Transcript Zilver PTX
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 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 3 Effectiveness Endpoint Primary Patency (PSVR < 2.0) 83.1% 76.7% Zilver PTX 65.3% 32.8% 60.0% 29.8% Optimal PTA (p < 0.01 vs. Zilver PTX) PTA (p < 0.01 vs. Zilver PTX) 4 Patency (PSVR < 2.0) for Primary Zilver PTX vs. Standard Care (PTA with Provisional Bare Stenting) 83.1% 76.7% 67.0% 61.0% Group Zilver PTX Standard Care (p < 0.01 vs. Zilver PTX) 12 month Restenosis Rate Zilver PTX 16.9% Standard Care 33.0% Reduction 49% 5 Patency (PSVR < 2.0) for Zilver PTX vs. BMS Is the drug effect significant? 89.9% 83.0% 73.0% 65.9% Group Zilver PTX Bare Zilver (p = 0.01 vs. Zilver PTX) 12 month Restenosis Rate Zilver PTX 10.1% Bare Zilver 27.0% Reduction 63% 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: 1. PTA and optimal PTA 2. 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%