D.Rizik, tryton breakfast symposium introduction_the challenge of treating bifurcation lesions

Scottsdale-LincolnHealthNetwork
Tryton Breakfast Symposium
Session Introduction:
The Challenge of Treating
Bifurcation Lesions
David G. Rizik, M.D., F.A.C.C., F.S.C.A.I.
Chief Scientific Officer
Director of Structural & Coronary Interventions
HonorHealth and the Scottsdale-Lincoln
HealthNetwork
HonorHealth/Scottsdale-LincolnHealthNetwork
Disclosure	
  Statement	
  of	
  
Financial	
  Interest
I,  (David  G  Rizik,  MD),  DO  NOT  have  a  
financial  interest/arrangement  or  
affiliation  with  one  or  more  organizations  
that  could  be  perceived  as  a  real  or  
apparent  conflict  of  interest  in  the  
context  of  the  subject  of  this  
presentation
Scottsdale-LincolnHealthNetwork
Q1: Why is stenting the standard for the
treatment of these lesions subsets?
• Discrete
• Long  Segmental
• Calcified
• Eccentric  
• Saphenous  Vein  Graphs
• CTO’s
• In-­Stent  Restenosis
• Thrombotic
• Type  A,  B1,  B2,  C
A1: Stenting provides a wide variety of lesion
subsets predictable procedural
success with a durable result.
Scottsdale-LincolnHealthNetwork
Q2: What is the only major lesion subset which
stenting is not the current Standard?
A2: Bifurcation Lesions: Workhorse stents do not
provide the same predictable and durable results as
straight lesion
Scottsdale-LincolnHealthNetwork
Bifurcation Lesions are Common
“All  Comers”  Studies %  Patients %  Lesions
Leaders  Trial1,2 29.1% 21.6%
Nobori  23 17.5% 16.9%
xSearch4 22.2% N/A
Average 22.9% 19.3%
1.  Windecker  et  al.      Lancet  2008;;  372:  1163–73
2.  Wykrzykowska,  EuroPCR  ’09
3.  Danzi,  EuroPCR  ‘09
4.  Serruys,  ACC  ‘08
Scottsdale-LincolnHealthNetwork
Treatment of Branching Geometry Lesions Using
Currently Available Technology Yield Complications
• Thrombosis  Rate
– Incidence:    3.6-­
3.9%
– Hazard  Ratio:  4.6-­
6.5
• Restenosis  Rates
– Angiographic  20-­
40%
Scottsdale-LincolnHealthNetwork
Bifurcation Lesions:
Large Variation: Extent of Disease, Angle & Diameter
Case  Courtesy  of  Drs
Kutcher  &  Holland,  USA
Courtesy  of    P  Brunel,  
France
Courtesy  of  Dr.  Dumonteil,  
France  
Courtesy  of  Prof.  R.  
Kornowski,  Israel
Courtesy  of  Dr.  Th.  Lefèvre,  
France
Courtesy  of  Dr.  Schulze,  
Germany
Courtesy  of  Dr.  M.  Lesiak,  
Poland
Courtesy  of    Drs.  E.  Grübe -­
R.  Müller,  Germany
Like finger prints: No two bifurcations are alike
Scottsdale-LincolnHealthNetwork
5 Year Follow-Up Nordic Bifurcation Study
Simple  vs Complex  Stenting  Strategy  in  Non-­LM  PCI
• MACE event were low and did not differ
significantly in patients treated with a
simple versus a complex bifurcation stenting
technique.
• Stent thrombosis rate was not increased in
patients treated with 2-stents.
Scottsdale-LincolnHealthNetwork Meta-Analysis: NORDIC I & BBC I (Non LM Bifurcations)
Probability  of  MACE  (Death/MI/TVR)
Difference  in  MACE  
favoring  a  simple  strategy  
What  is  the  relevance  of  
peri-­procedural  MI  ?
25-­50%  of  patients  in  randomized
trials  have  little  or  no  SB  disease.
