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

  • Tepe G Department of Radiology, Klinikum Rosenheim, Rosenheim, Germany.
  • Zeller T Clinic Cardiology and Angiology II, Universitäts-Herzzentrum Freiburg-Bad Krozingen, Bad Krozingen, Germany.
  • Moscovic M Angiology Clinic, Institute of Cardiovascular Diseases, Kosice, Slovakia.
  • Corpataux JM Department of Vascular Surgery, Lausanne University Hospital, Lausanne, Switzerland.
  • Christensen JK Department of Radiology, Kolding Hospital, Kolding, Denmark.
  • Keirse K Department of Vascular Surgery, Regional Hospital Heilig Hart, Tienen, Belgium.
  • Nano G 1st Vascular Surgery Department, IRCCS Policlinico San Donato, San Donato Milanese, Italy.
  • Schroeder H Center for Diagnostic Radiology and Minimally Invasive Therapy, Jewish Hospital, Berlin, Germany.
  • Binkert CA Radiology Institute, Kantonsspital Winterthur, Winterthur, Switzerland.
  • Brodmann M Division of Angiology, Department of Internal Medicine, Medical University Graz, Austria.
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  • 2020-01-29
Published in:
  • Journal of endovascular therapy : an official journal of the International Society of Endovascular Specialists. - 2020
chronic limb-threatening ischemia
critical limb ischemia
drug-coated balloon
drug-eluting balloon
femoropopliteal segment
paclitaxel
peripheral artery disease
superficial femoral artery
Aged
Amputation
Angioplasty, Balloon
Asia
Australia
Cardiovascular Agents
Coated Materials, Biocompatible
Equipment Design
Europe
Female
Femoral Artery
Humans
Limb Salvage
Male
Paclitaxel
Peripheral Arterial Disease
Popliteal Artery
Progression-Free Survival
Prospective Studies
Registries
Time Factors
Vascular Access Devices
Vascular Patency
English 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.
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  • English
Open access status
hybrid
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https://sonar.ch/global/documents/145167
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