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

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.

Download Full-text

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

CardioVascular and Interventional Radiology ◽

10.1007/s00270-020-02693-1 ◽

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

Download Full-text

Efficacy and safety of 12 versus 48 months of dual antiplatelet therapy after implantation of a drug-eluting stent: the OPTImal DUAL antiplatelet therapy (OPTIDUAL) trial: study protocol for a randomized controlled trial

Trials ◽

10.1186/1745-6215-14-56 ◽

2013 ◽

Vol 14 (1) ◽

pp. 56 ◽

Cited By ~ 11

Author(s):

Gérard Helft ◽

Claude Le Feuvre ◽

Jean Louis Georges ◽

Didier Carrie ◽

Florence Leclercq ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Antiplatelet Therapy ◽

Study Protocol ◽

Dual Antiplatelet Therapy ◽

Controlled Trial ◽

Drug Eluting Stent ◽

Efficacy And Safety ◽

Randomized Controlled ◽

Drug Eluting

Download Full-text

Paclitaxel-Coated Zilver PTX Drug-Eluting Stent Treatment Does Not Result in Increased Long-Term All-Cause Mortality Compared to Uncoated Devices

CardioVascular and Interventional Radiology ◽

10.1007/s00270-019-02324-4 ◽

2019 ◽

Vol 43 (1) ◽

pp. 8-19 ◽

Cited By ~ 11

Author(s):

Michael D. Dake ◽

Gary M. Ansel ◽

Marc Bosiers ◽

Andrew Holden ◽

Osamu Iida ◽

...

Keyword(s):

Controlled Trial ◽

Drug Eluting Stent ◽

Randomized Controlled ◽

Level Data ◽

All Cause Mortality ◽

Post Market ◽

Drug Eluting ◽

Zilver Ptx

Abstract Purpose Patient-level data from two large studies of the Zilver PTX drug-eluting stent (DES) with long-term follow-up and concurrent non-drug comparator groups were analyzed to determine whether there was an increased mortality risk due to paclitaxel. Methods Data from the Zilver PTX randomized controlled trial (RCT) and Zilver PTX and bare metal stent (BMS) Japan post-market surveillance studies were analyzed. Five-year follow-up is complete in both DES studies; follow-up for the BMS study was limited to 3 years and is complete. Kaplan–Meier analyses assessed mortality. A Cox proportional hazards model identified significant factors related to mortality. Results In the RCT, there were 336 patients treated with the DES and 143 patients treated with percutaneous transluminal angioplasty (PTA) or BMS. In Japan, there were 904 DES patients and 190 BMS patients. There was no difference in all-cause mortality for the DES compared to PTA/BMS in the RCT (19.1% DES versus 17.1% PTA/BMS through 5 years, p = 0.60) or Japan (15.8% DES versus 15.3% BMS through 3 years, p = 0.89). Cox proportional hazard models revealed that age, tissue loss, and congestive heart failure were significantly associated with mortality in the RCT, and critical limb ischemia, age, renal failure, and gender were significantly associated with mortality in Japan (all p < 0.05). Neither treatment with Zilver PTX (p = 0.46 RCT, p = 0.49 Japan) nor paclitaxel dose (p = 0.86 RCT, p = 0.07 Japan) was associated with mortality. Conclusion Analyses of the Zilver PTX patient-level data demonstrated no increase in long-term all-cause mortality. Level of Evidence Zilver PTX RCT: Level 1, randomized controlled trial; Japan PMS studies: Level 3, post-market surveillance study.

Download Full-text

Efficacy and safety of low-dose clopidogrel in Japanese patients after drug-eluting stent implantation: a randomized pilot trial

Heart and Vessels ◽

10.1007/s00380-012-0318-6 ◽

2012 ◽

Vol 29 (1) ◽

pp. 1-6 ◽

Cited By ~ 2

Author(s):

Kenji Ohkubo ◽

Yoshihide Fujimoto ◽

Yo Iwata ◽

Hideki Kitahara ◽

Tadayuki Kadohira ◽

...

Keyword(s):

Stent Implantation ◽

Low Dose ◽

Pilot Trial ◽

Japanese Patients ◽

Drug Eluting Stent ◽

Efficacy And Safety ◽

Drug Eluting

Download Full-text

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

Current Pharmaceutical Design ◽

10.2174/1381612826666200625110349 ◽

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.

Download Full-text

A Randomized, Placebo‐controlled Trial to Assess the Efficacy and Safety of Sitagliptin in Japanese Patients with Type 2 Diabetes and Inadequate Glycemic Control on Ipragliflozin

Diabetes Obesity and Metabolism ◽

10.1111/dom.14346 ◽

2021 ◽

Author(s):

Yutaka Seino ◽

Kohei Kaku ◽

Takashi Kadowaki ◽

Taro Okamoto ◽

Asako Sato ◽

...

Keyword(s):

Type 2 Diabetes ◽

Glycemic Control ◽

Controlled Trial ◽

Japanese Patients ◽

Efficacy And Safety ◽

Inadequate Glycemic Control

Download Full-text

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

Journal of Endovascular Therapy ◽

10.1177/1526602816666261 ◽

2016 ◽

Vol 23 (6) ◽

pp. 889-895 ◽

Cited By ~ 12

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.

Download Full-text

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

JACC Cardiovascular Interventions ◽

10.1016/j.jcin.2015.01.031 ◽

2015 ◽

Vol 8 (7) ◽

pp. 877-884 ◽

Cited By ~ 64

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

Download Full-text

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

International Journal of Technology Assessment in Health Care ◽

10.1017/s0266462320001609 ◽

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.

Download Full-text