Medizinische Universität Graz - Research portal
Selected Publication:
SHR Neuro Cancer Cardio Lipid Metab Microb
Tepe, G; Zeller, T; Moscovic, M; Corpataux, JM; Christensen, JK; Keirse, K; Nano, G; Schroeder, H; Binkert, CA; Brodmann, M.
Paclitaxel-Coated Balloon for the Treatment of Infrainguinal Disease: 12-Month Outcomes in the All-Comers Cohort of BIOLUX P-III Global Registry.
J Endovasc Ther. 2020; 27(2):304-315
Doi: 10.1177/1526602819898804
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- Co-authors Med Uni Graz
- Brodmann Marianne
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- 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.
- Find related publications in this database (using NLM MeSH Indexing)
- Aged -
- Amputation -
- Angioplasty, Balloon - adverse effects
- Angioplasty, Balloon - instrumentation
- Angioplasty, Balloon -
- Angioplasty, Balloon -
- Cardiovascular Agents - administration & dosage
- Cardiovascular Agents - adverse effects
- Coated Materials, Biocompatible -
- Equipment Design -
- Equipment Design -
- Female -
- Femoral Artery - diagnostic imaging
- Femoral Artery - physiopathology
- Humans -
- Limb Salvage -
- Male -
- Paclitaxel - administration & dosage
- Paclitaxel - adverse effects
- Peripheral Arterial Disease - diagnostic imaging
- Peripheral Arterial Disease - physiopathology
- Peripheral Arterial Disease - therapy
- Popliteal Artery - diagnostic imaging
- Popliteal Artery - physiopathology
- Progression-Free Survival -
- Prospective Studies -
- Registries -
- Time Factors -
- Vascular Access Devices -
- Vascular Patency -
- Find related publications in this database (Keywords)
- chronic limb-threatening ischemia
- critical limb ischemia
- drug-coated balloon
- drug-eluting balloon
- femoropopliteal segment
- paclitaxel
- peripheral artery disease
- superficial femoral artery