maurizio d’amico md — clinical evidence – based safety and efficacy of a biolimus eluting...
DESCRIPTION
Maurizio D’Amico MD — Clinical evidence – based safety and efficacy of a biolimus eluting stent with biodegradable polymer technologyTRANSCRIPT
![Page 1: Maurizio D’Amico MD — Clinical evidence – based safety and efficacy of a biolimus eluting stent with biodegradable polymer technology](https://reader033.vdocuments.us/reader033/viewer/2022052901/556c98b5d8b42a44468b457f/html5/thumbnails/1.jpg)
Clinical evidence – based safety and efficacy of a biolimus eluting stent with
biodegradable polymer technology
Maurizio D’Amico MD Cardiovascular Department Molinette Hospital
Turin
![Page 2: Maurizio D’Amico MD — Clinical evidence – based safety and efficacy of a biolimus eluting stent with biodegradable polymer technology](https://reader033.vdocuments.us/reader033/viewer/2022052901/556c98b5d8b42a44468b457f/html5/thumbnails/2.jpg)
Biolimus Eluting Stent
![Page 3: Maurizio D’Amico MD — Clinical evidence – based safety and efficacy of a biolimus eluting stent with biodegradable polymer technology](https://reader033.vdocuments.us/reader033/viewer/2022052901/556c98b5d8b42a44468b457f/html5/thumbnails/3.jpg)
Biolimus Eluting Stent
Simultaneous release of biolimus A9 and degradation of PLA Polymer over 6-9 months
![Page 4: Maurizio D’Amico MD — Clinical evidence – based safety and efficacy of a biolimus eluting stent with biodegradable polymer technology](https://reader033.vdocuments.us/reader033/viewer/2022052901/556c98b5d8b42a44468b457f/html5/thumbnails/4.jpg)
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
![Page 5: Maurizio D’Amico MD — Clinical evidence – based safety and efficacy of a biolimus eluting stent with biodegradable polymer technology](https://reader033.vdocuments.us/reader033/viewer/2022052901/556c98b5d8b42a44468b457f/html5/thumbnails/5.jpg)
Biolimus Eluting Stent
![Page 6: Maurizio D’Amico MD — Clinical evidence – based safety and efficacy of a biolimus eluting stent with biodegradable polymer technology](https://reader033.vdocuments.us/reader033/viewer/2022052901/556c98b5d8b42a44468b457f/html5/thumbnails/6.jpg)
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™
![Page 7: Maurizio D’Amico MD — Clinical evidence – based safety and efficacy of a biolimus eluting stent with biodegradable polymer technology](https://reader033.vdocuments.us/reader033/viewer/2022052901/556c98b5d8b42a44468b457f/html5/thumbnails/7.jpg)
LEADERS trial
![Page 8: Maurizio D’Amico MD — Clinical evidence – based safety and efficacy of a biolimus eluting stent with biodegradable polymer technology](https://reader033.vdocuments.us/reader033/viewer/2022052901/556c98b5d8b42a44468b457f/html5/thumbnails/8.jpg)
LEADERS trial design
Biolimus-Eluting stents Sirolimus-Eluting stents
![Page 9: Maurizio D’Amico MD — Clinical evidence – based safety and efficacy of a biolimus eluting stent with biodegradable polymer technology](https://reader033.vdocuments.us/reader033/viewer/2022052901/556c98b5d8b42a44468b457f/html5/thumbnails/9.jpg)
LEADERS Patient demographics
![Page 10: Maurizio D’Amico MD — Clinical evidence – based safety and efficacy of a biolimus eluting stent with biodegradable polymer technology](https://reader033.vdocuments.us/reader033/viewer/2022052901/556c98b5d8b42a44468b457f/html5/thumbnails/10.jpg)
LEADERS Patient characteristics
