Journal of Vascular Surgery
Volume 52, Issue 3 , Pages 584-591.e7 , September 2010

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

Presented at the Southern Association for Vascular Surgery, Paradise Island, Bahamas, January 21, 2010.

  • Karen McQuade, MD

      Affiliations

    • Department of Vascular Surgery, Baylor University Medical Center, Dallas, TX
  • ,
  • Dennis Gable, MD

      Affiliations

    • Department of Vascular Surgery, Baylor University Medical Center, Dallas, TX
    • Corresponding Author InformationReprint requests: Dr Dennis R. Gable, Department of General and Vascular Surgery, Baylor University Medical Center, 621 N. Hall St., Ste. 100, Dallas, TX 75226
  • ,
  • Greg Pearl, MD

      Affiliations

    • Department of Vascular Surgery, Baylor University Medical Center, Dallas, TX
  • ,
  • Brian Theune, MD

      Affiliations

    • Department of Vascular Surgery, Womack Army Medical Center, Fort Bragg, NC
  • ,
  • Steve Black, MSPH

      Affiliations

    • Department of Vascular Surgery, Baylor University Medical Center, Dallas, TX

Received 22 January 2010 ,Accepted 30 March 2010.

References 

  1. McQuade K, Gable DMD, Hohman S, Pearl G, Theune B. Two-year randomized prospective comparison of percutaneous ePTFE/nitinol self-expanding stent graft vs prosthetic femoral-popliteal bypass in the treatment of superficial femoral artery occlusive disease. J Vasc Surg. 2008;49:109–116
  2. Lammer J, Dake MD, Bleyn J, Katzen B, Cejna M, Piquet P, et al. International Trial Study Group Peripheral arterial obstruction: prospective study of treatment with a transluminally placed self-expanding stent graft. Radiology. 2000;217:95–104
  3. Railo M, Roth W, Edgren J, Biancari F, Ikonen T, Albäck A, et al. Preliminary results with endoluminal femoropopliteal thrupass. Ann Chir Gynaecol. 2001;90:15–18
  4. Jahnke T, Andresen R, Müller-Hülsbeck S, Schafer F, Voshage G, Heller M, et al. Hemobahn stent grafts for treatment of femoropopliteal arterial obstructions: midterm results of a prospective trial. J Vasc Interv Radiol. 2003;14:41–51
  5. Turicchia G, Cevolani M, Altini R, Stancanelli V. Mid-term results in PTFE endograft treatment of femoropopliteal occlusive disease. Osp Ital Chir. 2003;9:93–96
  6. Bleyn J, Schol F, Vanhandenhove I, Vercaeren P, Marien C. Endovascular reconstruction of the superficial femoral artery. In:  Becquemin JP,  Alimi YS,  Watelet J,  Loisance D editor. Controversies and updates in vascular and cardiac surgery. Vol. 14:Torino, Italy: Edizioni Minerva Medica; 2004;p. 87–91
  7. Panetta T. Endovascular femoropopliteal bypass with multiple stent grafts. Endovascular Today. 2005;4(Supplement):12–14
  8. Chopra P. Endoluminal femoropopliteal bypass using the Viabahn Stent Graft (Endograft): primary and secondary patency in 60 patients (70 limbs) with 3-year follow-up. Abstract presented at the 14th Annual Advanced Interventional Management Symposium. (AIMS) November 13-16, 2006. New York, NY. Page II 2.1.
  9. Coats R, Adams J, Humphrey P. SFA revascularization using the Viabahn Endoprosthesis. Endovascular Today. 2006;5:76–78
  10. Fischer M, Schwabe C, Schulte K-L. Value of the Hemobahn/Viabahn Endoprosthesis in the treatment of long chronic lesions of the superficial femoral artery: 6 years of experience. J Endovasc Ther. 2006;13:281–290
