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

Martin  B.  Leon,  MD  Columbia  University  Medical  CenterCardiovascular  Research  Foundation

New  York  City

Monday,  October  31,  2016

9  mins

Disclosure  Statement  of  Financial  InterestTCT  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

Bifurcation  Lesions  are  Still  a  Challenge!

• Require  more  time,  anxiety,  skill,  and  equipment  (cost)

• Increased  complicationsperi-­‐procedural  MIs,stent  thrombosis,  andrestenosis

• Suboptimal  angiographic  outcomes  (esp.  side  branch  ostium)

Tryton Concept:  Treat  Bifurcation  Lesions  with    Ease,  Confidence  &    

Consistent  Efficacy  

≈  20%  of  PCIs  Involve  a  Bifurcation  Lesion

Bifurcation  Lesions  are  Still  a  Challenge!

TCT  2005:  Stent  Technology  InnovationUnfulfilled  Promises?

Tryton:The  SoleSurvivor!

Tryton Study  Design

DES  (main  vessel)  +  Provisional  side  branch

Baseline  Angiography  – Eligible  for  Randomization

Angiographic  F/Uat  9  months

Clinical  F/U  at  9  months

ê

ê

ê

ê

ê

%  DS  side  branchn~374

Tryton side  branch  +  DES  (main  vessel)

êê

TVFPrimary  Endpoint

ê

N  =  704

IVUS  F/Uat  9  months

ê

IVUS  Cohort    n~96

Clinical  F/U  at  9  months

Angiographic  F/Uat  9  months

IVUS  F/Uat  9  months

Largest  Coronary            Bifurcation  RCT  Ever!

Tryton  Pivotal  RCT

Genereux  P.  J  Am  Coll Cardiol 2015;  65:533-­‐43Genereux  P.  Cath    Cardiovasc Interv 2015;  epub

%

15.6

0

12.1

4.3

11.3

0

9.2

3.50

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

ProvisionalTryton

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)

40.6

32.130.4

22.2

0

5

10

15

20

25

30

35

40

45

SB  %  Diameter  Stenosis SB  Binary  Restenosis

ProvisionalTryton

P = 0.004

P = 0.260

Provisional N=81,  Tryton =64

%

Angiographic Outcomes (QCA)Side Branch ≥  2.25  mm  9  Months

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

Tryton  EU  Experience    Left  Main  Intervention

Baseline Final

ESC/EACTS  Guidelines.    CABG  =  PCI  for  low  risk  patients

Complex  “True”  Bifurcations’Value’  of  Tryton

Take-­‐Home  MessagesTryton 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)

Take  Home  MessagesTryton 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)!

Take  Home  MessagesTryton 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  Trytonfor  LM  bifurcations    

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