Full Drug-Eluting Stent Jacket: Two-Year Results of a Single-Center Experience With Zilver PTX Stenting for Long Lesions in the Femoropopliteal Arteries

2018 ◽  
Vol 25 (3) ◽  
pp. 295-301 ◽  
Author(s):  
John A. Phillips ◽  
Anna Falls ◽  
Raghu Kolluri ◽  
Aaron Whipp ◽  
Christy Collins ◽  
...  
Keyword(s):  
Velocity Ratio ◽  
Peak Systolic Velocity ◽  
Major Amputation ◽  
Lesion Group ◽  
Drug Eluting Stent ◽  
Lesion Length ◽  
Entire Cohort ◽  
Single Center Experience ◽  
Drug Eluting ◽  
Zilver Ptx

Purpose: To evaluate the 1- and 2-year patency and reintervention rates with the Zilver PTX drug-eluting stent (DES) in long complex femoropopliteal disease. Methods: A retrospective review was conducted of 89 consecutive patients (mean age 68.7±9.8 years; 86 men) with femoropopliteal occlusive disease (Rutherford category 2–6) treated with the Zilver PTX between December 2012 and December 2013. Mean lesion length for the entire cohort was 24.2±11.3 cm (median 24.0, range 4–48). The patient population was dichotomized into a short lesion (≤20 cm) group (n=41; mean lesion length 13.3±5.6 cm) and the full DES jacket (>20 cm) group (n=48; mean lesion length 33.0±6.5 cm). Primary endpoints were duplex-derived restenosis (peak systolic velocity ratio >2.5), clinically driven reintervention, and major amputation. Results: The incidence of restenosis was lower in the short lesion group at 1 year (19% vs 40% for the longer lesions, p=0.050) and 2 years (39% vs 54%, respectively; p=0.331). The short lesion group had significantly lower rates of reintervention at both 1 year (2% vs 21% in long lesions, p=0.009) and 2 years (12% vs 33%, p=0.019). Conclusion: Treatment of femoropopliteal lesions >20 cm with the Zilver PTX appears to be a clinically effective therapy for patients with symptomatic peripheral artery disease. However, there is an increase in restenosis and a need for reintervention that continues to progress up to 2 years.

scholarly journals Effectiveness and Safety of a Paclitaxel-Eluting Stent for Superficial Femoral Artery Lesions up to 190 mm: One-Year Outcomes of the Single-Arm IMPERIAL Long Lesion Substudy of the Eluvia Drug-Eluting Stent

2020 ◽  
Vol 27 (2) ◽  
pp. 296-303 ◽  
Author(s):  
Jaafer Golzar ◽  
Yoshimitsu Soga ◽  
Anvar Babaev ◽  
Osamu Iida ◽  
Daizo Kawasaki ◽  
...  
Keyword(s):  
Velocity Ratio ◽  
Peak Systolic Velocity ◽  
Duplex Ultrasound ◽  
Target Lesion ◽  
Primary Patency ◽  
Occlusive Disease ◽  
Target Lesion Revascularization ◽  
Drug Eluting Stent ◽  
Kaplan Meier ◽  
Drug Eluting

Purpose: To report the clinical effect of a drug-eluting stent on femoropopliteal occlusive disease in patients with long lesions. Materials and Methods: The global IMPERIAL Long Lesion substudy ( ClinicalTrials.gov identifier NCT02574481) is a prospective, single-arm, multicenter trial of the Eluvia Drug-Eluting Vascular Stent for treating femoropopliteal lesions >140 mm and ≤190 mm in length. Fifty patients (mean age 68.2 years; 32 men) with long lesions (mean length 162.8±34.7 mm) were enrolled; 20 patients had diabetes. Fourteen of the lesions were severely calcified and 16 were occluded. Primary patency (duplex ultrasound peak systolic velocity ratio ≤2.4 in the absence of clinically-driven target lesion revascularization or bypass of the target lesion) and major adverse events [30-day all-cause death and 1-year target limb major amputation or target lesion revascularization (TLR)] were assessed at 12 months. Results: At 12 months, no deaths, target limb amputations, or stent thrombosis had occurred. The Kaplan-Meier estimate of primary patency was 91.0% (95% CI 82.5% to 99.6%). The MAE-free rate at 12 months was 93.5% due to 3 clinically-driven TLRs. The corresponding Kaplan-Meier estimate of freedom from TLR was 93.9% (95% CI 87.2% to 100%). Conclusion: The IMPERIAL Long Lesion substudy demonstrated excellent patency and safety through 1 year among patients with long femoropopliteal occlusive disease treated with the Eluvia stent.

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.

