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

Tran, Kenneth; Ullery, Brant W.; Kret, Marcus R.; Lee, Jason T.

doi:10.1016/j.avsg.2016.08.006

Cited by 13 publications

(6 citation statements)

References 18 publications

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“…Data from recent reports with the use of different devices (drug-eluting balloons, drug-eluting stents, covered and uncovered stents) in the treatment of SFA lesions longer than 20 cm showed a significant paucity of results at a follow-up time longer than 1 year, whereas the few studies with a longer follow-up yielded poor results in terms of patency of the treated segment. 9,14,15,31 As a consequence, there is agreement also from "endoenthusiastic" interventionalists that the real challenge for endovascular surgery is the treatment of long lesions and chronic total occlusions of the SFA. 13 In such situations, a surgical bypass at the above-the-knee level can still represent an effective option, with satisfactory follow-up results in terms of graft patency as reported in Table IV, symptom relief, and limb preservation.…”

Section: Discussionmentioning

confidence: 99%

Results from a multicenter registry of heparin-bonded expanded polytetrafluoroethylene graft for above-the-knee femoropopliteal bypass

Piffaretti

Dorigo

Castelli

et al. 2018

Journal of Vascular Surgery

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Section: Discussionmentioning

confidence: 99%

Results from a multicenter registry of heparin-bonded expanded polytetrafluoroethylene graft for above-the-knee femoropopliteal bypass

Piffaretti

Dorigo

Castelli

et al. 2018

Journal of Vascular Surgery

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“…5 We have also reported favorable clinical outcomes with Zilver PTX in a real-world setting, with high patency and low rates of major adverse limb events (MALE). 6…”

Section: Introductionmentioning

confidence: 99%

Paclitaxel exposure and long-term mortality of patients treated with the Zilver PTX drug-eluting stent

et al. 2020

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Objectives Paclitaxel-eluting stents have demonstrated improved patency over balloon angioplasty and bare metal stenting for endovascular interventions in the femoral-popliteal segment. Recently, concerns have arisen regarding the safety of paclitaxel use and its association with mortality. This study aims to examine real-world, long-term mortality, and patency of patients treated with the Zilver PTX drug-eluting stent. Methods Patients treated with the PTX stent after FDA approval between 2013 and 2015 were identified from an institutional database. Demographic, procedural, and device information was collected and initial- and lifetime-exposure dose of paclitaxel was calculated. The primary outcome was all-cause mortality and its association with paclitaxel exposure. Long-term patency was also evaluated. Results Seventy-nine procedures involving PTX placement were performed on 64 individual patients during the study period, with 15 (23.4%) having bilateral procedures. Average age was 70 years, and 71.9% were male. Forty-five patients (70.3%) were claudicants, and 19 (29.7%) had chronic, limb-threatening ischemia. An average of 2.3 PTX stents, totaling 203 mm in length, were placed per procedure. Paclitaxel exposure was 1.87 mg/procedure initially (range 0.38–4.03 mg), and average lifetime exposure was 4.65 mg/patient (range 0.38–27.91 mg). Average follow-up was 59.6 months. Kaplan–Meier estimated survival was 96.9%, 81.2% and 71.7% at one , three, and five years. On multivariate analysis, no specific factors were associated with overall morality including initial paclitaxel dose (HR 0.99, 95% CI 0.99–1.00) and lifetime paclitaxel exposure (HR 0.98, 95% CI 0.89–1.08). Kaplan–Meier primary patency was 76.2%, 60.1%, and 29.3% at one, two, and five years, respectively. Secondary patency was 92.2%, 85.4%, and 75.2% at the same intervals. Conclusions At a mean follow-up of five years, exposure to higher doses of paclitaxel from Zilver PTX does not appear to be associated with increased mortality compared to lower doses in real-world patients. Long-term patency rates confirm the efficacy of Zilver PTX, and further investigation may be warranted before abandoning paclitaxel use altogether.

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“…8 Adding to the original trials, emerging real-world data are also encouraging. 3,5,6 Although all small series, these results provide support that the improved primary patency rates and reduced reintervention rates seen in the industry trials translate to real-world patient care. One of the major drawbacks of using DES in lieu of BMS has been the device cost, which is significantly greater than conventional BMS.…”

Section: Discussionmentioning

confidence: 68%

Implementation of drug-eluting stents for the treatment of femoropopliteal disease provides significant cost-to-system savings in a single-state outpatient simulation

Sridharan¹,

Liang²,

Robinson

et al. 2018

Journal of Vascular Surgery

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

Cited by 13 publications

References 18 publications

Results from a multicenter registry of heparin-bonded expanded polytetrafluoroethylene graft for above-the-knee femoropopliteal bypass

Results from a multicenter registry of heparin-bonded expanded polytetrafluoroethylene graft for above-the-knee femoropopliteal bypass

Paclitaxel exposure and long-term mortality of patients treated with the Zilver PTX drug-eluting stent

Implementation of drug-eluting stents for the treatment of femoropopliteal disease provides significant cost-to-system savings in a single-state outpatient simulation

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