Maurizio D’Amico MD — Clinical evidence – based safety and efficacy of a biolimus eluting...
-
Upload
pavel-fedotov -
Category
Health & Medicine
-
view
75 -
download
4
description
Transcript of Maurizio D’Amico MD — Clinical evidence – based safety and efficacy of a biolimus eluting...
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
Biolimus Eluting Stent
Simultaneous release of biolimus A9 and degradation of PLA Polymer over 6-9 months
1 1
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
Biolimus Eluting Stent
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
LEADERS trial design
Biolimus-Eluting stents Sirolimus-Eluting stents
LEADERS Patient demographics
LEADERS Patient characteristics
LEADERS Patient flow-clinical
LEADERS MACE (Cardiac Death,MI and ci-TVR)
LEADERS Cardiac Death
LEADERS Clinically-Indicated TVR
LEADERS Patient Oriented Composite Endpoint (All-Cause Death,Any MI,All Revascularization)
LEADERS Definite Stent Thrombosis (ARC)
LEADERS Effect of DAPT Discontinuation
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 Study flowchart
LEADERS-AMI Patient Demographics
LEADERS-AMI Clinical Presentations/Cardiac Enzymes (1/2)
LEADERS-AMI Clinical Presentations/Cardiac Enzymes (2/2)
LEADERS-AMI Lesion complexity
LEADERS-AMI Cardiac Death
LEADERS-AMI Cardiac Death
(STEMI Patients)
LEADERS-AMI MACE*
LEADERS-AMI MACE*
(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
e-BioMatrix Registry
e-BioMatrix Registry Demographics
e-BioMatrix Registry Indication for PCI
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 MACE Components
e-BioMatrix Registry 12-month MACE Rates in e-BioMatrix and
LEADERS
e-BioMatrix Registry Stent Thrombosis
e-BioMatrix Registry Major Bleeding
e-BioMatrix Registry Mortality associated with Stent Thrombosis and
Major Bleeding
e-BioMatrix Registry Conclusions
Global LEADERS
Global LEADERS
LEADERS-BIFURCATION
LEADERS-BIFURCATION
LEADERS-BIFURCATION
LEADERS-BIFURCATION
LEADERS-BIFURCATION
LEADERS-BIFURCATION
LEADERS-BIFURCATION
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.
Ability to deploy the stent across the lesion
Stent profile and cell geometry
PCI procedure
Does stent design impact the outcome in
bifurcation treatment?
Short term Outcome
Long term Outcome
Stent profile and cell geometry Stent drug coating
Stent polymer Stent strut thickness
No evidence that platform material (stainless steel, chrome-cobalt or others) has an impact on clinical and angiographic outcome.