Long-Term Effectiveness of the Zilver PTX Drug-Eluting Stent for Femoropopliteal Peripheral Artery Disease in Patients with No Patent Tibial Runoff Vessels—Results from the Zilver PTX Japan Post-Market Surveillance Study

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

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Abstract

Purpose To evaluate 2-year results of the Zilver PTX (Cook Medical, Bloomington, Indiana) drug-eluting stent (DES) for femoropopliteal peripheral artery disease (PAD) in patients with no continuous patent infrapopliteal runoff arteries compared with patients with ≥ 1 continuous patent runoff vessels. Materials and Methods A retrospective analysis of patients with femoropopliteal PAD enrolled in the Zilver PTX Post-Market Surveillance Study in Japan was performed. There were no exclusion criteria. Outcomes, including freedom from target lesion revascularization (TLR), patency, and clinical benefit, for the no-runoff group (n = 54) were compared with the runoff group (n = 846). Results The 2 groups were similar in terms of demographics, lesion characteristics, and comorbidities (P >.05). There was a higher incidence of critical limb ischemia in the no-runoff group compared with the runoff group (44.8% vs 19.7%; P <.01). There were 3 amputations (5.6%) in the no-runoff group versus 7 amputations (0.8%) in the runoff group (P =.02). At 2 years, freedom from TLR rates were 81.3% versus 83.8% (P =.87), patency rates were 68.4% versus 70.7% (P =.95), and clinical benefit rates were 73.7% versus 80.0% (P =.16) in the no-runoff versus runoff group, respectively. Conclusions Results in patients with no continuous patent tibial runoff were favorable through 2 years and similar to results for patients with ≥ 1 continuous patent runoff vessels, indicating that the Zilver PTX DES may be a valid treatment option for patients with these difficult-to-treat lesions.

Original languageEnglish (US)
Pages (from-to)9-17.e1
JournalJournal of Vascular and Interventional Radiology
Volume29
Issue number1
DOIs
Publication statusPublished - Jan 2018
Externally publishedYes

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ASJC Scopus subject areas

  • Radiology Nuclear Medicine and imaging
  • Cardiology and Cardiovascular Medicine

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