title: Drug-eluting balloons for the treatment of the superficial femoral artery in-stent restenosis: 2-year follow-up.
abstract: OBJECTIVE
  The aim of this prospective registry was to evaluate the safety and efficacy at 2-year follow-up of the use of drug-eluting balloons (DEBs) for the treatment of superficial femoral artery (SFA) in-stent restenosis (ISR).
  
  
  BACKGROUND
  The use of DEBs for the treatment of SFA ISR is associated with a satisfactory primary patency rate at 1 year, but no data are available for longer follow-up. Unfortunately, when DEBs were used to treat SFA de novo lesions, the occurrence of restenosis increased by 50% between the first and the second years of follow-up.
  
  
  METHODS
  From December 2009 to December 2010, 39 consecutive patients underwent percutaneous transluminal angioplasty of SFA ISR at our institution (Clinica Montevergine, Mercogliano, Italy). All patients underwent conventional SFA percutaneous transluminal angioplasty and final post-dilation with paclitaxel-eluting balloons (IN.PACT, Medtronic Inc., Minneapolis, Minnesota). Patients were evaluated for up to 24 months.
  
  
  RESULTS
  During follow-up, 1 patient died of heart failure and another of sudden death, for a 2-years rate of cardiovascular mortality rate of 5.12 %. The primary patency rate at 2 years was 70.3% (11 of 37 patients experienced restenosis recurrence at 2-year follow-up). The treatment of complex ISR lesions (classes II and III) was associated with an increased rate of recurrent restenosis compared with class I (33.3 % and 36.3 % vs. 12.5%; p = 0.05).
  
  
  CONCLUSIONS
  The data suggest that adjunctive use of DEBs for the treatment of SFA ISR is a safe and effective therapeutic strategy up to 2 years of follow-up.
authors.affiliation: Division of Cardiology, Clinical and Experimental Department of Medicine, University of Messina, Messina, Italy.
authors.forename: Vittorio
authors.initials: V
authors.lastname: Virga
authors.affiliation: Division of Cardiology, Department of Advanced Biomedical Sciences, University of Napoli "Federico II," Naples, Italy. Electronic address: geko50@hotmail.com.
authors.forename: Eugenio
authors.initials: E
authors.lastname: Stabile
authors.affiliation: Invasive Cardiology Laboratory, Cardiology Division, Clinica Montevergine, Mercogliano, Italy.
authors.forename: Giancarlo
authors.initials: G
authors.lastname: Biamino
authors.affiliation: Invasive Cardiology Laboratory, Cardiology Division, Clinica Montevergine, Mercogliano, Italy.
authors.forename: Luigi
authors.initials: L
authors.lastname: Salemme
authors.affiliation: Invasive Cardiology Laboratory, Cardiology Division, Clinica Montevergine, Mercogliano, Italy.
authors.forename: Angelo
authors.initials: A
authors.lastname: Cioppa
authors.affiliation: Division of Cardiology, Department of Advanced Biomedical Sciences, University of Napoli "Federico II," Naples, Italy.
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Giugliano
authors.affiliation: Invasive Cardiology Laboratory, Cardiology Division, Clinica Montevergine, Mercogliano, Italy.
authors.forename: Tullio
authors.initials: T
authors.lastname: Tesorio
authors.affiliation: Invasive Cardiology Laboratory, Cardiology Division, Clinica Montevergine, Mercogliano, Italy.
authors.forename: Linda
authors.initials: L
authors.lastname: Cota
authors.affiliation: Invasive Cardiology Laboratory, Cardiology Division, Clinica Montevergine, Mercogliano, Italy.
authors.forename: Grigore
authors.initials: G
authors.lastname: Popusoi
authors.affiliation: Invasive Cardiology Laboratory, Cardiology Division, Clinica Montevergine, Mercogliano, Italy.
authors.forename: Armando
authors.initials: A
authors.lastname: Pucciarelli
authors.affiliation: Invasive Cardiology Laboratory, Cardiology Division, Clinica Montevergine, Mercogliano, Italy.
authors.forename: Giovanni
authors.initials: G
authors.lastname: Esposito
authors.affiliation: Division of Cardiology, Department of Advanced Biomedical Sciences, University of Napoli "Federico II," Naples, Italy.
authors.forename: Bruno
authors.initials: B
authors.lastname: Trimarco
authors.affiliation: Invasive Cardiology Laboratory, Cardiology Division, Clinica Montevergine, Mercogliano, Italy.
authors.forename: Paolo
authors.initials: P
authors.lastname: Rubino
mesh_terms: D000800:Angioplasty, Balloon / Q000009:adverse effects* / Q000295:instrumentation*; D002317:Cardiovascular Agents / Q000008:administration & dosage*; D020099:Coated Materials, Biocompatible; D003251:Constriction, Pathologic; D004867:Equipment Design; D005263:Femoral Artery; D005500:Follow-Up Studies; D006801:Humans; D007558:Italy; D017239:Paclitaxel / Q000008:administration & dosage*; D058729:Peripheral Arterial Disease / Q000175:diagnosis / Q000628:therapy*; D011446:Prospective Studies; D012008:Recurrence; D012042:Registries; D019233:Retreatment; D015607:Stents; D013997:Time Factors; D016896:Treatment Outcome; D062666:Vascular Access Devices
chemical_list: D002317:Cardiovascular Agents; D020099:Coated Materials, Biocompatible; D017239:Paclitaxel
keywords: drug-eluting balloon; in-stent restenosis; superficial femoral artery