Cook Medical Zilver PTX Drug-Eluting Peripheral Stents

2013 ◽  
Vol 43 (14) ◽  
pp. 107-108
Keyword(s):  
Drug Eluting ◽  
Cook Medical ◽  
Zilver Ptx

scholarly journals “Low Echoic Area” around stent after bare and drug-coated stenting or stent graft placement for superficial femoral artery disease

2021 ◽  
Vol 9 ◽  
pp. 2050313X2110145
Author(s):  
Yoshimitsu Soga ◽  
Kenji Ando
Keyword(s):  
Stent Graft ◽  
Femoral Artery ◽  
Superficial Femoral Artery ◽  
Drug Eluting Stent ◽  
Drug Eluting ◽  
Cook Medical ◽  
Artery Disease ◽  
Zilver Ptx ◽  
Cordis Corporation

Restenosis after stent implantation in femoropopliteal lesions is still big issue. However, restenosis has been reduced by the recent new drug-eluting stent “Eluvia” (Boston Scientific, Marlborough, MA, USA). However, it was reported that “low echoic area (LEA)” finding around stent by ultrasound that they called “aneurysmal degeneration,” but no blood flow was identified outside the stent was confirmed after Eluvia implantation. In this report, we describe the similar findings that were observed after other types of stents (S.M.A.R.T. bare-nitinol stent (Cordis Corporation, Hialeah, FL, USA), Zilver PTX drug-coated stent (Cook Medical, Bloomington, IN, USA), and Viabahn stent graft (W. L. Gore & Associates, Newark, Delaware, USA)) for superficial femoral artery disease. These findings did not change to “aneurysmal change” during the follow-up.

PP329 An Australian Cost-Effectiveness Analysis Of The EluviaTM Drug-Eluting Stent For Treatment Of Symptomatic Lower-Limb Peripheral Artery Disease

2020 ◽  
Vol 36 (S1) ◽  
pp. 28-29
Author(s):  
William A. Gray ◽  
Thathya V. Ariyaratne ◽  
Robert I. Griffiths ◽  
Peter W.M. Elroy ◽  
Stacey L. Amorosi ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Healthcare System ◽  
Lower Limb ◽  
Sensitivity Analyses ◽  
Public Healthcare ◽  
System Perspective ◽  
Healthcare System Perspective ◽  
Drug Eluting ◽  
Zilver Ptx ◽  
Cost Parameters

IntroductionDespite advances in endovascular interventions, including the introduction of drug-eluting stents (DES), high target lesion revascularization (TLR) rates still burden the treatment of symptomatic lower-limb peripheral arterial disease (PAD). EluviaTM, a novel, sustained-release, paclitaxel-eluting DES, was shown to further reduce TLRs when compared with the paclitaxel-coated Zilver® PTX® stent, in the IMPERIAL randomized controlled trial. This evaluation estimated the cost-effectiveness of Eluvia when compared with Zilver PTX in Australia, based on 12-month clinical outcomes from the IMPERIAL trial.MethodsA state-transition, decision-analytic model with a 12-month time horizon was developed from an Australian public healthcare system perspective. Cost parameters were obtained from the Australian National Hospital Cost Data Collection Cost Report (2016–17). All costs were captured in Australian dollars (AUD), where AUD 1 = USD 0.69 (June 2020). Complete sets of clinical parameters (primary patency loss, TLR, amputation, and death) and cost parameters from their respective distributions were bootstrapped in samples of 1,000 patients, for each intervention arm of the model. One-way and probabilistic sensitivity analyses were performed.ResultsAt 12 months, modeled TLR rates were 4.5 percent for Eluvia and 8.9 percent for Zilver PTX, and mean total direct costs were AUD 6,537 [USD 4,511] and AUD 6,908 [USD 4,767], respectively (Eluvia average per patient savings; overall cohort=AUD 371 [USD 256]; diabetic cohort=AUD 625 [USD 431]). In probabilistic sensitivity analyses, Eluvia was cost-effective relative to Zilver PTX in 92.0 percent of all simulations at a threshold of $10,000 per TLR avoided. Eluvia was more effective and less costly (dominant) than Zilver PTX in 76.0 percent of simulations.ConclusionsIn the first year after the intervention, Eluvia was more effective and less costly than Zilver PTX, making Eluvia the dominant treatment strategy for treatment of symptomatic lower-limb PAD, from an Australian public healthcare system perspective. These findings should be considered when formulating policy and practice guidelines in the context of priority setting and making evidence-based resource allocation decisions for treatment of PAD in Australia.