![Page 11: Maurizio D’Amico MD — Clinical evidence – based safety and efficacy of a biolimus eluting stent with biodegradable polymer technology](https://reader033.vdocuments.us/reader033/viewer/2022052901/556c98b5d8b42a44468b457f/html5/thumbnails/11.jpg)
LEADERS Patient flow-clinical
![Page 12: Maurizio D’Amico MD — Clinical evidence – based safety and efficacy of a biolimus eluting stent with biodegradable polymer technology](https://reader033.vdocuments.us/reader033/viewer/2022052901/556c98b5d8b42a44468b457f/html5/thumbnails/12.jpg)
LEADERS MACE (Cardiac Death,MI and ci-TVR)
![Page 13: Maurizio D’Amico MD — Clinical evidence – based safety and efficacy of a biolimus eluting stent with biodegradable polymer technology](https://reader033.vdocuments.us/reader033/viewer/2022052901/556c98b5d8b42a44468b457f/html5/thumbnails/13.jpg)
LEADERS Cardiac Death
![Page 14: Maurizio D’Amico MD — Clinical evidence – based safety and efficacy of a biolimus eluting stent with biodegradable polymer technology](https://reader033.vdocuments.us/reader033/viewer/2022052901/556c98b5d8b42a44468b457f/html5/thumbnails/14.jpg)
LEADERS Clinically-Indicated TVR
![Page 15: Maurizio D’Amico MD — Clinical evidence – based safety and efficacy of a biolimus eluting stent with biodegradable polymer technology](https://reader033.vdocuments.us/reader033/viewer/2022052901/556c98b5d8b42a44468b457f/html5/thumbnails/15.jpg)
LEADERS Patient Oriented Composite Endpoint (All-Cause Death,Any MI,All Revascularization)
![Page 16: Maurizio D’Amico MD — Clinical evidence – based safety and efficacy of a biolimus eluting stent with biodegradable polymer technology](https://reader033.vdocuments.us/reader033/viewer/2022052901/556c98b5d8b42a44468b457f/html5/thumbnails/16.jpg)
LEADERS Definite Stent Thrombosis (ARC)
![Page 17: Maurizio D’Amico MD — Clinical evidence – based safety and efficacy of a biolimus eluting stent with biodegradable polymer technology](https://reader033.vdocuments.us/reader033/viewer/2022052901/556c98b5d8b42a44468b457f/html5/thumbnails/17.jpg)
LEADERS Effect of DAPT Discontinuation
![Page 18: Maurizio D’Amico MD — Clinical evidence – based safety and efficacy of a biolimus eluting stent with biodegradable polymer technology](https://reader033.vdocuments.us/reader033/viewer/2022052901/556c98b5d8b42a44468b457f/html5/thumbnails/18.jpg)
LEADERS Definite ST (ARC)
Landmark Analysis @1 Year
![Page 19: Maurizio D’Amico MD — Clinical evidence – based safety and efficacy of a biolimus eluting stent with biodegradable polymer technology](https://reader033.vdocuments.us/reader033/viewer/2022052901/556c98b5d8b42a44468b457f/html5/thumbnails/19.jpg)
LEADERS Stratified Analysis of MACE@5 years
![Page 20: Maurizio D’Amico MD — Clinical evidence – based safety and efficacy of a biolimus eluting stent with biodegradable polymer technology](https://reader033.vdocuments.us/reader033/viewer/2022052901/556c98b5d8b42a44468b457f/html5/thumbnails/20.jpg)
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
![Page 21: Maurizio D’Amico MD — Clinical evidence – based safety and efficacy of a biolimus eluting stent with biodegradable polymer technology](https://reader033.vdocuments.us/reader033/viewer/2022052901/556c98b5d8b42a44468b457f/html5/thumbnails/21.jpg)
![Page 22: Maurizio D’Amico MD — Clinical evidence – based safety and efficacy of a biolimus eluting stent with biodegradable polymer technology](https://reader033.vdocuments.us/reader033/viewer/2022052901/556c98b5d8b42a44468b457f/html5/thumbnails/22.jpg)
LEADERS-AMI Study flowchart
