title: Balloon angioplasty versus implantation of nitinol stents in the superficial femoral artery.
abstract: BACKGROUND
  Because stent implantation for disease of the superficial femoral artery has been associated with high rates of late clinical failure, percutaneous transluminal angioplasty is preferred for endovascular treatment, and stenting is recommended only in the event of suboptimal technical results. We evaluated whether primary implantation of a self-expanding nitinol (nickel-titanium) stent yielded anatomical and clinical benefits superior to those afforded by percutaneous transluminal angioplasty with optional secondary stenting.
  
  
  METHODS
  We randomly assigned 104 patients who had severe claudication or chronic limb ischemia due to stenosis or occlusion of the superficial femoral artery to undergo primary stent implantation (51 patients) or angioplasty (53 patients). Restenosis and clinical outcomes were assessed at 6 and 12 months.
  
  
  RESULTS
  The mean (+/-SD) length of the treated segment was 132+/-71 mm in the stent group and 127+/-55 mm in the angioplasty group. Secondary stenting was performed in 17 of 53 patients (32 percent) in the angioplasty group, in most cases because of a suboptimal result after angioplasty. At 6 months, the rate of restenosis on angiography was 24 percent in the stent group and 43 percent in the angioplasty group (P=0.05); at 12 months the rates on duplex ultrasonography were 37 percent and 63 percent, respectively (P=0.01). Patients in the stent group were able to walk significantly farther on a treadmill at 6 and 12 months than those in the angioplasty group.
  
  
  CONCLUSIONS
  In the intermediate term, treatment of superficial-femoral-artery disease by primary implantation of a self-expanding nitinol stent yielded results that were superior to those with the currently recommended approach of balloon angioplasty with optional secondary stenting. (ClinicalTrials.gov number, NCT00281060.).
authors: Department of Angiology, Medical University of Vienna, Vienna General Hospital, Vienna, Austria. martin.schillinger@meduniwien.ac.at
authors: Martin
authors: M
authors: Schillinger
authors: Schila
authors: S
authors: Sabeti
authors: Christian
authors: C
authors: Loewe
authors: Petra
authors: P
authors: Dick
authors: Jasmin
authors: J
authors: Amighi
authors: Wolfgang
authors: W
authors: Mlekusch
authors: Oliver
authors: O
authors: Schlager
authors: Manfred
authors: M
authors: Cejna
authors: Johannes
authors: J
authors: Lammer
authors: Erich
authors: E
authors: Minar