Long-Term Effectiveness of a Drug-Eluting Stent for Femoropopliteal In-Stent Restenosis: Subanalysis of the Zilver PTX Japan Post-Market Surveillance Study

Masayuki Sugimoto, Kimihiro Komori, Hiroyoshi Yokoi, Takao Ohki, Kimihiko Kichikawa, Masato Nakamura, Shinsuke Nanto, Erin E. O’Leary, Aaron E. Lottes, Alan T. Saunders, Michael D. Dake

Research output: Contribution to journalArticlepeer-review

Abstract

Purpose: To present a subgroup analysis of patients from a large real-world study evaluating the safety and effectiveness of the Zilver PTX drug-eluting stent (DES) for treating femoropopliteal in-stent restenosis (ISR). Materials and Methods: This study examined patients enrolled in the Zilver PTX Japan Post-Market Surveillance Study (ClinicalTrials.gov identifier NCT02254837), a prospective, multicenter registry of 904 symptomatic patients with 1082 femoropopliteal lesions treated with the DES at 95 institutions in Japan. Five-year outcomes, including mortality, stent radiography, freedom from target lesion revascularization (TLR), and clinical benefit, were evaluated for 177 patients (mean age 74.2±8.3 years; 118 men) with 204 ISR lesions treated with the Zilver DES. Over half of the patients (108, 61.0%) were diabetic. Mean lesion length was 17.8±10.4 cm, and a third (72, 35.3%) were total occlusions. Outcome measures were all-cause mortality, thrombosis, freedom from TLR, and clinical benefit, defined as freedom from persistent or deteriorating ischemic symptoms. Results: No device-related or procedure-related deaths or paclitaxel-related adverse events were reported. All-cause mortality was 25.1% at 5 years. Stent fracture was observed in 5 stents through 5 years. The 5-year rate of freedom from clinically-driven TLR was 73.4%, and the rate of clinical benefit was 63.6%. Improvement in Rutherford category and ankle-brachial index was sustained through 5 years. Conclusion: The safety and effectiveness of the Zilver PTX stent for the treatment of femoropopliteal ISR lesions demonstrated that this device provides a favorable treatment option in this difficult-to-treat subgroup.

Original languageEnglish (US)
JournalJournal of Endovascular Therapy
DOIs
StateAccepted/In press - 2020
Externally publishedYes

Keywords

  • drug-eluting stent
  • in-stent restenosis
  • mortality
  • occlusion
  • peripheral artery disease
  • target lesion revascularization

ASJC Scopus subject areas

  • Surgery
  • Radiology Nuclear Medicine and imaging
  • Cardiology and Cardiovascular Medicine

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