TY - JOUR
T1 - 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
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.
N1 - Funding Information: This study was sponsored by Cook Medical. The authors thank Anthony O. Ragheb, PhD, and Sarah Boylen of Cook Research Incorporated, a contract research organization and Cook Group Company, for assistance with data analysis, figure preparation, and critical review of the manuscript. Publisher Copyright: © 2017 SIR
PY - 2018/1
Y1 - 2018/1
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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U2 - 10.1016/j.jvir.2017.08.014
DO - 10.1016/j.jvir.2017.08.014
M3 - Article
C2 - 29122449
SN - 1051-0443
VL - 29
SP - 9-17.e1
JO - Journal of Vascular and Interventional Radiology
JF - Journal of Vascular and Interventional Radiology
IS - 1
ER -