title: Treatment of femoropopliteal in-stent restenosis with paclitaxel-eluting stents.
abstract: OBJECTIVE
  This study sought to evaluate the outcomes of drug-eluting stent treatment for femoropopliteal in-stent restenosis (ISR).
  
  
  BACKGROUND
  ISR after femoropopliteal interventions is an increasing problem. Although the role of drug-eluting stents in the treatment of coronary ISR is well defined, no published studies have examined drug-eluting stents in the treatment of femoropopliteal ISR.
  
  
  METHODS
  This study examines 108 patients with 119 ISR lesions who were enrolled in the ZILVER-PTX single-arm study, a prospective, multicenter clinical trial of 787 patients. All patients were treated with paclitaxel-eluting nitinol stents.
  
  
  RESULTS
  Mean patient age was 68.3 ± 9.4 years; 61.1% of patients were men. Mean lesion length was 133.0 ± 91.7 mm; 33.6% of lesions were >150 mm long and 31.1% of lesions were totally occluded. Procedural success was achieved in 98.2% of lesions with 2.1 ± 1.2 stents placed per lesion. Primary patency was 95.7% at 6 months and 78.8% at 1 year. Freedom from target lesion revascularization was 96.2% at 6 months, 81.0% at 1 year, and 60.8% at 2 years. Forty patients experienced major adverse events, exclusively target lesion revascularization. Before treatment, 81.1% of patients had Rutherford scores ≥3; at 2 years, 60.9% of patients had Rutherford scores ≤1. Both ankle brachial index and walking impairment questionnaire scores significantly improved following treatment. The 1-year fracture rate of stents used in ISR lesions was 1.2%. No significant risk factors associated with loss of patency were identified.
  
  
  CONCLUSIONS
  Treatment of femoropopliteal ISR with paclitaxel-eluting stents results in favorable acute, midterm, and long-term outcomes. (Zilver PTX Global Registry [ZILVER-PTX]; NCT01094678).
authors.affiliation: Department of Cardiology and Angiology, Universitäts-Herzzentrum Freiburg-Bad Krozingen, Bad Krozingen, Germany. thomas.zeller@universitaets-herzzentrum.de
authors.forename: Thomas
authors.initials: T
authors.lastname: Zeller
authors.forename: Michael D
authors.initials: MD
authors.lastname: Dake
authors.forename: Gunnar
authors.initials: G
authors.lastname: Tepe
authors.forename: Klaus
authors.initials: K
authors.lastname: Brechtel
authors.forename: Elias
authors.initials: E
authors.lastname: Noory
authors.forename: Ulrich
authors.initials: U
authors.lastname: Beschorner
authors.forename: Patricia L
authors.initials: PL
authors.lastname: Kultgen
authors.forename: Aljoscha
authors.initials: A
authors.lastname: Rastan
mesh_terms: D000368:Aged; D000497:Alloys; D000800:Angioplasty, Balloon / Q000009:adverse effects / Q000295:instrumentation*; D055109:Ankle Brachial Index; D002170:Canada; D002317:Cardiovascular Agents / Q000008:administration & dosage*; D003251:Constriction, Pathologic; D018572:Disease-Free Survival; D054855:Drug-Eluting Stents; D005060:Europe; D005080:Exercise Test; D005260:Female; D005263:Femoral Artery / Q000503:physiopathology; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D017239:Paclitaxel / Q000008:administration & dosage*; D058729:Peripheral Arterial Disease / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy*; D011150:Popliteal Artery / Q000503:physiopathology; D011446:Prospective Studies; D011474:Prosthesis Design; D011475:Prosthesis Failure; D012008:Recurrence; D012042:Registries; D056910:Republic of Korea; D012307:Risk Factors; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome; D014654:Vascular Patency
chemical_list: D000497:Alloys; D002317:Cardiovascular Agents; C013616:nitinol; D017239:Paclitaxel