Martin B. Leon, MD Key Messages Tryton Pivotal: Randomized Trial and 5 mins Tryton Pivotal: Randomized Trial and Confirmatory Study – Implications for Everyday Practice Key Messages Martin B. Leon, MD Columbia University Medical Center Cardiovascular Research Foundation New York City Tuesday, October 13, 2015

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. Affiliation / Financial Relationship Company 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

TCT 2005: Stent Technology Innovation Unfulfilled Promises? Tryton: The Sole Survivor!

Largest Coronary Bifurcation RCT Ever! Tryton Study Design Baseline Angiography – Eligible for Randomization  Largest Coronary Bifurcation RCT Ever!   Tryton side branch + DES (main vessel) DES (main vessel) + Provisional side branch N = 704   TVF Primary Endpoint Clinical F/U at 9 months Clinical F/U at 9 months   Previously presented TCT Oct.30. 2013 Angiographic F/U at 9 months % DS side branch n~374 Angiographic F/U at 9 months   IVUS F/U at 9 months IVUS Cohort n~96 IVUS F/U at 9 months

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

Target Vessel Failure (TVF) Primary Endpoint (not met) % P= 0.108 Provisional Tryton P = 0.109 P =0.564 Previously presented TCT Oct.30. 2013 Non Hierarchical

Target Vessel Failure (TVF) Side Branch ≥ 2.25 mm TVF Diff (95% CI) = -4.3%(-12.9,4.4%) % P= 0.383 Provisional Tryton P = 0.563 P =0.769 Previously presented TCT Oct.30. 2013 (22/141) (16/141) (17/141) (13/141) (6/139) (5/141) Non Hierarchical Provisional N=143 Tryton N=146

Angiographic Outcomes (QCA) Side Branch ≥ 2.25 mm 9 Months % Provisional N=81, Tryton =64

Confirmatory Study: Primary Endpoint Peri-Procedural MI 3x ULN CKMB Performance Goal – 17.9% 133 pts % IDE >2.25 Appendix VII Table 16a In hospital complications Performance goal from Protocol Section 7.1.1 VERIFIED BY:DF 14/133 Primary Endpoint Met

Complex “True” Bifurcations ’Value’ of Tryton Previously presented TCT Oct.30. 2013

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)

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