title: Sirolimus-eluting stents for the treatment of obstructive superficial femoral artery disease: six-month results.
abstract: BACKGROUND
  Stent implantation for obstructive femoropopliteal artery disease has been associated with poor long-term outcomes. This study evaluated the effectiveness of shape memory alloy recoverable technology (SMART) nitinol self-expanding stents coated with a polymer impregnated with sirolimus (rapamycin) versus uncoated SMART Stents in superficial femoral artery obstructions.
  
  
  RESULTS
  Thirty-six patients were recruited for this double-blind, randomized, prospective trial. All patients had chronic limb ischemia and femoral artery occlusions (57%) or stenoses (average lesion length, 85 +/- 57 mm). Patients were eligible for randomization after successful guidewire passage across the lesion. Eighteen patients received sirolimus-eluting SMART Stents and 18 patients received uncoated SMART Stents. The primary end point of the study was the in-stent mean percent diameter stenosis, as measured by quantitative angiography at 6 months. The instent mean percent diameter stenosis was 22.6% in the sirolimus-eluting stent group versus 30.9% in the uncoated stent group (P = 0.294). The in-stent mean lumen diameter was significantly larger in the sirolimus-eluting stent group (4.95 mm versus 4.31 mm in the uncoated stent group; P = 0.047). No serious adverse events (death or prolonged hospitalization) were reported.
  
  
  CONCLUSIONS
  The use of sirolimus-eluting SMART Stents for superficial femoral artery occlusion is feasible, with a trend toward reducing late loss compared with uncoated stents. The coated stent also proved to be safe and was not associated with any serious adverse events.
authors.affiliation: Department of Diagnostic Radiology, University of Tübingen, Eberhard-Karls-University, Hoppe-Seyler-Str 3, 72076 Tübingen, Germany. stephan.duda@med.uni-tuebingen.de
authors.forename: Stephan H
authors.initials: SH
authors.lastname: Duda
authors.forename: Benjamin
authors.initials: B
authors.lastname: Pusich
authors.forename: Goetz
authors.initials: G
authors.lastname: Richter
authors.forename: Peter
authors.initials: P
authors.lastname: Landwehr
authors.forename: Vincent L
authors.initials: VL
authors.lastname: Oliva
authors.forename: Alexander
authors.initials: A
authors.lastname: Tielbeek
authors.forename: Benjamin
authors.initials: B
authors.lastname: Wiesinger
authors.forename: Jan Bart
authors.initials: JB
authors.lastname: Hak
authors.forename: Hans
authors.initials: H
authors.lastname: Tielemans
authors.forename: Gerhard
authors.initials: G
authors.lastname: Ziemer
authors.forename: Ecatarina
authors.initials: E
authors.lastname: Cristea
authors.forename: Alexandra
authors.initials: A
authors.lastname: Lansky
authors.forename: Jean P
authors.initials: JP
authors.lastname: Bérégi
mesh_terms: D000368:Aged; D001157:Arterial Occlusive Diseases / Q000000981:diagnostic imaging / Q000628:therapy*; D003251:Constriction, Pathologic; D054855:Drug-Eluting Stents; D005260:Female; D005263:Femoral Artery / Q000000981:diagnostic imaging / Q000473:pathology; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage; D007383:Intermittent Claudication / Q000628:therapy; D008297:Male; D011859:Radiography; D012008:Recurrence; D020123:Sirolimus / Q000008:administration & dosage; D015607:Stents; D016896:Treatment Outcome
chemical_list: D007166:Immunosuppressive Agents; D020123:Sirolimus