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P. Genereux, the tryton stent_dedicated bifurcation stent in coronary bifurcation

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228 g v01 rev. 1 p. genereux, the tryton stent_dedicated bifurcation stent in coronary bifurcation

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P. Genereux, the tryton stent_dedicated bifurcation stent in coronary bifurcation

  1. 1. Philippe  Généreux,  MD Columbia  University  Medical  Center Cardiovascular  Research  Foundation New  York  City The  TRYTON  Stent Dedicated  Bifurcation  Stent  in  Coronary   Bifurcation TCT  2016,  Washington
  2. 2. Disclosure  Statement  of  Financial  Interest Philippe  Généreux,  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 • Consulting  Fees/Honoraria • Major  Stock  Shareholder/Equity • Boston  Scientific,  CSI,   TRYTON  Medical • Abbott  Vascular,  CSI,   Edwards  Lifesciences,   TRYTON  Medical,   Soundbite  Medical  Inc.,   SIG.NUM,  SARANAS • Soundbite  Medical  Inc.,   SIG.NUM
  3. 3. Bifurcation  Lesions     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. Randomized  Bifurcation  Stent  Studies (NORDIC,  BBC  ONE,  CACTUS)
  5. 5. TRYTON  Side  Branch  Stent Transition   Zone Side  Branch   Zone Main  Branch   Zone 8  mm 4.5  mm 6.5  mm Tryton  is  a  Cobalt  alloy  bare  metal  stent
  6. 6. Tryton Side  Branch  Stent  Sizes
  7. 7. Tryton Deployment  Sequence Tryton positioned   and  deployed  after   pre-­dilatation   (secures  and  protects   side  branch) Main  vessel  treated   with  approved  DES   through  main   vessel  portion  of   Tryton Kissing  balloon   post-­dilatation  to   insure  complete  lesion   &  ostium coverage
  8. 8. TRYTON  Pivotal  RCT Généreux et  al.  J  Am Coll  Cardiol 2015;;65:533–43
  9. 9. Tryton Study  Design DES  (main  vessel)  +   Provisional  side  branch Baseline  Angiography  – Eligible  for  Randomization True  bifurcation  with  SB≥  2.5mm  by  visual  estimation 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
  10. 10. TRYTON  Pivotal  RCT   Primary  Non-­Inferiority  Endpoint Not  Met % 12.8 0 10.7 3.6 17.4 0 15.1 4.7 0 2 4 6 8 10 12 14 16 18 20 TVF Cardiac  Death Target  Vessel  MI Clinically  Driven  TVR Non  Hierarchical   P=  0.11 P  =  0.11 P  =0.56 Provisional Tryton Généreux et  al.  J  Am Coll  Cardiol 2015;;65:533–43
  11. 11. 38.6 31.6 0 10 20 30 40 50 60 P=0.002 Provisional Tryton Side  Branch  %DS  (In-­segment) Secondary  Endpoint % Secondary  Superiority  Endpoint  Met Angiographic  Cohort  n=326 Généreux et  al.  J  Am Coll  Cardiol 2015;;65:533–43
  12. 12. 14 33 49 152 164 104 66 68 24 10 11 6 0 20 40 60 80 100 120 140 160 180 ≥  2.25  mm: 41%  of  ITT  lesions Side  Branch  RVD  (Core  Lab)#Frequency Pre  Procedure  Side  Branch  Size
  13. 13. TRYTON  Large  SBs  Sub-­Analysis: Side  Branches  ≥2.25mm Généreux et  al.  Catheter  Cardiovasc Interv.  2015  
