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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)
61
56
78
80 77
103
131
0
200
400
600
800
1000
1200
1400
1600
2010 2011 2012 2013 2014 2015 2016	
  (9mo)
PCI PCI	
  LM3.9%
3.8%
5.6%
6.2%
6.0% 8.4%
12.2%
PCI-­LMCA  
Ist Dept.  of  Cardiology,  Medical  University  in  Poznan
ESC/EACTS  Revasc.  
Guidelines
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
Clinical  Outcome
R-­J.  van  Geuns,  EuroPCR  2014
Angiographic  analysis    
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
✔
✔
✔
✔
✔
59  YO  male  patient.  Previous  MI,  HT,  DM  type  II
EF  ~30%,  ICD
LM  restenosis  after  BVS  implantation  (LM-­LAD)
Difficult  LCx take-­off Pre-­dilat.  3.0  x  15  mm
Tryton  positioning  &  implantation
SB  stenting
MV  stenting  (SB  protected,  wire  removed)
MV  DES  positioning  &  implantationPost  implantation.  Good  
access  to  MV
POT,  final  kissing  and  IInd POT
Final  result
ClearStent  view
LCx
LAD
LM
OCT  Image
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

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M.Lesiak, eu perspective on left main - the final frontier

  • 1. EU  Perspective  on  Left  Main  -­ The  Final  Frontier Maciej  Lesiak,  MD Department  of  Cardiology,  University  of   Medical  Sciences  in  Poznan
  • 2. 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
  • 3. ESC/EACTS  Guidelines    2014   CABG  =  PCI  for  low  risk  patients PCI-­LMCA:    Guide  Line  IB  (equal  to  CABG)
  • 4. 61 56 78 80 77 103 131 0 200 400 600 800 1000 1200 1400 1600 2010 2011 2012 2013 2014 2015 2016  (9mo) PCI PCI  LM3.9% 3.8% 5.6% 6.2% 6.0% 8.4% 12.2% PCI-­LMCA   Ist Dept.  of  Cardiology,  Medical  University  in  Poznan ESC/EACTS  Revasc.   Guidelines
  • 5. 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
  • 6. 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
  • 7. 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
  • 8. 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%  
  • 9. 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
  • 10. Clinical  Outcome R-­J.  van  Geuns,  EuroPCR  2014
  • 11. Angiographic  analysis     R-­J.  van  Geuns,  EuroPCR  2014
  • 12. 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
  • 13. 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
  • 14. 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
  • 15. 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 ✔ ✔ ✔ ✔ ✔
  • 16. 59  YO  male  patient.  Previous  MI,  HT,  DM  type  II EF  ~30%,  ICD LM  restenosis  after  BVS  implantation  (LM-­LAD)
  • 17. Difficult  LCx take-­off Pre-­dilat.  3.0  x  15  mm
  • 18. Tryton  positioning  &  implantation SB  stenting
  • 19. MV  stenting  (SB  protected,  wire  removed) MV  DES  positioning  &  implantationPost  implantation.  Good   access  to  MV
  • 20. POT,  final  kissing  and  IInd POT
  • 22. 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