Randomized Trial of the SMART Stent versus Balloon Angioplasty in Long Superficial Femoral Artery Lesions: The SUPER Study
- 2.2k Downloads
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.
KeywordsBalloon 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.
- 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
- 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
- 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
- 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
- 22.UK Department of Health (2008) Guidance on the routine collection of patient reported outcome measures. Department of Health, LondonGoogle Scholar
- 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
- 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