Zilver PTX Post-market Surveillance Study of Paclitaxel-Eluting Stents for Treating Femoropopliteal Artery Disease in Japan: 2-Year Results

Kichikawa, Kimihiko; Ichihashi, Shigeo; Yokoi, Hiroyoshi; Ohki, Takao; Nakamura, Masato; Komori, Kimihiro; Nanto, Shinsuke; O’Leary, Erin E.; Lottes, Aaron E.; Snyder, Scott A.; Dake, Michael D.

doi:10.1007/s00270-018-2110-1

Cited by 26 publications

(16 citation statements)

References 18 publications

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“…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 were evaluated in realworld patients with complex femoropopliteal artery lesions through 5 years [13,14]. Follow-up in the study is complete.…”

Section: Japan Post-market Surveillance Studymentioning

confidence: 99%

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

Dake

Ansel

Bosiers³

et al. 2019

Cardiovasc Intervent Radiol

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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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Section: Japan Post-market Surveillance Studymentioning

confidence: 99%

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

Dake

Ansel

Bosiers³

et al. 2019

Cardiovasc Intervent Radiol

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“…Table 1 lists real-world registries and single-center studies that have examined different endovascular treatments for complex femoropopliteal disease. 4,7–20 Clearly, the IN.PACT Global clinical cohort has complex disease presentations comparable to these other real-world studies. Unfortunately, we do not see homogeneity in the nomenclature for complex real-world femoropopliteal lesions across the different databases and registries.…”

Section: Putting the Study To The Testmentioning

confidence: 58%

“…Table 2 lists the studies with their efficacy and safety endpoints for BMS, DCBs, and drug-eluting stents (DES) in treating real-world femoropopliteal lesions. 4,9,10,13,17,17,20,24 The gap in the midterm data is filled in by the IN.PACT Global study. When performing a crude comparison to other treatment strategies, the IN.PACT Global study achieves impressive efficacy outcomes, which hold up well at 36 months.…”

Section: Putting the Study To The Testmentioning

confidence: 99%

Commentary: Leave Nothing Behind: No Stent, No Restenosis, No Mortality

2020

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It is well-known and often argued by practicing physicians that the highly selected patients in the randomized controlled trials (RCTs) of lower extremity arterial disease do not often match the patients encountered in real-world practice. 1 Therefore, it is imperative to review and understand real-world studies to see if the proof of concept is carried on from the RCTs to the ground reality. Drug-coated balloon (DCB) angioplasty for femoropopliteal arterial disease can be considered a landmark endovascular treatment strategy in the field of symptomatic lower extremity occlusive disease. 1,2 In the October 2020 issue of the JEVT, Torsello et al 4 present the 3-year outcomes of the IN.PACT Global study of DCB angioplasty in a real-world femoropopliteal cohort. To put these results into perspective, we need to thread back into history. The IN.PACT Global study 2 (ClinicalTrials.gov identifier NCT01609296) was designed to see how DCB angioplasty fared in real-world, complex femoropopliteal disease, including long lesions (≥15 cm), in-stent restenoses (ISR), chronic total occlusions (CTOs) ≥5 cm long, calcified lesions, and TransAtlantic Inter-Society Consensus (TASC) C/D lesions, as well as in the setting of poor runoff, popliteal artery involvement, and bilateral disease. The clinical presentation in the 1535 participants was consistent with claudication and chronic limb-threatening ischemia (CLTI). The first publication from the IN.PACT Global study, 5 in a 131-patient ISR subgroup (mean lesion length 17.17 cm, 34% CTOs, 59.1% with calcifications, 88% with diffuse ISR, and 42% with TASC C/D lesions), 5 found a 1-year clinically-driven target lesion revascularization (CD-TLR) rate of 7.3%, with estimated primary patency of 88.7%. The primary safety outcomes were achieved in 92.7%. The 2-year outcomes reported by Micari et al 6 on 1406 patients (1773 lesions) in the clinical cohort study were promising, with estimated freedom from CD-TLR as high as 83.3% and meeting the composite safety endpoint in 81.7%. It is reassuring to know that these positive results were sustained through 36 months, 4 with estimated freedom from CD-TLR at 76.9% and a composite safety endpoint of 75.6%. Notably, the death rate climbed from 7.0% at 24 months to 11.6% at 36 months.

