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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

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


Zilver ptx randomized trial

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


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%


Patency psvr 2 0 for primary zilver ptx vs standard care pta with provisional bare stenting
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%


Patency psvr 2 0 for zilver ptx vs bms is the drug effect significant
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%


Conclusions
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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