Medizinische Universität Graz - Research portal
Selected Publication:
SHR Neuro Cancer Cardio Lipid Metab Microb
Zeller, T; Beschorner, U; Pilger, E; Bosiers, M; Deloose, K; Peeters, P; Scheinert, D; Schulte, KL; Rastan, A; Brodmann, M.
Paclitaxel-Coated Balloon in Infrapopliteal Arteries: 12-Month Results From the BIOLUX P-II Randomized Trial (BIOTRONIK'S-First in Man study of the Passeo-18 LUX drug releasing PTA Balloon Catheter vs. the uncoated Passeo-18 PTA balloon catheter in subjects requiring revascularization of infrapopliteal arteries).
JACC Cardiovasc Interv. 2015; 8(12):1614-1622
Doi: 10.1016/j.jcin.2015.07.011
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- Co-authors Med Uni Graz
- Brodmann Marianne
- Pilger Ernst
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- Abstract:
- The aim of BIOLUX P-II (BIOTRONIK'S-First in Man study of the Passeo-18 LUX drug releasing PTA Balloon Catheter vs. the uncoated Passeo-18 PTA balloon catheter in subjects requiring revascularization of infrapopliteal arteries) trial was to compare the safety and efficacy of a novel paclitaxel-coated drug-eluting balloon (DEB) versus an uncoated balloon (percutaneous transluminal angioplasty [PTA]) in de novo or native restenotic lesions of the infrapopliteal arteries in patients with claudication and critical limb ischemia. DEB have shown promising results in femoropopliteal lesions, but data for infrapopliteal lesions are scarce. In this prospective, multicenter, randomized first-in-man study, 72 patients were randomized 1:1 to either a Passeo-18 Lux DEB (Biotronik AG, Buelach, Switzerland) (n = 36) or Passeo-18 PTA (n = 36). Follow-up assessments were scheduled at 1, 6, and 12 months, with angiographic assessment at 6 months. Adverse events were adjudicated by an independent clinical events committee, and angiographic parameters were assessed by an independent core laboratory. The primary safety endpoint (a composite of all-cause mortality, target extremity major amputation, target lesion thrombosis, and target vessel revascularization at 30 days) was 0% in the DEB group versus 8.3% in the PTA group (p = 0.239). The primary performance endpoint (patency loss at 6 months) was 17.1% in the DEB group versus 26.1% in the PTA group (p = 0.298), and major amputations of the target extremity occurred in 3.3% versus 5.6% of the patients at 12 months, respectively. The Passeo-18 Lux DEB has been proven to be safe and effective in infrapopliteal lesions with comparable outcomes to PTA. Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
- Find related publications in this database (using NLM MeSH Indexing)
- Adolescent -
- Adult -
- Aged -
- Aged, 80 and over -
- Amputation -
- Angioplasty, Balloon - adverse effects
- Angioplasty, Balloon - instrumentation
- Angioplasty, Balloon - mortality
- Cardiovascular Agents - administration & dosage
- Coated Materials, Biocompatible -
- Critical Illness -
- Equipment Design -
- Female -
- Humans -
- Intermittent Claudication - diagnosis
- Intermittent Claudication - mortality
- Intermittent Claudication - physiopathology
- Intermittent Claudication - therapy
- Ischemia - diagnosis
- Ischemia - mortality
- Ischemia - physiopathology
- Ischemia - therapy
- Limb Salvage -
- Male -
- Middle Aged -
- Paclitaxel - administration & dosage
- Peripheral Arterial Disease - diagnosis
- Peripheral Arterial Disease - mortality
- Peripheral Arterial Disease - physiopathology
- Peripheral Arterial Disease - therapy
- Popliteal Artery - diagnostic imaging
- Popliteal Artery - physiopathology
- Prospective Studies -
- Radiography -
- Recurrence -
- Time Factors -
- Treatment Outcome -
- Vascular Access Devices -
- Vascular Patency -
- Young Adult -
- Find related publications in this database (Keywords)
- below-the-knee
- critical limb ischemia
- drug-coated balloon
- drug-eluting balloon
- infrapopliteal
- peripheral artery disease