Maurizio D’Amico MD — Clinical evidence – based safety and efficacy of a biolimus eluting stent with biodegradable polymer technology

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Health & Medicine

Clinical evidence – based safety and efficacy
of a biolimus eluting stent with
biodegradable polymer technology
Maurizio D’Amico MD
Cardiovascular Department Molinette Hospital
Turin

Biolimus Eluting Stent
Simultaneous release of biolimus A9 and degradation of PLA Polymer
over 6-9 months

11
Biolimus Eluting Stent
• Derived from rapamycin, developed by Biosensors specially for stent applications
• Cytostatic drug with proven immunosoppresive and antiprofilerative properties
• Waste reduction in blood flow and exposure to systemic level to greater
localization of the drug and absorption by the tissues thanks to:
• High lipophilicity
• Coating abluminal

The platform
Enhanced flexibility and navigability
• Curved connectors
• Quadrature link exclusive design
• Open cells drawing
• 6 crowns Ø da 2.25 a 3.00
mm
• 9 crownsØ da 3.50 a 4.00 mm
Available models
Optimized access to side branch
1.56 mm BioMatrix Flex™

LEADERS
trial design
Biolimus-Eluting stents Sirolimus-Eluting stents

LEADERS
MACE (Cardiac Death,MI and ci-TVR)

LEADERS
Patient Oriented Composite Endpoint
(All-Cause Death,Any MI,All Revascularization)

LEADERS
Definite ST (ARC)
Landmark Analysis @1 Year

LEADERS
Stratified Analysis of MACE@5 years

LEADERS
Conclusions
• Biodegradable polymer BES maintained non-inferiority and
improved long-term clinical outcomes compared to SES
through 5 years (Psup =0.071)
• Biodegradable polymer BES demonstrated a 74% relative risk
reduction in very late definite stent thrombosis (VLST)
• The benefit of biodegradable polymer BES emerged in the very
late phase and was mainly driven by a lower risk of MACE
associated with definite VLST

LEADERS-AMI
Clinical Presentations/Cardiac Enzymes (1/2)

LEADERS-AMI
Clinical Presentations/Cardiac Enzymes (2/2)

LEADERS-AMI
Cardiac Death
(STEMI Patients)

LEADERS-AMI
Clinical Outcomes at 5 years FU

LEADERS-AMI
Conclusions
• Biodegradable polymer BES provided significant
improvements in clinical outcomes in patients with AMI
at 5 years follow up , compared with SES with durable
polymer stent
• The benefit appeared more significant in the subgroup of
patients with STEMI, suggesting that BES should be
favourably considered for treating STEMI patients

e-BioMatrix Registry
Lesion Characteristics

e-BioMatrix Registry
PCI Procedure: Stents

e-BioMatrix Registry
MACE (Primary Endpoint)
Cardiac Death, MI, ci-TVR

e-BioMatrix Registry
12-month MACE Rates in e-BioMatrix and
LEADERS

e-BioMatrix Registry
Mortality associated with Stent Thrombosis and
Major Bleeding

LEADERS-BIFURCATION
Conclusions
•A one stent strategy is the most prevalent
stenting technique
•In patients with bifurcation lesions:
Observed trend for more MI with BES
(p=NS)
Significantly greater TVR/TLR with SES
(p<0.05)
Overall MACE at 12 months was similar
between BES and SES (p=NS).

Does stent design impact
the outcome in
bifurcation treatment?
Registries Randomised Control Trials
Evidence exists from registries and randomised trials
which suggests that stent design does impact on outcome
in bifurcation lesions.

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