title: Sustained benefit at 2 years for covered stents versus bare-metal stents in long SFA lesions: the VIASTAR trial.
abstract: OBJECTIVE
  The hypothesis that covered stents are superior to bare-metal stents (BMS) in long femoropopliteal artery disease was tested. The one-year results of the VIASTAR trial revealed a patency benefit of covered stents in the treatment-per-protocol (TPP) analysis only.
  
  
  METHODS
  A prospective, randomized, single-blind, multicenter study evaluated 141 patients with symptomatic peripheral arterial disease (PAD) after treatment with heparin-bonded covered stents (VIABAHN(®) Endoprosthesis) or BMS. Clinical outcomes and patency rates were assessed at 1, 6, 12, and 24 months. Mean lesion length was 19.0 ± 6.3 cm in the VIABAHN(®) versus 17.3 ± 6.6 cm in the BMS group.
  
  
  RESULTS
  The 24-month primary patency rates in the VIABAHN(®) and BMS group were: intention-to-treat 63.1 (95 % CI 0.52-0.76) versus 41.2 % (95 % CI 0.29-0.57; log rank p = 0.04) and TPP 69.4 (95 % CI 0.58-0.83) versus 40.0 % (95 % CI 0.28-0.56; log rank p = 0.004). Freedom from target-lesion-revascularization (TLR) was 79.4 (95 % CI 0.70-0.90) versus 73.0 % (95 % CI 0.63-0.85) for VIABAHN(®) versus BMS (log rank p = 0.37). For the TPP group in lesions ≥20 cm, the 24-month patency rates were 65.2 (95 % CI 0.50-0.85) versus 26.7 % (95 % CI 0.12-0.59; log rank p = 0.004) for VIABAHN(®) versus BMS, and freedom from TLR was 80.0 (95 % CI 0.68-0.94) versus 61.9 % (95 % CI 0.44-0.87; log rank p = 0.13). The ankle brachial index was 0.89 ± 0.18 versus 0.91 ± 0.17 (p = 0.76) at 24-month in the VIABAHN(®) versus the BMS group, respectively.
  
  
  CONCLUSIONS
  At 24-month, this trial in PAD patients with long femoropopliteal lesions demonstrated a significantly improved primary patency rate for heparin-bonded covered stents compared to BMS, however, without a significant impact on clinical outcomes and TLR rate (Reg. Nr. ISRCTN48164244).
authors.affiliation: The Department of Cardiovascular and Interventional Radiology, Department of Biomedical Imaging and Image-guided Therapy, Medical University Vienna, Waehringer Guertel 18-20, 1090, Vienna, Austria, jlammer@gmx.at.
authors.forename: Johannes
authors.initials: J
authors.lastname: Lammer
authors.forename: Thomas
authors.initials: T
authors.lastname: Zeller
authors.forename: Klaus A
authors.initials: KA
authors.lastname: Hausegger
authors.forename: Philipp J
authors.initials: PJ
authors.lastname: Schaefer
authors.forename: Manfred
authors.initials: M
authors.lastname: Gschwendtner
authors.forename: Stefan
authors.initials: S
authors.lastname: Mueller-Huelsbeck
authors.forename: Thomas
authors.initials: T
authors.lastname: Rand
authors.forename: Martin
authors.initials: M
authors.lastname: Funovics
authors.forename: Florian
authors.initials: F
authors.lastname: Wolf
authors.forename: Aljoscha
authors.initials: A
authors.lastname: Rastan
authors.forename: Michael
authors.initials: M
authors.lastname: Gschwandtner
authors.forename: Stefan
authors.initials: S
authors.lastname: Puchner
authors.forename: Ulrich
authors.initials: U
authors.lastname: Beschorner
authors.forename: Robin
authors.initials: R
authors.lastname: Ristl
authors.forename: Maria
authors.initials: M
authors.lastname: Schoder
mesh_terms: D000368:Aged; D055109:Ankle Brachial Index; D000925:Anticoagulants / Q000008:administration & dosage; D020099:Coated Materials, Biocompatible / Q000627:therapeutic use*; D054855:Drug-Eluting Stents; D004867:Equipment Design; D005260:Female; D005263:Femoral Artery / Q000000981:diagnostic imaging; D005500:Follow-Up Studies; D006493:Heparin / Q000008:administration & dosage; D006801:Humans; D008297:Male; D058729:Peripheral Arterial Disease / Q000628:therapy*; D011150:Popliteal Artery / Q000000981:diagnostic imaging; D011446:Prospective Studies; D016037:Single-Blind Method; D014057:Tomography, X-Ray Computed; D016896:Treatment Outcome; D018615:Ultrasonography, Doppler, Color
chemical_list: D000925:Anticoagulants; D020099:Coated Materials, Biocompatible; D006493:Heparin