Cook Medical evaluates paclitaxel-eluting stent in Japanese post-market surveillance study

Cook Medical today touted long-term outcomes linked to its Zilver PTX drug-eluting stent in patients with femoropopliteal lesions.

The assessment was part of a five-year follow-up study being conducted in Japan to better evaluate the drug-eluting stent in real-world patients. The data were presented by Dr. Michael Dake at this year’s VIVA conference in Las Vegas.

The first 900 patients treated with the DES in Japan were enrolled in the post-market surveillance study. The company defined clinical benefit as freedom from persistant or worsening claudication, rest pain, ulcer or tissue loss.

The Cook Medical team also performed subgroup analyses to evaluate the drug-device product in patients with chronic renal failure, no continuous patent infrapopliteal runoff vessels and in-stent restenosis.

Data through four years show the freedom from target lesion revascularization rate was 78.4%. Subgroup analyses showed that after two years, the freedom from TLR rate was similar for patients with and without chronic renal failure.

The Zilver PTX drug-eluting stent ‘may be a vaild treatment option for patients with these difficult-to-treat lesion,’ the presentation said.