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A Journal on Cardiac, Vascular and Thoracic Surgery

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The Journal of Cardiovascular Surgery 2013 February;54(1):115-22

language: English

The Zilver® PTX® Single Arm Study: 12-month results from the TASC C/D lesion subgroup

Bosiers M. 1, Peeters P. 2, Tessarek J. 3, Deloose K. 1, Strickler S. 4

1 Department of Vascular Surgery, AZ St-Blasius, Dendermonde, Belgium;
2 Department of Cardiovascular and Thoracic Surgery, Imelda Hospital, Bonheiden, Belgium;
3 Department of Vascular Surgery, St Bonifatius Hospital, Lingen, Germany;
4 MED Institute, Inc., West Lafayette, Indiana, USA


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.

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