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

1. Martin B. Leon, MD
Columbia University Medical Center
Cardiovascular Research Foundation
New York City
Tuesday, October 13, 2015
5 mins

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

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

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. %
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. 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. 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. Complex “True” Bifurcations
’Value’ of Tryton

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