Original title: Treatment of Femoropopliteal In-Stent Restenosis With Paclitaxel-Eluting Stents. Zilver PTX Global Registry. ZILVER-PTX. Reference: Thomas Zeller et al. J Am Coll Cardiol Intv 2013;6:274–81.

Femoropopliteal in-stent restenosis (ISR) is reported in between 19% and 37% of lesions a year and this incidence increases with lesion length. 

The ZILVER-PTX study tested the self-expanding paclitaxel-eluting nitinol stent (Cook Medical, Bloomington, Indiana) in a wide array of patients both for novo lesions and restenosis in the femoropopliteal and infrapatellar territories. This work reports results specifically to in-stent restenosis of femoropopliteal territory. The complete study included 787 patients, 108 admitted for in-stent restenosis. The mean lesion length was 33 ± 91.7 and 33.6% of these were over 150mm; 31.1% of treated lesions were occlusive restenosis.

Primary patency (Kaplan-Meier estimated) was 95.7% at 6 months and 78.8% at twelve months. Clinically driven target lesion revascularization (TLR) was practically the same as patency over the same period. After treatment, significant improvements in ankle brachial index and in patient-perceived walking distance were also observed. 63.2% of patients at 12 months and 60.9% of patients at 24 months had Rutherford scores ≤1. The fracture rate of stents was systematically assessed with x-rays and was a low 1.2% a year.

Conclusion: 

This subcohort of ZILVER-PTX study is to date the largest prospective series to assess mid and long term results of endovascular treatment of in-stent restenosis in femoropopliteal territory. Stent in-stent placement of paclitaxel eluting stents show promise in the mid and long term.

Editorial Comment: 

The absence of a control branch is one of the main limitations of this study and of others that have assessed femoropopliteal territory outcomes. In fact, at present there are over 10 ongoing randomized controlled trials comparing drug-eluting balloons to uncoated balloons for the treatment of femoropopliteal ISR and, to our knowledge, there are no published studies, or ongoing studies, comparing different drug eluting balloons against drug eluting stents. Angioplasty materials for femoropopliteal territory are still questionable, and operator experience and device availability continue to be what makes the final difference. 

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