Long-Term Effectiveness of a Drug-Eluting Stent for Femoropopliteal In-Stent Restenosis: Subanalysis of the Zilver PTX Japan Post-Market Surveillance Study

2020 ◽  
pp. 152660282096670
Author(s):  
Masayuki Sugimoto ◽  
Kimihiro Komori ◽  
Hiroyoshi Yokoi ◽  
Takao Ohki ◽  
Kimihiko Kichikawa ◽  
...  
Keyword(s):  
Clinical Benefit ◽  
Drug Eluting Stent ◽  
Market Surveillance ◽  
Stent Restenosis ◽  
Post Market Surveillance ◽  
All Cause Mortality ◽  
Post Market ◽  
Drug Eluting ◽  
Zilver Ptx ◽  
In Stent Restenosis

Purpose To present a subgroup analysis of patients from a large real-world study evaluating the safety and effectiveness of the Zilver PTX drug-eluting stent (DES) for treating femoropopliteal in-stent restenosis (ISR). Materials and Methods This study examined patients enrolled in the Zilver PTX Japan Post-Market Surveillance Study ( ClinicalTrials.gov identifier NCT02254837), a prospective, multicenter registry of 904 symptomatic patients with 1082 femoropopliteal lesions treated with the DES at 95 institutions in Japan. Five-year outcomes, including mortality, stent radiography, freedom from target lesion revascularization (TLR), and clinical benefit, were evaluated for 177 patients (mean age 74.2±8.3 years; 118 men) with 204 ISR lesions treated with the Zilver DES. Over half of the patients (108, 61.0%) were diabetic. Mean lesion length was 17.8±10.4 cm, and a third (72, 35.3%) were total occlusions. Outcome measures were all-cause mortality, thrombosis, freedom from TLR, and clinical benefit, defined as freedom from persistent or deteriorating ischemic symptoms. Results No device-related or procedure-related deaths or paclitaxel-related adverse events were reported. All-cause mortality was 25.1% at 5 years. Stent fracture was observed in 5 stents through 5 years. The 5-year rate of freedom from clinically-driven TLR was 73.4%, and the rate of clinical benefit was 63.6%. Improvement in Rutherford category and ankle-brachial index was sustained through 5 years. Conclusion The safety and effectiveness of the Zilver PTX stent for the treatment of femoropopliteal ISR lesions demonstrated that this device provides a favorable treatment option in this difficult-to-treat subgroup.

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.

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

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

2019 ◽  
Vol 43 (1) ◽  
pp. 8-19 ◽  
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.

Abstract 11277: Comparison Among Drug-Eluting Balloon, Drug-Eluting Stent, and Plain Balloon Angioplasty for Treatment of In-Stent Restenosis: A Network Meta-Analysis of 11 Randomized Controlled Trials

Circulation ◽  
2014 ◽  
Vol 130 (suppl_2) ◽  
Author(s):  
Jonghanne Park ◽  
Joo Myung Lee ◽  
Jeehoon Kang ◽  
Ki-Hyun Jeon ◽  
Ji-hyun Jung ◽  
...  
Keyword(s):  
Meta Analysis ◽  
Statistical Significance ◽  
Drug Eluting Stent ◽  
Controlled Trials ◽  
Randomized Controlled ◽  
Stent Restenosis ◽  
All Cause Mortality ◽  
Drug Eluting ◽  
Drug Eluting Balloon ◽  
In Stent Restenosis

