Real-World Performance of Paclitaxel Drug-Eluting Bare Metal Stenting (Zilver PTX) for the Treatment of Femoropopliteal Occlusive Disease.

BACKGROUND

The aim of this study was to evaluate the performance and predictors of stent failure of paclitaxel drug-eluting stents for the treatment of femoropopliteal disease.

METHODS

A retrospective review of clinical and angiographic data was performed for patients treated for femoropopliteal disease with the Zilver PTX (Cook Medical, Bloomington, IN) stent by a single operator between 2012 and 2015 at a tertiary referral center. Clinical grading was determined by both Rutherford classification and the Society for Vascular Surgery's Wound, Ischemia, and Foot Infection (WIFi) scoring system, and lesions were classified anatomically by the TransAtlantic Intersociety Consensus (TASC) II criteria. Treated lesions included those with prior in-stent restenosis and long-segment disease. Primary clinical end points were stent failure, need for reintervention, and major adverse limb events (MALE). Kaplan-Meier methods and Cox proportional hazard models were used to evaluate factors affecting outcomes.

RESULTS

Zilver PTX stents were placed in 52 limbs among 46 patients (71.1% male, mean age 72.6 years) with a median follow-up of 11.1 (range 1-26) months. Limbs were treated for life-disabling claudication in 76.9% and critical limb ischemia in 23.1%. Disease severity was highly variable, with 21 (40.4%) limbs with TASC C or D lesions and 16 (30.7%) treated for restenosis after prior endovascular treatment. During follow-up, 6 (12.7%) limbs experienced loss of stent patency (5 occlusions, one >50% restenosis). Four limbs underwent target lesion revascularization, 2 required open bypass, 2 underwent thrombolysis, and no patients required major amputation. Primary patency was 88.9%, 81.6%, and 81.6% at 6, 12, and 18 months, respectively. Treated lesion length (hazard ratio [HR] 4.99, 95% confidence interval [CI] 1.14-21.75) was the only independent predictor of patency loss. Freedom from target lesion revascularization at 6, 12, and 18 months was 94.2%, 87.8%, and 87.8%, respectively. Freedom from MALE (composite of thrombolysis, major amputation, and bypass operation) was 97.5%, 90.9%, and 79.6% at 6, 12, and 18 months, respectively. Chronic renal insufficiency was the only factor that trended toward increased risk of MALE (HR 9.92, 95% CI 0.86-113.35) within a multivariate model.

CONCLUSIONS

Our real-world experience supports the continued use of the Zilver PTX for the treatment of both de novo lesions and lesions with prior endovascular revascularization in the femoropopliteal segment. Routine follow-up between 6 and 12 months postoperatively is essential for detecting early restenosis and guiding reintervention. Careful attention when treating complex lesions and long-segment disease remains important for selecting the optimal revascularization strategy for individual patients and optimizing stent patency.