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The Emerging Paradigm of Stent Biocompatibility: Current Status and Future Directions
Dr Miles DalbyConsultant CardiologistHonorary Senior LecturerRoyal Brompton & Harefield NHS TrustImperial College
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Biotonik Speaker BureauConor Speaker BureauMSD Speaker BureauTranslumina Research GrantBoston Scientific Research FundingVolcano Research support
Conflicts of Interest
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0.81.3
0.0
1.3 1.3
2.6
1.2
4.14.9
1.4
0
2
4
6
8
Late stentthrombosis
Thrombosis-related events
Cardiac death Non-fatal MI Death or MIEve
nts
bet
wee
n 6
-18
mo
nth
s (%
) BMS DES
0.81.3
0.0
1.3 1.3
2.6
1.2
4.14.9
1.4
0
2
4
6
8
Late stentthrombosis
Thrombosis-related events
Cardiac death Non-fatal MI Death or MIEve
nts
bet
wee
n 6
-18
mo
nth
s (%
) BMS DES
What makes a good stent…….
Acute performance: OK Anti-Restenotic Efficacy: OKSafety………………..n=????? t=?????
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Evolution in Stent Biocompatibility
Coated Bare Metal Stent: Prokinetic
Drug Eluting Erodable Polymer Stent: Costar
Bioabsorbable stent: Magic
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316L steel stent tube in fibrinogen solution with applied current via electrode (time wrapping 1:10)
Silicon Carbide and Thromboresistance
316LA-SiC:H
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Silicon Carbide
Stainless Steel
0.5 µm
0.25 µm
0 µm
0.5 µm
0.25 µm
0 µm
Silicon Carbide and ThromboresistanceB
ioco
mpati
bili
ty
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Silicon Carbide and Thromboresistance
Chandler loop
Silicon Carbide Stainless Steel
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Silicon Carbide and Endothelialisation
Exposure of 316L and SiC to endothelial cells for 24h:
Light microscopy Atomic Force Microscopy
SiC
3
16L
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Co-Star Paclitaxel eluting stent
Bridge Elements
Poly (lactide co-glycolide)
Bioresorbable polymer
Nanodroplet injection method Explant at 180 days
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Costar architecture and apposition: OCT
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Costar Stent Overlap: OCT
<100um
Costar:• Good acute performance (clinical experience and OCT)• Fully absorbable Polymer resulting in BMS• Platform for future drug release strategies
2 x 3mm 12 atm overlap no post dilatation
0
2
4
6
8
d3
0 M
AC
E (
%)
No Overlap Overlap
Costar IIBlind aggregate d30 MACE
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Magnesium Alloy Bioabsorbable Stent
• Biocompatibility• Imaging• Re-Intervention• Surgery• ?Reduction in late thrombosis risk • Return of vascular function
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PROGRESS AMS-1: FIM
% n % n % n
MACE 0 0 0 0 23.8 15
Death 0 0 0 0 0 0
Q-wave MI 0 0 0 0 0 0
Non Q wave MI 0 0 0 0 0 0
Ischemic Driven TLR
0 0 0 0 23.8 15
Primary Endpoint: Feasibility and safety at 4 months with MACE<30%. N=63
30-DayIn Hospital 4-Month
NegativeRemodeling /Recoil
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15 Months after AMS implantation in human
IVUS OCT
Courtesy of Pr. Carlo di Mario
• Very thin neointima
• perfect ingrow of AMS
• completed healing of the stented vessel
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A B
C D
Bare Metal Stent
AbsorbableMetal Stent
AMS: AMS: 16-row MSCT 16-row MSCT CompatibleCompatible
Lind et al Heart 91:1604, 2005
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Stent Resorption and Vasoreactivity?
2.7
2.75
2.8
2.85
2.9
2.95
3
3.05
3.1
3.15
Pre ISDN Post ISDN
Dia
met
er (
mm
)
Pre-ISDN
Post-ISDN
Stent segment
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passivatingmatrix
Mid / long term
Addition of suitable drug
Passivating coating
Short term: AMS2
The future of the AMS platformThe future of the AMS platform
Reduction ofDegradation Rate
Increase ofRadial Force
Optimization of mechanical stability
Improved Geometrical Design
ImprovedAlloy / Metallography
Inhibition ofside effects
DREAMS
Use AMS2as basic platform