Original Title: Zilver PTX Post-Market Surveillance Study of Paclitaxel-Eluting Stents for Treating Femoropopliteal Artery Disease in Japan 12-Month Results.
Reference: Hiroyoshi Yokoi et al. J Am Coll Cardiol Intv. 2016;9(3):271-277.
This multicenter prospective study carried out in Japan assessed the paclitaxel eluting stent Zilver PTX in an unselected real world population very different to that compliant with inclusion/exclusion criteria, usually included in randomized studies.
The Zilver PTX is the first DES approved to treat the superficial femoral artery. Previous results from a large randomized study and a complementary large single-arm study supported the safety and effectiveness of this stent in selected lesions.
In the present study, there were no exclusion criteria and all consecutive patients with symptomatic peripheral artery disease receiving Zilver PTX were enrolled. Clinical driven target lesion revascularization was defined as any reintervention on a ≥50% diameter lesion associated to symptom recurrence. The clinical benefit was defined as freedom from persistent symptoms, intermittent claudication or symptom worsening. And patency was assessed by Doppler.
907 patients were enrolled in 95 hospitals across Japan. The population presented numerous comorbidities including a high incidence of diabetes (58.8%), chronic kidney failure (43.8%) and critical limb ischemia (21.5%). Lesions were also complex, average length was 14.7 cm, 41.6% were total occlusions and 18.6% were instent restenosis.
At 12 months, the rate of clinically justified lesions free from reintervention was 91%, and clinical benefit rate was 87.7%. Primary patency rate reached 86.4%.
Conclusion
Despite lesions were far more challenging, outcomes in this study were similar to those of prior studies, which confirms the benefit of the Zilver PTX in the real world population.
Editorial Comment
The original studies on Zilver PTX had shown the superiority of this device vs. standard treatment (conventional balloon and conventional provisional stenting) or vs. conventional stents. This large post launch registry confirms the benefit in both more complex lesions and more complex patients.