A single center experience of Zilver PTX for femoro-popliteal lesions

Background: Clinical trial data show overall favorable outcomes of paclitaxel-eluting stents for treatment of femoro-popliteal (FP) occlusive disease. However, external validity of trial results may be restricted to less complex FP lesions, and limited data on outcomes of paclitaxel-eluting stents in real world practice have been published. Methods: This is a retrospective analysis of data of all patients who received Zilver (R) PTX (R) for FP lesion from February 2013 to October 2014 at our center. The primary endpoint was primary patency, defined as peak systolic velocity ratio <2.0 by Doppler ultrasound, or angiographic diameter stenosis <50%, or freedom from clinically driven target lesion revascularization. Results: Seventy-eight patients received Zilver (R) PTX (R) for FP lesions in the pre-specified time period. Of them, 63 had follow-up data and were included in this study. Mean patient age was 66.3 +/- 9.4 years, and 57.1% of the patients were men. Participants had a high prevalence of diabetes (49.2%), hypertension (93.7%), hyperlipidemia (93.7%), previous coronary revascularization (52.4%), or previous peripheral arterial disease (77.8%). Critical limb ischemia was present in 25.4% of the patients, Trans-Atlantic Inter-Society Consensus (TASC) class C or D in 76.2%, in-stent restenosis (ISR) in 36.5%, and total occlusion in 69.8%. Mean lesion length was 218.9 +/- 128.3 mm, mean number of stents was 2.02 +/- 1.0, and total stent length was 189.0 +/- 128.5 mm. Mean follow-up was 270.4 +/- 190.3 days. Primary patency rate at 1 year was 66.7% by Kaplan-Meier survival curve. When compared with patients with primary patency at follow up, those with an adverse outcome had higher prevalence of TASC II class C or D lesions (100% vs. 68.8%, p = 0.013), and were more likely to have ISR (66.7% vs. 27.1%, p = 0.012), longer lesion (291.3 +/- 138.7 vs. 195.7 +/- 117.1, p = 0.011), and incomplete coverage of the lesion (full coverage of lesions: 40% vs. 77.1%, p = 0.011). Conclusion: Post marketing use of Zilver (R) PTX (R) for the treatment of FP lesions is associated with lower patency rates compared with clinical trial data. This may be related to the high prevalence of TASC II class C or D lesions and ISR in real world practice. Future studies should be more representative of contemporary clinical practice. (C) 2016 Elsevier Inc. All rights reserved.