title: Sustained benefit at 2 years of primary femoropopliteal stenting compared with balloon angioplasty with optional stenting.
abstract: BACKGROUND
  Primary stenting with self-expanding nitinol stents of the superficial femoral artery yielded improved morphological and clinical results compared with balloon angioplasty with optional stenting until 12 months in a randomized controlled trial. We now report 2-year data on restenosis and clinical outcomes of these patients.
  
  
  RESULTS
  Of 104 patients with chronic limb ischemia and superficial femoral artery obstructions, 98 (94%) could be followed up until 2 years after intervention for occurrence of restenosis (>50%) by duplex ultrasound and for clinical and hemodynamic outcome by treadmill walking distance and ankle brachial index. Restenosis rates at 2 years were 45.7% (21 of 46) versus 69.2% (36 of 52) in favor of primary stenting compared with balloon angioplasty with optional secondary stenting by an intention-to-treat analysis (P=0.031). Consistently, stenting (whether primary or secondary; n=63) was superior to plain balloon angioplasty (n=35) with respect to the occurrence of restenosis (49.2% versus 74.3%; P=0.028) by a treatment-received analysis. Clinically, patients in the primary stent group showed a trend toward better treadmill walking capacity (average, 302 versus 196 m; P=0.12) and better ankle brachial index values (average, 0.88 versus 0.78; P=0.09) at 2 years, respectively. Reintervention rates tended to be lower after primary stenting (17 of 46 [37.0%] versus 28 of 52 [53.8%]; P=0.14).
  
  
  CONCLUSIONS
  At 2 years, primary stenting with self-expanding nitinol stents for the treatment of superficial femoral artery obstructions yields a sustained morphological benefit and a trend toward clinical benefit compared with balloon angioplasty with optional stenting.
authors.affiliation: Department of Angiology, Medical University, Vienna, Austria. martin.schillinger@meduniwien.ac.at
authors.forename: Martin
authors.initials: M
authors.lastname: Schillinger
authors.forename: Schila
authors.initials: S
authors.lastname: Sabeti
authors.forename: Petra
authors.initials: P
authors.lastname: Dick
authors.forename: Jasmin
authors.initials: J
authors.lastname: Amighi
authors.forename: Wolfgang
authors.initials: W
authors.lastname: Mlekusch
authors.forename: Oliver
authors.initials: O
authors.lastname: Schlager
authors.forename: Christian
authors.initials: C
authors.lastname: Loewe
authors.forename: Manfred
authors.initials: M
authors.lastname: Cejna
authors.forename: Johannes
authors.initials: J
authors.lastname: Lammer
authors.forename: Erich
authors.initials: E
authors.lastname: Minar
mesh_terms: D000368:Aged; D000497:Alloys; D000800:Angioplasty, Balloon / Q000592:standards*; D001157:Arterial Occlusive Diseases / Q000628:therapy; D005080:Exercise Test; D005260:Female; D005263:Femoral Artery; D005500:Follow-Up Studies; D006083:Graft Occlusion, Vascular / Q000000981:diagnostic imaging; D006801:Humans; D008297:Male; D008875:Middle Aged; D016491:Peripheral Vascular Diseases / Q000628:therapy; D011150:Popliteal Artery; D015607:Stents / Q000592:standards*; D016896:Treatment Outcome; D014463:Ultrasonography
chemical_list: D000497:Alloys; C013616:nitinol