title: 2-year results of paclitaxel-eluting balloons for femoropopliteal artery disease: evidence from a multicenter registry.
abstract: OBJECTIVE
  This study aimed to appraise 2-year outcomes after percutaneous treatment of femoropopliteal artery disease with paclitaxel-eluting balloons.
  
  
  BACKGROUND
  Percutaneous transluminal angioplasty with paclitaxel-eluting balloons for femoropopliteal artery disease has provided favorable 1-year results.
  
  
  METHODS
  Consecutive patients with Rutherford class 2 to 4 disease due to femoropopliteal lesions ≤15 mm long and with 3- to 7-mm reference vessel diameter were prospectively enrolled in a multicenter registry. Endpoints of interest included primary patency, major adverse events (the composite of death, amputation, or target lesion revascularization), changes in Rutherford class, ankle-brachial index, absolute claudication distance, and quality of life after ≥24 months.
  
  
  RESULTS
  A total of 105 patients (114 lesions) treated with paclitaxel-eluting balloons and provisional stenting were enrolled, and final procedural success was obtained in all. Follow-up after 27 ± 3 months was obtained in 98 (93.3%) patients, showing that primary patency was maintained in 71 (72.4%), and major adverse events had occurred in 17 (17.5%), with persistently significant benefits in Rutherford class, ankle-brachial index, absolute claudication distance, and quality of life (all p < 0.001). Secondary patency rate was achieved in 89 cases (84.7%).
  
  
  CONCLUSIONS
  PEBs are associated with favorable functional and clinical outcomes at 2 years in patients with femoropopliteal artery disease requiring percutaneous revascularization.
authors.affiliation: Cardiology Unit, GVM Care and Research, Maria Eleonora Hospital, Palermo, Italy. antoniomicari@tiscali.it
authors.forename: Antonio
authors.initials: A
authors.lastname: Micari
authors.forename: Angelo
authors.initials: A
authors.lastname: Cioppa
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Vadalà
authors.forename: Fausto
authors.initials: F
authors.lastname: Castriota
authors.forename: Armando
authors.initials: A
authors.lastname: Liso
authors.forename: Alfredo
authors.initials: A
authors.lastname: Marchese
authors.forename: Chiara
authors.initials: C
authors.lastname: Grattoni
authors.forename: Paolo
authors.initials: P
authors.lastname: Pantaleo
authors.forename: Alberto
authors.initials: A
authors.lastname: Cremonesi
authors.forename: Paolo
authors.initials: P
authors.lastname: Rubino
authors.forename: Giancarlo
authors.initials: G
authors.lastname: Biamino
mesh_terms: D000368:Aged; D000800:Angioplasty, Balloon / Q000009:adverse effects / Q000295:instrumentation*; D055109:Ankle Brachial Index; D002317:Cardiovascular Agents / Q000008:administration & dosage*; D020099:Coated Materials, Biocompatible; D003251:Constriction, Pathologic; D005080:Exercise Test; D005260:Female; D005263:Femoral Artery / Q000503:physiopathology; D006801:Humans; D007558:Italy; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage*; D058729:Peripheral Arterial Disease / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy*; D011150:Popliteal Artery / Q000503:physiopathology; D011446:Prospective Studies; D011788:Quality of Life; D012008:Recurrence; D012042:Registries; D015607:Stents; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome; D062666:Vascular Access Devices; D014654:Vascular Patency
chemical_list: D002317:Cardiovascular Agents; D020099:Coated Materials, Biocompatible; D017239:Paclitaxel