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Zilver PTX stent resistant to fracture at two years
No safety concerns reported in the interim analysis.
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A paclitaxel-eluting peripheral stent was associated with low fracture rates and high rates of event-free survival.
The interim registry analysis included six-month, 12-month and 24-month data from the clinical trial of the paclitaxel-eluting peripheral stent (Zilver PTX, Cook Medical). The researchers enrolled 240 patients who had drug-eluting stents in the randomized arm of the clinical study, and 791 patients were enrolled in the registry arm. The study endpoints were event-free survival and freedom from target lesion revascularization.
Data were collected from 742 patients in the six-month group, 666 patients in the 12-month group and 220 patients in the 24-month group. According to the analysis, event-free survival was 95% in the six-month group, 87% in the 12-month group and 78% in the 24-month group. Freedom from TLR was 96% in the six-month group, 88% in the 12-month group and 82% in the 24-month group. Ongoing analysis of stents using X-ray revealed a 1.4% (21/1,486) stent fracture rate at six months and 1.8% (21/1,198) at 12-months.
“The Zilver PTX stent platform appears to have excellent durability in terms of fracture resistant in the superficial femoral artery,” Michael D. Dake, MD, a professor of cardiothoracic surgery at Stanford University School of Medicine in California, said in a presentation. “Outcomes at two years show no safety concerns apparent and favorable effectiveness in terms of target lesion revascularization outcomes in comparison to the literature.” – by Eric Raible
For more information:
- Dake MD. #LB2. Presented at: Vascular Annual Meeting; June 11-14, 2009; Denver.