Paclitaxel-Coated Balloon for the Treatment of Infrainguinal Disease: 12-Month Outcomes in the All-Comers Cohort of BIOLUX P-III Global Registry

Gunnar Tepe, Thomas Zeller, Matej Moscovic, Jean-Marc Corpataux, Johnny Kent Christensen, Koen Keirse, Giovanni Nano, Henrik Schroeder, Christoph A Binkert, Marianne Brodmann

Research output: Contribution to journalArticlepeer-review

Abstract

Purpose: To further investigate the safety and performance of the Passeo-18 Lux drug-coated balloon (DCB) for the treatment of atherosclerotic infrainguinal disease under real-world conditions. Materials and Methods: BIOLUX P-III is an international, prospective, observational registry (ClinicalTrials.gov identifier NCT02276313) conducted at 41 centers in Europe, Asia, and Australia with follow-up visits at 6, 12, and 24 months. Of 700 patients (mean age 70.0±10.2 years; 439 men) with 863 lesions in the all-comers cohort, 330 (47.1%) patients had diabetes and 234 (37.7%) had chronic limb-threatening ischemia. The majority (79.3%) of lesions were in the femoropopliteal segment; of all lesions, 645 (74.9%) were calcified and 99 (11.5%) had in-stent restenosis (ISR). The mean lesion length was 84.7±73.3 mm. The primary clinical endpoint was major adverse events (MAEs) within 6 months, a composite of device- and procedure-related mortality through 30 days, major target limb amputation, and clinically-driven target lesion revascularization (TLR). The primary performance endpoint was clinically-driven TLR within 12 months. Results: At 6 and 12 months, freedom from MAEs was 94.0% and 89.5% in the all-comers cohort: 95.0% and 91.2% in the femoropopliteal group and 95.3% and 88.0% in the ISR subgroup, respectively. Freedom from clinically-driven TLR at 12 months was 93.1% in the all-comers cohort, 93.9% in the femoropopliteal lesions, and 89.4% for ISR lesions. All-cause mortality was 6.1% in the all-comers cohort: 5.9% in both the femoropopliteal and ISR subgroups. There were no device- or procedure-related deaths at up to 12 months. The Rutherford category improved in >80% of all subgroups at 12 months. Conclusion: In a real-world patient population, the safety and performance of the Passeo-18 Lux DCB for the treatment of atherosclerotic infrainguinal lesions are maintained, with good performance outcomes and low complication rates at 12 months.

Original languageEnglish
Pages (from-to)304-315
Number of pages12
JournalJournal of endovascular therapy : an official journal of the International Society of Endovascular Specialists
Volume27
Issue number2
DOIs
Publication statusPublished - Apr 2020

Keywords

  • Aged
  • Amputation
  • Angioplasty, Balloon/adverse effects
  • Asia
  • Australia
  • Cardiovascular Agents/administration & dosage
  • Coated Materials, Biocompatible
  • Equipment Design
  • Europe
  • Female
  • Femoral Artery/diagnostic imaging
  • Humans
  • Limb Salvage
  • Male
  • Paclitaxel/administration & dosage
  • Peripheral Arterial Disease/diagnostic imaging
  • Popliteal Artery/diagnostic imaging
  • Progression-Free Survival
  • Prospective Studies
  • Registries
  • Time Factors
  • Vascular Access Devices
  • Vascular Patency

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