  14. 14. 10.3 15.6 9.2 12.1 21.7 11.3 19.2 9.2 5.5 4.33.1 3.5 0 5 10 15 20 25 30 35 <2.25  mm ≥2.25  mm <2.25  mm ≥2.25  mm <2.25  mm ≥2.25  mm Provisional TRYTON  StentEvent  Rate  (%) 44/20320/195 22/141 18/195 17/141 6/195 6/13916/141 39/203 13/141 11/201 5/141 Side  Branch  Size TVF OR  =2.42 [1.37,4.28] OR  =0.69   [0.35,1.38] P  for  interaction=0.006 Target  Vessel  MI OR  =2.34 [1.29,4.25] OR  =0.74   [0.35,1.59] P  for  interaction=0.02 Clinically  Driven  TVR OR  =1.82 [0.66,5.03] OR  =0.81 [0.24,2.73] P  for  interaction=0.32 Généreux et  al.  Catheter  Cardiovasc Interv.  2015  
  15. 15. 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 = 0.26 Angiographic Outcomes (QCA) Side Branch ≥  2.25  mm 9  Months Provisional N=81 Tryton N=64 % Généreux et  al.  Catheter  Cardiovasc Interv.  2015  
  16. 16. TRYTON  Confirmatory  Study
  17. 17. TRYTON  Confirmatory  Study Rationale • To  prospectively  confirm  the  safety   (periprocedural MI)  of  the  TRYTON   dedicated  bifurcation  stent  in  the   treatment  of  true  bifurcation  lesions   involving  large  side  branches  (≥2.25mm   by  QCA  analysis)
  18. 18. TRYTON  Confirmatory  Study   Angiographic  Inclusion  Criteria:  No  Change • Single  de  novo  “true”  bifurcation  lesion   • Native  coronary  artery   • Medina  1.1.1,  1.0.1,  or  0.1.1  by  visual  estimation • Symptoms  or  objective  evidence  of  ischemia • Vessel  diameter:   • Main  branch:  ≥  2.5  mm  and  ≤  4.0  mm;; • Side  branch:  ≥  2.5  mm  and  ≤  3.5  mm   • Lesion  length:   • Main  vessel  ≤  28  mm;;  Side  branch  ≤  5  mm • Multi-­vessel  disease  and  staging  allowed • Enrolment  allowed  after  successful  treatment  of     ≤  2  non-­complex  non-­target  lesions  
  19. 19. TRYTON  Confirmatory  Study Review  Clinical  Selection  Criteria/Informed  Consent Baseline  Angiography Review  Angiographic  Selection  Criteria N=133 patients   TRYTON stent  side  branch  first  step DES  in  Main  branch  second  step Primary  End  point:  Periprocedural MI   >3X  URL  CK-­MB  48hrs  post  PCI Clinical  F/U:  30  days  and  1  year ITT  when  TRYTON  stent  enters  the  guide  catheter
  20. 20. TRYTON  Confirmatory  Study Performance  Goal:  Sample  Size  Calculation • Powered  Endpoint:   • Peri-­procedural  MI  3x  CK-­MB  @48hrs   • Observed  Rate  in  IDE  provisional:  11.9%   • Power:  90%       • Delta:  6.0% • 1-­sided  95%  upper  confidence  bound   • Performance  Goal:  17.9% • N  =  133 • Anticipated  4%  lost  of  follow-­up • CK-­MB  missing,  RVD  <2.25mm
  21. 21. TRYTON  Confirmatory  Study: Study  Recruitment 28  Investigational  Centers US  =13,  OUS  =15 12  months  enrolment
  22. 22. Baseline  Characteristics:  Demographic Confirmatory  Study       Randomized  IDE  ≥2.25mm   TRYTON (N=133) TRYTON (N=146) Provisional (N=143) Age  (years) 65.6±9.5 64.5±10.7 65.2±9.2 Male 69.9% 79.5% 81.8% MI 32.3% 29.7% 40.4% PCI 39.8% 37.0% 43.4% CABG 2.3% 3.4% 3.5% TIA  /  CVA 6.8% 8.9% 5.7% CHF 6.0% 1.4% 0.0% Diabetes  Mellitus 25.8% 25.3% 28.7% Hypertension  * 82  %* 68.5%  * 76.8% Hypercholesterolemia 71.2% 72.2% 77.0% Current  Smoking 21.1% 17.1% 15.5% Atrial  Fibrillation 7.5% 12.3% 8.4% * P<0.05
