CardioVascular and Interventional Radiology

, Volume 36, Issue 2, pp 353–361 | Cite as

Randomized Trial of the SMART Stent versus Balloon Angioplasty in Long Superficial Femoral Artery Lesions: The SUPER Study

  • Nicholas ChalmersEmail author
  • Paul T. Walker
  • Anna-Maria Belli
  • Anthony P. Thorpe
  • Paul S. Sidhu
  • Graham Robinson
  • Mariella van Ransbeeck
  • Steven A. Fearn
Clinical Investigation



To determine whether primary stenting reduces the rate of restenosis compared with balloon angioplasty alone in the endovascular treatment of long superficial femoral artery lesions; and to assess the effect of treatment on quality of life.


A total of 150 patients with superior femoral artery occlusion or severe stenosis of 5–22 cm length from 17 UK centers were randomized to either primary stenting with the SMART stent or balloon angioplasty (i.e., percutaneous transluminal angioplasty, PTA). Bailout stent placement was permitted in case of inadequate result from PTA. The primary end point was restenosis measured by duplex ultrasound at 1 year. Quality-of-life assessments were performed by the EuroQol (EQ)-5D questionnaire.


Mean lesion length was 123.0 mm in the stent group and 116.8 mm in the PTA group. A total of 140 (93.3 %) of 150 had total occlusions. At 12 months’ follow-up, restenosis measured by Duplex ultrasound was not significantly different between the stent and PTA groups by intention-to-treat or as-treated analyses: 47.2 versus 43.5 % (p = 0.84) and 40.8 versus 46.7 % (p = 0.68), respectively. There were fewer target lesion revascularizations in patients randomized to stenting, but this did not reach statistical significance (12.5 vs. 20.8 %, p = 0.26). There was no difference in the rate of amputation. Patients in both groups reported improved quality of life.


Primary stenting of long lesions in predominantly occluded superficial femoral arteries does not reduce the rate of binary restenosis compared with balloon angioplasty and bailout stenting. Both treatment strategies conferred a meaningful and sustained improvement to the quality of life of patients with severe superficial femoral artery disease.


Balloon angioplasty Long lesions Randomized trial SMART stent Superficial femoral artery 



The SUPER study was sponsored and funded by Cordis Clinical Research.

Conflict of interest

SF and MvR are paid employees of Cordis, Johnson & Johnson. The other authors declare that they have no conflict of interest.


