Radiation Safety Michael Shortsleeve, MD Thomas Osborne, MD MAH.
Michael Dake, MD
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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 Interests/Stock Options – NovoStent – Vatrix – Amaranth – CVRx – Endoluminl Sciences – REVA Medical – TriVascular • 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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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 - PowerPoint PPT Presentation
Transcript of Michael Dake, MD
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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%
