Randomized Trial of the SMART Stent versus Balloon Angioplasty in Long Superficial Femoral Artery Lesions: The SUPER Study
- Nicholas ChalmersAffiliated withDepartment of Radiology, Manchester Royal Infirmary Email author
- , Paul T. WalkerAffiliated withDepartment of Radiology, James Cook University Hospital
- , Anna-Maria BelliAffiliated withDepartment of Radiology, St. George’s Healthcare NHS Trust
- , Anthony P. ThorpeAffiliated withDepartment of Radiology, Aberdeen Royal Infirmary
- , Paul S. SidhuAffiliated withDepartment of Radiology, King’s College Hospital
- , Graham RobinsonAffiliated withDepartment of Radiology, Hull Royal Infirmary
- , Mariella van RansbeeckAffiliated withCordis, Johnson & Johnson Medical NV/SA
- , Steven A. FearnAffiliated withCordis, Johnson & Johnson Medical Ltd.
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
- Randomized Trial of the SMART Stent versus Balloon Angioplasty in Long Superficial Femoral Artery Lesions: The SUPER Study
CardioVascular and Interventional Radiology
Volume 36, Issue 2 , pp 353-361
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- Balloon angioplasty
- Long lesions
- Randomized trial
- SMART stent
- Superficial femoral artery
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- Author Affiliations
- 1. Department of Radiology, Manchester Royal Infirmary, Oxford Road, Manchester, M13 9WL, UK
- 2. Department of Radiology, James Cook University Hospital, Marton Road, Middlesborough, Cleveland, TS4 3BW, UK
- 3. Department of Radiology, St. George’s Healthcare NHS Trust, Blackshaw Road, London, SW17 0QT, UK
- 4. Department of Radiology, Aberdeen Royal Infirmary, Aberdeen, AB25 2ZN, Scotland, UK
- 5. Department of Radiology, King’s College Hospital, Denmark Hill, London, SE5 9RS, UK
- 6. Department of Radiology, Hull Royal Infirmary, Kingston upon Hull, HU3 2JZ, UK
- 7. Cordis, Johnson & Johnson Medical NV/SA, Waterloo Office Park, Drève Richelle 161 H, Waterloo, 1410, Belgium
- 8. Cordis, Johnson & Johnson Medical Ltd., Pinewood Campus, Nine Mile Ride, Wokingham, RG40 9EW, UK