Free Amphilimus Drug Eluting Stent for Infrapopliteal Arterial Disease in Patients with Critical Limb Ischemia: A New Device in the Armamentarium
title_full Polymer Free Amphilimus Drug Eluting Stent for Infrapopliteal Arterial Disease in Patients with Critical Limb Ischemia: A New Device in the Armamentarium
title_fullStr Polymer Free Amphilimus Drug Eluting Stent for Infrapopliteal Arterial Disease in Patients with Critical Limb Ischemia: A New Device in the Armamentarium
title_full_unstemmed Polymer Free Amphilimus Drug Eluting Stent for Infrapopliteal Arterial Disease in Patients with Critical Limb Ischemia: A New Device in the Armamentarium
title_short Polymer Free Amphilimus Drug Eluting Stent for Infrapopliteal Arterial Disease in Patients with Critical Limb Ischemia: A New Device in the Armamentarium
title_sort polymer free amphilimus drug eluting stent for infrapopliteal arterial disease in patients with critical limb ischemia: a new device in the armamentarium
topic Review
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9866247/
https://www.ncbi.nlm.nih.gov/pubmed/36676663
http://dx.doi.org/10.3390/medicina59010039
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