Study Shows 41% Reduction in Restenosis with Zilver® PTX® Drug-Eluting Stent at Five Years

The annual Vascular Interventional Advances (VIVA) bash has been taking place in Las Vegas (where else?) this week, and has spawned the usual flurry of pronouncements from companies keen to waft their good news in our direction. One such is Cook Vascular, which has seen five-year results from the Zilver PTX drug eluting stent study presented at the meeting. And why not? After all, the results are rather encouraging.


The 479 patient Zilver PTX randomized controlled trial is the largest and longest-running clinical trial of a drug-eluting stent for treating peripheral arterial disease (PAD). Results, presented by Michael Dake, M.D., of Stanford University, have confirmed long-term patency for patients treated with Cook’s drug eluter.

Data from the Zilver® PTX® Randomized Controlled Trial of Paclitaxel-Eluting Stents for Femoropopliteal Disease showed 5-year primary patency of 66.4 percent in the superficial femoral artery (SFA) for patients treated with Cook’s paclitaxel-eluting stent. This compares to 43.4 percent patency for patients with balloon angioplasty or provisional bare metal stent placement.

Investigator comments

“At five years, Zilver PTX demonstrated a 48 percent reduction in reintervention and a 41 percent reduction in restenosis compared to standard care,” Dr. Dake told the VIVA audience. “Five-year data for Zilver PTX versus bare metal stenting confirm a sustained benefit for the paclitaxel-eluting stent. Zilver PTX continues to show benefit through five years with no late catch-up.”

Company comments

“Cook’s commitment to providing clinical evidence of the effectiveness of drug-eluting devices in the peripheral vessels is unmatched. With this new data showing durable patency at five years, we’re confident our Zilver PTX stent offers PAD patients a lasting benefit,” said Mark Breedlove, vice president and global leader of Cook Medical’s Peripheral Intervention clinical division.

Source: Cook Medical, Business Wire

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