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Two-Year ZILVER PTX Trial Results Show Drug-Coated Stents Keep Leg Arteries Open: Presented at ISET 2011

MIAMI BEACH, Fla.--(BUSINESS WIRE)--Jan 17, 2011 - Drug-coated stents hold promise as a safe and lasting solution for the treatment of clogged leg arteries, suggest two-year results of the Zilver PTX Trial being presented at the 23rd annual International Symposium on Endovascular Therapy (ISET). Blocked leg arteries are a symptom of peripheral arterial disease (PAD), which affects 8 to 12 million Americans.

The multicenter, prospective, randomized Zilver PTX trial includes a total of 479 patients treated at 55 institutions: about half received the Zilver PTX (paclitaxel-coated) stent and the rest received angioplasty alone to open blocked superficial femoral arteries, which provide blood to the lower legs. Patients who received angioplasty that did not succeed initially were then randomized to a provisional group to receive either paclitaxel-coated or bare-metal stents.

Two-year data on 278 patients – with approximately 50 percent getting the Zilver PTX stent, 25 percent getting angioplasty alone, 12.5 percent getting angioplasty plus provisional bare metal stent, and 12.5 percent getting angioplasty plus provisional Zilver PTX stent – are being presented at ISET. After two years, 74.8 percent of arteries remained open in patients who received the drug-coated stents. There was no imaging of the angioplasty-only group after the first year, at which point only 32.8 percent had arteries that remained open. After two years, event-free survival was 86.6 percent for Zilver PTX patients. No patient deaths were related to the study device or procedure.

In the provisional stenting group at two years, 81.2 percent of arteries treated with drug-coated stents remained opened vs. 62.7 percent of those treated with bare-metal stents.

“There's evidence of a significant drug effect even at two years, with a much higher rate of the arteries remaining open than with angioplasty or with bare metal stents,” said Michael Dake, M.D., lead investigator for the Zilver Trial and Thelma and Henry Doelger Professor in the Department of Cardiovascular Surgery at the Stanford University School of Medicine in Stanford, Calif. “We have not had long-term problems with late thrombosis or aneurysm which also suggests the results are safe and durable.”

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Contact: Media Contact for International Symposium on Endovascular Therapy
Ashley Mattys, 312-558-1770


Posted: January 2011