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“…The global clinical program for the DES (Zilver PTX, Cook Medical, Bloomington, IN, USA) consists of multiple Cook-sponsored pre-market (i.e., Zilver PTX randomized controlled trial [RCT], single-arm study [SAS], and China study) and post-market clinical (i.e., US post-approval study [US PAS] and Japan post-market surveillance study [PMS]) studies. A detailed description of the study design, inclusion and exclusion criteria, and results have been previously published for three of the five trials included in this analysis [1,5,[8][9][10][11]. Table 1 describes the study characteristics for the five studies included in the current analysis.…”

Section: Methodsmentioning

confidence: 99%

Prediction Model for Freedom from TLR from a Multi-study Analysis of Long-Term Results with the Zilver PTX Drug-Eluting Peripheral Stent

Dake

Fanelli

Lottes

et al. 2020

Cardiovasc Intervent Radiol

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Purpose Develop a prediction model to determine the impact of patient and lesion factors on freedom from target lesion revascularization (ffTLR) for patients who are candidates for Zilver PTX drug-eluting stent (DES) treatment for femoropopliteal lesions. Methods Patient factors, lesion characteristics, and TLR results from five global studies were utilized for model development. Factors potentially associated with TLR (sex, age, diabetes, hypertension, hypercholesterolemia, renal disease, smoking status, Rutherford classification, lesion length, reference vessel diameter (RVD), popliteal involvement, total occlusion, calcification severity, prior interventions, and number of runoff vessels) were analyzed in a Cox proportional hazards model. Probability of ffTLR was generated for three example patient profiles via combinations of patient and lesion factors. TLR was defined as reintervention performed for ≥ 50% diameter stenosis after recurrent clinical symptoms. Results The model used records from 2227 patients. The median follow-up time was 23.9 months (range: 0.03–60.8). The Kaplan–Meier estimates for ffTLR were 90.5% through 1 year and 75.2% through 5 years. In a multivariate analysis, sex, age, Rutherford classification, lesion length, RVD, total occlusion, and prior interventions were significant factors. The example patient profiles have predicted 1-year ffTLRs of 97.4, 92.3, and 86.0% and 5-year predicted ffTLRs of 92.8, 79.5, and 64.8%. The prediction model is available as an interactive web-based tool (https://cooksfa.z13.web.core.windows.net). Conclusions This is the first prediction model that uses an extensive dataset to determine the impact of patient and lesion factors on ffTLR through 5 years and provides an interactive web-based tool for expected patient outcomes with the Zilver PTX DES. Clinical Trial Registrations Zilver PTX RCT unique identifier: NCT00120406; Zilver PTX single-arm study unique identifier: NCT01094678; Zilver PTX China study unique identifier: NCT02171962; Zilver PTX US post-approval study unique identifier: NCT01901289; Zilver PTX Japan post-market surveillance study unique identifier: NCT02254837. Levels of Evidence Zilver PTX RCT: Level 2, randomized controlled trial; Single-arm study: Level 4, large case series; China study: Level 4, case series; US post-approval study: Level 4, case series Japan PMS study: Level 4, large case series.

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Zilver PTX Post-market Surveillance Study of Paclitaxel-Eluting Stents for Treating Femoropopliteal Artery Disease in Japan: 2-Year Results

Cited by 26 publications

References 18 publications

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

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

Commentary: Leave Nothing Behind: No Stent, No Restenosis, No Mortality

Prediction Model for Freedom from TLR from a Multi-study Analysis of Long-Term Results with the Zilver PTX Drug-Eluting Peripheral Stent

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