Cook Medical reveals four-year Zilver PTX FTLR trial data

Data proves drug-eluting stent provides longer-term results and reduces re-intervention rates by 45%

Four-year freedom from target lesion revascularisation (FTLR) trial data presented this week shows that 83.2% of patients with femoropopliteal lesions who were treated with Cook Medical’s Zilver PTX self-expanding paclitaxel-coated nitinol stent did not require revascularisation.

This compares to 69.4% of patients treated with the percutaneous transluminal angioplasty (PTA) and a bare metal stent (BMS).

The Zilver PTX trial, a multicentre, prospective, randomised study, was designed to evaluate the stent as a treatment for peripheral arterial disease (PAD) in the superficial femoral artery (SFA).

This study has really helped us confirm the long-term value of our drug-elution technology. In an ageing population, it is now more important than ever to improve restenosis rates

The principal investigator of the trial, Dr Michael Dake, professor of cardiothoracic surgery at Stanford University Medical School, presented the four-year FTLR data at the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) meeting in Barcelona. Following his presentation, a number of European experts also shared their experiences with the stent and discussed why and when physicians should use drug-eluting devices to treat lesions in the SFA.

Dr Dake said: “The four-year freedom from TLR data documents the sustained clinical benefit of Zilver PTX. When compared to standard of care therapy, consisting of either successful PTA or provisional bare stent placement after sub-optimal PTA, the paclitaxel-eluting Zilver stent provides a 45% reduction in the re-intervention rate.”

The Zilver PTX

Since Zilver PTX received CE mark approval in 2009, it has already been used to treat more than 20,000 patients worldwide. Clinicians across the UK, and in markets including the US, Japan and Australia, now use the solution to treat SFA lesions.

“It’s exciting to be the first company to present four-year data for a stent to treat PAD,” said Andy Förster, EMEA leader for Cook’s peripheral intervention clinical division. “This study has really helped us confirm the long-term value of our drug-elution technology. PAD affects around four million people in the UK alone and is increasingly prevalent among an older demographic. In an ageing population, it is now more important than ever to improve restenosis rates. We’re proud to be able to offer this longer-lasting treatment to physicians and their patients.”

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