![Page 23: Maurizio D’Amico MD — Clinical evidence – based safety and efficacy of a biolimus eluting stent with biodegradable polymer technology](https://reader033.vdocuments.us/reader033/viewer/2022052901/556c98b5d8b42a44468b457f/html5/thumbnails/23.jpg)
LEADERS-AMI Patient Demographics
![Page 24: Maurizio D’Amico MD — Clinical evidence – based safety and efficacy of a biolimus eluting stent with biodegradable polymer technology](https://reader033.vdocuments.us/reader033/viewer/2022052901/556c98b5d8b42a44468b457f/html5/thumbnails/24.jpg)
LEADERS-AMI Clinical Presentations/Cardiac Enzymes (1/2)
![Page 25: Maurizio D’Amico MD — Clinical evidence – based safety and efficacy of a biolimus eluting stent with biodegradable polymer technology](https://reader033.vdocuments.us/reader033/viewer/2022052901/556c98b5d8b42a44468b457f/html5/thumbnails/25.jpg)
LEADERS-AMI Clinical Presentations/Cardiac Enzymes (2/2)
![Page 26: Maurizio D’Amico MD — Clinical evidence – based safety and efficacy of a biolimus eluting stent with biodegradable polymer technology](https://reader033.vdocuments.us/reader033/viewer/2022052901/556c98b5d8b42a44468b457f/html5/thumbnails/26.jpg)
LEADERS-AMI Lesion complexity
![Page 27: Maurizio D’Amico MD — Clinical evidence – based safety and efficacy of a biolimus eluting stent with biodegradable polymer technology](https://reader033.vdocuments.us/reader033/viewer/2022052901/556c98b5d8b42a44468b457f/html5/thumbnails/27.jpg)
LEADERS-AMI Cardiac Death
![Page 28: Maurizio D’Amico MD — Clinical evidence – based safety and efficacy of a biolimus eluting stent with biodegradable polymer technology](https://reader033.vdocuments.us/reader033/viewer/2022052901/556c98b5d8b42a44468b457f/html5/thumbnails/28.jpg)
LEADERS-AMI Cardiac Death
(STEMI Patients)
![Page 29: Maurizio D’Amico MD — Clinical evidence – based safety and efficacy of a biolimus eluting stent with biodegradable polymer technology](https://reader033.vdocuments.us/reader033/viewer/2022052901/556c98b5d8b42a44468b457f/html5/thumbnails/29.jpg)
LEADERS-AMI MACE*
![Page 30: Maurizio D’Amico MD — Clinical evidence – based safety and efficacy of a biolimus eluting stent with biodegradable polymer technology](https://reader033.vdocuments.us/reader033/viewer/2022052901/556c98b5d8b42a44468b457f/html5/thumbnails/30.jpg)
LEADERS-AMI MACE*
(STEMI Patients)
![Page 31: Maurizio D’Amico MD — Clinical evidence – based safety and efficacy of a biolimus eluting stent with biodegradable polymer technology](https://reader033.vdocuments.us/reader033/viewer/2022052901/556c98b5d8b42a44468b457f/html5/thumbnails/31.jpg)
LEADERS-AMI Clinical Outcomes at 5 years FU
![Page 32: Maurizio D’Amico MD — Clinical evidence – based safety and efficacy of a biolimus eluting stent with biodegradable polymer technology](https://reader033.vdocuments.us/reader033/viewer/2022052901/556c98b5d8b42a44468b457f/html5/thumbnails/32.jpg)
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
![Page 33: Maurizio D’Amico MD — Clinical evidence – based safety and efficacy of a biolimus eluting stent with biodegradable polymer technology](https://reader033.vdocuments.us/reader033/viewer/2022052901/556c98b5d8b42a44468b457f/html5/thumbnails/33.jpg)
e-BioMatrix Registry
![Page 34: Maurizio D’Amico MD — Clinical evidence – based safety and efficacy of a biolimus eluting stent with biodegradable polymer technology](https://reader033.vdocuments.us/reader033/viewer/2022052901/556c98b5d8b42a44468b457f/html5/thumbnails/34.jpg)
e-BioMatrix Registry
