Heparin-bonded covered stents versus bare-metal stents for complex femoropopliteal artery lesions: the randomized VIASTAR trial (Viabahn endoprosthesis with PROPATEN bioactive surface [VIA] versus bare nitinol stent in the treatment of long lesions in superficial femoral artery occlusive disease)

J Am Coll Cardiol. 2013 Oct 8;62(15):1320-7. doi: 10.1016/j.jacc.2013.05.079. Epub 2013 Jul 10.


Objectives: The hypothesis that endovascular treatment with covered stents has equal risks but higher efficacy than bare-metal stents (BMS) in long femoropopliteal artery disease was tested.

Background: Although endovascular treatment of short superficial femoral artery lesions revealed excellent results, efficacy in long lesions remains unsatisfactory.

Methods: In a prospective, randomized, single-blind, multicenter study, 141 patients with symptomatic peripheral arterial disease were assigned to treatment with heparin-bonded, covered stents (Viabahn 72 patients) or BMS (69 patients). Clinical outcomes and patency rates were assessed at 1, 6, and 12 months.

Results: Mean ± SD lesion length was 19.0 ± 6.3 cm in the Viabahn group and 17.3 ± 6.6 cm in the BMS group. Major complications within 30 days were observed in 1.4%. The 12-month primary patency rates in the Viabahn and BMS groups were: intention-to-treat (ITT) 70.9% (95% confidence interval [CI]: 0.58 to 0.80) and 55.1% (95% CI: 0.41 to 0.67) (log-rank test p = 0.11); treatment per-protocol (TPP) 78.1% (95% CI: 0.65 to 0.86) and 53.5% (95% CI: 0.39 to 0.65) (hazard ratio: 2.23 [95% CI: 1.14 to 4.34) (log-rank test p = 0.009). In lesions ≥20 cm, (TransAtlantic Inter-Society Consensus class D), the 12-month patency rate was significantly longer in VIA patients in the ITT analysis (VIA 71.3% vs. BMS 36.8%; p = 0.01) and the TPP analysis (VIA 73.3% vs. BMS 33.3%; p = 0.004). Freedom from target lesion revascularization was 84.6% for Viabahn (95% CI: 0.72 to 0.91) versus 77.0% for BMS (95% CI: 0.63 to 0.85; p = 0.37). The ankle-brachial index in the Viabahn group significantly increased to 0.94 ± 0.23 compared with the BMS group (0.85 ± 0.23; p < 0.05) at 12 months.

Conclusions: This randomized trial in symptomatic patients with peripheral arterial disease who underwent endovascular treatment for long femoropopliteal lesions demonstrated significant clinical and patency benefits for heparin-bonded covered stents compared with BMS in lesions ≥20 cm and for all lesions in the TPP analysis. In the ITT analysis for all lesions, which was flawed by major protocol deviations in 8.5% of the patients, the difference was not significant. (GORE VIABAHN® endoprosthesis with bioactive propaten surface versus bare nitinol stent in the treatment of TASC B, C and D lesions in superficial femoral artery occlusive disease; ISRCTN48164244).

Keywords: ABI; BMS; CDUS; CI; ITT; PAD; PTA; RCT; SFA; TASC; TLR; TPP; TransAtlantic Inter-Society Consensus; VIA; Viabahn endoprosthesis; WIQ; angioplasty; ankle-brachial index; bare-metal stent(s); color-coded Doppler ultrasound; confidence interval; covered stent; ePTFE; expanded polytetrafluoroethylene; intention-to-treat; percutaneous transluminal balloon angioplasty; peripheral arterial disease; randomized controlled trial; stent; stent graft; superficial femoral artery; target lesion revascularization; treatment per-protocol; walking impairment questionnaire.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Alloys
  • Ankle Brachial Index
  • Anticoagulants / administration & dosage*
  • Coated Materials, Biocompatible
  • Drug-Eluting Stents*
  • Female
  • Femoral Artery / surgery
  • Heparin / administration & dosage*
  • Humans
  • Male
  • Peripheral Arterial Disease / therapy*
  • Polytetrafluoroethylene
  • Popliteal Artery / surgery
  • Proportional Hazards Models
  • Prospective Studies
  • Single-Blind Method
  • Stents
  • Vascular Patency


  • Alloys
  • Anticoagulants
  • Coated Materials, Biocompatible
  • nitinol
  • Polytetrafluoroethylene
  • Heparin

Associated data

  • ISRCTN/ISRCTN48164244