M.Lesiak, eu perspective on left main - the final frontier
EU Perspective on Left Main -
The Final Frontier
Maciej Lesiak, MD
Department of Cardiology, University of
Medical Sciences in Poznan
Disclosure Statement of Financial Interest
• Grant/Research Support
• Consulting Fees/Honoraria
• Abbott Vascular
• Abbott Vascular, AstraZeneca,
Biotronik, Boston Scientific, Volcano,
St Jude
Within the past 12 months, I or my spouse/partner have had a financial
interest/arrangement or affiliation with the organization(s) listed below.
Affiliation/Financial Relationship Company
ESC/EACTS Guidelines 2014
CABG = PCI for low risk patients
PCI-LMCA: Guide Line IB (equal to CABG)
PCI in Left Main – Meta-analysis
Athappan et al. JACC Cardiovasc Interv 2013;;6:1219-304
Favors PCI Favors CABG
Mortality
1 year 3 years
5 years
Favors PCI Favors CABG
Favors PCI Favors CABG
P=0.26
P=0.80
P=0.13
PCI in Left Main – Meta-analysis
Athappan et al. JACC Cardiovasc Interv 2013;;6:1219-304
TVR at 5 years
Favors PCI Favors CABG
Stroke at 5 years
Favors PCI Favors CABG
MI at 5 years
P=0.00
P=0.00
P=0.34
Left Main Stem
Large
Short
Important side branch (LCX is the largest
side branch in coronary system)
Wide bifurcation angle
Optimal main vessel stenting an SB protection of crucial
importance
Magro M et al. EuroIntervention
2013;8:1259-‐1269
Tryton LM
Registry
Retrospective,
9
European
centers
2008-‐2011
(learning
curve)
Medina
1,1,1
– 63%
Prospective LMCA Registry
• European collaboration of 8 sites
• Large Diameter Device (3.0-3.5 and 3.5-4.0 mm)
• Standardized Operation Procedure (SOP)
¡ Post Tryton Deployment ‘POT’ inflation
• Angiographic Analysis (Procedural & 6 months)
• IVUS Analysis (Procedural & 6 months)
• Independent CoreLab analysis
• LM > 10 mm
R-J. van Geuns, EuroPCR 2014
Tryton LM PCI
Limitations Addressed with Current Design
• Procedural reliability
¡ Loss of LCx
¡ Hemodynamic instability
• Long term durability
¡ Restenosis
¡ Stent thrombosis
• Impact Main vs Side Branch First Strategy
Addressed with current designs
May require DES Design?
Addressed with current designs
Addressed with current designs
Standard Design: Published Experience
• Safety
¡ High Procedural Success
¡ No Thrombosis Signal observed (Low numbers)
• Efficacy
¡ High Procedural Success
¡ TVR = 13%
• All SB (LCx or Ramus)
• All RVD <2.3 mm
STANDARD Length (18mm)*
Tryton SHORT Design: Product Details
SHORT Length (15mm)
Design Features
• Stent Design: 3 mm shorter main vessel zone
• Markers Position Optimized for Large Vessels
• Improved delivery system
* Large vessels sizes
4.5mm
3mm
Left Main Clinical Path
Tryton Standard
•Studied in e-Tryton and
Pivotal Trial
Large Vessel
•Studied in Pivotal
•Rotterdam Initiated Left
Main Study
Left Main Stent (CE)
•Designed specifically for
ULMCA disease
•Facilitates usage with
stents up to 6.0mm in
diameter
Left Main Clinical
Indication (CE)
•Evidence supporting
“larger vessels”
eTryton Left Main
Registry
•Real World Usage
•POT vs. No KISS
•OCT
•SHORT stent
Standard Large Diameter Left Main Stent (CE) Left Main Indication(CE)
eTryton Left Main
Registry SHORT
2008 2011 2013 2014 2016
Confidential
✔
✔
✔
✔
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59 YO male patient. Previous MI, HT, DM type II
EF ~30%, ICD
LM restenosis after BVS implantation (LM-LAD)
Conclusion
• LMCA stenting more and more common in current practice
• LCx - the largest side branch in coronary system
• Clinical studies support safety and efficacy of Tryton SB stent
compared with provisional stenting in lesions involving large
SBs
• LD short design makes Tryton a perfect tool for distal LM
stenting
• Drug version very welcome to further improve long term
durability