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 EvidencePost-market surveillance study, Level III.
Highlights
There were numerous comorbidities including a high incidence of diabetes (58.8%) and chronic kidney disease (43.6%)
21.4% of patients were classified with critical limb ischemia
Despite 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)
Summary
Endovascular therapy with balloon angioplasty and/or stent placement is a standard treatment for peripheral arterial disease (PAD). The primary patency rate after BMS placement in the FP lesions has been reported to be 53–81%, 36–72%, 19–66% at 1, 2, 3 years [1,2,3], and these results highly vary depending on the lesion backgrounds. To combat this issue, Zilver PTX stent, a polymer-free, paclitaxel-coated nitinol-eluting stent (DES), is available for clinical use. One-year outcomes demonstrated the safety and effectiveness of the DES in patients with complex lesions [4].
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