Paclitaxel-Coated Balloon in Infrapopliteal Arteries

• Published in: JACC. Cardiovascular interventions Vol. 8; no. 12; pp. 1614 - 1622
• Main Authors: Zeller, Thomas, MD, Beschorner, Ulrich, MD, Pilger, Ernst, MD, Bosiers, Marc, MD, Deloose, Koen, MD, Peeters, Patrick, MD, Scheinert, Dierk, MD, PhD, Schulte, Karl-Ludwig, MD, PhD, Rastan, Aljoscha, MD, Brodmann, Marianne, MD, PhD
• Format: Journal Article
• Language: English
• Published: Elsevier Inc 01.10.2015
• Subjects: below-the-knee; Cardiovascular; critical limb ischemia; drug-coated balloon; drug-eluting balloon; infrapopliteal; peripheral artery disease; DEB; CLI; peripheral artery disease; target lesion revascularization; drug-eluting balloon; objective performance goal; OPG; ABI; drug-coated balloon; n-Butyryl tri-n-hexyl citrate; major adverse event(s); below-the-knee; ankle brachial index; MAE; BTHC; percutaneous transluminal angioplasty; critical limb ischemia; infrapopliteal; quantitative vascular angiography; TLR; PTA; QVA
• ISSN: 1936-8798; 1876-7605
• DOI: 10.1016/j.jcin.2015.07.011

Abstract Objectives 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. Background DEB have shown promising results in femoropopliteal lesions, but data for infrapopliteal lesions are scarce. Methods 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. Results 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. Conclusions The Passeo-18 Lux DEB has been proven to be safe and effective in infrapopliteal lesions with comparable outcomes to PTA.