Objective: The optimal treatment option for in-stent restenosis (ISR) is not established. We performed a Bayesian network meta-analysis comparing the efficacy and safety of drug-eluting balloon (DEB), drug-eluting stent (DES) or plain old balloon angioplasty (POBA) for treatment of ISR. Design: Systemic review and Bayesian network meta-analysis using random-effects model. The primary outcome was target lesion revascularization (TLR). The secondary outcomes were myocardial infarction (MI), all-cause mortality or major adverse cardiovascular events (MACE). The pairwise posterior median odds ratio (OR) with 95% credible interval (CrI) was the effect measure. Data Sources: PubMed, EMBASE, BioMed Central, Cochrane Central Register of Controlled Trials, ClinicalTrials.gov, conference proceedings through February 2014. Eligibility Criteria for Selecting Studies: Randomized controlled trials (RCTs) comparing DEB, DES, or POBA for treatment of ISR. Results: This analysis included 2,059 patients from 11 RCTs. The risk of TLR was markedly lower in patients treated with DEB (OR 0.22, 95% CrI 0.10-0.42) or DES (OR 0.24, 95% CrI 0.11-0.47) than in those treated with POBA. The risk of TLR (OR 0.92, 95% CrI 0.43-1.90) was similar between DEB and DES. The risk of MI or all-cause mortality was lowest in the DEB group compared with DES or POBA, which did not meet statistical significance. The risk of MACE was significantly lower in DEB (OR 0.24, 95% CrI 0.12-0.39) or DES (OR 0.28, 95% CrI 0.14-0.53) than in POBA, but it was similar between DEB and DES group (OR 0.84, 95% CrI 0.45-1.50). The probability to be ranked as the best treatment were 59.9% (DEB), 40.1% (DES), and 0.1% (POBA) in terms of TLR, whereas, 63.0% (DEB), 35.3% (POBA), and 1.7% (DES) in terms of MI. Conclusions: DEB or DES was markedly better than POBA in preventing TLR, but not for MI or mortality in treatment of ISR. DEB resulted in less MI than DES without statistical significance.

scholarly journals Paclitaxel-coated balloon angioplasty vs. drug-eluting stenting for the treatment of coronary in-stent restenosis: a comprehensive, collaborative, individual patient data meta-analysis of 10 randomized clinical trials (DAEDALUS study)

2019 ◽  
Vol 41 (38) ◽  
pp. 3715-3728 ◽  
Author(s):  
Daniele Giacoppo ◽  
Fernando Alfonso ◽  
Bo Xu ◽  
Bimmer E P M Claessen ◽  
Tom Adriaenssens ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Randomized Clinical Trials ◽  
Meta Analysis ◽  
Target Lesion ◽  
Drug Eluting Stent ◽  
Stent Restenosis ◽  
All Cause Mortality ◽  
Drug Eluting ◽  
In Stent Restenosis

Abstract Aims Consensus is lacking regarding the best treatment for coronary in-stent restenosis (ISR). The two most effective treatments are angioplasty with paclitaxel-coated balloon (PCB) and repeat stenting with drug-eluting stent (DES) but individual trials were not statistically powered for clinical endpoints, results were heterogeneous, and evidence about comparative efficacy and safety in relevant subsets was limited. Methods and results The Difference in Anti-restenotic Effectiveness of Drug-eluting stent and drug-coated balloon AngiopLasty for the occUrrence of coronary in-Stent restenosis (DAEDALUS) study was a comprehensive, investigator-initiated, collaborative, individual patient data meta-analysis comparing angioplasty with PCB alone vs. repeat stenting with DES alone for the treatment of coronary ISR. The protocol was registered with PROSPERO (CRD42017075007). All 10 available randomized clinical trials were included with 1976 patients enrolled, 1033 assigned to PCB and 943 to DES. At 3-year follow-up, PCB was associated with a significant increase in the risk of target lesion revascularization (TLR) compared with DES [hazard ratio (HR) 1.32, 95% CI 1.02–1.70, P = 0.035; number-needed-to-harm 28.5]. There was a significant interaction between treatment effect and type of restenosed stent (P = 0.029) with a more marked difference in patients with DES-ISR and comparable effects in patients with bare-metal stent-ISR. At 3-year follow-up, the primary safety endpoint of all-cause death, myocardial infarction, or target lesion thrombosis was comparable between treatments (HR 0.80, 95% CI 0.58–1.09, P = 0.152). A pre-specified subgroup analysis indicated a significant interaction between treatment effect and type of DES used to treat ISR (P = 0.033), with a lower incidence of events associated with PCB compared with first-generation DES and similar effect between PCB and second-generation DES (HR 1.06, 95% CI 0.71–1.60, P = 0.764). Long-term all-cause mortality was similar between PCB and DES (HR 0.81, 95% CI 0.53–1.22, P = 0.310); results were consistent comparing PCB and non-paclitaxel-based DES (HR 1.42, 95% CI 0.80–2.54, P = 0.235). Myocardial infarction and target lesion thrombosis were comparable between treatments. Conclusions In patients with coronary ISR, repeat stenting with DES is moderately more effective than angioplasty with PCB at reducing the need for TLR at 3 years. The incidence of a composite of all-cause death, myocardial infarction, or target lesion thrombosis was similar between groups. The rates of individual endpoints, including all-cause mortality, were not significantly different between groups.

