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

Research output: Contribution to journalArticle

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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
StatePublished - Jan 2018
Externally publishedYes

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Drug-Eluting Stents
Peripheral Arterial Disease
Japan
Amputation
Comorbidity
Ischemia
Extremities
Arteries
Demography
Incidence

ASJC Scopus subject areas

  • Radiology Nuclear Medicine and imaging
  • Cardiology and Cardiovascular Medicine

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

In: Journal of Vascular and Interventional Radiology, Vol. 29, No. 1, 01.2018, p. 9-17.e1.

Research output: Contribution to journalArticle

Cipollari, Stefano ; Yokoi, Hiroyoshi ; Ohki, Takao ; Kichikawa, Kimihiko ; Nakamura, Masato ; Komori, Kimihiro ; Nanto, Shinsuke ; O'Leary, Erin E. ; Lottes, Aaron E. ; Saunders, Alan T. ; Dake, Michael D. / 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. In: Journal of Vascular and Interventional Radiology. 2018 ; Vol. 29, No. 1. pp. 9-17.e1.
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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.",
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AU - Cipollari, Stefano

AU - Yokoi, Hiroyoshi

AU - Ohki, Takao

AU - Kichikawa, Kimihiko

AU - Nakamura, Masato

AU - Komori, Kimihiro

AU - Nanto, Shinsuke

AU - O'Leary, Erin E.

AU - Lottes, Aaron E.

AU - Saunders, Alan T.

AU - Dake, Michael D.

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N2 - 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.

AB - 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.

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