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Paclitaxel-Coated Balloon Angioplasty for the Treatment of Infrainguinal Arteries: 24-Month Outcomes in the Full Cohort of BIOLUX P-III Global Registry

PURPOSE: After promising small randomized trials, the aim of BIOLUX P-III was to further investigate the safety and performance of the Passeo-18 lx drug-coated balloon in infrainguinal arteries under real-world conditions. METHODS: BIOLUX P-III is a global prospective single-arm study with follow-up...

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Autores principales: Tepe, Gunnar, Zeller, Thomas, Moscovic, Matej, Corpataux, Jean-Marc, Christensen, Johnny Kent, Keirse, Koen, Nano, Giovanni, Schroeder, Henrik, Binkert, Christoph A., Brodmann, Marianne
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer US 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7806550/
https://www.ncbi.nlm.nih.gov/pubmed/33083853
http://dx.doi.org/10.1007/s00270-020-02663-7
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author Tepe, Gunnar
Zeller, Thomas
Moscovic, Matej
Corpataux, Jean-Marc
Christensen, Johnny Kent
Keirse, Koen
Nano, Giovanni
Schroeder, Henrik
Binkert, Christoph A.
Brodmann, Marianne
author_facet Tepe, Gunnar
Zeller, Thomas
Moscovic, Matej
Corpataux, Jean-Marc
Christensen, Johnny Kent
Keirse, Koen
Nano, Giovanni
Schroeder, Henrik
Binkert, Christoph A.
Brodmann, Marianne
author_sort Tepe, Gunnar
collection PubMed
description PURPOSE: After promising small randomized trials, the aim of BIOLUX P-III was to further investigate the safety and performance of the Passeo-18 lx drug-coated balloon in infrainguinal arteries under real-world conditions. METHODS: BIOLUX P-III is a global prospective single-arm study with follow-up at 6, 12 and 24 months. The primary safety endpoint was freedom from major adverse events (MAE) within 6 months. The primary performance endpoint was freedom from clinically driven target lesion revascularization (TLR) within 12 months. RESULTS: 877 patients/1084 lesions were enrolled. Diabetes mellitus was present in 47.7%, and 42.1% had critical limb ischemia (CLI). The mean lesion length was 89.0 mm with 76.1% of calcified lesions, and 24.9% occluded. At 24 months, freedom from MAE was 83.1% in the full cohort; 84.9% in the femoropopliteal population (592 patients, 691 lesions); 77.7% for long lesions (187 subjects/192 lesions); and 72.5% in the in-stent restenosis (ISR) subgroup (103 subjects/116 lesions). Twenty-four-month freedom from clinically driven TLR was 88.1% in the full cohort; 88.9% in the femoropopliteal population; 80.3% for the long lesions; and 78.4% for ISR. Twenty-four-month all-cause mortality was 12.0% in the full cohort, 10.2% in the femoropopliteal population, 14.8% for the long lesions and 12.0% for ISR. There was no device- or procedure-related death up to 24-month follow-up. CONCLUSION: The BIOLUX P-III 24-month outcomes confirm the safety and performance of Passeo-18 lx in infrainguinal arteries in a large population treated under real-world conditions with low complication rates and good clinical outcomes (NCT02276313). ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1007/s00270-020-02663-7) contains supplementary material, which is available to authorized users.
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spelling pubmed-78065502021-01-21 Paclitaxel-Coated Balloon Angioplasty for the Treatment of Infrainguinal Arteries: 24-Month Outcomes in the Full Cohort of BIOLUX P-III Global Registry Tepe, Gunnar Zeller, Thomas Moscovic, Matej Corpataux, Jean-Marc Christensen, Johnny Kent Keirse, Koen Nano, Giovanni Schroeder, Henrik Binkert, Christoph A. Brodmann, Marianne Cardiovasc Intervent Radiol Clinical Investigation PURPOSE: After promising small randomized trials, the aim of BIOLUX P-III was to further investigate the safety and performance of the Passeo-18 lx drug-coated balloon in infrainguinal arteries under real-world conditions. METHODS: BIOLUX P-III is a global prospective single-arm study with follow-up at 6, 12 and 24 months. The primary safety endpoint was freedom from major adverse events (MAE) within 6 months. The primary performance endpoint was freedom from clinically driven target lesion revascularization (TLR) within 12 months. RESULTS: 877 patients/1084 lesions were enrolled. Diabetes mellitus was present in 47.7%, and 42.1% had critical limb ischemia (CLI). The mean lesion length was 89.0 mm with 76.1% of calcified lesions, and 24.9% occluded. At 24 months, freedom from MAE was 83.1% in the full cohort; 84.9% in the femoropopliteal population (592 patients, 691 lesions); 77.7% for long lesions (187 subjects/192 lesions); and 72.5% in the in-stent restenosis (ISR) subgroup (103 subjects/116 lesions). Twenty-four-month freedom from clinically driven TLR was 88.1% in the full cohort; 88.9% in the femoropopliteal population; 80.3% for the long lesions; and 78.4% for ISR. Twenty-four-month all-cause mortality was 12.0% in the full cohort, 10.2% in the femoropopliteal population, 14.8% for the long lesions and 12.0% for ISR. There was no device- or procedure-related death up to 24-month follow-up. CONCLUSION: The BIOLUX P-III 24-month outcomes confirm the safety and performance of Passeo-18 lx in infrainguinal arteries in a large population treated under real-world conditions with low complication rates and good clinical outcomes (NCT02276313). ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1007/s00270-020-02663-7) contains supplementary material, which is available to authorized users. Springer US 2020-10-20 2021 /pmc/articles/PMC7806550/ /pubmed/33083853 http://dx.doi.org/10.1007/s00270-020-02663-7 Text en © The Author(s) 2020 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) .
spellingShingle Clinical Investigation
Tepe, Gunnar
Zeller, Thomas
Moscovic, Matej
Corpataux, Jean-Marc
Christensen, Johnny Kent
Keirse, Koen
Nano, Giovanni
Schroeder, Henrik
Binkert, Christoph A.
Brodmann, Marianne
Paclitaxel-Coated Balloon Angioplasty for the Treatment of Infrainguinal Arteries: 24-Month Outcomes in the Full Cohort of BIOLUX P-III Global Registry
title Paclitaxel-Coated Balloon Angioplasty for the Treatment of Infrainguinal Arteries: 24-Month Outcomes in the Full Cohort of BIOLUX P-III Global Registry
title_full Paclitaxel-Coated Balloon Angioplasty for the Treatment of Infrainguinal Arteries: 24-Month Outcomes in the Full Cohort of BIOLUX P-III Global Registry
title_fullStr Paclitaxel-Coated Balloon Angioplasty for the Treatment of Infrainguinal Arteries: 24-Month Outcomes in the Full Cohort of BIOLUX P-III Global Registry
title_full_unstemmed Paclitaxel-Coated Balloon Angioplasty for the Treatment of Infrainguinal Arteries: 24-Month Outcomes in the Full Cohort of BIOLUX P-III Global Registry
title_short Paclitaxel-Coated Balloon Angioplasty for the Treatment of Infrainguinal Arteries: 24-Month Outcomes in the Full Cohort of BIOLUX P-III Global Registry
title_sort paclitaxel-coated balloon angioplasty for the treatment of infrainguinal arteries: 24-month outcomes in the full cohort of biolux p-iii global registry
topic Clinical Investigation
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7806550/
https://www.ncbi.nlm.nih.gov/pubmed/33083853
http://dx.doi.org/10.1007/s00270-020-02663-7
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