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Home > Vascular Annual Meeting > LB2. Interim Report on the Zilver® PTX™ Clinical Study

LB2. Interim Report on the Zilver® PTX™ Clinical Study

Michael D. Dake, for the Zilver® PTX™ Investigators
Stanford University School of Medicine, Stanford, CA

OBJECTIVES: The Zilver® PTX™ Drug-Eluting Peripheral Stent (DES) is undergoing clinical study to evaluate its potential for improving the treatment of femoropopliteal artery disease.  The clinical study includes more than 1000 patients treated with the DES. Approximately 240 DES patients were enrolled in the Randomized arm of the study, and 760 DES patients were enrolled in the Registry arm of the study. Enrollment is complete and this is an interim report of Registry outcomes, including two-year follow-up results.

METHODS: The Zilver® PTX™ Registry is a prospective, multicenter, single-arm study with relatively broad inclusion criteria (e.g., no maximum lesion length, de novo or restentoic lesions, including in-stent restenosis). The endpoints include event-free survival (EFS) and freedom from target lesion revascularization (TLR). Imaging follow-up includes duplex ultrasound and stent x-ray at 6 and 12 months.
 
RESULTS: This interim analysis includes 6-, 12-, and 24-month data from 742 patients (843 lesions), 592 patients (673 lesions), and 177 patients (221 lesions), respectively. The corresponding EFS rates were 95%, 87%, and 78%, and freedom from TLR rates were 96%, 89%, and 82%. Evaluation of stent x-rays is ongoing and currently suggests fractures in approximately 1.4% (21/1486) of stents at 6 months and 1.8% (21/1198) at 12 months.  Clinical measures (ABI, Rutherford score, walking distance and speed scores) showed significant improvement, which was maintained through 24 months.

CONCLUSIONS: Interim results from the Registry, including two-year follow-up, indicate no safety concerns, low fracture rates, high rates of EFS and freedom from TLR, and clinical improvement with the DES.  Ongoing Registry follow-up, as well as the Randomized study, will continue to evaluate the performance of the Zilver® PTX™ Drug-Eluting Stent.

AUTHOR DISCLOSURES: M.D. Dake, Grants/Research Support: W.L. Gore, Inc.,Medtronic, Inc., Cook, Inc., Abbott Vascular, Inc., Cordis Endovascular, Consultant: W.L. Gore, Inc., Abbott Vascular, Inc., Medtronic, Inc., eV3, Inc., Guidant, Angiodynamics, Cordis Endovascular, Honorarium: Cook Medical.