1. 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

2. Disclosure Statement of Financial Interest TCT 2015 San Francisco, CA; Oct 11-15, 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

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

4. 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
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

5. 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

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

7. 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
(22/141)
(16/141)
(17/141)
(13/141)
(6/139)
(5/141)
Non Hierarchical
Provisional N=143
Tryton N=146

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

9. 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

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

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. 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