Cook's Zilver PTX Postmarket Study in Japan Shows Positive Outcomes at 24 Months

November 3, 2015—The 24-month results from the Zilver PTX Postmarket Study, conducted in Japan, were presented by Hiroyoshi Yokoi, MD, during the second of two Late-Breaking Trials sessions at VIVA 15, the 13th annual Vascular InterVentional Advances meeting. The meeting, which is sponsored by VIVA Physicians, Inc., is being held November 2–5, 2015, at the Wynn Las Vegas in Las Vegas, Nevada. The session moderators are Michael R. Jaff, DO, and Krishna Rocha-Singh, MD.

According to the VIVA summary, the paclitaxel-coated Zilver PTX stent (Cook Medical) is the first drug-eluting stent approved for treatment of peripheral artery disease in the superficial femoral artery. Previously reported results from a large randomized study and a complementary large single-arm study supported the safety and effectiveness of the Zilver PTX. This multicenter, prospective, postmarket surveillance study in Japan is evaluating the Zilver PTX stent in real-world patients with complex lesions of femoropopliteal arteries.

The first, approximately 900, patients in Japan were enrolled in the study and treated with the Zilver PTX. Clinically driven target lesion revascularization was defined as reintervention performed for ≥  50% diameter stenosis after recurrent clinical symptoms of peripheral artery disease. Clinical benefit was defined as freedom from persistent or worsening symptoms of ischemia. Patency was evaluated by duplex ultrasound where physicians considered this standard of care. In total, 907 patients with 1,075 lesions were treated with 1,861 Zilver PTX devices at 95 institutions in Japan.

The current study enrolled patients with more complex diseases, compared to enrollment in previous trials of the Zilver PTX, including significantly more chronic kidney disease (44%; P < .01) and higher Rutherford classification (22% critical limb ischemia; P < .01). The lesions were also significantly longer (mean lesion length, 15 cm; P < .01) and more challenging (19% in-stent restenosis, 7% with no patent run-off vessels; P < .01).

Dr. Yokoi reported that follow-up through 24 months was obtained for > 85% of eligible patients. Freedom from target lesion revascularization was 85%, and clinical benefit was 79.3% through 24 months, with the 24-month patency rate at 72.3%. This study continues to show positive, long-term outcomes for the Zilver PTX stent in complex lesions, providing further evidence for the benefit of the Zilver PTX stent, concluded Dr. Yokoi.