title: De novo superficial femoropopliteal artery lesions: peripheral cutting balloon angioplasty and restenosis rates--randomized controlled trial.
abstract: OBJECTIVE
  To prospectively determine, in a randomized controlled trial, whether cutting balloon angioplasty (CBA) yields superior morphologic and clinical outcomes at 6 months compared with the 6-month outcomes after conventional percutaneous transluminal angioplasty (PTA) in patients with short de novo superficial femoropopliteal artery (SFA) lesions.
  
  
  METHODS
  This study was approved by the ethics committees of the two participating centers, and informed consent was obtained from all patients. The authors randomly assigned 43 patients (26 men, 17 women; median age, 69 years) who had 5 cm or shorter de novo SFA lesions in association with intermittent claudication or chronic limb ischemia to undergo CBA or PTA. The patients were followed up clinically, and restenosis was assessed with duplex ultrasonography (US) at 6 months. chi(2) and Mann-Whitney U tests were used to compare data between the two treatment groups.
  
  
  RESULTS
  The US-determined 6-month restenosis rate was 32% (seven patients) in the PTA group versus 62% (13 patients) in the CBA group (P = .048). Sixteen (73%) PTA group patients versus eight (38%) CBA group patients were asymptomatic at follow-up (P = .059). There was no significant difference in ankle-brachial index (median, 0.83 vs 0.77 for PTA vs CBA group, respectively; P = .56) or pain-free walking distance (median, >1000 m vs 600 m for PTA vs CBA group, respectively; P = .17) between the two groups.
  
  
  CONCLUSIONS
  CBA did not prove to be superior to conventional PTA for treatment of short de novo SFA lesions and yielded increased restenosis rates at 6 months.
authors.affiliation: Departments of Angiology and Radiology, Vienna General Hospital, Medical University, Vienna, Austria.
authors.forename: Jasmin
authors.initials: J
authors.lastname: Amighi
authors.forename: Martin
authors.initials: M
authors.lastname: Schillinger
authors.forename: Petra
authors.initials: P
authors.lastname: Dick
authors.forename: Oliver
authors.initials: O
authors.lastname: Schlager
authors.forename: Schila
authors.initials: S
authors.lastname: Sabeti
authors.forename: Wolfgang
authors.initials: W
authors.lastname: Mlekusch
authors.forename: Markus
authors.initials: M
authors.lastname: Haumer
authors.forename: Rainer
authors.initials: R
authors.lastname: Mathies
authors.forename: Gerald
authors.initials: G
authors.lastname: Heinzle
authors.forename: Antonius
authors.initials: A
authors.lastname: Schuster
authors.forename: Christian
authors.initials: C
authors.lastname: Loewe
authors.forename: Renate
authors.initials: R
authors.lastname: Koppensteiner
authors.forename: Johannes
authors.initials: J
authors.lastname: Lammer
authors.forename: Erich
authors.initials: E
authors.lastname: Minar
authors.forename: Manfred
authors.initials: M
authors.lastname: Cejna
mesh_terms: D000368:Aged; D000800:Angioplasty, Balloon; D001157:Arterial Occlusive Diseases / Q000628:therapy*; D005260:Female; D005263:Femoral Artery; D006801:Humans; D008297:Male; D011150:Popliteal Artery; D012008:Recurrence