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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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slide1

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
slide3

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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