  1. 1.
    Duda SH, Pusich B, Richter G et al (2002) Sirolimus-eluting stents for the treatment of obstructive superficial femoral artery disease: six-month results. Circulation 106:1505–1509PubMedCrossRefGoogle Scholar
  2. 2.
    Duda SH, Bosiers M, Lammer J et al (2005) Sirolimus-eluting versus bare nitinol stent for obstructive superficial femoral artery disease: the SIROCCO II trial. J Vasc Interv Radiol 16:331–338PubMedCrossRefGoogle Scholar
  3. 3.
    Mewissen MW (2004) Self-expanding Nitinol stents in the femoropopliteal segment: technique and mid-term results. Tech Vasc Interv Radiol 7:2–5PubMedCrossRefGoogle Scholar
  4. 4.
    Vogel TR, Shindelman LE, Nackman GB, Graham AM (2003) Efficacious use of nitinol stents in the femoral and popliteal arteries. J Vasc Surg 38:1178–1184PubMedCrossRefGoogle Scholar
  5. 5.
    Schillinger M, Sabeti S, Loewe C et al (2006) Balloon angioplasty versus implantation of nitinol stents in the superficial femoral artery. N Engl J Med 354:1879–1888PubMedCrossRefGoogle Scholar
  6. 6.
    EuroQol Group (1990) EuroQol—a new facility for the measurement of health-related quality of life. Health Policy 16:199–208CrossRefGoogle Scholar
  7. 7.
    Dolan P, Gudex C, Kind P, Williams A (1995) A social tariff for EuroQol: results from a UK general population survey. Centre for Health Economics Discussion Paper 138. CHE, Centre for Health Economics, University of YorkGoogle Scholar
  8. 8.
    Krankenberg H, Schlüter M, Steinkamp HJ et al (2007) 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 116:285–293PubMedCrossRefGoogle Scholar
  9. 9.
    Dick P, Wallner H, Sabeti S et al (2009) Balloon angioplasty versus stenting with nitinol stents in intermediate length superficial femoral artery lesions. Catheter Cardiovasc Interv 74:1090–1095PubMedCrossRefGoogle Scholar
  10. 10.
    Laird JR, Katzen BT, Scheinert D et al (2010) Nitinol stent implantation versus balloon angioplasty for lesions in the superficial femoral artery and proximal popliteal artery. Twelve-month results from the RESILIENT randomized trial. Circ Cardiovasc Interv 3:267–276PubMedCrossRefGoogle Scholar
  11. 11.
    Twine CP, Coulston J, Shandall A et al (2009) Angioplasty versus stenting for superficial femoral artery lesions. Cochrane Database Syst Rev 15(2):CD006767Google Scholar
  12. 12.
    Sabeti S, Schillinger M, Amighi J et al (2004) Primary patency of femoropopliteal arteries treated with nitinol versus stainless steel self-expanding stents: propensity score–adjusted analysis. Radiology 232:516–521PubMedCrossRefGoogle Scholar
  13. 13.
    Tasc II (2007) Inter-Society Consensus for the management of peripheral arterial disease. Eur J Vasc Endovasc Surg 33:1–75CrossRefGoogle Scholar
  14. 14.
    Davies MG, Bismuth J, We Saad et al (2010) Outcomes of interventions for recurrent disease after endoluminal intervention for superficial femoral artery disease. J Vasc Surg 52:331–339PubMedCrossRefGoogle Scholar
  15. 15.
    Cheng SWK, Ting ACW, Wong J (2001) Endovascular stenting of superficial femoral artery stenosis and occlusions: results and risk factor analysis. Cardiovasc Surg 9:133–140PubMedCrossRefGoogle Scholar
  16. 16.
    Gray BH, Sullivan TM, Childs MB et al (1997) High incidence of restenosis/reocclusion of stents in the percutaneous treatment of long-segment superficial femoral artery disease after suboptimal angioplasty. J Vasc Surg 25:74–83PubMedCrossRefGoogle Scholar
  17. 17.
    Kim SJ, Kim W, Kim JB et al (2010) Factors of success and patency after subintimal angioplasty in patients with TransAtlantic inter-society consensus C and D severe lower extremity occlusive disease. J Am Coll Cardiol 105(9 Suppl 1):20A–21AGoogle Scholar
  18. 18.
    Hameed A, Gluege S, Reinhart R (2009) Subintimal angioplasty: to stent or not to stent. J Invasive Cardiol 21:E154–E156PubMedGoogle Scholar
  19. 19.
    Bosiers M, Deloose K, Callaert J et al (2012) In lower extremity PTAs intraluminal is better than subintimal. J Cardiovasc Surg (Torino) 53:223–227Google Scholar
  20. 20.
    Schmieder GC, Richardson AI, Scott EC et al (2008) Selective stenting in subintimal angioplasty: analysis of primary stent outcomes. J Vasc Surg 48:1175–1180PubMedCrossRefGoogle Scholar
  21. 21.
    Sabeti S, Czerwenka-Wenkstetten A, Dick P et al (2007) Quality of life after balloon angioplasty versus stent implantation in the superficial femoral artery: findings from a randomized controlled trial. J Endovasc Ther 14:431–437PubMedCrossRefGoogle Scholar
  22. 22.
    UK Department of Health (2008) Guidance on the routine collection of patient reported outcome measures. Department of Health, LondonGoogle Scholar
  23. 23.
    National Institute for Health and Clinical Excellence (2008) Guide to the methods of technology appraisal. National Institute for Health and Clinical Excellence, London, pp 38–39Google Scholar
  24. 24.
    de Vries M, Ouwendijk R, Kessels AG et al (2005) Comparison of generic and disease-specific questionnaires for the assessment of quality of life in patients with peripheral arterial disease. J Vasc Surg 41:261–268PubMedCrossRefGoogle Scholar
  25. 25.
    BASIL Trial Participants (2005) Bypass versus Angioplasty in Severe Ischaemia of the Leg (BASIL): multicentre, randomised controlled trial. Lancet 366:1925–1934CrossRefGoogle Scholar
  26. 26.
    Longworth L, Buxton MH, Sculpher M et al (2005) Estimating utility data from clinical indicators for patients with stable angina. Eur J Health Econ 6:347–353PubMedCrossRefGoogle Scholar
  27. 27.
    Serruys PW, Unger F, Sousa JE (2001) Comparison of coronary artery bypass surgery and stenting for the treatment of multi-vessel disease. N Engl J Med 344:1117–1124PubMedCrossRefGoogle Scholar
  28. 28.
    Dake MD, Ansel GM, Jaff MR et al (2011) Paclitaxel-eluting stents show superiority to balloon angioplasty and bare metal stents in femoropopliteal disease. Circ Cardiovasc Interv 4:495–504PubMedCrossRefGoogle Scholar
  29. 29.
    Schlager O, Francesconi M, Haumer M et al (2007) Duplex sonography versus angiography for assessment of femoropopliteal arterial disease in a “real-world” setting. J Endovasc Ther 14:452–459PubMedCrossRefGoogle Scholar
  30. 30.
    Schillinger M, Sabeti S, Dick P et al (2007) Sustained benefit at 2 years of primary femoropopliteal stenting compared with balloon angioplasty with optional stenting. Circulation 115:2745–2749PubMedCrossRefGoogle Scholar
  31. 31.
    Laird JR, Katzen BT, Scheinert D et al (2012) Nitinol stent implantation versus balloon angioplasty for lesions in the superficial femoral and proximal popliteal arteries of patients with claudication: three-year follow-up from the RESILIENT randomised trial. J Endovasc Ther 19:1–9PubMedCrossRefGoogle Scholar
  32. 32.
    Tendera M, Aboyans V, Bartelink ML et al (2011) ESC guidelines on the diagnosis and treatment of peripheral artery diseases. Eur Heart J 32:2851–2906PubMedCrossRefGoogle Scholar

Copyright information

© Springer Science+Business Media New York and the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) 2012

Authors and Affiliations

  • Nicholas Chalmers
    • 1
    Email author
  • Paul T. Walker
    • 2
  • Anna-Maria Belli
    • 3
  • Anthony P. Thorpe
    • 4
  • Paul S. Sidhu
    • 5
  • Graham Robinson
    • 6
  • Mariella van Ransbeeck
    • 7
  • Steven A. Fearn
    • 8
  1. 1.Department of RadiologyManchester Royal InfirmaryManchesterUK
  2. 2.Department of RadiologyJames Cook University HospitalMiddlesboroughUK
  3. 3.Department of RadiologySt. George’s Healthcare NHS TrustLondonUK
  4. 4.Department of RadiologyAberdeen Royal InfirmaryAberdeenScotland, UK
  5. 5.Department of RadiologyKing’s College HospitalLondonUK
  6. 6.Department of RadiologyHull Royal InfirmaryKingston upon HullUK
  7. 7.CordisJohnson & Johnson Medical NV/SAWaterlooBelgium
  8. 8.CordisJohnson & Johnson Medical Ltd.WokinghamUK

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