Endeavor IV-A Randomized Comparison of a Zotarolimus-Eluting Stent Endeavor IV-A Randomized...

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Endeavor IV: A Randomized Endeavor IV: A Randomized Comparison of a Comparison of a Zotarolimus-Eluting Stent Zotarolimus-Eluting Stent and a Paclitaxel-Eluting and a Paclitaxel-Eluting Stent in Patients with Stent in Patients with Coronary Artery Disease Coronary Artery Disease Martin B. Leon, MD Martin B. Leon, MD Columbia University Medical Center Columbia University Medical Center Cardiovascular Research Foundation Cardiovascular Research Foundation New York City New York City Monday, October 22, 2007 Monday, October 22, 2007

Transcript of Endeavor IV-A Randomized Comparison of a Zotarolimus-Eluting Stent Endeavor IV-A Randomized...

  • 1. Endeavor IV: A Randomized Comparison of a Zotarolimus-Eluting Stent and a Paclitaxel-Eluting Stent in Patients with Coronary Artery Disease Martin B. Leon, MDColumbia University Medical Center Cardiovascular Research Foundation New York City Monday, October 22, 2007

2. Presenter Disclosure Information for TCT 2007; October 20-25, 2007 Martin B. Leon, M.D. Scientific Advisory Board: Medtronic Vascular, Abbott Vascular, Cordis-JNJ, and Boston Scientific 3. Endeavor DES System PC Technology Drug: Zotarolimus Stent Delivery System Driver Cobalt Alloy Stent 4. Polymer and Drug Matrix Tissue Blood PC Basecoat( 1m thick) Drug Layer 90% Zotarolimus (10 g/mm) 10% PC ( 2-4m thick) PC Overspray( 0.1 m thick) Stent Strut 3.0 mm Stents 500x magnification Illustrative Not to Scale Taxus Cypher Endeavor 5. Porcine Drug Elution Kinetics and PK

  • Zotarolimus is hydrophobic and rapidly elutes fromthe hydrophilic PC polymer matrix within 14 days

Blood and Arterial Tissue Zotarolimus Concentration

  • Zotarolimus is highly lipophilic enabling rapid arterial tissue loading and drug retention which is sustained for ~28 days

Drug Elution by Recovered Drug from Stent Concentration (Blood) ng/ml Days Concentration (Tissue) ng/ml Blood Tissue % Drug Eluted Time (Days) 65 87 98 99 6. Biocompatibility (Inflammation Scores)

  • Porcine inflammation scores show mild response to a3X overdose (30g/mm)and6X overdose (overlapping 30g/mm)at all chronic time points up to 180 days with single and overlapped stents.

*CVPath, Dr Renu Virmani Inflammation Scores Inflammation Scores 1 28 to 180 days Inflammation Scores 1 28 to 180 days Inflammation Scores Days Days 1 Bare stent controls matched with test groups 2 Not Done *P