Abstract 2524: Long-Term (4 year) Outcome following Drug Eluting Stent Implantation versus Coronary Artery By-pass Surgery in Unprotected Left Main Coronary artery Lesions

Circulation ◽  
2008 ◽  
Vol 118 (suppl_18) ◽  
Author(s):  
Alaide Chieffo ◽  
Valeria Magni ◽  
Francesco Maisano ◽  
Alfonso Ielasi ◽  
Azeem Latib ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Coronary Artery ◽  
Composite Endpoint ◽  
Drug Eluting Stent ◽  
Target Vessel Revascularization ◽  
Single Center Experience ◽  
Cerebrovascular Events ◽  
Drug Eluting ◽  
One Year

One-year outcome following drug-eluting stent (DES) implantation versus coronary artery by-pass grafting (CABG) in unprotected LMCA lesions have been previously reported from our center. Methods and results Two hundred forty-nine consecutive patients with an unprotected LMCA stenosis electively treated (107 with PCI and DES implantation and 142 with CABG) in our Center, between March 2002 and July 2004, were analysed. Hierarchical study end points were occurrence at 4 years of: death; death and/or myocardial infarction (MI); death, MI and/or stroke; target vessel revascularization (TVR, defined as any revascularization in left coronary system); and major cardiac cerebrovascular events (MACCE). A propensity analysis was performed to adjust for baseline differences between the two cohorts. At 4 year-clinical follow-up, no difference was found between PCI and CABG in the occurrence of death (respectively 12.0% vs. 14.1%; unadjusted odds ratio- OR=0.845; 95% confidence interval-CI=0.365 to 1.890; P=0.80; adjusted OR=0.652; 95% CI=0.254 to 1.620; P=0.42). At adjusted analysis, PCI group showed a trend toward a lower occurrence of the composite endpoint of death and myocardial infarction (13.0% vs. 19.7%; adjusted OR=0.461; 95% CI=0.180 to 1.088; P=0.08). PCI was associated with a lower rate of the composite endpoint of death, MI and/or stroke (respectively 14.0% vs. 22.5%; unadjusted OR=0.519; 95% CI=0.238to 1.071; P=0.07; adjusted OR=0.431; 95% CI=0.175 to 0.971; P=0.04). Indeed, CABG was correlated to lower TVR (8.4% vs. 28% ; unadjusted OR= 5.018; 95% CI= 1.990-23.8; p=0.0001; adjusted OR= 5.928; 95% CI= 1.933 – 38.0; p= 0.0003). No difference was detected in the occurrence of MACCE ( in PCI 36.4% vs. 28.1% in CABG, unadjusted OR=1.409; 95% CI=0.798 to 2.509 P=0.259; adjusted OR=1.438; 95% CI=0.754 to 2.766; P=0.3007). Conclusions At 4 year-clinical follow-up, in this single-center experience, there was still no difference in the occurrence of MACCE between elective PCI with DES implantation and CABG in LMCA lesions. There was an advantage of PCI in the composite endpoint of death, MI and/or stroke, while a benefit in the need for reintervention was still found in CABG. :

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.

ZILVERPASS Study: ZILVER PTX Stent vs Bypass Surgery in Femoropopliteal Lesions

2020 ◽  
Vol 27 (2) ◽  
pp. 287-295 ◽  
Author(s):  
Marc Bosiers ◽  
Carlo Setacci ◽  
Gianmarco De Donato ◽  
Giovanni Torsello ◽  
Pierre Galvagni Silveira ◽  
...  
Keyword(s):  
Treatment Group ◽  
Complication Rate ◽  
Bypass Surgery ◽  
Velocity Ratio ◽  
Bypass Graft ◽  
Peak Systolic Velocity ◽  
Target Lesion ◽  
Primary Patency ◽  
Surgical Bypass ◽  
Zilver Ptx

Purpose: To report the 12-month results of a multicenter, prospective, randomized controlled trial to determine if the ZILVER PTX paclitaxel-eluting stent was noninferior in terms of safety and efficacy compared with surgical bypass. Materials and Methods: This is a study in symptomatic TransAtlantic Inter-Society Consensus (TASC) C and D femoropopliteal lesions comparing endovascular ZILVER PTX stenting vs surgical bypass surgery using a prosthetic graft ( ClinicalTrials.gov identifier NCT01952457). Between October 2013 and July 2017, 220 patients (mean age 68.6±10.5 years; 159 men) were enrolled and randomized to the ZILVER PTX treatment group (113, 51.4%) or the bypass treatment group (107, 48.6%). Most of the lesions were occlusions (208, 94.5%); the mean lesion length was 247.1±69.3 mm. The primary outcome measure was primary patency at 12 months, defined as no evidence of binary restenosis or occlusion within the target lesion or bypass graft based on a duplex-derived peak systolic velocity ratio <2.4 and no clinically-driven target lesion revascularization (TLR) in endovascular cases or reintervention to restore flow in the bypass. Results: The estimated 12-month primary patency rate was 74.5% (95% CI 66.3% to 82.7%) for the ZILVER PTX group vs 72.5% (95% CI 63.7% to 81.3%) for the bypass arm (p=0.998). Freedom from TLR at 12 months was 80.9% (95% CI 73.3% to 88.5%) for the ZILVER PTX group vs 76.2% (95% CI 68.0% to 84.4%) for the bypass group (p=0.471). The 30-day complication rate was significantly lower in the ZILVER PTX group (4.4% vs 11.3%, p=0.004). Also, procedure time and hospital stay were significantly shorter in the ZILVER PTX group (p<0.001 for both). Conclusion: With noninferior patency results, a lower complication rate, and shorter procedures and hospital stays, paclitaxel-eluting stenting might become a recommended treatment for long TASC C and D femoropopliteal lesions.

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.

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