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Michael Dake, MD

Michael Dake, MD. Within the past 12 months, the presenter or their spouse/partner have had a financial interest/arrangement or affiliation with the organization listed below. Research/Research Grants, Clinical Trial Support W. L. Gore Cook Medical Consulting Fees/Honoraria W. L. Gore

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Michael Dake, MD

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  1. Michael Dake, MD Within the past 12 months, the presenter or their spouse/partner have had a financial interest/arrangement or affiliation with the organization listed below. • 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

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

  4. Patency (PSVR < 2.0) for Primary Zilver PTX vs. Standard Care (PTA with Provisional Bare Stenting) 83.1% 76.7% Zilver PTX 67.0% Standard Care (p < 0.01 vs. Zilver PTX) 61.0%

  5. Patency (PSVR < 2.0) for Zilver PTX vs. BMSIs the drug effect significant? 89.9% 83.0% Zilver PTX 73.0% Bare Zilver (p = 0.01 vs. Zilver PTX) 65.9%

  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: • PTA and optimal PTA • 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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