After listening to the latest data for the Zilver PTX drug-eluting peripheral stent, 81% of delegates at yesterday’s stent data session voted against the motion that “plain old balloon and bare metal stents reign supreme in the superficial femoral artery”.
At the session, Frank Criado, Baltimore, USA, reviewed whether plain old balloons and bare metal stents were still the first-line treatment devices for the superficial femoral artery. He said that currently, vascular physicians were “addicted to stents” because they are predictable, easy to use, and widely available. According to Criado, there are disadvantages with this approach and these include monetary costs, the risk of in-stent restenosis, fractures and the possible need for re-intervention. However, with current positive data from the RESILIENT trial and the one-year data from the Zilver PTX trial, Criado predicted that the use of plain old balloons and bare metal stents—in the next five years—will be replaced by drug-eluting stents, drug-eluting balloons, mechanical and laser atherectomy, and endoluminal bypass.
In a following presentation, Marc Bosiers (Dendermonde, Belgium) discussed the use of the Zilver PTX in long lesions in the superficial femoral artery (>15cm). He said that stent integrity decreases as lesion length increases, but added that the Zilver PTX “provides better results in long lesions than bare metal stents”. Concluding his presentation, Bosiers announced the launch of the Zilverpass (The Cook Zilver PTX drug-eluting stent versus bypass surgery for the treatment of femoropopliteal TASC C and D lesions) study, which has a primary endpoint of patency at 12 months.
Michael Dake (Stanford, USA) then presented the three-year data from the Zilver PTX (Cook Medical) drug-eluting stent clinical trial. The Zilver PTX, according to Dake, is designed for the superficial femoral artery and is approved in Europe, Japan, and the USA. He reported that the Zilver PTX trial had a primary and secondary randomisation process. According to the results, event-free survival was 83.5% in the 185 patients who received the Zilver PTX stent compared with 72.7% in 189 patients who were treated with percutaneous transluminal angioplasty alone (p<0.01). The rate of freedom from target lesion revascularisation was 84% in the 185 patients and 70.2% in the 189 patients. Dake added that, at three years, the Zilver PTX demonstrated a low fracture rate of 2.1%.
Additionally, the primary patency of the Zilver PTX was 68.7% in 184 lesions vs. 22.8% in 207 lesions with percutaneous transluminal angiography. In a comparison between the Zilver PTX stent and a bare metal stent, the primary patency was 79.6% in 44 lesions and 56.3% in 53 lesions respectively. “Three-year results support sustained safety and effectiveness,” He concluded.