title: Clinical evaluation of a paclitaxel-eluting balloon for treatment of femoropopliteal arterial disease: 12-month results from a multicenter Italian registry.
abstract: OBJECTIVE
  This study evaluated the use of a paclitaxel-eluting balloon (PEB) for treatment of femoropopliteal arterial disease.
  
  
  BACKGROUND
  Conventional balloon angioplasty and stenting in this setting is associated with high restenosis rates within 12 months. Recent data suggest that PEB use may reduce restenosis. Twelve-month outcomes following PEB use with provisional stenting are described.
  
  
  METHODS
  This prospective registry enrolled patients (Rutherford class 2 to 4) with reference vessel diameter of 3 to 7 mm and lesion/occlusion length ≤ 15 cm. Endpoints included primary patency rate, target lesion revascularization, and changes in Rutherford class and ankle-brachial index. Walking capacity, absolute claudication distance, and quality of life were also assessed.
  
  
  RESULTS
  The registry enrolled 105 patients. Baseline ankle-brachial index was 0.56 ± 0.15. Baseline Rutherford classification was class 2 or 3 for most patients (91.5%). Most lesions were located in the superficial femoral artery (77.1%). Mean lesion length was 76.3 ± 38.3 mm; 29.8% of lesions were total occlusions. The device was successfully used in all patients and only 12.3% of lesions required stenting. At 12-month follow-up, 92 of 105 patients (87.6%) were evaluable; the primary patency rate was 83.7%; the target lesion revascularization rate was 7.6%; 85.6% of patients were Rutherford class 0 or 1; and mean ankle-brachial index was 0.86 ± 0.15. Quality of life and absolute claudication distance showed significant improvement from baseline to 12-month follow-up.
  
  
  CONCLUSIONS
  PEB treatment of femoropopliteal arterial disease resulted in consistent clinical improvement across multiple endpoints with a low rate of stenting and target lesion revascularization.
authors.affiliation: Cardiology Unit, Gruppo Villa Maria 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; D001157:Arterial Occlusive Diseases / Q000175:diagnosis / Q000503:physiopathology / Q000523:psychology / Q000628:therapy*; D002317:Cardiovascular Agents / Q000008:administration & dosage*; D057785:Catheters; D016009:Chi-Square Distribution; D020099:Coated Materials, Biocompatible; D003251:Constriction, Pathologic; D005260:Female; D005263:Femoral Artery / Q000503:physiopathology; D006801:Humans; D007558:Italy; D053208:Kaplan-Meier Estimate; D016014:Linear Models; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage*; D011150:Popliteal Artery / Q000503:physiopathology; D011446:Prospective Studies; D011788:Quality of Life; D020127:Recovery of Function; D012008:Recurrence; D012042:Registries; D012720:Severity of Illness Index; D013997:Time Factors; D016896:Treatment Outcome; D014654:Vascular Patency; D016138:Walking
chemical_list: D002317:Cardiovascular Agents; D020099:Coated Materials, Biocompatible; D017239:Paclitaxel