1. Martin
B.
Leon,
MD
Columbia
University
Medical
Center
Cardiovascular
Research
Foundation
New
York
City
Monday,
October
31,
2016
9
mins

2. Disclosure
Statement
of
Financial
Interest
TCT
2016
Washington,
DC; Oct
29
– Nov
2,
2016
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
• Shareholder / Equity Claret, Cathworks, Elixir, GDS, Medinol,
Mitralign, Valve Medical
Affiliation / Financial Relationship Company

3. Bifurcation
Lesions
are
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. Tryton Concept:
Treat
Bifurcation
Lesions
with
Ease,
Confidence
&
Consistent
Efficacy
≈
20%
of
PCIs
Involve
a
Bifurcation
Lesion
Bifurcation
Lesions
are
Still
a
Challenge!

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

6. 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
ê
ê
ê
ê
ê
% DS side branch
n~374
Tryton side branch +
DES (main vessel)
êê
TVF
Primary Endpoint
ê
N = 704
IVUS F/U
at 9 months
ê
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!

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

8. %
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)

9. 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

10. 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

11. Tryton
EU
Experience
Left
Main
Intervention
Baseline Final
ESC/EACTS
Guidelines.
CABG
=
PCI
for
low
risk
patients

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

13. 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)

14. Take
Home
Messages
Tryton in
Bifurcations
• The
main
advantage
of
the
TRYTON
two-­‐stent
strategy
to
the
practicing
interventionalist is
the
ability
to
achieve
predictable
(“low
stress”)
excellent
angiographic
and
clinical
outcomes
in
the
most
complex
bifurcation
lesions
(esp.
distal
LM
bifurcations)!

15. Take
Home
Messages
Tryton in
Bifurcations
• Stay
tuned
for…
– Imminent
FDA
approval
for
commercial
use
in
the
U.S.
– Continued
access
bifurcation
registry
in
the
U.S.
(75
centers)
– Announcement
of
marketing
agreement
in
the
U.S.
for
Tryton distribution
– Announcement
of
drug-­‐eluting
version
of
Tryton
for
LM
bifurcations

16. Cardinal
Health
signed
a
strategic
agreement
with
Tryton
Medical
and
is
committed
to
a
long-­‐term
relationship
in
the
U.S.
&
U.S.
Strategic
Alliance