title: Drug-Eluting vs Standard Balloon Angioplasty for Iliac Stent Restenosis: Midterm Results.
abstract: OBJECTIVE
  To assess the effectiveness of drug-eluting balloon (DEB) angioplasty for the treatment of iliac artery in-stent restenosis (ISR).
  
  
  METHODS
  Data from 18 patients (mean age 59.3±9.6 years; 11 men) treated with DEB for iliac ISR between October 2009 and August 2013 were retrospectively evaluated and compared with a control group of 22 patients (mean age 66.7±11.8 years; 16 men) treated with standard balloon angioplasty (BA). Primary endpoint of the study was the primary patency rate at 12 months. Secondary endpoints were 30-day and overall mortality, sustained clinical improvement [ankle-brachial index (ABI) and Rutherford category] and clinically driven target lesion revascularization (TLR). Follow-up examinations were performed by clinical examination, color duplex ultrasound, and ABI measurement at 12 months.
  
  
  RESULTS
  Mean length of the 21 lesions in the DEB group was 27.1±19.2 mm vs 20.0±11.4 mm for the 25 lesions in the BA group (p=0.508), while the grade of restenosis was 70.4%±18.4% and 64.0%±16.1% (p=0.255), respectively. Primary patency rates were 90.5% vs 85.7% at 6 months and 71.4% vs 75.6% at 12 months for DEB and BA, respectively (p=0.784). Five BA patients died during follow-up for reasons unrelated to the procedure, while no patient in the DEB group died (p=0.035). In both groups, Rutherford category and ABI significantly improved compared to pretreatment levels; there were no differences between the groups regarding these variables (p=0.367 and p=0.898, respectively). The TLR rate was 28.6% (6/21) in the DEB group and 20.0% (4/20) in the BA cohort (p=0.434).
  
  
  CONCLUSIONS
  Treatment of iliac ISR using DEBs is a safe procedure, with results comparable to BA treatment. Because of the limited number of patients in this study, further investigation of a larger cohort with longer follow-up is needed to define the role of DEBs in the treatment of iliac ISR.
authors.affiliation: Department of Vascular Surgery, St. Franziskus Hospital Münster, Germany stefan.stahlhoff@sfh-muenster.de.
authors.forename: Stefan
authors.initials: S
authors.lastname: Stahlhoff
authors.affiliation: Department of Vascular Surgery, St. Franziskus Hospital Münster, Germany Department of Vascular and Endovascular Surgery, University of Münster, Germany.
authors.forename: Konstantinos P
authors.initials: KP
authors.lastname: Donas
authors.affiliation: Department of Vascular Surgery, St. Franziskus Hospital Münster, Germany Department of Vascular and Endovascular Surgery, University of Münster, Germany.
authors.forename: Giovanni
authors.initials: G
authors.lastname: Torsello
authors.affiliation: Department of Vascular and Endovascular Surgery, University of Münster, Germany.
authors.forename: Nani
authors.initials: N
authors.lastname: Osada
authors.affiliation: Department of Vascular and Endovascular Surgery, University of Münster, Germany.
authors.forename: Monika
authors.initials: M
authors.lastname: Herten
mesh_terms: D000368:Aged; D000800:Angioplasty, Balloon / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D055109:Ankle Brachial Index; D002317:Cardiovascular Agents / Q000008:administration & dosage*; D020099:Coated Materials, Biocompatible; D003251:Constriction, Pathologic; D005260:Female; D006801:Humans; D007083:Iliac Artery / Q000000981:diagnostic imaging / Q000503:physiopathology; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage*; D058729:Peripheral Arterial Disease / Q000175:diagnosis / Q000401:mortality / Q000503:physiopathology / Q000628:therapy*; D011859:Radiography; D012008:Recurrence; D019233:Retreatment; D012189:Retrospective Studies; D012307:Risk Factors; D015607:Stents; D013997:Time Factors; D016896:Treatment Outcome; D018615:Ultrasonography, Doppler, Color; D062666:Vascular Access Devices; D014654:Vascular Patency
chemical_list: D002317:Cardiovascular Agents; D020099:Coated Materials, Biocompatible; D017239:Paclitaxel
keywords: common iliac artery; drug-eluting balloon; external iliac artery; iliac artery; in-stent restenosis