Most  one  vs two  stent  trials  have  focused  
on  bifurcations  with  diminutive  SB  diameters
Scottsdale-LincolnHealthNetwork
More Contemporary Trials Involving Large Side
Branches Favor 2- stent Strategy
Scottsdale-LincolnHealthNetwork
Key Points
• Bifurcation  Lesions:  Continues  to  be  problem  
Only  Lesion  Subset  Not  Routinely  Stented
• Combined  Literature:    
Supports  Provisional  over  2  Stent  Strategies
• Study  Population  Primarily  Focused  on  Small  SB
– BBC  1
– Nordic  1
• Studies  with  Large  SB    Favors  2  Stent  Approach
– DK  Crush
– 2  Stent  ‘Simple’  Dedicated  Stent
• Tryton is  a  Dedicated  Side  Branch  Stent:    
Focused  on  Providing  Straight  Forward  2  stent  
solution
Scottsdale-LincolnHealthNetwork
Tryton Side Branch Stent
Product Features
• Cobalt  Chromium  (CoCr)
• Strut  thickness:  84µm
• Delivery  System:    Rapid  Exchange  
• Side  Branch  Diameters:    2.5-­3.5  mm
• Guide  Size:    ≥  5  Fr (Operator’s  Choice)
• Guide  Wire:    0.014”  (Operator’s  Choice)
• Main  Vessel  Stent:    Workhorse  DES  (Operator’s  
Choice)
Scottsdale-LincolnHealthNetwork
Tryton Side Branch Stent™
Main  Branch  Zone  
&  wedding  band
8mm
*:  5.5mm  for  Large  Vessel diameters
**:  18mm  for  Large  Vessel diameters
Total  stent
length:  
19mm**
Transition  Zone
4.5mm
Side  Branch  Zone
6.5mm*
Necessarily Employs a Save the Side Branch Strategy
Scottsdale-LincolnHealthNetwork
Tryton Deployment Sequence
1.  Wire  both  vessels  and  pre-­dilate  SB 2.  Position  Tryton
3.  Perform  P.O.T. 4.  Position  DES  and  remove  ‘jailed’  wire
5.  Deploy  DES  and  re-­wire  SB
6.  Simultaneous  Kissing  Balloon
Scottsdale-LincolnHealthNetwork
Complex LAD-Diagonal Lesion
A2: Treated Electively via right radial 6 Fr.
Sheath with Tryton Side Branch Stent
Case  Courtesy  of    Michael  Kutcher,  M.D.  
Wake  Forest  Baptist  Medical  Center
Scottsdale-LincolnHealthNetwork
Tryton Breakfast Symposium
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D.Rizik, tryton breakfast symposium introduction_the challenge of treating bifurcation lesions

  • 1. Scottsdale-LincolnHealthNetwork Tryton Breakfast Symposium Session Introduction: The Challenge of Treating Bifurcation Lesions David G. Rizik, M.D., F.A.C.C., F.S.C.A.I. Chief Scientific Officer Director of Structural & Coronary Interventions HonorHealth and the Scottsdale-Lincoln HealthNetwork HonorHealth/Scottsdale-LincolnHealthNetwork
  • 2. Disclosure  Statement  of   Financial  Interest I,  (David  G  Rizik,  MD),  DO  NOT  have  a   financial  interest/arrangement  or   affiliation  with  one  or  more  organizations   that  could  be  perceived  as  a  real  or   apparent  conflict  of  interest  in  the   context  of  the  subject  of  this   presentation
  • 3. Scottsdale-LincolnHealthNetwork Q1: Why is stenting the standard for the treatment of these lesions subsets? • Discrete • Long  Segmental • Calcified • Eccentric   • Saphenous  Vein  Graphs • CTO’s • In-­Stent  Restenosis • Thrombotic • Type  A,  B1,  B2,  C A1: Stenting provides a wide variety of lesion subsets predictable procedural success with a durable result.
