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Information contained herein for presentation outside of the U.S. and Japan only. Not to be reproduced, distributed or excerpted. AP2934106 Rev. A 1 Abbott Vascular's Bioresorbable Scaffold Programme, a new paradigm in PCI Richard J. Rapoza, PhD Divisional Vice President of R&D
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Information contained herein for presentation outside of the U.S. and Japan only. Not to be reproduced, distributed or excerpted. AP2934106 Rev. A 2 MY CONFLICTS OF INTEREST ARE: Full time employee of Abbott Vascular
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Information contained herein for presentation outside of the U.S. and Japan only. Not to be reproduced, distributed or excerpted. AP2934106 Rev. A 3 The Evolution of PCI Treatment Options BenefitsDetrimentsTLR PTCA 1970s Minimally invasive alternative to CABG Excellent long-term durability of results for patients who did well through ~6 months Acute/sub-acute closure High restenosis rates due to negative vessel remodeling 30 – 50% BMS 1980s Eliminated abrupt and sub-acute closure Reduced restenosis rates compared to PTCA Neointimal hyperplasia resulting in in-stent restenosis 15 – 30% DES 2000s Significantly reduced neointimal hyperplasia Reduced restenosis rates compared to BMS Late and very late stent thrombosis Dependence on long-term DAPT 5 – 10% Each of these new technologies addressed the shortcomings of the previous technology, but with their introduction arrived new, significant concerns
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Information contained herein for presentation outside of the U.S. and Japan only. Not to be reproduced, distributed or excerpted. AP2934106 Rev. A 4 A New Therapy?: Vascular Restoration Therapy Medical Therapy PCI CABG PTCAStenting VRT Devices Used: BDC BMS DES BVS
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Information contained herein for presentation outside of the U.S. and Japan only. Not to be reproduced, distributed or excerpted. AP2934106 Rev. A 5 Vascular Restoration Therapy (VRT) Restoration ResorptionRevascularization Restore vasomotor function Restore natural vessel structure Restore flow BMS & DES only accomplish this Only possible in the absence of a permanent implant Vessel is restored to a more natural state, capable of natural vascular function
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Information contained herein for presentation outside of the U.S. and Japan only. Not to be reproduced, distributed or excerpted. AP2934106 Rev. A 6 1 3 6 24 Mos Support Mass Loss Tie chains Molecular Weight 1218 Polylactide Degradation vs Lumen Support Data on file at Abbott Vascular.
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Information contained herein for presentation outside of the U.S. and Japan only. Not to be reproduced, distributed or excerpted. AP2934106 Rev. A 7 Model derived from Prabhu S and Hossainy S, J. Biomed. Mater. Res., Pt. A 2007; 80: 732. Tests were performed by and data are on file at Abbott Vascular. BVS Resorption in Healthy Porcine Model 1 4 5 2 3 1 month 1 6 months 2 1 year 3 18 months 10X Magnification 4 2 years 5
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Information contained herein for presentation outside of the U.S. and Japan only. Not to be reproduced, distributed or excerpted. AP2934106 Rev. A 8 Photos taken by and on file at Abbott Vascular. 2 years3 years 4 years Tests performed by and data on file at Abbott Vascular. 1.5 years % Mass Remaining 45 0 - 5 0 0 Long Term Biological Response