  23. 23. Baseline  Characteristics:  Presentation Confirmatory  Study Randomized  IDE  ≥2.25mm   TRYTON   (N=133) TRYTON (N=146) Provisional (N=143) Recent  MI NA 8.9% 11.2% Angina  Type Stable 73.7% 74.0% 68.5% Unstable 18.0% 19.2% 23.8% CCS  Class I 15.3% 15.7% 17.0% II 55.1% 56.9% 58.5% III 27.6% 24.5% 20.2% IV 2.0% 2.9% 4.3% Ischemia  + 64.2% 61.7% 63.9% LVEF 56.3±9.5 57.1±9.4 56.8±10.7
  24. 24. Medina  Classification:  Angio Core   Laboratory  Confirmation T:  0% P:  2.8% Con:  0%   “True” Bifurcation T:  88.3% P:  86.8% Con:  100% T:  45.9% P:  39.9% Con:  50.4%   T:  16.4% P:  16.8% Con: 15.0%   T:  26.0% P:  30.1% Con:  34.6%   T:  2.1% P:  5.6% Con:  0%   T:  4.1% P:  2.8% Con:  0%   T:  5.5% P:  2.1% Con:  0%   P=Provisional    T=Tryton Con=Confirmatory
  25. 25. Baseline  Characteristics:  Main  Branch Confirmatory  Study Randomized  IDE  ≥2.25mm   TRYTON (N=133) TRYTON (N=146) Provisional (N=143) Vessel  Location LAD 75.2% 71.2% 65.7% LCX 20.3% 19.9% 25.2% RCA 3.8% 8.9% 9.1% Lesion  Location Ostial 10.5% 8.2% 7.0% Proximal 50.4% 44.5% 44.1% Mid 15.8% 20.5% 18.2% Distal 23.3% 26.7% 30.8% RVD  (mm) 3.12±0.37 3.09±0.35 3.06±0.34 Lesion  Length  (mm) 17.23±7.89 16.14±6.84 16.05±6.53 Morphology angulation  ≥45o 8.3% 11.0% 9.8% thrombus 1.5% 0.0% 1.4% calcification  – mod/severe 29.3% 13.7% 18.9% TIMI  Flow  (baseline)  <  3 15.0% 7.5% 14.0%
  26. 26. Baseline  Characteristics:  Side  Branch Confirmatory  Study Randomized  trial  ≥2.25mm   TRYTON (N=133) TRYTON (N=146) Provisional (N=143) Vessel  Location LAD 75.2% 72.6% 65.0% LCX 21.1% 18.5% 25.9% RCA 3.8% 8.9% 9.1% Lesion  Location Ostial 98.5% 96.6% 95.8% Proximal 1.5% 2.7% 2.8% Mid 0.0% 0.0% 0.0% Distal 0.0% 0.7% 1.4% RVD  (mm) 2.49±0.20 2.53±0.23 2.52±0.22 Lesion  Length  (mm) 5.94±2.53 4.80±1.24 4.60±0.86 Morphology angulation  ≥45o 18.0% 12.3% 24.5% thrombus 0.9% 0.0% 0.0% calcification  – mod/severe 9.8% 5.5% 5.6% TIMI  Flow  (baseline)  <  3 8.2% 4.1% 4.2%
  27. 27. TRYTON  Confirmatory  Study:  Acute   Angiographic  Result Confirmatory  Study Randomized  Trial  ≥2.25mm   TRYTON   (N=133) TRYTON (N=146) Provisional (N=143) Main  Vessel  (mm) Acute gain   In-­stent 1.81±0.47 1.77±0.46 1.78±0.40 In-­segment 1.49±0.48 1.38±0.46 1.45±0.44 Side Branch  (mm) Acute  gain In-­stent 1.58±0.43 1.53±0.36 na In-­segment 1.37±0.41* 1.26±0.36 0.59±0.48* * p<0.001
  28. 28. TRYTON  Confirmatory  Study:   Acute  Success Confirmatory  Study Randomized  Trial   ≥2.25mm   Acute Success(%) TRYTON (N=133) TRYTON (N=146) Provisional (N=143) Procedure  Success Achievement  of  final  in-­stent   diameter  <50%  in  SB  with  assigned   study  device 89.3%* (117/131) 87.4%   (125/143) 66.9%* (95/142) Device  Success Achievement  of  final  in-­stent  residual   stenosis  <30%  (by  QCA)  in  SB  using   the  assigned  study  device  without   malfunction 93.8%* (122/130) 94.4% (135/143) 35.9%* (51/142) Lesion  Success Achievement  of  final  in-­stent   diameter  of  <50%  (by  QCA)  within   the  side  branch 100%* (133/133) 100%   (141/141) 84.5%* (120/142) *  p<0.001
