title: Superiority of stent-grafts for in-stent restenosis in the superficial femoral artery: twelve-month results from a multicenter randomized trial.
abstract: OBJECTIVE
  To evaluate the short- and midterm outcomes of the Viabahn endoprosthesis with Propaten Bioactive Surface vs. standard balloon angioplasty for treatment of in-stent restenosis in the superficial femoral artery.
  
  
  METHODS
  Between June 2010 and February 2012, 83 patients with superficial femoral artery in-stent and Rutherford category 2 to 5 ischemia were enrolled at 7 sites participating in this prospective randomized controlled study (RELINE; ClinicalTrials.gov; identifier NCT01108861). The patients were randomized to treatment with either the heparin-bonded Viabahn endoprosthesis (n = 39: 29 men; mean age 67.7 ± 9.8 years) or a standard angioplasty balloon (n = 44: 32 men; mean age 69.0 ± 9.7 years). The primary effectiveness outcome was primary patency at 12 months, defined as no restenosis/occlusion within the target lesion based on duplex ultrasound and no target lesion revascularization. The primary safety endpoint was the incidence of serious device-related adverse events within 30 days of the procedure.
  
  
  RESULTS
  All patients randomized to receive dilation or the Viabahn stent-graft were treated according to their assignment. The technical success was 100% for the Viabahn group and 81.8% for the angioplasty group (p = 0.002) owing to 9 patients requiring a bailout procedure after unsuccessful angioplasty. The 12-month primary patency rates were 74.8% for the Viabahn group and 28.0% for the angioplasty group (p < 0.001). Excluding the 9 angioplasty patients who received bailout stenting, the primary patency for optimal balloon angioplasty was 37.0% (p < 0.001). Three patients experienced device-related adverse events within 30 days: occlusion of the target lesion (Viabahn group), peripheral embolization (angioplasty group), and reocclusion of the target lesion (angioplasty group).
  
  
  CONCLUSIONS
  In this study, the treatment of femoropopliteal in-stent restenosis with a Viabahn endoprosthesis showed significantly better results than treatment with a standard balloon at 1 year.
authors.affiliation: AZ Sint-Blasius, Dendermonde, Belgium office@fmrp.be.
authors.forename: Marc
authors.initials: M
authors.lastname: Bosiers
authors.affiliation: AZ Sint-Blasius, Dendermonde, Belgium.
authors.forename: Koen
authors.initials: K
authors.lastname: Deloose
authors.affiliation: AZ Sint-Blasius, Dendermonde, Belgium.
authors.forename: Joren
authors.initials: J
authors.lastname: Callaert
authors.affiliation: Imelda Hospital, Bonheiden, Belgium.
authors.forename: Jürgen
authors.initials: J
authors.lastname: Verbist
authors.affiliation: University Hospital Antwerp, Edegem, Belgium.
authors.forename: Jeroen
authors.initials: J
authors.lastname: Hendriks
authors.affiliation: University Hospital Antwerp, Edegem, Belgium.
authors.forename: Patrick
authors.initials: P
authors.lastname: Lauwers
authors.affiliation: Vascular Center ZOL, Genk, Belgium.
authors.forename: Herman
authors.initials: H
authors.lastname: Schroë
authors.affiliation: Vascular Center ZOL, Genk, Belgium.
authors.forename: Wouter
authors.initials: W
authors.lastname: Lansink
authors.affiliation: Leipzig Heart Center, Leipzig, Germany.
authors.forename: Dierk
authors.initials: D
authors.lastname: Scheinert
authors.affiliation: Leipzig Heart Center, Leipzig, Germany.
authors.forename: Andrej
authors.initials: A
authors.lastname: Schmidt
authors.affiliation: Universitäts-Herzzentrum Freiburg, Bad Krozingen, Germany.
authors.forename: Thomas
authors.initials: T
authors.lastname: Zeller
authors.affiliation: Universitäts-Herzzentrum Freiburg, Bad Krozingen, Germany.
authors.forename: Ulrich
authors.initials: U
authors.lastname: Beschorner
authors.affiliation: Universitäts-Herzzentrum Freiburg, Bad Krozingen, Germany.
authors.forename: Elias
authors.initials: E
authors.lastname: Noory
authors.affiliation: St Franziskus Hospital and University Hospital of Münster, Germany.
authors.forename: Giovanni
authors.initials: G
authors.lastname: Torsello
authors.affiliation: St Franziskus Hospital and University Hospital of Münster, Germany.
authors.forename: Martin
authors.initials: M
authors.lastname: Austermann
authors.affiliation: Imelda Hospital, Bonheiden, Belgium.
authors.forename: Patrick
authors.initials: P
authors.lastname: Peeters
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000800:Angioplasty, Balloon / Q000379:methods; D001530:Belgium; D020099:Coated Materials, Biocompatible; D003251:Constriction, Pathologic; D054855:Drug-Eluting Stents; D005260:Female; D005263:Femoral Artery; D005500:Follow-Up Studies; D005858:Germany; D006801:Humans; D008297:Male; D008875:Middle Aged; D058729:Peripheral Arterial Disease / Q000473:pathology / Q000628:therapy*; D011446:Prospective Studies; D012008:Recurrence; D016037:Single-Blind Method; D015607:Stents / Q000009:adverse effects; D013997:Time Factors; D016896:Treatment Outcome; D014654:Vascular Patency
chemical_list: D020099:Coated Materials, Biocompatible
keywords: balloon angioplasty; covered stent; endovascular therapy; in-stent restenosis; percutaneous transluminal angioplasty; peripheral artery disease; randomized controlled trial; stent-graft; superficial femoral artery