title: Excimer laser with adjunctive balloon angioplasty and heparin-coated self-expanding stent grafts for the treatment of femoropopliteal artery in-stent restenosis: twelve-month results from the SALVAGE study.
abstract: OBJECTIVE
  The aim of the study is to evaluate the safety and effectiveness of treating femoropopliteal in-stent restenosis (ISR) with debulking with excimer laser followed by implantation of a VIABAHN endoprosthesis.
  
  
  BACKGROUND
  The optimal treatment strategy for femoropopliteal ISR is unclear.
  
  
  METHODS
  The SALVAGE study is a multicenter prospective registry involving nine US centers. Patients with femoropopliteal ISR with moderate to severe intermittent claudication or critical limb ischemia (Rutherford categories 2-5) and an ankle-brachial index (ABI) =0.8 were treated with excimer laser and the VIABAHN endoprosthesis. The primary efficacy endpoint is primary patency at 12 months as measured by duplex ultrasonography. The primary safety endpoint is the major adverse event (MAE) rate at 30 days.
  
  
  RESULTS
  Twenty-seven patients were enrolled. The mean lesion length was 20.7 ± 10.3 cm. The majority of lesions were TASC (TASC I) C and D (81.4%). All lesions were pretreated with excimer laser and percutaneous transluminal angioplasty (PTA) prior to VIABAHN implantation. Technical success was achieved in 100% of cases. There were no MAE at 30 days. Primary patency at 12 months was 48%. The ankle brachial index increased from 0.58 ± 0.24 at baseline to 0.90 ± 0.17 at 12 months. There was improvement in all quality-of-life parameters. The 12-month TLR rate was 17.4%.
  
  
  CONCLUSIONS
  The strategy of excimer laser atherectomy and PTA followed by implantation of a self-expanding stent graft for the treatment of femoropopliteal ISR is safe and associated with high procedural success. Primary patency rate at 12-months was suboptimal; however, the TLR rate was low.
authors.affiliation: The Vascular Center, UC Davis Medical Center, Sacramento, California, USA. john.laird@ucdmc.ucdavis.edu
authors.forename: John R
authors.initials: JR
authors.lastname: Laird
authors.forename: Khung Keong
authors.initials: KK
authors.lastname: Yeo
authors.forename: Krishna
authors.initials: K
authors.lastname: Rocha-Singh
authors.forename: Tony
authors.initials: T
authors.lastname: Das
authors.forename: James
authors.initials: J
authors.lastname: Joye
authors.forename: Eric
authors.initials: E
authors.lastname: Dippel
authors.forename: Bhagat
authors.initials: B
authors.lastname: Reddy
authors.forename: Charles
authors.initials: C
authors.lastname: Botti
authors.forename: Michael R
authors.initials: MR
authors.lastname: Jaff
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000800:Angioplasty, Balloon / Q000009:adverse effects / Q000295:instrumentation*; D055109:Ankle Brachial Index; D000925:Anticoagulants / Q000008:administration & dosage*; D001157:Arterial Occlusive Diseases / Q000150:complications / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy*; D017073:Atherectomy / Q000009:adverse effects / Q000379:methods*; D020099:Coated Materials, Biocompatible; D003131:Combined Modality Therapy; D003251:Constriction, Pathologic; D054855:Drug-Eluting Stents; D005260:Female; D005263:Femoral Artery / Q000000981:diagnostic imaging / Q000503:physiopathology; D006493:Heparin / Q000008:administration & dosage*; D006801:Humans; D007383:Intermittent Claudication / Q000209:etiology / Q000628:therapy; D007511:Ischemia / Q000209:etiology / Q000628:therapy; D054018:Lasers, Excimer / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D011150:Popliteal Artery / Q000000981:diagnostic imaging / Q000503:physiopathology; D011446:Prospective Studies; D011474:Prosthesis Design; D012008:Recurrence; D012042:Registries; D013997:Time Factors; D016896:Treatment Outcome; D018616:Ultrasonography, Doppler, Duplex; D014481:United States; D014654:Vascular Patency
chemical_list: D000925:Anticoagulants; D020099:Coated Materials, Biocompatible; D006493:Heparin