Philippe Généreux, MD
Columbia University Medical Center
Cardiovascular Research Foundation
New York City
The TRYTON Stent
Dedicated Bifurcation Stent in Coronary
Bifurcation
TCT 2016, Washington

Disclosure Statement of Financial Interest
Philippe Généreux, 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
• Consulting Fees/Honoraria
• Major Stock Shareholder/Equity
• Boston Scientific, CSI,
TRYTON Medical
• Abbott Vascular, CSI,
Edwards Lifesciences,
TRYTON Medical,
Soundbite Medical Inc.,
SIG.NUM, SARANAS
• Soundbite Medical Inc.,
SIG.NUM

Bifurcation Lesions
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)

Randomized Bifurcation Stent Studies
(NORDIC, BBC ONE, CACTUS)

TRYTON Side Branch Stent
Transition
Zone
Side Branch
Zone
Main Branch
Zone
8 mm 4.5 mm 6.5 mm
Tryton is a Cobalt alloy bare metal stent

Tryton Side Branch Stent Sizes

Tryton Deployment Sequence
Tryton positioned
and deployed after
pre-­dilatation
(secures and protects
side branch)
Main vessel treated
with approved DES
through main
vessel portion of
Tryton
Kissing balloon
post-­dilatation to
insure complete lesion
& ostium coverage

TRYTON Pivotal RCT
Généreux et al. J Am Coll Cardiol 2015;;65:533–43

Tryton Study Design
DES (main vessel) +
Provisional side branch
Baseline Angiography – Eligible for Randomization
True bifurcation with SB≥ 2.5mm by visual estimation
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

TRYTON Pivotal RCT
Primary Non-­Inferiority 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= 0.11
P = 0.11
P =0.56
Provisional
Tryton
Généreux et al. J Am Coll Cardiol 2015;;65:533–43

38.6
31.6
0
10
20
30
40
50
60
P=0.002
Provisional
Tryton
Side Branch %DS (In-­segment)
Secondary Endpoint
%
Secondary Superiority Endpoint Met
Angiographic Cohort n=326
Généreux et al. J Am Coll Cardiol 2015;;65:533–43

14
33
49
152
164
104
66 68
24
10 11
6
0
20
40
60
80
100
120
140
160
180
≥ 2.25 mm:
41% of ITT lesions
Side Branch RVD (Core Lab)#Frequency
Pre Procedure Side Branch Size

TRYTON Large SBs Sub-­Analysis:
Side Branches ≥2.25mm
Généreux et al. Catheter Cardiovasc Interv. 2015

10.3
15.6
9.2
12.1
21.7
11.3
19.2
9.2
5.5 4.33.1 3.5
0
5
10
15
20
25
30
35
<2.25 mm ≥2.25 mm <2.25 mm ≥2.25 mm <2.25 mm ≥2.25 mm
Provisional TRYTON StentEvent Rate (%)
44/20320/195 22/141 18/195 17/141 6/195 6/13916/141 39/203 13/141 11/201 5/141
Side Branch Size
TVF
OR =2.42
[1.37,4.28]
OR =0.69
[0.35,1.38]
P for interaction=0.006
Target Vessel MI
OR =2.34
[1.29,4.25]
OR =0.74
[0.35,1.59]
P for interaction=0.02
Clinically Driven TVR
OR =1.82
[0.66,5.03] OR =0.81
[0.24,2.73]
P for interaction=0.32
Généreux et al. Catheter Cardiovasc Interv. 2015

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 = 0.26
Angiographic Outcomes (QCA)
Side Branch ≥ 2.25 mm 9 Months
Provisional N=81
Tryton N=64
%
Généreux et al. Catheter Cardiovasc Interv. 2015

TRYTON Confirmatory Study

TRYTON Confirmatory Study
Rationale
• To prospectively confirm the safety
(periprocedural MI) of the TRYTON
dedicated bifurcation stent in the
treatment of true bifurcation lesions
involving large side branches (≥2.25mm
by QCA analysis)

TRYTON Confirmatory Study
Angiographic Inclusion Criteria: No Change
• Single de novo “true” bifurcation lesion
• Native coronary artery
• Medina 1.1.1, 1.0.1, or 0.1.1 by visual estimation
• Symptoms or objective evidence of ischemia
• Vessel diameter:
• Main branch: ≥ 2.5 mm and ≤ 4.0 mm;;
• Side branch: ≥ 2.5 mm and ≤ 3.5 mm
• Lesion length:
• Main vessel ≤ 28 mm;; Side branch ≤ 5 mm
• Multi-­vessel disease and staging allowed
• Enrolment allowed after successful treatment of
≤ 2 non-­complex non-­target lesions

