A study published in October in the Journal of Endovascular Therapy has found that Zilver PTX (Cook Medical) drug-eluting stent is safe for treatment of patients with de novo and restenotic lesions of the above-the-knee femoropopliteal segment.
Michael D Dake, Stanford University School of Medicine, Stanford, California, USA, and colleagues set out to report a prospective, single-arm, multicentre, clinical study evaluating Zilver PTX in the treatment in the above-the-knee femoropopliteal segment.
The investigators enrolled patients with symptomatic (Rutherford category 2–6) de novo or restenotic lesions (including in-stent stenosis) of the above-the-knee femoropopliteal segment.
They enrolled 787 patients (578 men; mean age 66.6±9.5 years) between April 2006 and June 2008, at 30 international sites. Nine hundred lesions (24.3% restenotic lesions of which 59.4% were in-stent stenoses) were treated with 1,722 Zilver PTX stents. The mean lesion length was 99.5±82.1mm.
Results of the study showed that at 12-months, Kaplan-Meier estimates included an 89% event-free survival rate, an 86.2% primary patency rate, and a 90.5% rate of freedom from target lesion revascularisation.
Dake et al noted that there were no paclitaxel-related adverse events reported. The 12-month stent fracture rate was 1.5%.
The ankle brachial index, Rutherford score, and walking distance/speed scores significantly improved (p
Investigators wrote that these results indicated that the Zilver PTX drug-eluting stent is safe for treatment of patients with de novo and restenotic lesions of the above-the-knee femoropopliteal segment. At one year, the overall anatomical and clinical effectiveness results suggest that this stent is a promising endovascular therapy, they wrote.