Results Published From Cook Medical's Zilver PTX Japan Postmarket Surveillance Study

November 8, 2017—Results from the Zilver PTX Japan postmarket surveillance study of the Zilver PTX paclitaxel-eluting stent (Cook Medical) were published by Stefano Cipollari, MD, et al online in Journal of Vascular and Interventional Radiology (JVIR).

The study aimed to evaluate 2-year results of the Zilver PTX for femoropopliteal peripheral artery disease (PAD) in patients with no continuous patent infrapopliteal runoff arteries compared with patients with ≥ 1 continuous patent runoff vessels.

As summarized in JVIR, the investigators retrospectively analyzed patients with femoropopliteal PAD enrolled in the postmarket study in Japan. There were no exclusion criteria. 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).

Demographics, lesion characteristics, and comorbidities were similar between groups (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 three amputations (5.6%) in the no-runoff group versus seven amputations (0.8%) in the runoff group (P = .02).

In the no-runoff versus runoff group 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), respectively.

The investigators concluded that because 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, the Zilver PTX paclitaxel-eluting stent may be a valid treatment option for patients with these difficult-to-treat lesions.