VIVA.14: Zilver PTX holds strong at five years

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 - clinical trial

At five years, the Zilver PTX stent proved to be a durable treatment for peripheral artery disease with sustained benefit, results presented Nov. 4 at the 2014 Vascular Interventional Advances (VIVA) meeting showed.

“For one year out to five years, the benefit is even increasing in terms of patency,” presenter Michael Dake, MD, of the Stanford University School of Medicine, told Cardiovascular Business. “That is something that was not necessarily anticipated and it is good news. It recalibrates everyone’s thinking of what we can achieve and maybe need to expect to achieve in the future.”

The Zilver PTX clinical trial evaluated the safety and effectiveness of paclitaxel-eluting stents in patients with de novo or restenotic lesions in the superficial femoral artery. The study randomized 479 patients to be treated with either the Zilver PTX stent (Cook Medical) or balloon angioplasty and a bare-metal stent (PTA). Patients with suboptimal PTA underwent a second randomization of provisional stenting, receiving either the Zilver bare-metal stent or the Zilver PTX stent.

The trial met its 12-month primary endpoint goals showing noninferiority for event-free survival and superiority for primary patency for the Zilver PTX compared with standard care, at 90.4 percent vs. 82.6 percent and 83.1percent vs. 32.8 percent, respectively.

The device was approved by the FDA in 2012 and received CE mark in Europe in 2009.

Five-year results showed greater comparative benefit with the Zilver PTX on all fronts, with:

  • A freedom from target lesion revascularization rate of 83.1 percent vs. 67.6 percent;
  • A patency rate of 66.4 percent vs. 43.4 percent;
  • Clinical benefit, including freedom from persistent or worsening claudication, rest pain, ulcer or tissue loss, of 79.8 percent vs. 59.3 percent;
  • And for provisional stenting, a patency rate of 72.4 percent vs. 53 percent.

Dake noted that the lesions treated in the study were “moderately short” but more complex patients also may experience benefits.

“In certain subtypes of disease, this will be the go-to therapy,” Dake said. Drug-coated balloons or other therapies may prove to be the better option for other subtypes and no one device will meet all needs.

The more physicians learn through studies, the more they can discern the best course for an individual patient, he proposed. “We have an enhanced appreciation of the nuances of different types of disease that may respond relatively better or worse with the different types of therapies.”

Cook Medical funded the study.