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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.

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• 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

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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 EndpointPrimary Patency (PSVR < 2.0)

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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

Group12 month Restenosis

Rate Reduction

Zilver PTX 16.9%

49%Standard Care 33.0%

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Patency (PSVR < 2.0) for Zilver PTX vs. BMSIs the drug effect significant?

Zilver PTX

89.9%

83.0%

73.0%65.9%

Group12 month Restenosis

Rate Reduction

Zilver PTX 10.1%63%Bare Zilver 27.0%

Bare Zilver(p = 0.01 vs. Zilver PTX)

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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 PTA2. 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%