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1 Michael Dake, MD Research/Research Grants, Clinical Trial Support –W. L. Gore –Cook Medical Consulting Fees/Honoraria –W. L. Gore –Abbott Vascular Equity.

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Presentation on theme: "1 Michael Dake, MD Research/Research Grants, Clinical Trial Support –W. L. Gore –Cook Medical Consulting Fees/Honoraria –W. L. Gore –Abbott Vascular Equity."— Presentation transcript:

1 1 Michael Dake, MD Research/Research Grants, Clinical Trial Support –W. L. Gore –Cook Medical Consulting Fees/Honoraria –W. L. Gore –Abbott Vascular Equity Interests/Stock Options –NovoStent –Vatrix –Amaranth –CVRx –Endoluminl Sciences –REVA Medical –TriVascular –Cytograft Tissue Engineering Officer, Director, Board Member or other Fiduciary Role –VIVA Physicians Group Speaker’s Bureau –None Within the past 12 months, the presenter or their spouse/partner have had a financial interest/arrangement or affiliation with the organization listed below.

2 2 Prospective, multinational trial CEC and DSMB oversight Imaging Core Lab analyses Primary safety endpoint: 12-month event-free survival – Freedom from death, amputation, target lesion revascularization, or worsening Rutherford score (by 2 classes or to class 5 or 6) – Per-protocol cohort, Kaplan-Meier p-values from log-rank test Primary effectiveness endpoint: 12-month primary patency – Duplex ultrasonography, patent = PSVR < 2.0 (or angiography if available, patent = diameter stenosis < 50%) – Intent-to-treat cohort, Kaplan-Meier p-values from log-rank test Ongoing follow-up through 5 years Zilver PTX Randomized Trial

3 3 Zilver PTX 83.1% 32.8% 76.7% 29.8% Optimal PTA (p < 0.01 vs. Zilver PTX) 65.3% 60.0% PTA (p < 0.01 vs. Zilver PTX) Effectiveness Endpoint Primary Patency (PSVR < 2.0)

4 4 Patency (PSVR < 2.0) for Primary Zilver PTX vs. Standard Care (PTA with Provisional Bare Stenting) Standard Care (p < 0.01 vs. Zilver PTX) 83.1% 67.0% 76.7% 61.0% Zilver PTX Group 12 month Restenosis RateReduction Zilver PTX16.9% 49% Standard Care33.0%

5 5 Patency (PSVR < 2.0) for Zilver PTX vs. BMS Is the drug effect significant? Zilver PTX 89.9% 83.0% 73.0% 65.9% Group 12 month Restenosis RateReduction Zilver PTX10.1% 63% Bare Zilver27.0% Bare Zilver (p = 0.01 vs. Zilver PTX)

6 6 Conclusions Largest prospective, randomized trial for endovascular treatment of symptomatic femoropopliteal PAD (479 patients) Low Zilver stent fracture rate (0.9%) through 12 months Primary Zilver PTX stenting resulted in – Significantly better 12-month patient safety compared to PTA – Significantly higher 12-month patency compared to: 1.PTA and optimal PTA 2.Standard care (PTA with provisional BMS) Provisional Zilver PTX patency (89.9%) significantly higher than provisional BMS patency (73.0%) – PTX coating reduced 12-month restenosis rate by 63%


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