Long SFA lesions

Consider the demands of treating long-length lesions of the superficial femoral artery (SFA)

  • Lesion length is a predictor of patency outcomes for several treatment modalities
    • Drug-eluting stents
      • Lesion length has been shown to be an independent predictor of restenosis1
      • In a randomized study, COOK® ZILVER® PTX® Drug-Eluting Peripheral Stent has been shown to have lower patency in long lesions > 10 cm compared to those 10 cm or shorter2
    • Drug coated balloon (DCB)
      • Multivariate analysis of the Medtronic IN.PACT Global Study demonstrated that increasing lesion length was a predictor of increased risk for Clinically Driven Target Lesion Revascularization (CD TLR)3
    • Bare-metal stent (BMS)
      • The VIASTAR Trial demonstrated BMS had lower patency when treating lesions > 20 cm than when treating lesions shorter than 20 cm4 
  • Complications increase with lesion length
    • Risk of dissection when using DCB increases with lesion length5
    • For many BMS, the risk of in-stent restenosis and stent fracture increases with lesion length6-9
angiogram

Before

Proximal SFA disease and mid-SFA occlusion

Images courtesy of James Persky, M.D. Used with permission.

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angiogram

After

Post-placement of three 5 mm GORE® VIABAHN® Devices

Images courtesy of James Persky, M.D. Used with permission.

Read the full case study

The GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface*,† has demonstrated excellent patency and durability independent of lesion length4, 10-15

Proven patency

  • 88% primary patency at one year in lesions 22 cm in length12
  • 80% average primary patency demonstrated across seven multicenter, prospective, randomized or single arm studies with an average lesion length of 23 cm4, 10-15

Demonstrated durability

  • 97% three-year secondary patency in complex disease (27 cm average lesion length, 93% chronic total occlusions)16
  • Comparable clinical results to above knee surgical bypass (both prosthetic17 and native vein11) 

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* As used by Gore, PROPATEN Bioactive Surface refers to Gore's proprietary CBAS Heparin Surface. 

† Also referred to as the GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface in some regions.

  1. Iida O, Takahara M, Soga Y, et al; ZEPHYR Investigators. 1-year results of the ZEPHYR Registry (Zilver PTX for the Femoral Artery and Proximal Popliteal Artery): predictors of restenosis. JACC: Cardiovascular Interventions 2015;8(8):1105-1112. 
  2. Bausback Y. 2 year results of the REAL PTX Randomized Clinical Trial comparing Zilver PTX DES vs. DCB in femoropopliteal lesions. Presented at the 7th Munich Vascular Conference (MAC); December 7-9, 2017; Munich, Germany.
  3. Micari A, Brodmann M, Keirse K, et al; IN.PACT Global Study Investigators. Drug-coated balloon treatment of femoropopliteal lesions for patients with intermittent claudication and ischemic rest pain: 2-year results from the IN.PACT Global Study. JACC: Cardiovascular Interventions 2018;11(10):945-953. 
  4. Lammer J, Zeller T, Hausegger KA, et al. Sustained benefit at 2 years for covered stents versus bare-metal stents in long SFA lesions: the VIASTAR Trial. Cardiovascular & Interventional Radiology 2015;38(1):25-32.
  5. Brodmann M. Real world value of the In.Pact Admiral DCB (Medtronic) for fem-pop lesions: from the In.Pact Global Registry: what else does it tell us. Presented at the 44th Annual Symposium on Vascular and Endovascular Issues, Techniques, Horizons (VEITHsymposium); November 14-18, 2017; New York, NY. 
  6. Iida O, Nanto S, Uematsu M, Ikeoka K, Okamoto S, Nagata S. Influence of stent fracture on the long-term patency in the femoro-popliteal artery. JACC : Cardiovascular Interventions 2009;2(7):665-671.
  7. Scheinert D, Scheinert S, Sax J, et al. Prevalence and clinical impact of stent fractures after femoropopliteal stenting. Journal of the American College of Cardiology 2005;45(2):312-315. 
  8. U.S. Food and Drug Administration. Center for Devices and Radiological Health. FDA Summary of Safety and Effectiveness Data. GORE TIGRIS Vascular Stent. P160004. http://www.accessdata.fda.gov/cdrh_docs/pdf16/P160004B.pdf. Published July 27, 2016. Accessed July 17, 2018.
  9. W. L. Gore & Associates, Inc. Evaluation of the GORE® TIGRIS® Vascular Stent in the Treatment of Atherosclerotic Lesions of the Superficial Femoral and Proximal Popliteal Arteries. [Final Post-Approval Study Report-Executive Summary]. Flagstaff, AZ: W. L. Gore & Associates, Inc; 2017. MD165299.
  10.   Zeller T, Peeters P, Bosiers M, et al. Heparin-bonded stent-graft for the treatment of TASC II C and D femoropopliteal lesions: the Viabahn-25 cm Trial. Journal of Endovascular Therapy 2014;21(6):765-774.
  11.   Reijnen M, van Walraven L, Fritschy W, et al. 1-year results of a multicenter, randomized controlled trial comparing heparin-bonded endoluminal to femoropopliteal bypass. Journal of Cardiovascular Interventions 2017;10(22):2320-2331.
  12.   Ohki T, Kichikawa K, Yokoi H, et al. Long-term results of the Japanese multicenter Viabahn trial of heparin bonded endovascular stent grafts for long and complex lesions in the superficial femoral artery. Journal of Vascular Surgery. In press.
  13.   Saxon RR, Chervu A, Jones PA, et al. Heparin‑bonded, expanded polytetrafluoroethylene‑lined stent graft in the treatment of femoropopliteal artery disease: 1‑year results of the VIPER (Viabahn Endoprosthesis with Heparin Bioactive Surface in the Treatment of Superficial Femoral Artery Obstructive Disease) Trial. Journal of Vascular & Interventional Radiology 2013;24(2):165‑173.
  14.   Iida O. Twelve-month outcomes from the Japanese post-market surveillance study of the GORE® VIABAHN® Endoprosthesis as treatment for symptomatic peripheral arterial disease in the superficial femoral arteries. Presented at LEIPZIG Interventional Course (LINC)2021; January 25-29, 2021; Leipzig, Germany.
  15.   Iida O, Takahara M, Soga Y, et al; VANQUISH Investigators. One-year outcomes of heparin-bonded stent-graft therapy for real-world femoropopliteal lesions and the association of patency with the prothrombotic state based on the prospective, observational, multicenter Viabahn Stent-Graft Placement for Femoropopliteal Diseases Requiring Endovascular Therapy (VANQUISH) Study. Journal of Endovascular Therapy 2021;28(1):123-131.
  16.   GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface [Instructions for Use]. Flagstaff, AZ: W. L. Gore & Associates, Inc; 2021. MD174703.
  17.   McQuade K, Gable D, Pearl G, Theune B, Black S. Four-year randomized prospective comparison of percutaneous ePTFE/nitinol self-expanding stent graft versus prosthetic femoral-popliteal bypass in the treatment of superficial femoral artery occlusive disease. Journal of Vascular Surgery 2010;52(3):584-591. 

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