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Tepe, Gunnar [Verfasser:in]; Zeller, Thomas [Verfasser:in]; Moscovic, Matej [Verfasser:in]; Corpataux, Jean-Marc [Verfasser:in]; Christensen, Johnny Kent [Verfasser:in]; Keirse, Koen [Verfasser:in]; Nano, Giovanni [Verfasser:in]; Schröder, Henrik [Verfasser:in]; Binkert, Christoph A. [Verfasser:in]; Brodmann, Marianne [Verfasser:in]

Paclitaxel-coated balloon angioplasty for the treatment of infrainguinal arteries: 24-month outcomes in the full cohort of BIOLUX P-III Global Registry

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  • Medientyp: E-Book; Sonderdruck
  • Titel: Paclitaxel-coated balloon angioplasty for the treatment of infrainguinal arteries: 24-month outcomes in the full cohort of BIOLUX P-III Global Registry
  • Beteiligte: Tepe, Gunnar [Verfasser:in]; Zeller, Thomas [Verfasser:in]; Moscovic, Matej [Verfasser:in]; Corpataux, Jean-Marc [Verfasser:in]; Christensen, Johnny Kent [Verfasser:in]; Keirse, Koen [Verfasser:in]; Nano, Giovanni [Verfasser:in]; Schröder, Henrik [Verfasser:in]; Binkert, Christoph A. [Verfasser:in]; Brodmann, Marianne [Verfasser:in]
  • Erschienen: Berlin; Heidelberg: Springer Nature, 2021
  • Erschienen in: CardioVascular and interventional radiology ; 44 (2021), 207–217
  • Umfang: 1 Online-Ressource (11 Seiten); Diagramme; Supplementary material (1 Zip‐Datei: 1 .docx-Datei, 4 .TIF-Dateien)
  • Sprache: Englisch
  • DOI: 10.1007/s00270-020-02663-7
  • Identifikator:
  • Entstehung:
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  • Beschreibung: Abstract: Purpose<br>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.<br><br>Methods<br>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.<br><br>Results<br>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.<br><br>Conclusion<br>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)
  • Zugangsstatus: Freier Zugang