title: Nitinol stent implantation versus percutaneous transluminal angioplasty in superficial femoral artery lesions up to 10 cm in length: the femoral artery stenting trial (FAST).
abstract: BACKGROUND
  Endoluminal treatment of superficial femoral artery lesions is a matter of controversy. The present study was designed to investigate the impact of nitinol stenting of superficial femoral artery lesions with a maximum length of 10 cm on restenosis and clinical outcomes at 1 year.
  
  
  RESULTS
  Two hundred forty-four patients (168 men; 66+/-9 years) with a single superficial femoral artery lesion and chronic limb ischemia were randomized to implantation of a single Bard Luminexx 3 stent (123 patients) or stand-alone percutaneous transluminal angioplasty (PTA) (121 patients). Mean lesion length was 45 mm. Technical success (residual stenosis <50% for PTA, <30% for stenting) was achieved in 96 patients assigned to PTA (79%) and 117 patients assigned to stenting (95%); 13 PTA group patients (11%) "crossed over" to stenting. At 1 year, the primary end point of ultrasound-assessed binary restenosis was reached in 39 of 101 PTA group patients (38.6%) and 32 of 101 stent group patients (31.7%; absolute treatment difference, -6.9%; 95% CI, -19.7% to 6.2%; P=0.377). Target lesion revascularization rates at 1 year were 18.3% and 14.9%, respectively (absolute treatment difference, -3.3%; 95% CI, -13.0% to 6.4%; P=0.595). No statistically significant difference between treatment groups was observed at 12 months in the improvement by at least 1 Rutherford category of peripheral arterial disease.
  
  
  CONCLUSIONS
  In the present study of patients with short superficial femoral artery lesions, the hypothesized absolute difference of 20% in binary restenosis at 1 year between the implantation of a single Luminexx nitinol stent and stand-alone PTA could not be demonstrated. A smaller difference requiring a larger trial might have been missed.
authors.affiliation: Hamburg University Cardiovascular Center, Hamburg, Germany. krankenberg@herz-hh.de
authors.forename: Hans
authors.initials: H
authors.lastname: Krankenberg
authors.forename: Michael
authors.initials: M
authors.lastname: Schlüter
authors.forename: Hermann J
authors.initials: HJ
authors.lastname: Steinkamp
authors.forename: Karlheinz
authors.initials: K
authors.lastname: Bürgelin
authors.forename: Dierk
authors.initials: D
authors.lastname: Scheinert
authors.forename: Karl-Ludwig
authors.initials: KL
authors.lastname: Schulte
authors.forename: Erich
authors.initials: E
authors.lastname: Minar
authors.forename: Patrick
authors.initials: P
authors.lastname: Peeters
authors.forename: Marc
authors.initials: M
authors.lastname: Bosiers
authors.forename: Gunnar
authors.initials: G
authors.lastname: Tepe
authors.forename: Bernhard
authors.initials: B
authors.lastname: Reimers
authors.forename: Felix
authors.initials: F
authors.lastname: Mahler
authors.forename: Thilo
authors.initials: T
authors.lastname: Tübler
authors.forename: Thomas
authors.initials: T
authors.lastname: Zeller
mesh_terms: D000368:Aged; D000497:Alloys / Q000008:administration & dosage*; D000800:Angioplasty, Balloon / Q000379:methods; D019917:Blood Vessel Prosthesis Implantation / Q000379:methods; D005260:Female; D005263:Femoral Artery / Q000000981:diagnostic imaging / Q000473:pathology*; D006083:Graft Occlusion, Vascular / Q000000981:diagnostic imaging / Q000473:pathology / Q000628:therapy; D006801:Humans; D007511:Ischemia / Q000000981:diagnostic imaging / Q000473:pathology / Q000628:therapy; D008297:Male; D008875:Middle Aged; D015607:Stents; D014463:Ultrasonography
chemical_list: D000497:Alloys; C013616:nitinol