Two-Year Efficacy and Safety Results from the IMPERIAL Randomized Study of the Eluvia Polymer-Coated Drug-Eluting Stent and the Zilver PTX Polymer-free Drug-Coated Stent

2020 ◽  
Author(s):  
Stefan Müller-Hülsbeck ◽  
Andrew Benko ◽  
Yoshimitsu Soga ◽  
Masahiko Fujihara ◽  
Osamu Iida ◽  
...  
Keyword(s):  
Randomized Study ◽  
Free Drug ◽  
Drug Eluting Stent ◽  
Efficacy And Safety ◽  
Drug Eluting ◽  
Zilver Ptx

scholarly journals 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

2021 ◽  
Author(s):  
Osamu Iida ◽  
Masahiko Fujihara ◽  
Daizo Kawasaki ◽  
Shinsuke Mori ◽  
Hiroyoshi Yokoi ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Cohort Analysis ◽  
Randomized Study ◽  
Japanese Patients ◽  
Drug Eluting Stent ◽  
Efficacy And Safety ◽  
Level Of Evidence ◽  
Clinical Trial Registration ◽  
Drug Eluting ◽  
Zilver Ptx

Abstract 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.

Comparative Efficacy and Safety of Duration of Dual Antiplatelet Therapy in Patients with CAD Undergoing Drug-eluting Stent Implantation: A Systematic Review and Network Meta-analysis

2020 ◽  
Vol 26 (44) ◽  
pp. 5739-5745
Author(s):  
Jieqiong Guan ◽  
Wenjing Song ◽  
Pan He ◽  
Siyu Fan ◽  
Hong Zhi ◽  
...  
Keyword(s):  
Antiplatelet Therapy ◽  
Major Bleeding ◽  
Dual Antiplatelet Therapy ◽  
Meta Analysis ◽  
Cochrane Library ◽  
Drug Eluting Stent ◽  
Efficacy And Safety ◽  
Risk Of Bleeding ◽  
Increased Risk ◽  
Drug Eluting

Objective: The aim was to evaluate the efficacy and safety of duration of dual antiplatelet therapy (DAPT) for patients who received percutaneous coronary intervention (PCI) with a drug-eluting stent. Background: The optimal duration of DAPT to balance the risk of ischemia and bleeding in CAD patients undergoing drug-eluting stent (DES) implantation remains controversial. Methods: PubMed, Cochrane Library, Web of Science, Clinicaltrials.gov, CNKI and Wanfang Databases were searched for randomized controlled trials of comparing different durations of DAPT after DES implantation. Primary outcomes were major adverse cardiac and cerebrovascular events (MACCE), and major bleeding, and were pooled by Bayes network meta-analysis. Net adverse clinical and cerebral events were used to estimate the surface under the cumulative ranking (SUCRA) curves. The subgroup analysis based on clinical status, follow-up and area was conducted using traditional pairwise meta-analysis. Results: A total of nineteen trials (n=51,035) were included, involving six duration strategies. The network metaanalysis showed that T2 (<6-month DAPT followed by aspirin, HR:1.51, 95%CI:1.02-2.22), T3 (standard 6-month DAPT, HR:1.47, 95%CI:1.14-1.91), T4 (standard 12-month DAPT, HR:1.41, 95%CI:1.15-1.75) and T5 (18-24 months DAPT, HR:1.47, 95%CI:1.09-1.97) was associated with significantly increased risk of MACCE compared to T6 (>24-month DAPT). However, no significant difference was found in MACCE risk between T1 (<6-month DAPT followed by P2Y12 monotherapy) and T6. Moreover, T5 was associated with significantly increased risk of bleeding compared to T1(RR:3.94, 95%CI:1.66-10.60), T2(RR:3.65, 95%CI:1.32-9.97), T3(RR:1.93, 95%CI:1.21-3.50) and T4(RR:1.89, 95%CI:1.15-3.30). The cumulative probabilities showed that T6(85.0%), T1(78.3%) and T4(44.5%) were the most efficacious treatment compared to the other durations. In the ACS (<50%) subgroup, T1 was observed to significantly reduce the risk of major bleeding compared to T4, but not in the ACS (≥50%) subgroup. Conclusions: Compared with other durations, short DAPT followed by P2Y12 inhibitor monotherapy showed non-inferiority, with a lower risk of bleeding and not associated with an increased MACCE. In addition, the risk of major bleeding increased significantly, starting with DAPT for 18-month. Compared with the short-term treatment, patients with ACS with the standard 12-month treatment have a better prognosis, including lower bleeding rate and the decreased risk of MACCE. Due to study's limitations, the results should be verified in different risk populations.

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.

scholarly journals Long-Term Efficacy and Safety of Paclitaxel-Eluting Balloon for the Treatment of Drug-Eluting Stent Restenosis

2015 ◽  
Vol 8 (7) ◽  
pp. 877-884 ◽  
Author(s):  
Sebastian Kufner ◽  
Salvatore Cassese ◽  
Marco Valeskini ◽  
Franz-Josef Neumann ◽  
Stefanie Schulz-Schüpke ◽  
...  
Keyword(s):  
Drug Eluting Stent ◽  
Efficacy And Safety ◽  
Term Efficacy ◽  
Stent Restenosis ◽  
Drug Eluting

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.

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