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Abbott Vascular's Bioresorbable Scaffold Programme, a new paradigm in PCI

Abbott Vascular's Bioresorbable Scaffold Programme, a new paradigm in PCI. Richard J. Rapoza, PhD Divisional Vice President of R&D. MY CONFLICTS OF INTEREST ARE: Full time employee of Abbott Vascular. The Evolution of PCI Treatment Options.

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Abbott Vascular's Bioresorbable Scaffold Programme, a new paradigm in PCI

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  1. Abbott Vascular's Bioresorbable Scaffold Programme, a new paradigm in PCI Richard J. Rapoza, PhD Divisional Vice President of R&D

  2. MY CONFLICTS OF INTEREST ARE: Full time employee of Abbott Vascular

  3. The Evolution of PCI Treatment Options Each of these new technologies addressed the shortcomings of the previous technology, but with their introduction arrived new, significant concerns

  4. A New Therapy?: Vascular Restoration Therapy PCI Medical Therapy CABG PTCA Stenting VRT Devices Used: BVS BDC DES BMS

  5. Vascular Restoration Therapy(VRT) Vessel is restored to a more natural state, capable of natural vascular function Restoration Revascularization Resorption Restore flow Restore vasomotor function Restore natural vessel structure BMS & DES only accomplish this Only possible in the absence of a permanent implant

  6.                          Polylactide Degradation vs Lumen Support Tie chains Support Molecular Weight     Mass Loss   3 12 18 1 24 Mos 6 Data on file at Abbott Vascular.

  7. 1 month 1 1 year 2 years 6 months 4 18 months 2 5 10X Magnification 3 BVS Resorption in Healthy Porcine Model 4 3 5 2 1 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.

  8. Long Term Biological Response 1.5 years 4 years 2 years 3 years % Mass Remaining 45 0 - 5 0 0 Tests performed by and data on file at Abbott Vascular. Photos taken by and on file at Abbott Vascular.

  9. ABSORB Cohort B 6-Month QCA Cumulative Incidence Curve for Late Loss BMS LL = 0.85 ± 0.36 mm BVS Cohort A LL = 0.44 ± 0.35mm ■BVS Cohort A (n = 26) ■ BVS Cohort B1 (n = 42 ITT) ▲ EES (n = 22)* BVS Cohort B1 LL = 0.19 ± 0.18 mm  BMS (n = 27)* EES LL = 0.10 ± 0.23 mm ABSORB is a trademark of the Abbott Group of Companies * SPIRIT-FIRST Adapted from Serruys, PW. PCR 2010

  10. ABSORB Cohort A Clinical Results – Intent to treat No new MACE between 6 and 48 months Serruys, PW., AHA 2010. ABSORB is a trademark of the Abbott Group of Companies No thrombosis up to 4 years (all patients off clopidogrel) * 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

  11. ABSORB Cohort B Clinical Results - Intent to treat, Group 1 6 Months 30 Days 9 Months N = 45 Non-Hierarchical N = 45 N = 45 Cardiac Death (%) 0 0 0 1 (2.2) Myocardial Infarction n (%) 1 (2.2) 1 (2.2) Q-wave MI 0 0 0 1 (2.2) Non Q-wave MI 1 (2.2) 1 (2.2) 0 Ischemia Driven TLR n (%) 1 (2.2) 1 (2.2) PCI 1 (2.2) 0 1 (2.2) 0 CABG 0 0 Hierarchical MACE n (%) 1 (2.2) 2 (4.4) 2 (4.4) 1 (2.2) Hierarchical TLF n (%) 2 (4.4) 2 (4.4) No thrombosis by ARC or Protocol Serruys, PW., TCT 2010 Ormiston, J., TCT 2010 ABSORB is a trademark of the Abbott Group of Companies MACE: cardiac death, MI, ischemia-driven TLR TLF: cardiac death, MI, ischemmia-driven TLR, ischemia-driven TVR

  12. ABSORB Cohort B Clinical Results - Intent to treat, Group 1&2 6 Months 30 Days 9 Months N = 101 Non-Hierarchical N = 101 N = 101 Cardiac Death (%) 0 0 0 2 (2.0) Myocardial Infarction n (%) 3 (3.0) 3 (3.0) Q-wave MI 0 0 0 2 (2.0) Non Q-wave MI 3 (3.0) 3 (3.0) 0 Ischemia Driven TLR n (%) 2 (2.0) 2 (2.0) PCI 2 (2.0) 0 2 (2.0) 0 CABG 0 0 Hierarchical MACE n (%) 2 (2.0) 5 (5.0) 5 (5.0) 2 (2.0) Hierarchical TLF n (%) 5 (5.0) 5 (5.0) Serruys, PW., AHA 2010. No thrombosis by ARC or Protocol ABSORB is a trademark of the Abbott Group of Companies MACE: cardiac death, MI, ischemia-driven TLR TLF: cardiac death, MI, ischemmia-driven TLR, ischemia-driven TVR

  13. Baseline 6 mo follow up Baseline MLA: 7.39 mm2 Follow up MLA: 8.18 mm2 Coverage: 60 μm ABSORB Cohort B: OCT example Serruys, PW. PCR 2010 Serruys, PW. CCT 2010 ABSORB is a trademark of the Abbott Group of Companies

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