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Information contained herein for presentation outside of the U.S. and Japan only. Not to be reproduced, distributed or excerpted. AP2934106 Rev. A 9 ■ BVS Cohort A (n = 26) ■ BVS Cohort B1 (n = 42 ITT) ▲ EES (n = 22)* BMS (n = 27)* ABSORB Cohort B 6-Month QCA Cumulative Incidence Curve for Late Loss Adapted from Serruys, PW. PCR 2010 BMS LL = 0.85 ± 0.36 mm BVS Cohort A LL = 0.44 ± 0.35mm BVS Cohort B1 LL = 0.19 ± 0.18 mm EES LL = 0.10 ± 0.23 mm * SPIRIT-FIRST ABSORB is a trademark of the Abbott Group of Companies
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Information contained herein for presentation outside of the U.S. and Japan only. Not to be reproduced, distributed or excerpted. AP2934106 Rev. A 10 ABSORB Cohort A Clinical Results – Intent to treat Hierarchical 6 Months (n = 30) 12 Months (n = 29)* 24 Months (n = 29)* 36 Months (n = 29)* 48 Months (n = 29)* Ischemia Driven MACE 1 (3.3%)**1 (3.4%)** Cardiac Death0 (0.0%) MI1 (3.3%)**1 (3.4%)** Q-Wave MI 0 (0.0%) Non Q-Wave MI 1 (3.3%)**1 (3.4%)** Ischemia Driven TLR0 (0.0%) by PCI 0 (0.0%) by CABG 0 (0.0%) No new MACE between 6 and 48 months * One patient withdrew consent and missed the 9, 12, 18 month and 2, 3 and 4 year visits **This patient also underwent a TLR, not qualified as ID-TLR (DS = 42%) followed by post-procedural troponin qualified as NQMI and died from Hodgkin’s disease at 888 days post-procedure Serruys, PW., AHA 2010. No thrombosis up to 4 years (all patients off clopidogrel) ABSORB is a trademark of the Abbott Group of Companies
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Information contained herein for presentation outside of the U.S. and Japan only. Not to be reproduced, distributed or excerpted. AP2934106 Rev. A 11 ABSORB Cohort B Clinical Results - Intent to treat, Group 1 No thrombosis by ARC or Protocol Non-Hierarchical Cardiac Death (%) Myocardial Infarction n (%) Q-wave MI Non Q-wave MI Ischemia Driven TLR n (%) PCI CABG Hierarchical MACE n (%) Hierarchical TLF n (%) 30 Days 6 Months N = 45 0 0 1 (2.2) 0 0 0 0 0 0 2 (4.4) 1 (2.2) 2 (4.4) MACE: cardiac death, MI, ischemia-driven TLR TLF: cardiac death, MI, ischemmia-driven TLR, ischemia-driven TVR 9 Months N = 45 0 1 (2.2) 0 0 2 (4.4) Serruys, PW., TCT 2010 Ormiston, J., TCT 2010 ABSORB is a trademark of the Abbott Group of Companies
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Information contained herein for presentation outside of the U.S. and Japan only. Not to be reproduced, distributed or excerpted. AP2934106 Rev. A 12 ABSORB Cohort B Clinical Results - Intent to treat, Group 1&2 No thrombosis by ARC or Protocol Non-Hierarchical Cardiac Death (%) Myocardial Infarction n (%) Q-wave MI Non Q-wave MI Ischemia Driven TLR n (%) PCI CABG Hierarchical MACE n (%) Hierarchical TLF n (%) 30 Days 6 Months N = 101 0 0 2 (2.0) 3 (3.0) 0 0 2 (2.0) 3 (3.0) 2 (2.0) 0 0 0 0 5 (5.0) 2 (2.0) 5 (5.0) MACE: cardiac death, MI, ischemia-driven TLR TLF: cardiac death, MI, ischemmia-driven TLR, ischemia-driven TVR Serruys, PW., AHA 2010. 9 Months N = 101 0 3 (3.0) 0 2 (2.0) 0 5 (5.0) ABSORB is a trademark of the Abbott Group of Companies
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Information contained herein for presentation outside of the U.S. and Japan only. Not to be reproduced, distributed or excerpted. AP2934106 Rev. A 13 Baseline6 mo follow up Baseline MLA: 7.39 mm 2 Follow up MLA: 8.18 mm 2 Coverage: 60 μm ABSORB Cohort B: OCT example ABSORB is a trademark of the Abbott Group of Companies Serruys, PW. PCR 2010 Serruys, PW. CCT 2010
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