Document Detail

Nitinol stent implantation versus percutaneous transluminal angioplasty in superficial femoral artery lesions up to 10 cm in length: the femoral artery stenting trial (FAST).
MedLine Citation:
PMID:  17592075     Owner:  NLM     Status:  MEDLINE    
BACKGROUND: Endoluminal treatment of superficial femoral artery lesions is a matter of controversy. The present study was designed to investigate the impact of nitinol stenting of superficial femoral artery lesions with a maximum length of 10 cm on restenosis and clinical outcomes at 1 year. METHODS AND RESULTS: Two hundred forty-four patients (168 men; 66+/-9 years) with a single superficial femoral artery lesion and chronic limb ischemia were randomized to implantation of a single Bard Luminexx 3 stent (123 patients) or stand-alone percutaneous transluminal angioplasty (PTA) (121 patients). Mean lesion length was 45 mm. Technical success (residual stenosis <50% for PTA, <30% for stenting) was achieved in 96 patients assigned to PTA (79%) and 117 patients assigned to stenting (95%); 13 PTA group patients (11%) "crossed over" to stenting. At 1 year, the primary end point of ultrasound-assessed binary restenosis was reached in 39 of 101 PTA group patients (38.6%) and 32 of 101 stent group patients (31.7%; absolute treatment difference, -6.9%; 95% CI, -19.7% to 6.2%; P=0.377). Target lesion revascularization rates at 1 year were 18.3% and 14.9%, respectively (absolute treatment difference, -3.3%; 95% CI, -13.0% to 6.4%; P=0.595). No statistically significant difference between treatment groups was observed at 12 months in the improvement by at least 1 Rutherford category of peripheral arterial disease. CONCLUSIONS: In the present study of patients with short superficial femoral artery lesions, the hypothesized absolute difference of 20% in binary restenosis at 1 year between the implantation of a single Luminexx nitinol stent and stand-alone PTA could not be demonstrated. A smaller difference requiring a larger trial might have been missed.
Hans Krankenberg; Michael Schlüter; Hermann J Steinkamp; Karlheinz Bürgelin; Dierk Scheinert; Karl-Ludwig Schulte; Erich Minar; Patrick Peeters; Marc Bosiers; Gunnar Tepe; Bernhard Reimers; Felix Mahler; Thilo Tübler; Thomas Zeller
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Publication Detail:
Type:  Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't     Date:  2007-06-25
Journal Detail:
Title:  Circulation     Volume:  116     ISSN:  1524-4539     ISO Abbreviation:  Circulation     Publication Date:  2007 Jul 
Date Detail:
Created Date:  2007-07-19     Completed Date:  2007-08-07     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  0147763     Medline TA:  Circulation     Country:  United States    
Other Details:
Languages:  eng     Pagination:  285-92     Citation Subset:  AIM; IM    
Hamburg University Cardiovascular Center, Hamburg, Germany.
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MeSH Terms
Alloys / administration & dosage*
Angioplasty, Balloon* / methods
Blood Vessel Prosthesis Implantation* / methods
Femoral Artery / pathology*,  ultrasonography
Graft Occlusion, Vascular / pathology,  therapy,  ultrasonography
Ischemia / pathology,  therapy,  ultrasonography
Middle Aged
Reg. No./Substance:
0/Alloys; 52013-44-2/nitinol

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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