Comparable 2-Year Restenosis Rates Following Subintimal and Intraluminal Drug-Eluting Stent Implantation for Femoropopliteal Chronic Total Occlusion

2016 ◽  
Vol 23 (6) ◽  
pp. 889-895 ◽  
Author(s):  
Takayuki Ishihara ◽  
Mitsuyoshi Takahara ◽  
Osamu Iida ◽  
Yoshimitsu Soga ◽  
Keisuke Hirano ◽  
...  
Keyword(s):  
Chronic Total Occlusion ◽  
Primary Outcome ◽  
De Novo ◽  
Drug Eluting Stent ◽  
Significant Interaction Effect ◽  
Total Occlusion ◽  
Subintimal Angioplasty ◽  
Drug Eluting ◽  
Baseline Characteristics ◽  
Zilver Ptx

Purpose: To report midterm outcomes after subintimal vs intraluminal drug-eluting stent (DES) implantation for femoropopliteal (FP) chronic total occlusion (CTO). Methods: This subanalysis of the prospective, multicenter ZEPHYR study (ZilvEr PTX for tHe Femoral ArterY and Proximal Popliteal ArteRy) included 176 patients (mean age 74±8 years; 130 men) with 192 de novo FP CTOs that were evaluated by intravascular ultrasound after successful guidewire crossing. The primary outcome was the 2-year restenosis rate after subintimal (n=73) or intraluminal (n=119) DES implantation. Propensity score matching extracted 61 matched pairs (mean age 75 years; 49 men) for patency analysis to minimize baseline intergroup differences. Restenosis rates are reported with the 95% confidence interval (CI). Results: The 1-year restenosis rates in the groups with subintimal and intraluminal DES implantation were 45% (95% CI 32% to 59%) and 35% (95% CI 22% to 49%), respectively (p=0.352), whereas the corresponding rates at 2 years were not significantly different (p=0.648) at 56% (95% CI 41% to 71%) and 51% (95% CI 34% to 68%). Baseline characteristics had no significant interaction effect on the association of subintimal angioplasty with restenosis risk. Conclusion: In FP CTO, 2-year restenosis rates were comparable after subintimal or intraluminal DES implantation.

PP339 A Budget Impact Model Of The EluviaTM Drug-Eluting Stent from The Australian Public Hospital And National Payer Perspective

2020 ◽  
Vol 36 (S1) ◽  
pp. 29-29
Author(s):  
Nishath Altaf ◽  
Thathya V. Ariyaratne ◽  
Adrian Peacock ◽  
Irene Deltetto ◽  
Jad El-Hoss ◽  
...  
Keyword(s):  
Lower Limb ◽  
Public Hospital ◽  
Budget Impact ◽  
Healthcare Payer ◽  
Drug Eluting Stent ◽  
Public Healthcare ◽  
Impact Model ◽  
Drug Eluting ◽  
Budget Impact Model ◽  
Zilver Ptx

IntroductionImproving long-term outcomes like target lesions revascularizations (TLRs) is a focus for endovascular interventions aimed at treating symptomatic lower-limb peripheral arterial disease (PAD). EluviaTM, a paclitaxel-eluting drug-eluting stent (DES) was shown to further reduce TLRs when compared with the paclitaxel-coated Zilver® PTX® stent in the IMPERIAL trial, a global, randomized controlled study. This budget-impact evaluation investigated cost-savings from Eluvia-use when compared with Zilver PTX, relying on the 12- to 24-month outcomes from the IMPERIAL trial.MethodsA budget-impact model comparing Eluvia and Zilver PTX was developed from the Australian public healthcare payer, and an individual hospital perspective, with a 5-year time-horizon. Observed trial results were applied to each year's incident population and associated costs, and no extrapolation was conducted. The analysis used publicly available Australian national hospital cost data, population estimates, procedural statistics, epidemiological literature, and data from public hospital audits to verify eligible population for endovascular procedures (EVP) including DES. All costs were captured in Australian dollars (AUD), where AUD 1 = USD 0.69 (June 2020).ResultsAssuming 80-percent EVP eligibility, and a DES-use range of 10–28 percent, the 5-year model estimated potential national savings of AUD 4.3–12.1 million (M) [USD 3–8.3M] to the public healthcare payer, driven by reduced TLRs from Eluvia-use compared with Zilver-PTX. The model projected potential national savings of AUD 33.1–92.6M (USD 22.8–63.9M) to individual hospitals through reduced hospital bed days for adverse events (AE). The model forecasted 14,428–40,399 treated patients; 1,499–4,198 fewer TLRs; and 16,515–46,243 fewer hospital days for AE. At a state level, projected hospital savings were: New South Wales AUD 10.9–30.7M [USD 7.5–21.1M]; Victoria AUD 8.4–23.4M [USD 5.8–16.1M]; Queensland AUD 6.5–18.3M [USD 4.5–12.6M]; Western Australia AUD 3.4–9.5M [USD 2.3–6.5M]; South Australia AUD 2.3–6.4M [USD 1.6–4.4M].ConclusionsTreatment of symptomatic lower-limb PAD with the Eluvia DES could lead to potential savings for the Australian healthcare system, at the national, state, and the local hospital level, based on improved patient outcomes.

