Long-Term Effectiveness of the Zilver PTX Drug-Eluting Stent for Femoropopliteal Peripheral Artery Disease in Patients with No Patent Tibial Runoff Vessels—Results from the Zilver PTX Japan Post-Market Surveillance Study

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.

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Drug‐eluting stent, drug eluting balloon controversy in peripheral artery disease; what is the verdict?

Catheterization and Cardiovascular Interventions ◽

10.1002/ccd.29355 ◽

2020 ◽

Vol 96 (6) ◽

pp. 1315-1316

Author(s):

Ismail Dogu Kilic ◽

Mehmet Cilingiroglu

Keyword(s):

Peripheral Artery Disease ◽

Drug Eluting Stent ◽

Peripheral Artery ◽

Drug Eluting ◽

Artery Disease ◽

Drug Eluting Balloon

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PMU18 Budget IMPACT Analysis of the Eluvia Drug-Eluting Stent for Peripheral Artery Disease in Korea

Value in Health Regional Issues ◽

10.1016/j.vhri.2020.07.376 ◽

2020 ◽

Vol 22 ◽

pp. S72

Author(s):

S.W. Park ◽

T.V. Ariyaratne ◽

A. Peacock ◽

I. Deltetto ◽

S.J. Yoo ◽

...

Keyword(s):

Peripheral Artery Disease ◽

Impact Analysis ◽

Budget Impact ◽

Budget Impact Analysis ◽

Drug Eluting Stent ◽

Peripheral Artery ◽

Drug Eluting ◽

Artery Disease

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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

European Heart Journal ◽

10.1093/ehjci/ehaa946.2379 ◽

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

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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.

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