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Title: Sustained Benefit at 2 Years for Covered Stents Versus Bare-Metal Stents in Long SFA Lesions: The VIASTAR Trial

PurposeThe 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.MethodsA prospective, randomized, single-blind, multicenter study evaluated 141 patients with symptomatic peripheral arterial disease (PAD) after treatment with heparin-bonded covered stents (VIABAHN{sup ®} 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{sup ®} versus 17.3 ± 6.6 cm in the BMS group.ResultsThe 24-month primary patency rates in the VIABAHN{sup ®} 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{sup ®} 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{sup ®} 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 anklemore » brachial index was 0.89 ± 0.18 versus 0.91 ± 0.17 (p = 0.76) at 24-month in the VIABAHN{sup ®} versus the BMS group, respectively.ConclusionAt 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)« less
Authors:
 [1] ;  [2] ;  [3] ;  [4] ;  [5] ;  [6] ;  [7] ; ;  [1] ;  [2] ;  [8] ;  [1] ;
  1. Medical University Vienna, The Department of Cardiovascular and Interventional Radiology, Department of Biomedical Imaging and Image-guided Therapy (Austria)
  2. Universitaets-Herzzentrum Freiburg-Bad Krozingen, Department of Angiology (Germany)
  3. Klinikum Klagenfurt, The Department of Diagnostic and Interventional Radiology (Austria)
  4. University Clinics Schleswig-Holstein, The Department of Radiology (Germany)
  5. Elisabethinen Hospital, The Department of Diagnostic and Interventional Radiology (Austria)
  6. Diakonissen Hospital, The Department of Diagnostic and Interventional Radiology (Germany)
  7. Hietzing Hospital, The Department of Radiology (Austria)
  8. Medical University Vienna, The Department of Angiology (Austria)
Publication Date:
OSTI Identifier:
22470058
Resource Type:
Journal Article
Resource Relation:
Journal Name: Cardiovascular and Interventional Radiology; Journal Volume: 38; Journal Issue: 1; Conference: IROS 2015: Interventional Radiological Olbert Symposium, Berlin (Germany), 15-17 Jan 2015; Other Information: Copyright (c) 2015 Springer Science+Business Media New York and the Cardiovascular and Interventional Radiological Society of Europe (CIRSE); http://www.springer-ny.com; Country of input: International Atomic Energy Agency (IAEA)
Country of Publication:
United States
Language:
English
Subject:
62 RADIOLOGY AND NUCLEAR MEDICINE; ARTERIES; BIOMEDICAL RADIOGRAPHY; COMPARATIVE EVALUATIONS; DISEASES; HEPARIN; HYPOTHESIS; METALS; PATIENTS