![Page 35: Maurizio D’Amico MD — Clinical evidence – based safety and efficacy of a biolimus eluting stent with biodegradable polymer technology](https://reader033.vdocuments.us/reader033/viewer/2022052901/556c98b5d8b42a44468b457f/html5/thumbnails/35.jpg)
e-BioMatrix Registry Demographics
![Page 36: Maurizio D’Amico MD — Clinical evidence – based safety and efficacy of a biolimus eluting stent with biodegradable polymer technology](https://reader033.vdocuments.us/reader033/viewer/2022052901/556c98b5d8b42a44468b457f/html5/thumbnails/36.jpg)
e-BioMatrix Registry Indication for PCI
![Page 37: Maurizio D’Amico MD — Clinical evidence – based safety and efficacy of a biolimus eluting stent with biodegradable polymer technology](https://reader033.vdocuments.us/reader033/viewer/2022052901/556c98b5d8b42a44468b457f/html5/thumbnails/37.jpg)
e-BioMatrix Registry Lesion Characteristics
![Page 38: Maurizio D’Amico MD — Clinical evidence – based safety and efficacy of a biolimus eluting stent with biodegradable polymer technology](https://reader033.vdocuments.us/reader033/viewer/2022052901/556c98b5d8b42a44468b457f/html5/thumbnails/38.jpg)
e-BioMatrix Registry PCI Procedure: Stents
![Page 39: Maurizio D’Amico MD — Clinical evidence – based safety and efficacy of a biolimus eluting stent with biodegradable polymer technology](https://reader033.vdocuments.us/reader033/viewer/2022052901/556c98b5d8b42a44468b457f/html5/thumbnails/39.jpg)
e-BioMatrix Registry MACE (Primary Endpoint) Cardiac Death, MI, ci-TVR
![Page 40: Maurizio D’Amico MD — Clinical evidence – based safety and efficacy of a biolimus eluting stent with biodegradable polymer technology](https://reader033.vdocuments.us/reader033/viewer/2022052901/556c98b5d8b42a44468b457f/html5/thumbnails/40.jpg)
e-BioMatrix Registry MACE Components
![Page 41: Maurizio D’Amico MD — Clinical evidence – based safety and efficacy of a biolimus eluting stent with biodegradable polymer technology](https://reader033.vdocuments.us/reader033/viewer/2022052901/556c98b5d8b42a44468b457f/html5/thumbnails/41.jpg)
e-BioMatrix Registry 12-month MACE Rates in e-BioMatrix and
LEADERS
![Page 42: Maurizio D’Amico MD — Clinical evidence – based safety and efficacy of a biolimus eluting stent with biodegradable polymer technology](https://reader033.vdocuments.us/reader033/viewer/2022052901/556c98b5d8b42a44468b457f/html5/thumbnails/42.jpg)
e-BioMatrix Registry Stent Thrombosis
![Page 43: Maurizio D’Amico MD — Clinical evidence – based safety and efficacy of a biolimus eluting stent with biodegradable polymer technology](https://reader033.vdocuments.us/reader033/viewer/2022052901/556c98b5d8b42a44468b457f/html5/thumbnails/43.jpg)
e-BioMatrix Registry Major Bleeding
![Page 44: Maurizio D’Amico MD — Clinical evidence – based safety and efficacy of a biolimus eluting stent with biodegradable polymer technology](https://reader033.vdocuments.us/reader033/viewer/2022052901/556c98b5d8b42a44468b457f/html5/thumbnails/44.jpg)
e-BioMatrix Registry Mortality associated with Stent Thrombosis and
Major Bleeding
![Page 45: Maurizio D’Amico MD — Clinical evidence – based safety and efficacy of a biolimus eluting stent with biodegradable polymer technology](https://reader033.vdocuments.us/reader033/viewer/2022052901/556c98b5d8b42a44468b457f/html5/thumbnails/45.jpg)
e-BioMatrix Registry Conclusions
![Page 46: Maurizio D’Amico MD — Clinical evidence – based safety and efficacy of a biolimus eluting stent with biodegradable polymer technology](https://reader033.vdocuments.us/reader033/viewer/2022052901/556c98b5d8b42a44468b457f/html5/thumbnails/46.jpg)
