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.

View details for DOI 10.1016/j.jvir.2017.08.014

View details for PubMedID 29122449