scholarly journals TCTAP A-030 Drug Coated Balloon Versus Drug-eluting Stent for In-stent Restenosis After Drug-eluting Stent Implantation: A Meta-analysis

2021 ◽  
Vol 77 (14) ◽  
pp. S19
Author(s):  
Hendy Bhaskara Perdana Putra ◽  
Quri Meihaerani Savitri ◽  
Wally Wahyu Mukhammad ◽  
Atiyatum Billah ◽  
Alan Dharmasaputra ◽  
...  
Keyword(s):  
Stent Implantation ◽  
Meta Analysis ◽  
Drug Eluting Stent ◽  
Stent Restenosis ◽  
Drug Eluting ◽  
Drug Coated Balloon ◽  
In Stent Restenosis

The effect of REDV/TiO2 coating coronary stents on in-stent restenosis and re-endothelialization

2016 ◽  
Vol 31 (6) ◽  
pp. 911-922 ◽  
Author(s):  
Xiangshan Xu ◽  
Lijie Wang ◽  
Guofeng Wang ◽  
Yuanzhe Jin
Keyword(s):  
Metal Ion ◽  
316L Stainless Steel ◽  
Ceramic Coating ◽  
Bare Metal Stent ◽  
Drug Eluting Stent ◽  
Bare Metal ◽  
Metal Stent ◽  
Stent Restenosis ◽  
Drug Eluting ◽  
In Stent Restenosis

The coronary artery stent has been widely used in clinic. In-stent restenosis was mainly caused by the excessive proliferation of smooth muscle cell and the inflammation due to the metal ion released from stent scaffold of the drug-eluting stent. Thus, to reduce the in-stent restenosis and promote the vascular endothelialization have become a hot research point in this area. In this paper, a nano-TiO2 ceramic coating was deposited on 316L stainless steel to reduce the metal ion release and to inhibit the inflammation reaction. An endothelia cell selective adhesion peptide Arg-Glu-Asp-Val (REDV) coating was prepared on the ceramic coating by a polydopamine technology to promote the endothelialization. The corrosion test indicated that nano-TiO2 ceramic film could effectively decrease the nickel ion released from 316L stainless steel. REDV/TiO2 coating could promote the endothelial cell adhesion and proliferation, meanwhile REDV/TiO2 coating could also increase the nitric oxide concentration. Bare metal stent, TiO2-coated stent and REDV/TiO2-coated stent were implanted in the iliac arteries of rabbit model. In-stent restenosis and re-endothelialization were evaluated at 28 days post-implantation of the stents. The results showed that REDV/TiO2-coated stents could effectively reduce in-stent restenosis and promote re-endothelialization in comparison with TiO2-coated drug-eluting stent and bare metal stent. These results suggest that REDV/TiO2-coated drug-eluting stent maybe a good choice of the application for coronary artery disease.

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