title: Paclitaxel-releasing balloon in femoropopliteal lesions using a BTHC excipient: twelve-month results from the BIOLUX P-I randomized trial.
abstract: OBJECTIVE
  To evaluate the safety and efficacy of the novel Passeo-18 Lux paclitaxel-coated balloon compared with the Passeo-18 uncoated balloon in patients with symptomatic de novo or restenotic femoropopliteal lesions.
  
  
  METHODS
  Sixty patients (34 men; mean age 70.7 ± 10.1 years) in 5 European centers were enrolled in the BIOLUX P-I trial (ClinicalTrials.gov identifier NCT01056120) and randomized 1:1 to either the paclitaxel-coated balloon or the uncoated balloon. The primary endpoint was late lumen loss at 6 months. Secondary endpoints were binary restenosis at 6 months, clinically driven target lesion revascularization (TLR), change in ankle-brachial index and Rutherford classification, and major adverse events at 6 and 12 months.
  
  
  RESULTS
  At 6 months, patients treated with paclitaxel-coated balloons had a significantly lower late lumen loss (0.51 ± 0.72 vs. 1.04 ± 1.00 mm, p = 0.033) and binary restenosis (11.5% vs. 34.6%, p = 0.048) than the control group. Correspondingly, clinically driven TLR was lower in the paclitaxel-coated balloon group at 12 months [15.4% vs. 41.7% (p = 0.064) for the intention-to-treat population and 16.0% vs. 52.9%, (p = 0.020) for the as-treated population]. No death and one minor amputation were observed compared with two deaths and two minor amputations in the control group. No major amputations or thrombosis were reported.
  
  
  CONCLUSIONS
  The Passeo-18 Lux paclitaxel-coated balloon has been proven to be safe and effective in patients with femoropopliteal lesions, with superior performance outcomes compared with treatment with an uncoated balloon.
authors.affiliation: Park Hospital and Universitätsklinikum Leipzig, Germany dierk.scheinert@medizin-uni-leipzig.de.
authors.forename: Dierk
authors.initials: D
authors.lastname: Scheinert
authors.affiliation: Ev. Krankenhaus Königin Elisabeth Herzberge, Berlin, Germany.
authors.forename: Karl-Ludwig
authors.initials: KL
authors.lastname: Schulte
authors.affiliation: Universitaets-Herzzentrum Freiburg-Bad Krozingen, Germany.
authors.forename: Thomas
authors.initials: T
authors.lastname: Zeller
authors.affiliation: Medical University of Vienna, Austria.
authors.forename: Johannes
authors.initials: J
authors.lastname: Lammer
authors.affiliation: Rosenheim Hospital, Rosenheim, Germany.
authors.forename: Gunnar
authors.initials: G
authors.lastname: Tepe
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000800:Angioplasty, Balloon; D055109:Ankle Brachial Index; D001317:Austria; D002087:Butyrates / Q000008:administration & dosage; D002317:Cardiovascular Agents / Q000008:administration & dosage*; D020099:Coated Materials, Biocompatible; D005079:Excipients / Q000008:administration & dosage; D005260:Female; D005263:Femoral Artery / Q000000981:diagnostic imaging; D005500:Follow-Up Studies; D005858:Germany; D006801:Humans; D023821:Limb Salvage; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage*; D058729:Peripheral Arterial Disease / Q000000981:diagnostic imaging / Q000628:therapy*; D011150:Popliteal Artery / Q000000981:diagnostic imaging; D011446:Prospective Studies; D011859:Radiography; D016896:Treatment Outcome
chemical_list: D002087:Butyrates; D002317:Cardiovascular Agents; D020099:Coated Materials, Biocompatible; D005079:Excipients; C066757:butyryl-n-trihexylcitrate; D017239:Paclitaxel
keywords: BTHC; balloon angioplasty; drug-coated balloon; drug-eluting balloon; drug-releasing balloon; femoropopliteal lesions; occlusion; paclitaxel-coated balloon; peripheral artery disease; popliteal artery; restenosis; stenosis; superficial femoral artery