TRYTON Confirmatory Study
Review Clinical Selection Criteria/Informed Consent
Baseline Angiography
Review Angiographic Selection Criteria
N=133 patients
TRYTON stent side branch first step
DES in Main branch second step
Primary End point: Periprocedural MI
>3X URL CK-­MB 48hrs post PCI
Clinical F/U: 30 days and 1 year
ITT when TRYTON stent enters the guide catheter

TRYTON Confirmatory Study
Performance Goal: Sample Size Calculation
• Powered Endpoint:
• Peri-­procedural MI 3x CK-­MB @48hrs
• Observed Rate in IDE provisional: 11.9%
• Power: 90%
• Delta: 6.0%
• 1-­sided 95% upper confidence bound
• Performance Goal: 17.9%
• N = 133
• Anticipated 4% lost of follow-­up
• CK-­MB missing, RVD <2.25mm

TRYTON Confirmatory Study:
Study Recruitment
28 Investigational Centers
US =13, OUS =15
12 months enrolment

Baseline Characteristics: Demographic
Confirmatory Study Randomized IDE ≥2.25mm
TRYTON
(N=133)
TRYTON
(N=146)
Provisional
(N=143)
Age (years) 65.6±9.5 64.5±10.7 65.2±9.2
Male 69.9% 79.5% 81.8%
MI 32.3% 29.7% 40.4%
PCI 39.8% 37.0% 43.4%
CABG 2.3% 3.4% 3.5%
TIA / CVA 6.8% 8.9% 5.7%
CHF 6.0% 1.4% 0.0%
Diabetes Mellitus 25.8% 25.3% 28.7%
Hypertension * 82 %* 68.5% * 76.8%
Hypercholesterolemia 71.2% 72.2% 77.0%
Current Smoking 21.1% 17.1% 15.5%
Atrial Fibrillation 7.5% 12.3% 8.4%
* P<0.05

Baseline Characteristics: Presentation
Confirmatory Study Randomized IDE ≥2.25mm
TRYTON
(N=133)
TRYTON
(N=146)
Provisional
(N=143)
Recent MI NA 8.9% 11.2%
Angina Type
Stable 73.7% 74.0% 68.5%
Unstable 18.0% 19.2% 23.8%
CCS Class
I 15.3% 15.7% 17.0%
II 55.1% 56.9% 58.5%
III 27.6% 24.5% 20.2%
IV 2.0% 2.9% 4.3%
Ischemia + 64.2% 61.7% 63.9%
LVEF 56.3±9.5 57.1±9.4 56.8±10.7

Medina Classification: Angio Core
Laboratory Confirmation
T: 0%
P: 2.8%
Con: 0%
“True”
Bifurcation
T: 88.3%
P: 86.8%
Con: 100%
T: 45.9%
P: 39.9%
Con: 50.4%
T: 16.4%
P: 16.8%
Con: 15.0%
T: 26.0%
P: 30.1%
Con: 34.6%
T: 2.1%
P: 5.6%
Con: 0%
T: 4.1%
P: 2.8%
Con: 0%
T: 5.5%
P: 2.1%
Con: 0%
P=Provisional T=Tryton Con=Confirmatory

Baseline Characteristics: Main Branch
Confirmatory Study Randomized IDE ≥2.25mm
TRYTON
(N=133)
TRYTON
(N=146)
Provisional
(N=143)
Vessel Location
LAD 75.2% 71.2% 65.7%
LCX 20.3% 19.9% 25.2%
RCA 3.8% 8.9% 9.1%
Lesion Location
Ostial 10.5% 8.2% 7.0%
Proximal 50.4% 44.5% 44.1%
Mid 15.8% 20.5% 18.2%
Distal 23.3% 26.7% 30.8%
RVD (mm) 3.12±0.37 3.09±0.35 3.06±0.34
Lesion Length (mm) 17.23±7.89 16.14±6.84 16.05±6.53
Morphology
angulation ≥45o 8.3% 11.0% 9.8%
thrombus 1.5% 0.0% 1.4%
calcification – mod/severe 29.3% 13.7% 18.9%
TIMI Flow (baseline) < 3 15.0% 7.5% 14.0%

Baseline Characteristics: Side Branch
Confirmatory Study Randomized trial ≥2.25mm
TRYTON
(N=133)
TRYTON
(N=146)
Provisional
(N=143)
Vessel Location
LAD 75.2% 72.6% 65.0%
LCX 21.1% 18.5% 25.9%
RCA 3.8% 8.9% 9.1%
Lesion Location
Ostial 98.5% 96.6% 95.8%
Proximal 1.5% 2.7% 2.8%
Mid 0.0% 0.0% 0.0%
Distal 0.0% 0.7% 1.4%
RVD (mm) 2.49±0.20 2.53±0.23 2.52±0.22
Lesion Length (mm) 5.94±2.53 4.80±1.24 4.60±0.86
Morphology
angulation ≥45o 18.0% 12.3% 24.5%
thrombus 0.9% 0.0% 0.0%
calcification – mod/severe 9.8% 5.5% 5.6%
TIMI Flow (baseline) < 3 8.2% 4.1% 4.2%