Global LEADERS
![Page 47: Maurizio D’Amico MD — Clinical evidence – based safety and efficacy of a biolimus eluting stent with biodegradable polymer technology](https://reader033.vdocuments.us/reader033/viewer/2022052901/556c98b5d8b42a44468b457f/html5/thumbnails/47.jpg)
Global LEADERS
![Page 48: Maurizio D’Amico MD — Clinical evidence – based safety and efficacy of a biolimus eluting stent with biodegradable polymer technology](https://reader033.vdocuments.us/reader033/viewer/2022052901/556c98b5d8b42a44468b457f/html5/thumbnails/48.jpg)
LEADERS-BIFURCATION
![Page 49: Maurizio D’Amico MD — Clinical evidence – based safety and efficacy of a biolimus eluting stent with biodegradable polymer technology](https://reader033.vdocuments.us/reader033/viewer/2022052901/556c98b5d8b42a44468b457f/html5/thumbnails/49.jpg)
LEADERS-BIFURCATION
![Page 50: Maurizio D’Amico MD — Clinical evidence – based safety and efficacy of a biolimus eluting stent with biodegradable polymer technology](https://reader033.vdocuments.us/reader033/viewer/2022052901/556c98b5d8b42a44468b457f/html5/thumbnails/50.jpg)
LEADERS-BIFURCATION
![Page 51: Maurizio D’Amico MD — Clinical evidence – based safety and efficacy of a biolimus eluting stent with biodegradable polymer technology](https://reader033.vdocuments.us/reader033/viewer/2022052901/556c98b5d8b42a44468b457f/html5/thumbnails/51.jpg)
LEADERS-BIFURCATION
![Page 52: Maurizio D’Amico MD — Clinical evidence – based safety and efficacy of a biolimus eluting stent with biodegradable polymer technology](https://reader033.vdocuments.us/reader033/viewer/2022052901/556c98b5d8b42a44468b457f/html5/thumbnails/52.jpg)
LEADERS-BIFURCATION
![Page 53: Maurizio D’Amico MD — Clinical evidence – based safety and efficacy of a biolimus eluting stent with biodegradable polymer technology](https://reader033.vdocuments.us/reader033/viewer/2022052901/556c98b5d8b42a44468b457f/html5/thumbnails/53.jpg)
LEADERS-BIFURCATION
![Page 54: Maurizio D’Amico MD — Clinical evidence – based safety and efficacy of a biolimus eluting stent with biodegradable polymer technology](https://reader033.vdocuments.us/reader033/viewer/2022052901/556c98b5d8b42a44468b457f/html5/thumbnails/54.jpg)
LEADERS-BIFURCATION
![Page 55: Maurizio D’Amico MD — Clinical evidence – based safety and efficacy of a biolimus eluting stent with biodegradable polymer technology](https://reader033.vdocuments.us/reader033/viewer/2022052901/556c98b5d8b42a44468b457f/html5/thumbnails/55.jpg)
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).
![Page 56: Maurizio D’Amico MD — Clinical evidence – based safety and efficacy of a biolimus eluting stent with biodegradable polymer technology](https://reader033.vdocuments.us/reader033/viewer/2022052901/556c98b5d8b42a44468b457f/html5/thumbnails/56.jpg)
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.
![Page 57: Maurizio D’Amico MD — Clinical evidence – based safety and efficacy of a biolimus eluting stent with biodegradable polymer technology](https://reader033.vdocuments.us/reader033/viewer/2022052901/556c98b5d8b42a44468b457f/html5/thumbnails/57.jpg)
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.
![Page 58: Maurizio D’Amico MD — Clinical evidence – based safety and efficacy of a biolimus eluting stent with biodegradable polymer technology](https://reader033.vdocuments.us/reader033/viewer/2022052901/556c98b5d8b42a44468b457f/html5/thumbnails/58.jpg)