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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...
Autores principales: | , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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Springer US
2020
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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. |
format | Online Article Text |
id | pubmed-7806550 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2020 |
publisher | Springer US |
record_format | MEDLINE/PubMed |
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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