title: PTA versus carbofilm-coated stents in infrapopliteal arteries: pilot study.
abstract: OBJECTIVE
  To determine the primary success and short-term patency of stent application as a primary treatment modality for high-grade lesions of the infrapopliteal arteries compared with treatment with percutaneous transluminal angioplasty (PTA) in critical limb ischemia in a randomized prospective study.
  
  
  METHODS
  Endovascular therapy was performed on 95 lesions in 51 patients (mean age 72.0 years, range 47-80 years) who presented clinically with Fontaine stages III and IV. One patient underwent treatment in both limbs. After angiographic lesion identification, patients were randomized for treatment by PTA (53 lesions in 27 patients) or stent application (42 lesions in 24 patients). Follow-up by clinical investigation and conventional angiography or spiral CT angiography was performed in 37 patients (57 lesions) 6 to 12 months after the procedure, or when clinically indicated. Evaluation was performed by two observers, double-blinded, with thresholds for lesion restenosis of 50% and 70%. Statistical evaluation was performed on a lesion basis by Kaplan-Meier estimated probability rates, and log-rank and Wilcoxon tests. The primary endpoint was the angiographic patency rate of treated lesions.
  
  
  RESULTS
  The inter-reader agreement was high (kappa = 0.82). For the stent group the cumulative primary patency at 6 months was 83.7% at the 70% restenosis threshold, and 79.7% at the 50% restenosis threshold. For PTA, the primary patency at 6 months was 61.1% at the 70% restenosis threshold and 45.6% at the 50% restenosis threshold. Both results were statistically significant (p < 0.05).
  
  
  CONCLUSIONS
  Infrapopliteal stent application is an effective treatment modality for high-grade lesions in chronic critical limb ischemia. Compared with PTA, higher patency rates can be expected after 6 months.
authors.affiliation: Department of Angiography and Interventional Radiology, University of Vienna, Waehringer Guertel 18-20, 1090, Austria. Thomas.Rand@meduniwien.ac.at
authors.forename: T
authors.initials: T
authors.lastname: Rand
authors.forename: A
authors.initials: A
authors.lastname: Basile
authors.forename: M
authors.initials: M
authors.lastname: Cejna
authors.forename: D
authors.initials: D
authors.lastname: Fleischmann
authors.forename: M
authors.initials: M
authors.lastname: Funovics
authors.forename: M
authors.initials: M
authors.lastname: Gschwendtner
authors.forename: M
authors.initials: M
authors.lastname: Haumer
authors.forename: I
authors.initials: I
authors.lastname: Von Katzler
authors.forename: J
authors.initials: J
authors.lastname: Kettenbach
authors.forename: F
authors.initials: F
authors.lastname: Lomoschitz
authors.forename: C
authors.initials: C
authors.lastname: Luft
authors.forename: E
authors.initials: E
authors.lastname: Minar
authors.forename: B
authors.initials: B
authors.lastname: Schneider
authors.forename: M
authors.initials: M
authors.lastname: Schoder
authors.forename: J
authors.initials: J
authors.lastname: Lammer
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000800:Angioplasty, Balloon; D002244:Carbon; D020099:Coated Materials, Biocompatible; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007511:Ischemia / Q000000981:diagnostic imaging / Q000601:surgery*; D007866:Leg / Q000098:blood supply*; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D011150:Popliteal Artery / Q000000981:diagnostic imaging / Q000601:surgery*; D011446:Prospective Studies; D011859:Radiography; D018709:Statistics, Nonparametric; D015607:Stents; D016019:Survival Analysis; D016896:Treatment Outcome; D014654:Vascular Patency
chemical_list: D020099:Coated Materials, Biocompatible; D002244:Carbon