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M.Leon, establishing the new standard_definitve treatment for bifurcation lesions_closing remarks

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D2233 g v01 rev. 1 m.leon, establishing the new standard_definitve treatment for bifurcation lesions_closing remarks

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M.Leon, establishing the new standard_definitve treatment for bifurcation lesions_closing remarks

  1. 1. Martin  B.  Leon,  MD   Columbia  University  Medical  Center Cardiovascular  Research  Foundation New  York  City Monday,  October  31,  2016 9  mins
  2. 2. Disclosure  Statement  of  Financial  Interest TCT  2016  Washington,  DC; Oct  29  – Nov  2,  2016 Martin  B.  Leon,  MD Within  the  past  12  months,  I  or  my  spouse/partner  have  had  a  financial   interest/arrangement  or  affiliation  with  the  organization(s)  listed  below. • Grant  /  Research  Support Abbott,  Boston  Scientific,  Edwards   Lifescience,  Medtronic,  St.  Jude   Medical • Consulting  Fees  /  Honoraria Abbott,  Boston  Scientific   • Shareholder  /  Equity Claret,  Cathworks,  Elixir,  GDS,  Medinol, Mitralign,  Valve  Medical     Affiliation  /  Financial  Relationship Company
  3. 3. Bifurcation  Lesions  are   Still  a  Challenge! • Require  more  time,  anxiety,   skill,  and  equipment  (cost) • Increased  complications peri-­‐procedural  MIs, stent  thrombosis,  and restenosis • Suboptimal  angiographic   outcomes  (esp.  side  branch   ostium)
  4. 4. Tryton Concept:   Treat  Bifurcation  Lesions   with    Ease,  Confidence  &     Consistent  Efficacy   ≈  20%  of  PCIs  Involve  a   Bifurcation  Lesion Bifurcation  Lesions  are   Still  a  Challenge!
  5. 5. TCT  2005:  Stent  Technology  Innovation Unfulfilled  Promises? Tryton: The  Sole Survivor!
  6. 6. Tryton Study  Design DES  (main  vessel)  +   Provisional  side  branch Baseline  Angiography  – Eligible  for  Randomization Angiographic  F/U at  9  months Clinical  F/U   at  9  months ê ê ê ê ê %  DS  side  branch n~374 Tryton side  branch  +   DES  (main  vessel) êê TVF Primary  Endpoint ê N  =  704 IVUS  F/U at  9  months ê IVUS  Cohort     n~96 Clinical  F/U   at  9  months Angiographic  F/U at  9  months IVUS  F/U at  9  months Largest  Coronary             Bifurcation  RCT  Ever!
  7. 7. Tryton  Pivotal  RCT Genereux  P.  J  Am  Coll Cardiol 2015;  65:533-­‐43 Genereux  P.  Cath    Cardiovasc Interv 2015;  epub
  8. 8. % 15.6 0 12.1 4.3 11.3 0 9.2 3.5 0 2 4 6 8 10 12 14 16 18 TVF Cardiac  Death Target  Vessel  MI Clinically  Driven  TVR P=  0.383 P  =  0.563 P  =0.769 Provisional Tryton Target  Vessel  Failure  (TVF) Side  Branch  ≥  2.25 mm   Provisional  N=143 Tryton  N=146 TVF  Diff  (95%  CI)  =  -­4.3%(-­12.9,4.4%) Non  Hierarchical   (22/141) (16/141) (17/141) (13/141) (6/139) (5/141)
  9. 9. 40.6 32.1 30.4 22.2 0 5 10 15 20 25 30 35 40 45 SB  %  Diameter  Stenosis SB  Binary  Restenosis Provisional Tryton P = 0.004 P = 0.260 Provisional N=81,  Tryton =64 % Angiographic Outcomes (QCA) Side Branch ≥  2.25  mm  9  Months
  10. 10. Confirmatory  Study:  Primary  Endpoint   Peri-­‐Procedural  MI  3x  ULN  CKMB 11.2 10.5 0 5 10 15 20 PIVOTAL  Provisional  ≥2.25 Confirmatory  Study 16/143 14/133 % Performance  Goal  – 17.9% Primary  Endpoint  Met 133  pts
  11. 11. Tryton  EU  Experience     Left  Main  Intervention Baseline Final ESC/EACTS  Guidelines.    CABG  =  PCI  for  low  risk  patients
  12. 12. Complex  “True”  Bifurcations ’Value’  of  Tryton
  13. 13. Take-­‐Home  Messages Tryton in  Bifurcations • The  TRYTON  two-­‐stent  strategy  in  “true”  and  other   complex  bifurcations  with  large  side  branches,   compared  to  a  conventional  provisional  stent   strategy… – Provides  better  coverage  of  the  bifurcation (IVUS) – Reduces  the  need  for  bail-­‐out  stenting – Results  in  better  acute  angiographic  results – Has  a  similar  low  frequency  of  complications   (MIs  and  stent  thrombosis)
  14. 14. Take  Home  Messages Tryton in  Bifurcations • The  main  advantage  of  the  TRYTON  two-­‐stent   strategy  to  the  practicing  interventionalist is  the   ability  to  achieve  predictable  (“low  stress”)  excellent   angiographic  and  clinical  outcomes  in  the  most   complex  bifurcation  lesions  (esp.  distal  LM   bifurcations)!
  15. 15. Take  Home  Messages Tryton in  Bifurcations • Stay  tuned  for… – Imminent  FDA  approval  for  commercial  use  in   the  U.S. – Continued  access  bifurcation  registry  in  the  U.S.   (75  centers) – Announcement  of  marketing  agreement  in  the  U.S.   for  Tryton distribution – Announcement  of  drug-­‐eluting  version  of  Tryton for  LM  bifurcations    
  16. 16. Cardinal  Health  signed  a  strategic  agreement   with  Tryton  Medical  and  is  committed  to  a   long-­‐term  relationship  in  the  U.S.   & U.S.  Strategic  Alliance

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