One-Year Outcomes of Two Different Paclitaxel-Eluting Stents (Zilver PTX and Eluvia) for Trans-Atlantic Inter-Society Consensus Document (TASC) C/D Obstructive Femoropopliteal Lesions

Background: Endovascular therapy is one of the standard treatment options for patients with peripheral arterial disease. Paclitaxel-eluting stents (PES) have shown promising results in the treatment of obstructive femoropopliteal lesions. Two types of PES, namely, Zilver PTX (Cook Medical, USA) and Eluvia (Boston Scientific, USA), are available worldwide. However, no study has yet compared the outcomes of applying both PES types in the real world. Objectives: This study aimed to assess the one-year outcomes of two different types of PES for Trans-Atlantic Inter-Society Consensus Document (TASC) C/D obstructive femoropopliteal lesions following suboptimal angioplasty. Patients and Methods: This single-center, retrospective, observational study examined 37 limbs of 34 patients (30 males and four females) with the mean age of 71.9 ± 9.1 years (range, 53-90 years), who were included consecutively from February 2017 to May 2018. In all patients, either a Zilver PTX (Cook Medical) or an Eluvia (Boston Scientific) PES was used for TASC C/D obstructive femoropopliteal lesions following suboptimal angioplasty. Moreover, the patients’ one-year primary patency rate, freedom from clinically driven target lesion revascularization (TLR), and event-free survival rates were determined. Results: The mean lesion length was measured to be 24.6 ± 6.6 cm (range, 9 - 46 cm). Based on the results, 78% of the lesions (29 limbs) showed occlusion, and 46% (17 limbs) showed more than moderate calcification. According to the TASC classification, type D lesions were detected in 25 (68%) limbs, while type C lesions were detected in 12 (32%) limbs. The mean number of stents used was 2.5 ± 0.7 per limb (range, 1 - 3) to cover a mean length of 24.3 ± 7.9 cm (range, 6-35 cm). Overall, 56 Zilver PTX stents for 23 limbs and 36 Eluvia stents for 14 limbs were used. The Kaplan-Meier estimates of one-year primary patency and freedom from TLR were 78% and 88%, respectively (Zilver PTX stent, 76.3% and 81.2%, respectively; Eluvia stent, 91.7% and 100%, respectively). Major adverse events were reported in two patients (2/37, 5.4%), including acute thrombotic occlusion of the treated lesions. Conclusion: Both types of PES showed promising one-year outcomes for TASC C/D lesions regarding safety and efficacy, without any significant differences; therefore, they can be considered as an alternative therapeutic approach for surgery.

Clinical Outcome of Drug-Eluted Stenting (Zilver PTX) in Patients With Femoropopliteal Occlusive Disease a Single Center Experience

Background: Few industry sponsored trials reported satisfactory outcomes in the use of drug-eluting stents (DES) for treatment of femoropopliteal arterial disease. This study analyzed the early/late clinical outcome from a real world single center. Patient Populations/Methods: A total of 115 limbs treated with Zilver PTX were analyzed for: major adverse limb event (MALE: above ankle limb amputation/major intervention at 1 year), major adverse events (MAEs; death, amputation, and target lesion thrombosis/reintervention), primary patency (based on duplex ultrasound ± ankle brachial indexes), limb salvage, and amputation free survival rates (AFS) at 1 and 2 years. Results: Indications included claudication in 32% and critical limb threatening ischemia (CLTI) in 68%. Lesions treated included: superficial femoral artery (SFA) 66%, both SFA and popliteal artery (PA) 19% and PA 15%. Mean lesion length was 21 cm and 68% had total occlusion. 45% were Trans-Atlantic Inter-Society Consensus (TASC) TASC II D lesions and 55% A–C lesions. Mean follow-up was 18.4 months (1–76 months). Perioperative major morbidity rate was 8.7% with 0% mortality. MALE rate at 1 year was 17% (13.5% for claudication vs 19.2% for CLTI, p=0.4499). MAE rate was 30% for claudication versus 52% for CLTI (p=0.0392). Overall primary patency rates at 1 and 2 years were 75% and 54% (86% and 71% for claudication vs 70% and 46% for CLTI, respectively, p=0.0213). Primary patency rates at 1 and 2 years were 94% and 88% for TASC A-C lesions versus 50% and 16% for TASC D lesions (p<0.0001). Overall freedom from MALE rate at 1 and 2 years were 85% and 79% (86% and 86% for claudication vs 84% and 74% for CLTI, p=0.2391). These rates were 96% and 93% for TASC A-C lesions versus 70% and 50% for D lesions, respectively (p<0.0001). Limb salvage rates at 1 and 2 years were 93% and 86% (100% and 100% for claudication vs 89% and 78% for CLTI, p=0.012). Overall AFS rates at 1 and 2 years were 79% and 71% (93% and 82% for TASC A–C vs 59% and 59% for D lesions, p=0.001). Conclusion: Clinical outcomes after DES (Zilver PTX) in femoropopliteal arterial lesions were satisfactory for TASC A–C lesions but inferior/unsatisfactory for TASC D lesions.

