Document Detail


Balloon angioplasty versus implantation of nitinol stents in the superficial femoral artery.
MedLine Citation:
PMID:  16672699     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
BACKGROUND: Because stent implantation for disease of the superficial femoral artery has been associated with high rates of late clinical failure, percutaneous transluminal angioplasty is preferred for endovascular treatment, and stenting is recommended only in the event of suboptimal technical results. We evaluated whether primary implantation of a self-expanding nitinol (nickel-titanium) stent yielded anatomical and clinical benefits superior to those afforded by percutaneous transluminal angioplasty with optional secondary stenting. METHODS: We randomly assigned 104 patients who had severe claudication or chronic limb ischemia due to stenosis or occlusion of the superficial femoral artery to undergo primary stent implantation (51 patients) or angioplasty (53 patients). Restenosis and clinical outcomes were assessed at 6 and 12 months. RESULTS: The mean (+/-SD) length of the treated segment was 132+/-71 mm in the stent group and 127+/-55 mm in the angioplasty group. Secondary stenting was performed in 17 of 53 patients (32 percent) in the angioplasty group, in most cases because of a suboptimal result after angioplasty. At 6 months, the rate of restenosis on angiography was 24 percent in the stent group and 43 percent in the angioplasty group (P=0.05); at 12 months the rates on duplex ultrasonography were 37 percent and 63 percent, respectively (P=0.01). Patients in the stent group were able to walk significantly farther on a treadmill at 6 and 12 months than those in the angioplasty group. CONCLUSIONS: In the intermediate term, treatment of superficial-femoral-artery disease by primary implantation of a self-expanding nitinol stent yielded results that were superior to those with the currently recommended approach of balloon angioplasty with optional secondary stenting. (ClinicalTrials.gov number, NCT00281060.).
Authors:
Martin Schillinger; Schila Sabeti; Christian Loewe; Petra Dick; Jasmin Amighi; Wolfgang Mlekusch; Oliver Schlager; Manfred Cejna; Johannes Lammer; Erich Minar
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Publication Detail:
Type:  Comparative Study; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  The New England journal of medicine     Volume:  354     ISSN:  1533-4406     ISO Abbreviation:  N. Engl. J. Med.     Publication Date:  2006 May 
Date Detail:
Created Date:  2006-05-04     Completed Date:  2006-05-09     Revised Date:  2006-11-15    
Medline Journal Info:
Nlm Unique ID:  0255562     Medline TA:  N Engl J Med     Country:  United States    
Other Details:
Languages:  eng     Pagination:  1879-88     Citation Subset:  AIM; IM    
Copyright Information:
Copyright 2006 Massachusetts Medical Society.
Affiliation:
Department of Angiology, Medical University of Vienna, Vienna General Hospital, Vienna, Austria. martin.schillinger@meduniwien.ac.at
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT00281060
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MeSH Terms
Descriptor/Qualifier:
Aged
Alloys
Angioplasty, Balloon*
Female
Femoral Artery* / ultrasonography
Follow-Up Studies
Humans
Intermittent Claudication / etiology,  therapy*,  ultrasonography
Ischemia / etiology,  therapy*
Leg / blood supply
Logistic Models
Male
Middle Aged
Peripheral Vascular Diseases / complications,  therapy*
Recurrence
Statistics, Nonparametric
Stents*
Chemical
Reg. No./Substance:
0/Alloys; 52013-44-2/nitinol
Comments/Corrections
Comment In:
N Engl J Med. 2006 May 4;354(18):1944-7   [PMID:  16672707 ]
N Engl J Med. 2006 Aug 3;355(5):521-2; author reply 523-4   [PMID:  16888841 ]
N Engl J Med. 2006 Aug 3;355(5):522; author reply 523-4   [PMID:  16888842 ]
N Engl J Med. 2006 Aug 3;355(5):522; author reply 523-4   [PMID:  16888843 ]
N Engl J Med. 2006 Aug 3;355(5):521; author reply 523-4   [PMID:  16885559 ]

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