  11. Zander T, Llorens R, Rostagno R, Zerolo I, Rabellino N, Maynar M. Hemobahn/Viabahn endograft for long SFA lesions (Long term follow up). J Vasc Interv Radiol. 2006;17((2)Part 2):S57
  12. Saxon R, Coffman J, Gooding J, Ponec D. Long term patency of stent grafts in the treatment of long-segment femoropopliteal artery occlusive disease. J Vasc Interv Radiol. 2006;18:1341–1350
  13. Alimi Y, Hakam Z, Hartung O, Boufi M, Barthelelmy M, Aissi K, et al. Efficacy of Viabahn in the treatment of severe superficial artery lesions: which factors influence long-term patency?. Eur J Vasc Endovasc Surg. 2008;35:346–352
  14. Djelmami-Hani M. Presented at ACC/SCAI Meeting March 29- April 1, 2008, Chicago, Ill.
  15. Saxon RR, Dake MD, Vogelzang RL, Katzen BT, Becker GJ. Randomized, multicenter study comparing expanded polytetrafluoroethelene-covered endoprosthesis placement with percutaneous transluminal angioplasty in the treatment of superficial femoral artery occlusive disease. J Vasc Interv Radiol. 2008;19:823–832
  16. Verta M, Schneider J, Alonzn M, Hahn D. Percutaneous-Viabahn assisted subintimal recannalization for severe superficial artery occlusive disease. J Vasc Interv Radiol. 2008;19:493–498
  17. Kedora J, Hohmann S, Garrett W, Munschaur C, Theune B, Gable D. Randomized comparison of percutaneous Viabahn Stent grafts versus prosthetic femoral-popliteal bypass in the treatment of superficial femoral arterial occlusive disease. J Vasc Surg. 2007;45:10–16
  18. Ahn S, Rutheford R, Becker G, Camerota A, Johnston K, McClean G, et al. Reporting standards for lower extremity arterial endovascular procedures. J Vasc Surg. 1993;17:1103–1107
  19. Rutherford R, Baker D, Ernst C, Johnston K, Porter J, Ahn S. Recommended standards for reports dealing with lower extremity ischemia: revised version. J Vasc Surg. 1997;26:517–538
  20. Norgren L, Hiatt W, Dormandy J, Nehler M, Harris K, Fowkes F, et al. TASC II Working Group Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II). J Vasc Surg. 2007;45(suppl):S5–S67
  21. Rutherford R, Baker D, Ernst C, Ahn S, Jones D. Recommended standards for reports dealing with lower extremity ischemia: Rutherford version. J Vasc Surg. 1997;26:517–538
  22. Norgen L, Hiatt WR, Dormandy JA, Nehler MR, Harris KA, Fowkes FG, et al. TASC II Working Group Inter-society consensus for the management of peripheral arterial disease. Int Angiology. 2007;26:81–157
  23. Scott E, Biuckians A, Light R, Scibelli C, Milner T, Meier G, et al. Subintimal angioplasty for the treatment of claudication and critical limb ischemia: 3-year results. J Vasc Surg. 2007;46:959–964
  24. Schlager O, Dick P, Sabeti S, Amighi J, Miekusch W, Minar E, et al. Long segment SFA stenting-the dark sides: in stent restenosis, clinical deterioration, and stent fractures. J Endovasc Ther. 2005;12:676–684
  25. Schillinger M, Sabeti S, Loewe C, Dick P, Amighi J, Miekusch W, et al. Ballon angioplasty versus implantation of nitinol stents in the superficial femoral artery. N Engl J Med. 2006;354:1879–1888
  26. Krankenberg H, Schluter M, Steinkamp H, Burgelin K, Scheinert D, Schulte K, et al. Nitinol stent implantation versus percutaneous transluminal angioplasty in superficial femoral artery lesions up to 10 cm in length: the femoral artery stenting trial (FAST). Circulation. 2007;116:285–292
  27. Ansel G. Interim 1-year VIBRANT resultspresented for Gore Viabahn in SFA treatment. Presented at Vascular Interventional Advances, Las Vegas, Nevada, October 22, 2009.