TRYTON Confirmatory Study: Acute
Angiographic Result
Confirmatory Study Randomized Trial ≥2.25mm
TRYTON
(N=133)
TRYTON
(N=146)
Provisional
(N=143)
Main Vessel (mm)
Acute gain
In-­stent 1.81±0.47 1.77±0.46 1.78±0.40
In-­segment 1.49±0.48 1.38±0.46 1.45±0.44
Side Branch (mm)
Acute gain
In-­stent 1.58±0.43 1.53±0.36 na
In-­segment 1.37±0.41* 1.26±0.36 0.59±0.48*
* p<0.001

TRYTON Confirmatory Study:
Acute Success
Confirmatory Study
Randomized Trial
≥2.25mm
Acute Success(%)
TRYTON
(N=133)
TRYTON
(N=146)
Provisional
(N=143)
Procedure Success
Achievement of final in-­stent
diameter <50% in SB with assigned
study device
89.3%*
(117/131)
87.4%
(125/143)
66.9%*
(95/142)
Device Success
Achievement of final in-­stent residual
stenosis <30% (by QCA) in SB using
the assigned study device without
malfunction
93.8%*
(122/130)
94.4%
(135/143)
35.9%*
(51/142)
Lesion Success
Achievement of final in-­stent
diameter of <50% (by QCA) within
the side branch
100%*
(133/133)
100%
(141/141)
84.5%*
(120/142)
* p<0.001

TRYTON Confirmatory Study:
Resources Utilization
Confirmatory Study
Randomized Trial
≥2.25mm
TRYTON
(N=133)
TRYTON
(N=146)
Provisional
(N=143)
Procedure Time (min) 64.6±26.2 68.7±30.7 55.9±27.3
Fluoroscopy Time (min) 23.3±11.4* 24.0±13.8 11.6±5.4
Contrast Used (ml) 248.2±85.6 269.2±98.3 227±88.7
*p <0.001
~10 min more and ~30 ml more contrast
NORDIC IV 2 stents
(n=229)
92.6 min
22.8 min
238 ml

TRYTON Confirmatory Study:
Additional Stents (Site Reported)
2.2% (3/133)
1.5% (2/133)
Dissection: 2
Lesion Coverage: 0
Dissection: 1
Lesion Coverage: 2
Dissection: 1
Lesion Coverage: 3

TRYTON Confirmatory Study:
Peri-­Procedural MI 3x ULN CK-­MB
16/143 14/133
%
Performance Goal: 17.9%
Primary Endpoint Met
Error bars represent 1-­sided 95% CI
Pivotal Provisional
≥2.25mm
Confirmatory Study
11.2% 10.5%
16/143 14/133

TRYTON Confirmatory Study:
Peri-­Procedural MI 5x ULN CKMB
Pivotal Provisional
≥2.25mm
Confirmatory Study
6.8%
5.4%
7/103 7/130
%

TRYTON Confirmatory Study:
Procedural and 30-­day Follow-­up
Confirmatory Study Randomized Trial ≥2.25mm
Endpoints (%)
TRYTON
(N=133)
TRYTON
(N=146)
Provisional
(N=143)
Death
Procedural 0% (0) 0% (0) 0% (0)
30 day 0% (0) 0% (0) 0% (0)
Myocardial Infarction
Procedural (3x CKMB) 10.5% (14/133) 9.2% (13/141) 12.1% (17/141)
Procedural (5x CKMB) 4.5% (7/133) 3.4% (4/118) 6.8% (7/103)
30 day 10.8% (14/130)* 8.2% (12/146) 11.9% (17/143)*
Stent Thrombosis 0% (0) 0.7% (1/146) 0.0% (0/143)
* 2 patients in Confirmatory study have not completed 30 day follow-­up at datalock and 1 patient withdrew at 30 days

TRYTON Confirmatory Study
Conclusions
• The TRYTON Confirmatory Study,
assessing the safety of the TRYTON stent
in the treatment of bifurcation involving
large side branches, met its primary
endpoint (performance goal) related to
peri-­procedural MI
• This finding confirms the safety and
efficacy of the TRYTON dedicated
bifurcation stent in the treatment of
bifurcation involving large sides branches

TRYTON Confirmatory Study
Conclusions
• In light of the higher procedural success rate,
improved acute angiographic result, and
higher rate of side branch patency at 9-­month
follow-­up compared to provisional stenting,
the TRYTON Confirmatory Study and the
TRYTON IDE trial support the use of the
dedicated bifurcation TRYTON stent in
conjunction with standard DES in the
treatment of bifurcation lesions involving
large side branches

Tryton-­The Vision : To treat Bifurcation Lesions with the
Same Ease, Confidence & Efficacy as Straight Lesions

Thank You