bioabsorbable scaffold: is it the stent of the future?hntmmttn.vn/upload/file/dvc 13am/[cd4.32]...
TRANSCRIPT
Bioabsorbable scaffold: Is it the stent of the future?
A\ Prof. Trương Quang Bình MD, PhD, FSCAI
University Medical Center
Coronary Stenting
Bioabsorbable scaffold
The vessel will be free of any caging
and can regain its normal function
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
Bioresorbable scaffolds (BRS)
ABSORB III
ABSORB III
ABSORB III
September 14, 2017
Magmaris Bioabsorbable scaffold: Is magnesium safer than polymer?
Str
ictly
confidential-
for
inte
rnal
use
only
Magnesium Backbone
14
Thrombogenicity of the backbone
material
Resorption time Endothelialization Disturbance of the laminar blood
flow
Str
ictly
confidential-
for
inte
rnal
use
only
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
Str
ictly
confidential-
for
inte
rnal
use
only
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
Str
ictly
confidential-
for
inte
rnal
use
only
Magnesium Backbone
Thrombogenicity of the backbone
material
Resorption time
Endothelialization Disturbance of the laminar blood flow
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
Str
ictly
confidential-
for
inte
rnal
use
only
Magnesium Backbone
Thrombogenicity of the backbone
material
Resorption time Endothelialization Disturbance of the laminar blood flow
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
Str
ictly
confidential-
for
inte
rnal
use
only
Magnesium Backbone
21
Thrombogenicity of the backbone material
Resorption time Endothelialization
Disturbance of the laminar blood flow
Str
ictly
confidential-
for
inte
rnal
use
only
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
Str
ictly
confidential-
for
inte
rnal
use
only
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
Str
ictly
confidential-
for
inte
rnal
use
only
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
24
Str
ictly
confidential-
for
inte
rnal
use
only
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%
Str
ictly
confidential-
for
inte
rnal
use
only
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.
26
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%
Str
ictly
confidential-
for
inte
rnal
use
only
27
Str
ictly
confidential-
for
inte
rnal
use
only
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?
Str
ictly
confidential-
for
inte
rnal
use
only
Thank you !