  28. Lammer J, Schillinger M, Zeller T, Boone E, Zaugg M, Verta P, Schwartz L. First-in-human clinical trial of a nitinol self-expanding everolimus-eluting stent for prevention of restenosis following infrainguinal endovascular intervention: the STRIDES trial. Presented at CIRSE, Lisbon, Portugal, Sept. 19-23, 2009.
  29. Dake M. Two-Year Results of the ZILVER-PTX Drug-Eluting Stent for SFA Lesions. Presented at Veith Symposium New York, New York, November 19, 2009.
  30. Joels C, York J, Kalbaugh C, Cull D, Langan E, Taylor S. Surgical implications of early failed endovascular intervention of the superficial femoral artery. J Vasc Surg. 2008;47:562–565
  31. Dorrucci V. Treatment of superficial femoral artery occlusive disease. J Cardiovasc Surg. 2004;45:193–201
  32. Bates M, Aburahma A. An update on endovascular therapy of the lower extremities. J Endovasc Ther. 2004;11(suppl 2):II107–II127
  33. Bosiers M, Torsello G, Gibler H, Ruef J, Muller-Hulsbeck S, Jahnke T, et al. Nitinol stent implantation in long superficial femoral artery lesions: 12-month results of the DURABILITY I study. J Endovasc Ther. 2009;16:261–269
  34. Krankenberg H, Schluter M, Steinkamp H, Burglin K, Scheinart D, Schulte K, et al. Nitinol stent implantation versus percutaneous transluminal angioplastyin superficial femoral artery lesions up to 10 cm in length: the femoral artery stenting trial (FAST). Circulation. 2007;116:285–292
  35. Kazemi S, Bangash A, Djebmami-Hani M, Gupta A, Tumuburi R, Shalev Y, et al. Prospective randomized comparison of Viabahn stent graft versus SIlverhawk atherectomy for denovofemoralpopliteal occlusive disease (abstract only). Presented at TCT Oct 23, 2006.
  36. Zeller T, Rastan A, Sixt S, Schwarzwalder U, Schwarz T, Frank U, et al. Long-term results after directional atherectomy of femoro-popliteal lesions. J Am Coll Cardiol. 2006;48:1573–1578
  37. Samson R, Showalter D, Nair D, Merigliono K. Cryoplasty therapy of the superficial femoral and popliteal arteries: a reappraisal after 44 months' experience. Lepore JR M J Vasc Surg. 2008;48:634–637
  38. Schillinger M, Sabeti S, Dick P, Amidhi J, Mlekusch W, Schlager O, et al. Sustained benefit at 2 years of primary femoropopliteal stenting compared with balloon angioplasty with optional stenting. Circulation. 2007;115:2745–2749
  39. Dick P, Wallner H, Sabeti S, Loewe C, Mlekusch W, Lammer J, et al. Balloon angioplasty versus stenting with nitinol stents in intermediate length superficial femoral artery lesions. Catheter Cardiovasc Interv. 2009;74:1090–1095
  40. Schillinger M, Sebeti S, Loewe C, Dick P, Amighi J, Mlkusch W, et al. Balloon angioplasty versus implantation of nitinol stents in the superficial femoral artery. N Engl J Med. 2006;354:1879–1888

 Dr Gable has received research funding from W.L. Gore and Medtronic and has served as a consultant for W.L. Gore. Dr Pearl has received research funding from W.L. Gore. Mr Black has received consulting fees from W.L. Gore.

 Additional material for this article may be found online at www.jvascsurg.org.

 The editors and reviewers of this article have no relevant financial relationships to disclose per the JVS policy that requires reviewers to decline review of any manuscript for which they may have a competition of interest.

PII: S0741-5214(10)00904-3

doi: 10.1016/j.jvs.2010.03.071

Journal of Vascular Surgery
Volume 52, Issue 3 , Pages 584-591.e7 , September 2010