  29. 29. TRYTON  Confirmatory  Study:   Resources  Utilization   Confirmatory  Study Randomized  Trial   ≥2.25mm   TRYTON   (N=133) TRYTON (N=146) Provisional (N=143) Procedure  Time  (min) 64.6±26.2 68.7±30.7 55.9±27.3 Fluoroscopy  Time  (min) 23.3±11.4* 24.0±13.8 11.6±5.4 Contrast  Used  (ml) 248.2±85.6 269.2±98.3 227±88.7 *p  <0.001 ~10  min  more  and  ~30  ml  more  contrast NORDIC IV  2  stents (n=229) 92.6  min 22.8  min 238  ml
  30. 30. TRYTON  Confirmatory  Study:   Additional  Stents  (Site  Reported) 2.2% (3/133) 1.5% (2/133) Dissection: 2 Lesion  Coverage:    0   Dissection: 1 Lesion  Coverage:    2   Dissection: 1 Lesion  Coverage:    3  
  31. 31. TRYTON  Confirmatory  Study:   Peri-­Procedural  MI  3x  ULN  CK-­MB 16/143 14/133 % Performance  Goal: 17.9% Primary  Endpoint  Met Error  bars  represent  1-­sided  95%  CI Pivotal  Provisional   ≥2.25mm Confirmatory  Study 11.2% 10.5% 16/143 14/133
  32. 32. TRYTON  Confirmatory  Study:   Peri-­Procedural  MI  5x  ULN  CKMB Pivotal  Provisional   ≥2.25mm Confirmatory  Study 6.8% 5.4% 7/103 7/130 %
  33. 33. TRYTON  Confirmatory  Study:   Procedural  and  30-­day  Follow-­up Confirmatory  Study Randomized  Trial  ≥2.25mm   Endpoints  (%) TRYTON (N=133) TRYTON (N=146) Provisional (N=143) Death Procedural 0%  (0) 0%  (0) 0%  (0) 30  day 0%  (0) 0%  (0) 0%  (0) Myocardial  Infarction Procedural  (3x  CKMB) 10.5%  (14/133) 9.2%  (13/141) 12.1% (17/141) Procedural  (5x  CKMB) 4.5%  (7/133) 3.4%  (4/118) 6.8%  (7/103) 30  day   10.8%  (14/130)* 8.2%  (12/146) 11.9%  (17/143)* Stent  Thrombosis 0%    (0) 0.7%  (1/146) 0.0%  (0/143) *  2  patients  in  Confirmatory  study  have  not  completed  30  day  follow-­up  at  datalock and  1  patient  withdrew  at  30  days
  34. 34. TRYTON  Confirmatory  Study   Conclusions • The  TRYTON  Confirmatory  Study,   assessing  the  safety  of  the  TRYTON  stent   in  the  treatment  of  bifurcation  involving   large  side  branches,  met  its  primary   endpoint (performance  goal)  related  to   peri-­procedural  MI   • This  finding  confirms  the  safety  and   efficacy  of  the  TRYTON  dedicated   bifurcation  stent  in  the  treatment  of   bifurcation  involving  large  sides  branches    
  35. 35. TRYTON  Confirmatory  Study   Conclusions • In  light  of  the  higher  procedural  success  rate,   improved  acute  angiographic result,  and   higher  rate  of  side  branch  patency  at  9-­month   follow-­up  compared  to  provisional  stenting,   the  TRYTON  Confirmatory  Study  and  the   TRYTON  IDE  trial  support  the  use  of  the   dedicated  bifurcation  TRYTON  stent  in   conjunction  with  standard  DES  in  the   treatment  of  bifurcation  lesions  involving   large  side  branches
  36. 36. Tryton-­The  Vision  :  To  treat  Bifurcation  Lesions  with  the   Same  Ease,  Confidence  &    Efficacy  as  Straight  Lesions  
  37. 37. Thank  You

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