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  • 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

  • BRS BRS 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?

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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 Absorb Bioresorbable 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

  • 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

  • E n

    d o

    th e li a li sa

    ti o

    n [%

    ] Magmaris vs Absorb endothelialisation in

    rabbit model at 28 days

    euro

    FCR

    120

    100 -80

    -60 -40 -

    20 -0 -

    p

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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.113.000931 3 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.100.003210 4 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 platelets Activated 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–I 46 EU

    + Switzerland

    FIM TLF at 6 and 12 months

    Completed

    BIOSOLVE–IV 1065 Worldwide PMS

    Registry

    TLF at 12 months

    BIOSOLVE–II 123 Worldwide In-segment LLL

    at 6 months 24 months FU

    available

    FIM

    BIOSOLVE–III 61 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

    Study BIOSOLVE II

    n=123 BIOSOLVE 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

    Study BIOSOLVE-III3

    n=63 BIOSOLVE-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 !