bioabsorbable scaffold: is it the stent of the future?hntmmttn.vn/upload/file/dvc 13am/[cd4.32]...
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Bioabsorbable scaffold: Is it the stent of the future?
A\ Prof. Trương Quang Bình MD, PhD, FSCAI
University Medical Center
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Coronary Stenting
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Bioabsorbable scaffold
The vessel will be free of any caging
and can regain its normal function
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BRSBRS technology is anticipated not
only to eliminate the risk of VLST, but
also to contribute to the restoration of
physiological function of treated
vessels.
VLST = Very Late Stent Thrombosis
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Bioresorbable scaffolds (BRS)
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ABSORB III
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ABSORB III
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ABSORB III
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September 14, 2017
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Magmaris Bioabsorbable scaffold: Is magnesium safer than polymer?
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Magnesium Backbone
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Thrombogenicity of the backbone
material
Resorption time Endothelialization Disturbance of the laminar blood
flow
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Porcine Shunt Model: Magmaris vs leading polymeric scaffold
Waksman R et al. Comparison of Acute Thrombogenicity for Metallic and Polymeric Bioabsorbable Scaffolds: Magmaris vs ABSORB in a Porcine Arteriovenous Shunt Model. Cardiovascular ntervention. Submitted for publication.
Platelet coverage marker:CD61 and CD42b for adherent platelets
1 hour
▪ Magmaris and the leading polymeric scaffold were implanted in a silicon tube
▪ The test was repeated with different scaffold positions.
▪ Both scaffolds were exposed to porcine blood flow for one hour.
▪ After one hour, platelet coverage of the scaffold surface was analyzed by using immunostaining
▪ Platelet coverage is directly involved in thrombus formation
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euro
FCR
Results Shunt Study 1:Magmaris vs. Absorb vs. Orsiro
Scanning Electron Microscopy■ Significantly less thrombus deposition in Magmaris compared to Absorb
■ Less inflammatory cells in Magmaris compared to AbsorbBioresorbable ScaffoldsMagmaris ABSORB Orsiro
Arrows: thrombus deposition, arrowhed: inflammatory cells
Adherent Thrombi
Inflammation
Waksman R. et al., In press Circulation Cardiovascular Intervention
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Magnesium Backbone
Thrombogenicity of the backbone
material
Resorption time
Endothelialization Disturbance of the laminar blood flow
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Polymeric and Mg scaffolds in the same patient
Mg scaffold@ 18 months(RCA)
Polymeric scaffold@ 18 months
(LCX)
EuroPCR 2016 «Technical and procedural aspects» presented by Ralph Tölg, MD; Segeberger Kliniken, Bad Segeberg, Germany
▪ Low risk of late scaffold thrombosis due to fast resorption
▪ ~95% of magnesium is resorbed at 12 months.1
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Magnesium Backbone
Thrombogenicity of the backbone
material
Resorption time Endothelialization Disturbance of the laminar blood flow
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En
do
thelialisa
tio
n[%
]Magmaris vs Absorb endothelialisation in
rabbit model at 28 days
euro
FCR
120
100 -80
-60 -40 -
20 -0 -
p<0.004
Above struts In between
struts
p = 0.007
Overall
PLLA BRS
Waksman R. et al., EuroIntervention 2017; published online ahead of print
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Magnesium Backbone
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Thrombogenicity of the backbone material
Resorption time Endothelialization
Disturbance of the laminar blood flow
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Computer simulation: Impact of recoil on the hemodynamic flow
1 Schmidt W et al. In vitro performance investigation of bioresorbable scaffolds - Standard tests for vascular stents and beyond.Cardiovascular Revascularization Medicine. 2016; 17(6):375-383.2 Foin N et al. Incomplete Stent Apposition Causes High Shear Flow Disturbances and Delay in Neointimal Coverage as a Function of Strut to Wall Detachment Distance, DOI: 10.1161/CIRCINTERVENTIONS.113.0009313 Kolandaivelu K et al “Stent Thrombogenicicty Early in High-Risk Interventional Settings Is Drive by Stent design and Deployment and Protected by Polymer-Drug Coatings” DOI:10.1161/CIRCULTATIONAHA.100.0032104 Jiménez J.M., Davies P.F. Hemodynamically Driven Stent Strut Design. Annals of Biomedical Engineering. 2009
▪ Magmaris showed no recoil increase, whereas the leading polymeric scaffold diameter decreased >20% within 1st hour in a bench test.1
Magmaris Leading polymeric scaffold
Magmaris Leading polymeric scaffold
At implantation 1h after implantation
more recoil
Inactive plateletsActivated platelets
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Magmaris has a potential low scaffold thrombosis risk
Mg
Low risk of thrombus formation due to 20% less recoil1 and therefore less platelet activation
Low risk of thrombus formation in a pre-clinical shunt trial
Low risk of late scaffold thrombosis due to fast resorption:~95% magnesium is resorbed at 12ms
Low risk of thrombus formation due to 15% better endothelialization
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Magmaris clinical program
BIOSOLVE–I46 EU
+ Switzerland
FIM TLF at 6 and 12 months
Completed
BIOSOLVE–IV1065 Worldwide PMS
Registry
TLF at 12 months
BIOSOLVE–II123 Worldwide In-segment LLL
at 6 months24 months FU
available
FIM
BIOSOLVE–III61 EU
+ Switzerland
In hospital Procedural success
6 months FU available
Pivotal trial
Enrolling
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Magmaris Clinical Trials
1 BIOSOLVE-II 6m 2 BIOSOLVE-II 12m
No definite or probable late1 or very late2 scaffold thrombosis was observed with Magmaris in clinical trials up to 12 months
Time 6 month 12 month
StudyBIOSOLVE II
n=123BIOSOLVE II
n=123
TLF [%] 3.3 3.4
Definite or probable ST [%] 0% 0%
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Magmaris clinical trials
1 BIOSOLVE-II and –III; 2 BIOSOLVE-II; 3 Haude M et al. Sustained safety and clinical performance of a drug-eluting absorbable metal scaffold up to 24 month: pooled outcomes of BIOSOLVE-II and -III. EuroIntervention. 2017; Accepted for Fast Track Publication.
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No definite or probable late1 or very late2 scaffold thrombosis (ST) was
observed with Magmaris in clinical trials up to 24 months.3
Time 6 months 24 months
StudyBIOSOLVE-III3
n=63BIOSOLVE-II3
n=123
TLF 3.3% 5.9%
Definite or probable ST 0% 0%
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CONCLUSIONS▪ Magmaris:
(1) material with low thrombogenic,
(2) resorption faster,
(3) Endothelialization better, and
(4) less recoil and less platelet activation.
▪ Magmaris in Biosolve I, II, III: probable or definite ST 0% at 12 and 24 months follow up; Biosolve IV: safe
▪ Magmaris, with magnesium backbone, will be safer than BRS with polymer backbone =>will be the Stent of the future?
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Thank you !