24-Month Efficacy and Safety Results from Japanese Patients in the IMPERIAL Randomized Study of the Eluvia Drug-Eluting Stent and the Zilver PTX Drug-Coated Stent

Purpose The purpose of the study is to report 24-month efficacy and safety results for the Japanese patient cohort in a prospective randomized controlled trial (RCT) of drug-eluting stent (DES) use for peripheral artery disease. Materials and methods Patients in the global IMPERIAL RCT had femoropopliteal lesions treated with either the Eluvia DES (Boston Scientific, Marlborough, MA, USA) or the Zilver PTX drug-coated stent (Cook Medical, Bloomington, IN, USA). At 24 months, assessments included duplex ultrasound imaging for core laboratory vessel patency measurement, target lesion revascularization (TLR) rates, and clinical outcome measures. Results The Japanese cohort included 84 patients (56 treated with Eluvia and 28 with Zilver PTX). The clinically driven TLR rates were 5.6% (3/54) and 18.5% (5/27) for patients treated with Eluvia and Zilver PTX, respectively (difference -13.0%, 95%CI -28.8, 2.9%; p = 0.11). The Kaplan–Meier estimates for freedom from clinically driven TLR at 24 months were 94.3% for patients who received Eluvia and 80.4% for those who received Zilver PTX (log rank p = 0.05), and for primary patency they were 88.5% and 80.4%, respectively (log rank p = 0.28). Mortality rates were 5.6% (3/54) and 11.1% (3/27); p = 0.39. Rutherford classification improved by at least one category without TLR for 91.8% (45/49) and 68.2% (15/22) of patients (p = 0.03). Walking impairment score improvements were sustained over time. Conclusion The results at 24 months support the efficacy and safety of DES in Japanese patients, with sustained clinical improvements and numerically fewer reinterventions for those treated with Eluvia. Clinical trial Registration Clinicaltrials.gov identifier NCT02574481.https://clinicaltrials.gov/ct2/show/NCT02574481 Level of Evidence EBM Level III; cohort analysis of randomized trial.

A Budget Impact Model for the use of Drug-Eluting Stents in Patients with Symptomatic Lower-Limb Peripheral Arterial Disease: An Australian Perspective

Purpose Improvement in long-term outcomes through innovative, cost-effective medical technologies is a focus for endovascular procedures aimed at treating symptomatic lower-limb peripheral arterial disease (PAD). The advent of drug-eluting stents (DES) has improved symptomatic PAD treatment via a reduction in high rates of target lesion revascularisation (TLR). The present study aimed to compare the 5-year financial impact of treatment with Eluvia, a new paclitaxel-eluting stent, versus treatment with Zilver PTX, a drug-coated stent, among patients in Australia by developing a budget impact model (BIM). Methods A BIM was developed from an Australian public hospital payer perspective using Australian national cost weights (AUD), published literature, and public hospital audit data. Clinical outcomes, including clinically driven TLRs (CD-TLRs), adverse events, and length of stay, were based on the 2-year results of the IMPERIAL trial, which compared Eluvia DES to Zilver PTX. Results Assuming EVP eligibility rate of 80% and DES uses rate ranging from 10 to 28% (superficial femoral artery lesions only), the 5-year model forecasted a treatment population between 14,428 and 40,399 patients. The model estimated 1499–4198 fewer CD-TLRs and 16,515–46,243 fewer hospital days with Eluvia DES use. This translated to 5-year potential savings of $4.3–$12.1 million to the Australian public hospital payer attributable to reduced CD-TLRs for Eluvia DES and $33.1–$92.6 million to Australian public hospitals owing to reduced adverse events and hospital bed days. Conclusion Eluvia DES use as treatment for symptomatic lower-limb PAD could lead to potential savings for the Australian public healthcare system based on improved patient outcomes.

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

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

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.

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

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.

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

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&lt;0.0001), age (p&lt;0.0001), gender (p=0.001), renal failure (p&lt;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