ArticleCardiovascular and interventional radiology2019
Zilver PTX Post-market Surveillance Study of Paclitaxel-Eluting Stents for Treating Femoropopliteal Artery Disease in Japan: 2-Year Results.
Article in Cardiovascular and interventional radiology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02254837 (Zilver PTX Post-Market Surveillance Study of Paclitaxel-Eluting Stents for Treating Femoropopliteal Artery Disease in Japan), which is not on this map. Cited by 8 papers, 1 of them a synthesis that pooled it.
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Zilver PTX Post-Market Surveillance Study of Paclitaxel-Eluting Stents for Treating Femoropopliteal Artery Disease in Japan
Who cites it
8 citing papers in PubMed, 1 synthesis or guideline pooled it, 30 citations in OpenAlex.
- Performance of stenting in femoropopliteal disease: a systematic literature review and meta-analysis of proportions.Journal of comparative effectiveness research · 2026Pooled it
- 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.Cardiovascular and interventional radiology · 2021Trial
- 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 · 2020Trial
- Intravascular Imaging and Pathological Features of Drug-Coated Balloon Angioplasty in Atherosclerotic Porcine Peripheral Arteries.Journal of atherosclerosis and thrombosis · 2025Article
- Korean Multicenter Registry of ELUVIA Stent for Femoropopliteal Artery Disease: K-ELUVIA Registry.Korean circulation journal · 2024Article
- Is Calcium the Natural Enemy of Drug-Eluting Therapy?Cardiovascular and interventional radiology · 2024Article
- Development of a radiopaque, long-term drug eluting bioresorbable stent for the femoral-iliac artery.RSC advances · 2019Article
- Is There a Safety Concern for Drug-Coated Balloons in Peripheral Arterial Disease?Current cardiology reports · 2019Review
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Authors and funding
11 authors at 7 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeA prospective, multicenter post-market surveillance study in Japan evaluated the 2-year safety and effectiveness of the DES in real-world patients with complex femoropopliteal artery lesions.
methodsThere were no exclusion criteria, and consecutive symptomatic patients with femoropopliteal lesions treated with the DES were enrolled in the study. Clinically driven target lesion revascularization (TLR) was defined as reintervention performed for > 50% diameter stenosis after recurrent clinical symptoms of peripheral arterial disease. Clinical benefit was defined as freedom from persistent or deteriorating ischemic symptoms. Patency was evaluated by duplex ultrasound where physicians considered this standard of care.
resultsIn this study, 905 patients were enrolled at 95 institutions in Japan. There were numerous comorbidities including a high incidence of diabetes (58.8%) and chronic kidney disease (43.6%). Additionally, 21.4% of patients were classified with critical limb ischemia. Lesions were complex, with an average length of 14.6 ± 9.6 cm (range 0.5-40 cm), 41.5% total occlusions, and 18.7% in-stent restenosis. In total, 1861 DES were placed in 1080 lesions. Two-year follow-up was obtained for > 90% of eligible patients. Freedom from TLR was 83.7%, and clinical benefit was 80.0% through 2 years. The 2-year primary patency rate was 70.3%. Rutherford classification significantly improved (p < 0.01), with approximately 80% of patients classified as Rutherford class 0 or 1 at 2 years.
conclusionDespite more challenging lesion characteristics, 2-year results from the current study are similar to outcomes from the previous Zilver PTX studies, confirming the efficacy of the Zilver PTX DES in a complicated femoropopliteal lesion (Zilver PTX Post-Market Study in Japan; NCT02254837). LEVEL OF EVIDENCE: Post-market surveillance study, Level III.
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