  • 4. Scottsdale-LincolnHealthNetwork Q2: What is the only major lesion subset which stenting is not the current Standard? A2: Bifurcation Lesions: Workhorse stents do not provide the same predictable and durable results as straight lesion
  • 5. Scottsdale-LincolnHealthNetwork Bifurcation Lesions are Common “All  Comers”  Studies %  Patients %  Lesions Leaders  Trial1,2 29.1% 21.6% Nobori  23 17.5% 16.9% xSearch4 22.2% N/A Average 22.9% 19.3% 1.  Windecker  et  al.      Lancet  2008;;  372:  1163–73 2.  Wykrzykowska,  EuroPCR  ’09 3.  Danzi,  EuroPCR  ‘09 4.  Serruys,  ACC  ‘08
  • 6. Scottsdale-LincolnHealthNetwork Treatment of Branching Geometry Lesions Using Currently Available Technology Yield Complications • Thrombosis  Rate – Incidence:    3.6-­ 3.9% – Hazard  Ratio:  4.6-­ 6.5 • Restenosis  Rates – Angiographic  20-­ 40%
  • 7. Scottsdale-LincolnHealthNetwork Bifurcation Lesions: Large Variation: Extent of Disease, Angle & Diameter Case  Courtesy  of  Drs Kutcher  &  Holland,  USA Courtesy  of    P  Brunel,   France Courtesy  of  Dr.  Dumonteil,   France   Courtesy  of  Prof.  R.   Kornowski,  Israel Courtesy  of  Dr.  Th.  Lefèvre,   France Courtesy  of  Dr.  Schulze,   Germany Courtesy  of  Dr.  M.  Lesiak,   Poland Courtesy  of    Drs.  E.  Grübe -­ R.  Müller,  Germany Like finger prints: No two bifurcations are alike
  • 8. Scottsdale-LincolnHealthNetwork 5 Year Follow-Up Nordic Bifurcation Study Simple  vs Complex  Stenting  Strategy  in  Non-­LM  PCI • MACE event were low and did not differ significantly in patients treated with a simple versus a complex bifurcation stenting technique. • Stent thrombosis rate was not increased in patients treated with 2-stents.
  • 9. Scottsdale-LincolnHealthNetwork Meta-Analysis: NORDIC I & BBC I (Non LM Bifurcations) Probability  of  MACE  (Death/MI/TVR) Difference  in  MACE   favoring  a  simple  strategy   What  is  the  relevance  of   peri-­procedural  MI  ? 25-­50%  of  patients  in  randomized trials  have  little  or  no  SB  disease. Most  one  vs two  stent  trials  have  focused   on  bifurcations  with  diminutive  SB  diameters
  • 10. Scottsdale-LincolnHealthNetwork More Contemporary Trials Involving Large Side Branches Favor 2- stent Strategy
  • 11. Scottsdale-LincolnHealthNetwork Key Points • Bifurcation  Lesions:  Continues  to  be  problem   Only  Lesion  Subset  Not  Routinely  Stented • Combined  Literature:     Supports  Provisional  over  2  Stent  Strategies • Study  Population  Primarily  Focused  on  Small  SB – BBC  1 – Nordic  1 • Studies  with  Large  SB    Favors  2  Stent  Approach – DK  Crush – 2  Stent  ‘Simple’  Dedicated  Stent • Tryton is  a  Dedicated  Side  Branch  Stent:     Focused  on  Providing  Straight  Forward  2  stent   solution
  • 12. Scottsdale-LincolnHealthNetwork Tryton Side Branch Stent Product Features • Cobalt  Chromium  (CoCr) • Strut  thickness:  84µm • Delivery  System:    Rapid  Exchange   • Side  Branch  Diameters:    2.5-­3.5  mm • Guide  Size:    ≥  5  Fr (Operator’s  Choice) • Guide  Wire:    0.014”  (Operator’s  Choice) • Main  Vessel  Stent:    Workhorse  DES  (Operator’s   Choice)
  • 13. Scottsdale-LincolnHealthNetwork Tryton Side Branch Stent™ Main  Branch  Zone   &  wedding  band 8mm *:  5.5mm  for  Large  Vessel diameters **:  18mm  for  Large  Vessel diameters Total  stent length:   19mm** Transition  Zone 4.5mm Side  Branch  Zone 6.5mm* Necessarily Employs a Save the Side Branch Strategy
  • 14. Scottsdale-LincolnHealthNetwork Tryton Deployment Sequence 1.  Wire  both  vessels  and  pre-­dilate  SB 2.  Position  Tryton 3.  Perform  P.O.T. 4.  Position  DES  and  remove  ‘jailed’  wire 5.  Deploy  DES  and  re-­wire  SB 6.  Simultaneous  Kissing  Balloon
  • 15. Scottsdale-LincolnHealthNetwork Complex LAD-Diagonal Lesion A2: Treated Electively via right radial 6 Fr. Sheath with Tryton Side Branch Stent Case  Courtesy  of    Michael  Kutcher,  M.D.   Wake  Forest  Baptist  Medical  Center