title: 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).
abstract: OBJECTIVE
  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).
authors.affiliation: Departments of Cardiovascular and Interventional Radiology, Medical University Vienna, Vienna, Austria. Electronic address: johannes.lammer@meduniwien.ac.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: Robin
authors.initials: R
authors.lastname: Ristl
authors.forename: Maria
authors.initials: M
authors.lastname: Schoder
mesh_terms: D000368:Aged; D000497:Alloys; D055109:Ankle Brachial Index; D000925:Anticoagulants / Q000008:administration & dosage*; D020099:Coated Materials, Biocompatible; D054855:Drug-Eluting Stents; D005260:Female; D005263:Femoral Artery / Q000601:surgery; D006493:Heparin / Q000008:administration & dosage*; D006801:Humans; D008297:Male; D058729:Peripheral Arterial Disease / Q000628:therapy*; D011138:Polytetrafluoroethylene; D011150:Popliteal Artery / Q000601:surgery; D016016:Proportional Hazards Models; D011446:Prospective Studies; D016037:Single-Blind Method; D015607:Stents; D014654:Vascular Patency
chemical_list: D000497:Alloys; D000925:Anticoagulants; D020099:Coated Materials, Biocompatible; C013616:nitinol; D011138:Polytetrafluoroethylene; D006493:Heparin
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