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.