title: 1-Year Results of Paclitaxel-Coated Balloons for Long Femoropopliteal Artery Disease: Evidence From the SFA-Long Study.
abstract: The aim of this study was to appraise 1-year outcomes after percutaneous treatment of long femoropopliteal artery disease using paclitaxel-coated balloons.
  
  
  
  Percutaneous transluminal angioplasty with paclitaxel-coated balloons for TransAtlantic Inter-Society Consensus types A and B femoropopliteal artery disease has provided favorable results.
  
  
  
  Consecutive patients with Rutherford class 2 to 4 disease due to femoropopliteal lesions >15 cm long and with 4- to 7-mm reference vessel diameter were prospectively enrolled in a multicenter study. The primary study endpoint was primary patency at 12 months. Secondary endpoints included major adverse events (the composite of death, major target limb amputation, thrombosis at the target lesion site, or clinically driven non-target lesion target vessel revascularization), changes in Rutherford class, ankle-brachial index, and quality of life up to 24 months post-procedure.
  
  
  
  A total of 105 patients (mean age 68 ± 9 years, 81.9% men) treated with paclitaxel-coated balloons and provisional stenting were enrolled, and final procedural success was obtained in all. The mean treated lesion length was 251 ± 71 mm, including 63.4% moderate to severely calcified lesions and 49.5% total occlusions. The bailout stent rate was 10.9%. Follow-up after 12 months was obtained in 101 patients (96.2%), showing that primary patency was maintained in 84 (83.2%), and major adverse events had occurred in 7 (6.2%), with persistently significant clinical benefits in Rutherford class.
  
  
  
  Paclitaxel-coated balloons are associated with favorable functional and clinical outcomes at 1 year in patients with long femoropopliteal artery disease requiring percutaneous revascularization. (Drug Eluting Balloon [DEB] and Long Lesions of Superficial Femoral Artery [SFA] Ischemic Vascular Disease [DEB-SFA-LONG]; NCT01658540).
authors.affiliation: Cardiology Unit, Gruppo Villa Maria Care and Research, Maria Eleonora Hospital, Palermo, Italy. Electronic address: micariantonio@gmail.com.
authors.forename: Antonio
authors.initials: A
authors.lastname: Micari
authors.affiliation: Cardiology Unit, Gruppo Villa Maria Care and Research, Maria Eleonora Hospital, Palermo, Italy.
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Vadalà
authors.affiliation: Cardiology Unit, Gruppo Villa Maria Care and Research, Maria Cecilia Hospital, Cotignola, Italy.
authors.forename: Fausto
authors.initials: F
authors.lastname: Castriota
authors.affiliation: Cardiology Unit, Gruppo Villa Maria Care and Research, Città di Lecce Hospital, Lecce, Italy.
authors.forename: Armando
authors.initials: A
authors.lastname: Liso
authors.affiliation: Cardiology Unit, Gruppo Villa Maria Care and Research, Maria Cecilia Hospital, Cotignola, Italy.
authors.forename: Chiara
authors.initials: C
authors.lastname: Grattoni
authors.affiliation: Gruppo Villa Maria Care and Research, Maria Pia Hospital, Torino, Italy.
authors.forename: Paolo
authors.initials: P
authors.lastname: Russo
authors.affiliation: Gruppo Villa Maria Care and Research, Anthea Hospital, Bari, Italy.
authors.forename: Alfredo
authors.initials: A
authors.lastname: Marchese
authors.affiliation: Gruppo Villa Maria Care and Research, Instituto Clinico Ligure di Alta Specialita, Rapallo, Italy.
authors.forename: Paolo
authors.initials: P
authors.lastname: Pantaleo
authors.affiliation: Cardiology Unit, Gruppo Villa Maria Care and Research, Maria Eleonora Hospital, Palermo, Italy.
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Roscitano
authors.affiliation: Biostatistics and Biomathematics Unit, University of Brescia, Brescia, Italy.
authors.forename: Bruno Mario
authors.initials: BM
authors.lastname: Cesana
authors.affiliation: Cardiology Unit, Gruppo Villa Maria Care and Research, Maria Cecilia Hospital, Cotignola, Italy.
authors.forename: Alberto
authors.initials: A
authors.lastname: Cremonesi
mesh_terms: D000368:Aged; D000800:Angioplasty, Balloon / Q000009:adverse effects / Q000295:instrumentation*; D055109:Ankle Brachial Index; D002317:Cardiovascular Agents / Q000008:administration & dosage* / Q000009:adverse effects; D020099:Coated Materials, Biocompatible; D003251:Constriction, Pathologic; D004867:Equipment Design; D005260:Female; D005263:Femoral Artery / Q000000981:diagnostic imaging / Q000503:physiopathology; D006801:Humans; D007558:Italy; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage* / Q000009:adverse effects; D058729:Peripheral Arterial Disease / Q000000981:diagnostic imaging / Q000503:physiopathology / Q000628:therapy*; D011150:Popliteal Artery / Q000000981:diagnostic imaging / Q000503:physiopathology; D011446:Prospective Studies; D011788:Quality of Life; D013997:Time Factors; D016896:Treatment Outcome; D062666:Vascular Access Devices; D061205:Vascular Calcification / Q000000981:diagnostic imaging / Q000503:physiopathology / Q000628:therapy*; D014654:Vascular Patency
chemical_list: D002317:Cardiovascular Agents; D020099:Coated Materials, Biocompatible; D017239:Paclitaxel
keywords: paclitaxel-coated balloon; percutaneous transluminal angioplasty; peripheral artery disease