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The Tryton Pivotal: Randomized Trial & Confirmatory Study | Philippe Généreux, M.D.

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The Tryton Pivotal: Randomized Trial & Confirmatory Study | Philippe Généreux, M.D.

  1. 1. Philippe Généreux, MD for the Tryton Bifurcation Trial Investigators Columbia University Medical Center Cardiovascular Research Foundation New York City The TRYTON PIVOTAL: Randomized Trial & Confirmatory Study Dedicated Bifurcation Stent in Coronary Bifurcation Involving Large Side Branches TCT 2015, October 12th, 2015
  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. • Institutional Research Support • Consulting Fees/Honoraria • TRYTON Medical, Boston Scientific, Cardiovascular System inc. • Abbott Vascular, Cardiovascular System Inc, Pi Cardia, Edwards Lifesciences Affiliation/Financial Relationship Company
  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      % DS side branch n~374 Tryton side branch + DES (main vessel)  TVF Primary Endpoint  N = 704 IVUS F/U at 9 months  IVUS Cohort n~96 Clinical F/U at 9 months Angiographic F/U at 9 months IVUS F/U at 9 months
  10. 10. Provisional (n= 349) Tryton (n= 355) Additional Side Branch Stents (Site Reported)
  11. 11. 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
  12. 12. 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
  13. 13. 14 33 49 152 164 104 66 68 24 10 11 60 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
  14. 14. TRYTON Large SBs Sub-Analysis: Side Branches ≥2.25mm Généreux et al. Catheter Cardiovasc Interv. 2015
  15. 15. Provisional (n= 143) Tryton (n= 146) Side Branch Bail Out Stenting Nearly Eliminated in Tryton Group Side Branch ≥ 2.25 mm
  16. 16. % 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) Δ (Total Study Cohort) = 5.5% Généreux et al. Catheter Cardiovasc Interv. 2015
  17. 17. 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
  18. 18. 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 StentEventRate(%) 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
  19. 19. TRYTON Confirmatory Study
  20. 20. 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)
  21. 21. 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
  22. 22. 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
  23. 23. TRYTON Confirmatory Study: Study Recruitment 28 Investigational Centers US =13, OUS =15 12 months enrolment
  24. 24. 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
  25. 25. 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
  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
  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) 0% (0.0) 30 day 0% (0.0) 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) 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. Thank You

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