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Nitinol Stents With Polymer-Free Paclitaxel Coating for Lesions in the Superficial Femoral and Popliteal Arteries Above the Knee: Twelve-Month Safety and Effectiveness Results From the Zilver PTX Single-Arm Clinical Study

2011; SAGE Publishing; Volume: 18; Issue: 5 Linguagem: Inglês

10.1583/11-3560.1

1545-1550

Michael D. Dake, Dierk Scheinert, Gunnar Tepe, J. Teßarek, Fabrizio Fanelli, Marc Bosiers, Christof Ruhlmann, З. А. Кавтеладзе, Aaron E. Lottes, Anthony Ragheb, Thomas Zeller,

Coronary Interventions and Diagnostics

PurposeTo report a prospective, single-arm, multicenter clinical study evaluating the Zilver PTX drug-eluting stent for treating the above-the-knee femoropopliteal segment (NCT01094678; http://www.clinicaltrials.gov).MethodsThe Zilver PTX drug-eluting stent is a self-expanding nitinol stent with a polymer-free paclitaxel coating. Patients with symptomatic (Rutherford category 2–6) de novo or restenotic lesions (including in-stent stenosis) of the above-the-knee femoropopliteal segment were eligible for enrollment. Between April 2006 and June 2008, 787 patients (578 men; mean age 66.6±9.5 years) were enrolled at 30 international sites.ResultsNine hundred lesions (24.3% restenotic lesions of which 59.4% were in-stent stenoses) were treated with 1722 Zilver PTX stents; the mean lesion length was 99.5±82.1 mm. The 12-month Kaplan-Meier estimates included an 89.0% event-free survival rate, an 86.2% primary patency rate, and a 90.5% rate of freedom from target lesion revascularization. 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<0.001) from baseline to 12 months.ConclusionsThese results indicate 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 1 year, the overall anatomical and clinical effectiveness results suggest that this stent is a promising endovascular therapy.