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). The original version of this paper did not contain a list of BIOLUX P-III investigators. The purpose of this addendum is to acknowledge the contribution of all investigators who participated in the study. Collaborators: BIOLUX P-III Global Registry Investigators: Marianne Brodmann, Thomas Zeller, Jean- Marc Corpataux, Matej Moscovic, Gunnar Tepe, Koen Keirse, Giovanni Nano, Johannes B. Dahm, Johnny Kent Christensen, Reza Ghotbi, Christoph Binkert, Henrik Schro¨der, Denis Henroteaux, John Wang Chaw Chian, Eric Rosset, Enrique Alejandre Lafont, Sabrina Houthoofd, Miguel Araujo; Shaiful Azmi Yahaya, Don Robertson, Martin Freund, Lonneke Yo, Uei Pua, Roxanne Wu, Frank Hammer, Michael Lichtenberg, Janne Korhonen, Della Schiava, Ralf Langhoff, Stefano Michelagnoli, Secundino Llagostera, Jose-Maria Romero, Max Amor, Daniel Kretzschmar, Steven Kum, Patrice Mwipatayi, Albert J Smeets, Francisco Javier Serrano Hernando, Jost Philipp Scha¨fer, Gil Marques, Jos C. van den Berg, Ramesh Velu, Karlis Kupcs.

Paclitaxel-Coated Balloon Angioplasty for the Treatment of Infrainguinal Arteries: 24-Month Outcomes in the Full Cohort of BIOLUX P-III Global Registry / G. Tepe, T. Zeller, M. Moscovic, J.-. Corpataux, J.K. Christensen, K. Keirse, G. Nano, H. Schroeder, C.A. Binkert, M. Brodmann. - In: CARDIOVASCULAR AND INTERVENTIONAL RADIOLOGY. - ISSN 0174-1551. - 44:2(2021 Feb), pp. 207-217. [10.1007/s00270-020-02663-7]

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

G. Nano;
2021

Abstract

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). The original version of this paper did not contain a list of BIOLUX P-III investigators. The purpose of this addendum is to acknowledge the contribution of all investigators who participated in the study. Collaborators: BIOLUX P-III Global Registry Investigators: Marianne Brodmann, Thomas Zeller, Jean- Marc Corpataux, Matej Moscovic, Gunnar Tepe, Koen Keirse, Giovanni Nano, Johannes B. Dahm, Johnny Kent Christensen, Reza Ghotbi, Christoph Binkert, Henrik Schro¨der, Denis Henroteaux, John Wang Chaw Chian, Eric Rosset, Enrique Alejandre Lafont, Sabrina Houthoofd, Miguel Araujo; Shaiful Azmi Yahaya, Don Robertson, Martin Freund, Lonneke Yo, Uei Pua, Roxanne Wu, Frank Hammer, Michael Lichtenberg, Janne Korhonen, Della Schiava, Ralf Langhoff, Stefano Michelagnoli, Secundino Llagostera, Jose-Maria Romero, Max Amor, Daniel Kretzschmar, Steven Kum, Patrice Mwipatayi, Albert J Smeets, Francisco Javier Serrano Hernando, Jost Philipp Scha¨fer, Gil Marques, Jos C. van den Berg, Ramesh Velu, Karlis Kupcs.
Drug-coated balloon; Peripheral artery disease; Paclitaxel; Femoral artery; Critical limb ischemia;
Settore MED/22 - Chirurgia Vascolare
20-ott-2020
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/2434/882143
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