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The Zilver® PTX® Single Arm Study: 12-month results from the TASC C/D lesion subgroup.
MedLine Citation:
PMID:  23296421     Owner:  NLM     Status:  In-Data-Review    
Abstract/OtherAbstract:
AIM: The aim of the present article was to report the 12-month results of the Zilver® PTX® Single Arm StudyTASC C/D de novo lesion subgroup.
METHODS: The Zilver PTX Drug-Eluting Peripheral Stent is a self-expanding nitinol stent with a polymer-free paclitaxel coating. This is a prospective, single-arm, multicentre clinical study evaluating the Zilver PTX Drug-Eluting Peripheral Stent for treating patients with symptomatic lesions in the above-the-knee femoropopliteal artery. This study enrolled 787 patients (900 lesions) with Rutherford class 2 or higher treated with the Zilver PTX stent; 135 were long de novo lesions, corresponding to TASC II Class C or D.
RESULTS: The 135 long lesions had a mean length of 226.1±43.6 mm. The 12-month Kaplan-Meier estimates included a 77.6% primary patency rate, an 84.7% event-free survival rate, and an 85.4% rate of freedom from target lesion revascularization (TLR). The 12-month stent fracture rate was 2.1%.
CONCLUSION: The primary patency rates in the analysis of the TASC C/D de novo lesion subgroup of the Zilver PTX Single Arm Study indicate that endovascular therapy outcomes with a paclitaxel eluting stent may equal those of bypass surgery. Endovascular treatment with DES may play an important role for treatment of patients who present with TASC C or D femoropopliteal lesions.
Authors:
M Bosiers; P Peeters; J Tessarek; K Deloose; S Strickler
Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  The Journal of cardiovascular surgery     Volume:  54     ISSN:  0021-9509     ISO Abbreviation:  J Cardiovasc Surg (Torino)     Publication Date:  2013 Feb 
Date Detail:
Created Date:  2013-01-08     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  0066127     Medline TA:  J Cardiovasc Surg (Torino)     Country:  Italy    
Other Details:
Languages:  eng     Pagination:  115-22     Citation Subset:  IM    
Affiliation:
Department of Vascular Surgery, AZ St-Blasius, Dendermonde, Belgium - marc.bosiers@telenet.be.
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