scholarly journals Possible effect of direct oral anti-coagulant for preventing long stenting lesion from in-stent restenosis in femoropopliteal segment: Case report with angioscopy findings

2020 ◽  
Vol 8 ◽  
pp. 2050313X2094553
Author(s):  
Taketsugu Tsuchiya ◽  
Satori Akita ◽  
Minako Oda ◽  
Takaaki Takamura ◽  
Katsuhide Kitagawa ◽  
...  
Keyword(s):  
De Novo ◽  
Successful Outcome ◽  
Drug Eluting Stent ◽  
Vein Thrombosis ◽  
Stent Restenosis ◽  
Balloon Catheters ◽  
Nitinol Stents ◽  
Drug Eluting ◽  
Zilver Ptx ◽  
In Stent Restenosis

A 64-year-old female underwent a successful first percutaneous intervention using MISAGO stents for a de novo femoropopliteal lesion. Subsequently, three more effective procedures were done using balloon catheters for in-stent restenosis. In May 2016, a fourth procedure using Zilver PTX stent for in-stent restenosis was carried out. For this final procedure, we added direct oral anti-coagulant as she had additional problem of popliteal vein thrombosis and her femoropopliteal segment remained clear. A Zilver PTX stent, a drug-eluting stent for a peripheral artery, was expected to bring superior outcomes compared to conventional bare nitinol stents (i.e. MISAGO stent). But subsequent studies reported that Zilver PTX stent was not more effective than conventional bare nitinol stents. In our above mentioned case, her angioscopy findings suggest that her successful outcome appears to be related to the added direct oral anti-coagulant.

Provisional Stenting Using the Zilver PTX Drug-Eluting Stent After Drug-Coated Balloon Angioplasty: Initial Experience From the Double Drug Dose “3D” Study

2019 ◽  
Vol 27 (1) ◽  
pp. 34-41
Author(s):  
Fabrizio Fanelli ◽  
Alessandro Cannavale ◽  
Michele Citone ◽  
Mariangela Santoni ◽  
Marianna Gazzetti ◽  
...  
Keyword(s):  
Primary Patency ◽  
Drug Eluting Stent ◽  
Secondary Patency ◽  
Systemic Complications ◽  
Aneurysm Formation ◽  
Drug Eluting ◽  
Provisional Stenting ◽  
Zilver Ptx ◽  
Drug Coated Balloon

Purpose: To explore the provisional use of a drug-eluting stent (DES) after suboptimal drug-coated balloon (DCB) angioplasty in complex, calcified femoropopliteal lesions. Materials and Methods: A prospective, single-center, investigator-initiated pilot study enrolled 15 patients (mean age 71.3 years; 9 men) with symptomatic stenosis (n=6) or occlusion (n=9) of the native superficial femoral and/or proximal popliteal arteries who experienced suboptimal DCB dilation despite postdilation. Lesion characteristics were evaluated with computed tomography angiography and duplex ultrasound confirmed by intravascular ultrasound. Follow-up included clinical and imaging evaluations as well as blood tests to monitor inflammatory markers. Endpoints included systemic inflammation, acute/chronic thrombosis, aneurysm formation, and mortality. Results: Provisional stenting was required for residual stenosis >50% in 4 cases and flow-limiting dissection in 11. Provisional spot stenting was done using the Zilver PTX DES. Clinical improvement was observed in all cases. After 24-month follow-up all patients were alive and in good clinical condition. One- and 2-year primary patency rates were 93.3% and 92.9%, respectively; secondary patency was 100%. Restenosis required reintervention in 2 cases. No local or systemic complications or toxicity were observed due to the use of a double dose of paclitaxel. No significant increase in any inflammation marker was observed in the perioperative period, and no aneurysm formation was seen over 24 months of follow-up. Conclusion: Combined DCB plus DES therapy seems to be safe and correlated with high primary patency following suboptimal angioplasty. Larger studies are required to confirm the safety and efficacy of this approach.

