Japanese Postmarket Study Data Published for Cook Medical's Zilver PTX Stent to Treat SFA Disease

February 3, 2016—In the Journal of the American College of Cardiology (JACC): Cardiovascular Interventions, Hiroyoshi Yokoi, MD, et al published the 12-month results from the Japanese postmarket surveillance study of the Zilver PTX paclitaxel-eluting stent (Cook Medical) for treating femoropopliteal artery disease (2016;9:271–277).

The multicenter, prospective, Zilver PTX postmarket surveillance study evaluated the device in real-world patients with complex lesions. The Zilver PTX device was approved in Japan and the United States in 2012 and in Europe in 2009. 

As summarized in JACC: Cardiovascular Interventions, there were no exclusion criteria, and consecutive patients with symptomatic peripheral artery disease treated with the Zilver PTX were enrolled in the study. Clinically driven target lesion revascularization (TLR) 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.

The investigators reported that 907 patients were enrolled at 95 institutions in Japan. There were numerous comorbidities, including a high incidence of diabetes (58.8%), chronic kidney disease (43.8%), and critical limb ischemia (21.5%). Lesions were complex, with an average length of 14.7 cm, 41.6% total occlusions, and 18.6% in-stent restenosis. In total, 1,861 Zilver PTX stents were placed in 1,075 lesions. Twelve-month follow-up was obtained for > 95% of eligible patients. Freedom from TLR was 91%, and clinical benefit was 87.7% through 12 months. The 12-month primary patency rate was 86.4%.

Despite more challenging lesions, results from this study are similar to outcomes from the previous Zilver PTX studies, confirming the benefit of the Zilver PTX drug-eluting stent in a real-world patient population, concluded the investigators in JACC: Cardiovascular Interventions.

In May 2014, Dr. Yokoi presented the 1-year data at EuroPCR in Paris, France. In November 2015, Dr. Yokoi presented the 24-month results from the Japanese Zilver PTX postmarket study at VIVA 15, the 13th annual Vascular InterVentional Advances meeting in Las Vegas, Nevada.