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

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

Abstract

Purpose: A 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.

Methods: There 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.

Results: In 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.

Conclusion: 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).

Level of evidence: Post-market surveillance study, Level III.

Keywords: Drug eluting stent; Femoropopliteal artery; Paclitaxel-eluting stent; Peripheral artery disease.

Conflict of interest statement

Conflict of interest

Dr. Kichikawa has received speakers’ fees from Cook Medical. Dr. Yokoi has received speakers’ fees from Cook Medical. Dr. Ohki has received research fees for clinical trials. Drs. O’Leary, Lottes, Snyder are paid employees of Cook Research Incorporated., a contract research organization and Cook Group Company. Dr. Dake is a member of the scientific advisory board for W.L. Gore and Associates and has received consulting fees from Cook Medical and Novate Medical. All other authors have reported that they have no conflicts relevant to the contents of this paper to disclose.

Ethical Approval

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards. This article does not contain any studies with animals performed by any of the authors.

Informed Consent

For this type of study, informed consent processes were determined by each institution’s ethical committee policy to specify whether informed consent was necessary or outcome data could be abstracted while protecting patient’s rights without requiring individual patient consent.

Consent for Publication

For this type of study, consent for publication is not required.

Figures

Fig. 1
Fig. 1
2-Year freedom from TLR. The Kaplan–Meier curve shows 83.7% freedom from TLR through 2 years for patients treated with the DES. The life table is included. DES drug-eluting stent, TLR target lesion revascularization
Fig. 2
Fig. 2
2-Year clinical benefit. The Kaplan–Meier curve shows 80.0% clinical benefit through 2 years for patients treated with the DES. The life table is included. DES drug-eluting stent
Fig. 3
Fig. 3
2-Year primary patency. The Kaplan–Meier curve shows 70.3% primary patency through 2 years for lesions treated with the DES. The life table is included. DES drug-eluting stent

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Source: PubMed

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