Progenitor Endothelial Cell Capturing with a Drug Eluting Stent Stephen M Rowland, PhD VP R&D and Clinical Affairs, OrbusNeich Medical Washington, DC 25 February, 2013
Disclosure Employee of OrbusNeich Medical, Inc.
COMBO Dual Therapy Stent 316L Stainless Steel Stent Strut Cross-section Nanometer Thick CD34 Antibody Layer Abluminal Sirolimus Release Matrix 3 – 5 μm 316L SST Stent Strut 100 μm Lumen SIDE Design features: Abluminal biodegradable polymer matrix Sirolimus elution Genous technology for accelerated endothelial coverage Vessel SIDE
Clinical Performance Conducted 3 studies with the Combo stent including multiple imaging modalities: REMEDEE stable angina patients (N=180) EGO Combo stable angina patients (N=61) REMEDEE OCT STEMI & non-STEMI patients (N=60) Shed light on 3 aspects of healing: EARLY: Strut “coverage” OCT @ 2 - 9 months MID TERM: restenosis NI formation & Late Loss QCA @ 9 months LONG TERM: Biostability NI Characterization @ 9 months OCT: Low Intensity Tissue & Micro Vessels in NI IVUS-VH: Necrotic Core in NI
Strut Coverage % (OCT) Median & IQR REMEDEE OCT, U. Landmesser, TCT 2012, Miami, FL EGO Combo; S. Lee, TCT 2012, Miami, FL * BASE-OCT: Pasi Karjalainen, ICI meeting 2010
Cumulative Frequency Distribution of In-stent Late Lumen Loss * Haude M et al., TCT 2012, Miami, FL
Histograms of In-stent Late Loss (QCA) Combo (REMEDEE, 9 mo) n=109 Taxus (REMEDEE, 9 mo) n=52 % In-Stent Late Loss [mm] In-Stent Late Loss [mm] Genous * (Healing IIb, 6 mo) n=86 ISLL distributions show different patterns: Combo slight tail Taxus bi-modal appearance Genous similar to BMS % In-Stent Late Loss [mm] Haude M et al., TCT 2012, Miami, FL
NI Tissue Characterization (IVUS-VH) REMEDEE (9 month FU) p = 0.08 p = 0.28 p = 0.33 p = 1.00 p = 0.52 n = 10 n = 5 Haude M et al., Poster Presentation: 2012, EuroPCR, Paris, France
NI Tissue Characterization (OCT) REMEDEE (9 month FU) p = 0.08 p = 0.40 p = 0.04 n = 24 n = 10 Haude M et al., Poster Presentation: 2012, EuroPCR, Paris, France
Lessons Learned Signature of the Combo Stent reflects: Abluminal drug delivery and Luminal EPC capture Translating into: Early Rapid strut coverage with endothelium Mid Term DES-like late loss (control of restenosis) Long Term Uniform homogeneous tissue with a reduced accumulation of newly formed necrotic core/neo-atherosclerosis
COMBO Dual Therapy Stent Clinical Trial Program REMEDEE EGO COMBO REMEDEE OCT COMBO Post Market COMBO Japan & US N= 183 N= 61 N= 60 N= TBD N= TBD Randomized Multicenter Trial with 9 Month Angiographic FU Prospective, Single Center Serial OCT Assessment from 2-5 Months “All Comers” Expanded Indication Optimal DAPT Duration Mechanisms of Healing Platform Development HBD WG1 PoC Single Protocol Randomized Randomized Multicenter OCT Assessment at 2 Months vs EES OCT & IVUS / VH Subset Analyses Completed Clinical FU Ongoing 2-5 and 9 Months Completed Pending 24 Month FU Completed Clinical FU Ongoing Under Preparation Under Preparation
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