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Tryton Pivotal: Randomized Trial and Confirmatory Study - Key Messages

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TCT2015 Presentation - Martin B. Leon, M.D.

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Tryton Pivotal: Randomized Trial and Confirmatory Study - Key Messages

  1. 1. Martin B. Leon, MD Columbia University Medical Center Cardiovascular Research Foundation New York City Tuesday, October 13, 2015 5 mins
  2. 2. Disclosure Statement of Financial Interest TCT 2015 San Francisco, CA; Oct 11-15, 2015 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, Medtronic, St. Jude Medical • Shareholder / Equity Claret, Coherex, Elixir, GDS, Medinol, Mitralign, Valve Medical Affiliation / Financial Relationship Company
  3. 3. TCT 2005: Stent Technology Innovation Unfulfilled Promises? Tryton: The Sole Survivor!
  4. 4. 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      % 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 Largest Coronary Bifurcation RCT Ever!
  5. 5. Tryton Pivotal RCT Genereux P. J Am Coll Cardiol 2015; 65:533-43 Genereux P. Cath Cardiovasc Interv 2015; epub
  6. 6. Target Vessel Failure (TVF) Primary 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= 0.108 P = 0.109 P =0.564 Provisional Tryton
  7. 7. % 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)
  8. 8. 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
  9. 9. 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
  10. 10. Complex “True” Bifurcations ’Value’ of Tryton
  11. 11. 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)
  12. 12. Take Home Messages Tryton in Bifurcations • The main advantage of the TRYTON two-stent strategy to the practicing interventionalists is the ability to achieve predictable (“low stress”) excellent angiographic and clinical outcomes in the most complex bifurcation lesions! • Stay tuned for… – FDA approval after confirmatory registry results – LM Tryton; the new standard for LM bifurcation stenting

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