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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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MY CONFLICTS OF INTEREST ARE:
Full time employee of Abbott Vascular
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The Evolution of PCI Treatment OptionsBenefits Detriments TLR
PTCA1970s
• 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%
BMS1980s
• Eliminated abrupt and sub-acute closure• Reduced restenosis rates compared to PTCA
• Neointimal hyperplasia resulting in in-stent restenosis
15 – 30%
DES2000s
• 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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A New Therapy?: Vascular Restoration Therapy
Medical Therapy PCI CABG
PTCA Stenting VRT
Devices Used: BDC BMS DES BVS
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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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1 3 6 24 Mos
Support
Mass Loss
Tie chains
MolecularWeight
12 18
Polylactide Degradation vs Lumen Support
Data on file at Abbott Vascular.
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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
523
1 month
1
6 months
2
1 year
3
18 months
10X Magnification
4
2 years
5
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8Photos taken by and on file at Abbott Vascular.
2 years 3 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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0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
-0.5 0 0.5 1 1.5 2
In-Stent Late-Loss (mm)
% P
atie
nts BVS 1.0
BVS 1.1
EES
BMS
■ BVS Cohort A (n = 26) ■ BVS Cohort B1 (n = 42 ITT) ▲ EES (n = 22)* BMS (n = 27)*
ABSORB Cohort B 6-Month QCACumulative 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 trademarkof the Abbott Group of Companies
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ABSORB Cohort A Clinical Results – Intent to treat
Hierarchical6 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%)** 1 (3.4%)** 1 (3.4%)** 1 (3.4%)**
Cardiac Death 0 (0.0%) 0 (0.0%) 0 (0.0%) 0 (0.0%) 0 (0.0%)
MI 1 (3.3%)** 1 (3.4%)** 1 (3.4%)** 1 (3.4%)** 1 (3.4%)**
Q-Wave MI 0 (0.0%) 0 (0.0%) 0 (0.0%) 0 (0.0%) 0 (0.0%)
Non Q-Wave MI 1 (3.3%)** 1 (3.4%)** 1 (3.4%)** 1 (3.4%)** 1 (3.4%)**
Ischemia Driven TLR 0 (0.0%) 0 (0.0%) 0 (0.0%) 0 (0.0%) 0 (0.0%)
by PCI 0 (0.0%) 0 (0.0%) 0 (0.0%) 0 (0.0%) 0 (0.0%)
by CABG 0 (0.0%) 0 (0.0%) 0 (0.0%) 0 (0.0%) 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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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 MINon Q-wave MI
Ischemia Driven TLR n (%)PCICABG
Hierarchical MACE n (%)
Hierarchical TLF n (%)
30 Days 6 MonthsN = 45N = 45
0 0
1 (2.2) 1 (2.2)0 0
1 (2.2) 1 (2.2)
1 (2.2)01 (2.2)0
0 0
1 (2.2) 2 (4.4)
1 (2.2) 2 (4.4)
MACE: cardiac death, MI, ischemia-driven TLRTLF: cardiac death, MI, ischemmia-driven TLR, ischemia-driven TVR
9 MonthsN = 45
0
1 (2.2)0
1 (2.2)
1 (2.2)1 (2.2)
0
2 (4.4)
2 (4.4)
Serruys, PW., TCT 2010
Ormiston, J., TCT 2010ABSORB is a trademark of the Abbott Group of Companies
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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 MINon Q-wave MI
Ischemia Driven TLR n (%)PCICABG
Hierarchical MACE n (%)
Hierarchical TLF n (%)
30 Days 6 MonthsN = 101N = 101
0 0
2 (2.0) 3 (3.0)0 0
2 (2.0) 3 (3.0)
2 (2.0)02 (2.0)0
0 0
2 (2.0) 5 (5.0)
2 (2.0) 5 (5.0)
MACE: cardiac death, MI, ischemia-driven TLRTLF: cardiac death, MI, ischemmia-driven TLR, ischemia-driven TVR
Serruys, PW., AHA 2010.
9 MonthsN = 101
0
3 (3.0)0
3 (3.0)
2 (2.0)2 (2.0)
0
5 (5.0)
5 (5.0)
ABSORB is a trademark of the Abbott Group of Companies
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Baseline 6 mo follow up
BaselineMLA: 7.39 mm2
Follow upMLA: 8.18 mm2
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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