Long lesions of the superficial femoral artery (SFA) present complex challenges for endovascular management

As lesion length increases, treatment outcomes typically worsen, with decreased patency demonstrated in studies of drug-eluting stents, drug-coated balloons and bare metal stents.1-7

Proven outcomes in long SFA lesions

The GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface* has demonstrated excellent patency and durability independent of lesion length.4, 8-11

Durable clinical outcomes

The following outcomes were first presented during the late-breaking clinical trials session at VIVA 2023.

PROVEN PATENCY

 

Kaplan-Meier curve of primary, primary-assisted and secondary patency rates through 5 years.

 

Proven patency in challenging SFA disease at 1 year, with durable outcomes in real-world lesions through 5 years.13

DEMONSTRATED DURABILITY

 

Kaplan-Meier curve of freedom from target lesion revascularization through 5 years.

 

Five-year freedom from target lesion revascularization (fTLR).13

See the results

Six-year follow-up imaging shows freedom from re-occlusion despite significant popliteal lesion progression caused by chronic atherosclerotic disease.

Initial Angiograms

Prior to treatment with the VIABAHN® Device

    Proximal SFA

      Distal SFA

      Six-year follow-up angiograms

      Patency maintained with the VIABAHN® Device

        Proximal SFA

          Distal SFA

          Images courtesy of Osamu Iida, M.D. Used with permission.

          Extending a robust evidence base

          Proven patency in complex SFA lesions across 7 multicenter, prospective, randomized or single-arm studies.4,8-12,14

          1,089

          lesions studied

          71%

          chronic total occlusions (CTO)

          23 cm

          average lesion length‡

          80%

          average primary patency§

          Consider the demands of treating long-length lesions of the 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 restenosis.1
              • 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 shorter.2
            • 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 stents (BMS)
              • The VIASTAR Trial demonstrated BMS had lower patency when treating lesions > 20 cm than when treating lesions shorter than 20 cm.4 
          • Complications increase with lesion length
            • Risk of dissection when using DCB increases with lesion length.5
            • For many BMS, the risk of stent fracture increases with lesion length and is associated with a loss of patency.6,7

          * As used by Gore, Heparin Bioactive Surface refers to Gore’s proprietary CBAS® Heparin Surface

          ‡ Weighted average lesion length.

          § One-year weighted average primary patency.

          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. 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). Journal of the American College of Cardiology 2013;62(15):1320-1327.

          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. 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.

          9. Reijnen MMPJ, van Walraven LA, Fritschy WM, 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.

          10. 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 2021;74(6):1958-1967.e2. https://www.sciencedirect.com/science/article/pii/S0741521421010119

          11. 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.

          12. Iida O, Ohki T, Soga Y, et al. Twelve-month outcomes from the Japanese post-market surveillance study of the Viabahn Endoprosthesis as treatment for symptomatic peripheral arterial disease in the superficial femoral arteries. Journal of Endovascular Therapy 2022;29(6):855-865.

          13. Iida O, Ohki T, Soga Y, et al. Five-Year outcomes of the GORE VIABAHN Endoprosthesis for the treatment of complex femoropopliteal lesions from a Japanese post-market surveillance study. Vascular Medicine 2024;29(4):416-423.

          14. 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.

          15. GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface Instructions for Use (IFU). W. L. Gore & Associates, Inc. Accessed August 9, 2023. https://eifu.goremedical.com

          COOK and ZILVER PTX are trademarks of Cook Medical, Inc.

          IFU Consult instructions

          Refer to Instructions for Use at eifu.goremedical.com for a complete description of all applicable indications, warnings, precautions and contraindications for the markets where this product is available. RXOnly

          INDICATIONS FOR USE IN EUROPE:  The GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface is indicated for the treatment of:

          • de novo or restenotic lesions in the iliac arteries
          • de novo or restenotic lesions in the superficial femoral artery and proximal popliteal artery
          • in-stent restenotic lesions in the superficial femoral artery and proximal popliteal artery
          • stenosis or thrombotic occlusion at the venous anastomosis of synthetic arteriovenous (AV) access grafts and in the venous outflow of dialysis access circuits, including the central veins
          • popliteal artery aneurysms and isolated visceral artery aneurysms
          • traumatic or iatrogenic vessel injuries in arteries that are located in the chest cavity, abdominal cavity, or pelvis (except for aorta, coronary, innominate, carotid, vertebral, and pulmonary arteries)

          CONTRAINDICATIONS:

          • Non-compliant lesions where full expansion of an angioplasty balloon catheter was not achieved during pre-dilatation, or where lesions cannot be dilated sufficiently to allow passage of the delivery system.
          • Do not use the GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface in patients with known hypersensitivity to heparin, including those patients who have had a previous incident of Heparin-Induced Thrombocytopenia (HIT) type II. 
          Product may not be available in all countries. Please check with your Gore representative for availability.
          25PL2072-EN01