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

Vascular ◽  
2020 ◽  
pp. 170853812096437
Author(s):  
Jordan R Stern ◽  
Kenneth Tran ◽  
Venita Chandra ◽  
E John Harris ◽  
Jason T Lee
Keyword(s):  
Real World ◽  
Drug Eluting Stent ◽  
Secondary Patency ◽  
Kaplan Meier ◽  
Drug Eluting ◽  
Lifetime Exposure ◽  
Zilver Ptx ◽  
Long Term Mortality

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.

scholarly journals Paclitaxel-coated Zilver PTX drug-eluting stent treatment does not result in increased long-term all-cause mortality compared to uncoated devices from Japan post-market surveillance study

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
H Yokoi
Keyword(s):  
Real World ◽  
Drug Eluting Stent ◽  
Long Term Outcomes ◽  
Risk Of Mortality ◽  
All Cause Mortality ◽  
Post Market ◽  
Drug Eluting ◽  
Zilver Ptx

Abstract Purpose Favorable long-term outcomes with the Zilver PTX drug-eluting stent (DES) in treating patients with femoropopliteal lesions have been demonstrated. A multicenter, prospective, post-market surveillance study (PMS) in Japan evaluated this DES in a real-world patient population. Recently, meta-analysis that grouped both DES and drug-coated balloons (DCB) together indicated a higher incidence of late all-cause mortality for paclitaxel- based devices compared to uncoated balloon or bare-metal stent (BMS) at 2 years up to 5 years. To evaluate the long-term safety of the Zilver PTX DES, compared with BMS using Japan-PMS study. Methods The Japan DES PMS had no exclusion criteria and enrolled consecutive patients with symptomatic PAD involving the above-the-knee femoropopliteal arteries. Safety and effectiveness of the DES was evaluated in real-world patients with complex femoropopliteal artery lesions through 5 years. Follow-up in the study is complete. The concurrent Japan BMS PMS also had no exclusion criteria and enrolled consecutive patients with symptomatic PAD involving the above-the-knee femoropopliteal arteries. Patients who were enrolled in the BMS study but who also had a DES placed (n=18) were excluded from the current analysis. Follow-up in the BMS study was only required through 3 years and is complete. Results The Japan DES PMS enrolled 904 DES patients, and the Japan BMS PMS enrolled 190 BMS patients. In the DES group, there were 127 deaths through 3 years and 186deaths through 5 years. In the BMS group, there were 22 deaths through 3 years. Through 3 years, the risk of mortality was 15.7% for DES group and 15.3% for BMS group. Through 5 years, the risk of mortality was 25.8% for the DES group. There was no difference in mortality between the two groups (log-rank p=0.92).The Cox proportional hazards model revealed that CLI (p<0.0001), age (p<0.0001), gender (p=0.001), renal failure (p<0.0001) were significantly associated with mortality. Hypercholesterolemia (p=0.004) was associated with lower risk of mortality. Treatment with Zilver PTX (p=0.49) was not associated with mortality. In the covariate analysis of paclitaxel dose, the significant factors were identical to the treatment analysis, and there was no association or trend of paclitaxel dose (p=0.07) with mortality. Conclusion Analyses of the paclitaxel-coated Zilver PTX DES utilizing patient-level data from the Japan PMS demonstrated no increase in long-term all-cause mortality. The 5-year results from this real-world, all-comers study continue to show positive long-term outcomes and demonstrate the benefit of the Zilver PTX DES across a broad patient population. Funding Acknowledgement Type of funding source: Private company. Main funding source(s): COOK

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