TCT2015 Presentation - Antonio L. Bartorelli, M.D.

1. Tryton Pivotal IDE-RCT Results
Implications For Everyday Practice
Integrating Dedicated Technology
Antonio L. Bartorelli, FACC, FESC
Centro Cardiologico Monzino
University of Milan
Milan, Italy
Stent Expansion & Lesion Coverage
Insights From Intravascular Imaging

2. Disclosure Statement of Financial Interest
• Speaker bureau
• Consulting
Fees/Honoraria
• Tryton, Abbott Vascular
• Abbott Vascular
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

3. Agenda
 Insights from intravascular imaging
 IVUS: IUVANT Study
 OCT
 Clinical Cases

4. TRYTON Side-Branch Stent: Intents and Benefits
Complex Bifurcation Lesions: Predictability & Durability of Stenting
 Side Branch
 Secure Side Branch
 Provide Scaffolding and Expansion
 Main Branch
 State-of-the-Art DES

5. IUVANT Study
Intravascular Ultrasound Evaluation of Tryton Stent
 Post-procedural and 9-month IVUS analysis
– MV: proximal and distal 5 mm from carina
– SB: proximal 5 mm from carina
Bartorelli AL et al. CCI 20015;85:544–553
 32 patients (33 BL) with angiographic apparent disease in MV and SB in 87.9% by site
 and 75% by core lab evaluation
 100% procedural success (Tryton+Xience V) including FKB

6. IUVANT Study:
Intravascular Ultrasound Evaluation of Tryton Stent
IVUS analysis site
Main Vessel (%) 96 (93,109)
Side Branch (%) 88 (77,100)
Carina Main Vessel (%) 135 (99,166)
Carina Side Branch (%) 116 (91,130)
Mean Post-procedure Percent Stent Expansion (defined as minimum
stent area divided by distal reference lumen area)
D1 LAD
Carina frames were choses
as the first end-diastolic
frames showing “figure-of-
eight” shape for carina
analysis
Impressive Carinal Expansion
Bartorelli AL et al. CCI 20015;85:544–553

7. In-segment
late lumen loss
(mm)
In-segment
diameter
stenosis (%)
In-stent late
lumen loss
(mm)
In-segment
diameter
stenosis (%)
Proximal MV 0.29 ± 0.46 17.6 ± 14.1 0.31 ± 0.35 13.5 ± 11.7
Distal MV 0.13 ± 0.26 12.0 ± 9.6 0.34 ± 0.24 2.5 ± 13.9
Side Branch 0.31 ± 0.26 18.5 ± 11.5 0.41 ± 0.27 25.4 ± 9.6
IUVANT Study
Intravascular Ultrasound Evaluation of Tryton Stent
QCA Results @ 9-month Follow-up
Binary Restenosis: One MV in-segment and one SB in-stent
Bartorelli AL et al. CCI 2015;85:544–553

8.  Tryton Design:
 Transition Zone Panels: Flare and rotate,
accommodates SB-MV transition and angle
 Thin struts (84 µm)
 Main Branch Zone:
Insures MV DES access and full expansion
IUVANT Study: Impressive Carinal Expansion
Stent Design & Delivery Technique
Bartorelli AL et al. CCI 2015;85:544–553
Transition
Zone
Side Branch
Zone
Main Branch
Zone

9.  Implantation Protocol (Key Features):
Tryton Pivotal & Confirmation Study Protocol
 Aggressive lesion preparation
 Precise positioning
 Post-Tryton deployment POT dilation
 Final kissing balloon (NC balloons of appropriate
size)
IUVANT Study: Impressive Carinal Expansion
Stent Design & Delivery Technique
Bartorelli AL et al. CCI 2015;85:544–553

10. Tryton Assessment With OCT
Final angio result (LCx-OM1)
CF
x
OM1LCx
wire
LCx max strut separation= 160 µm
LCx max strut separation= 150 µm
Ferrante G et al. CCI 2009;73:69-72
OCT MV and SB Images shows good apposition and uniform
strut coverage with minimal strut-vessel separation
OCT high spatial resolution: accurate strut apposition & lesion coverage

11. Prospective Evaluation of the Tryton Side-
Branch Stent with OCT – The PYTON Study
Dubois C et al CCI 2013;81:E155-E164
 20 patients treated with Tryton + Xience V
 Lesion success 95% (1 failure to advance Tryton)
 9-month angio and OCT follow-up (high-quality OCT available in 13 patients)
OCT assessed strut coverage in proximal MV, POC (polygon of confluence), distal MV & SB
Prox MV
Vessel fly
3-D reconstruction
Dist MVPOC

12. Proximal MV Distal MV Side
Branch
POC
Covered struts/patient 245 ± 84 193 ± 76 131 ± 23 83 ± 31
RUTSS (%) 4.00 ± 5.79 0.73 ± 1.26 0 2.47 ± 3.64
Free floating
struts/patient
0 0 0 1.85 ± 3.34
Uncovered free
floating struts (%)
- - - 16 ± 31
Prospective Evaluation of the Tryton Side-
Branch Stent with OCT – The PYTON Study
At 9 months, ratio of uncovered to total stent struts (RUTSS) in POC was low (2.47)
with only 1.85 struts/patient floating, 16% of which not covered by neointima
Dubois C et al CCI 2013;81:E155-E164

13. Monzino Case 1
Baseline
May 4, 2009
Coronary angiography
 Proximal LAD lesion and mid LAD-D1 lesion: Medina 1,1,1 with large plaque
burden and long side branch lesion
Case concerns
 Preserve large D1 and fully cover long side branch disease
 Durability of the acute result in a young patient
 45-year-old man with
hypercholesterolemia
 Recent onset of rest angina, severe
LAD lesion at MSCT coronary
angiography

14. POST TRYTON
May 4, 2009
Complete treatment of MV and long SB lesions
 D1 secured with a Tryton stent (3.5/2.5 x 19 mm)
 D1 long lesion fully covered with a 2.5 x 8 mm Xience V stent
 Deployment of a DES (3.0 x 28 mm Xience V) in mid LAD
 Sequential post-dilation of LAD and D1 and FKB with NC balloons
 Proximal LAD lesion treated with a 3.5 x 12 mm Promus stent
Monzino Case 1

15. 6-month F/U
December 14, 2009
9-month follow-up
 No symptoms
 No restenosis in LAD or D1
Monzino Case 1

16. 56-month F/U
January 9, 2014
56-months F/U
 Performed because atypical chest pain
and equivocal ECG stress test
 Unchanged angiographic results from 9
to 56 months
Monzino Case 1

17. Monzino Case 2
 59-year-old men
 Risk factors: family history of CAD, previous smoker, hypertension,
hypercolesterolemia
 Previous (July 2015) primary PCI of RCA for inferior STEMI
 LAD-D1 Medina 1,1,1 bifurcation lesion scheduled for September 2015

18. OCT Evaluation
D1 ostium
Distal LAD
Prox LAD
POC
Dragonfly OPTIS
OCT catheter

19. Tryton Side-Branch Stent
Transition
Zone
Side-Branch
Zone
Main-Branch
Zone
3.5/2.5 x 19 mm (tapered DS)
Tryton positioning
3.5/2.5 x 19 mm @ 12 atm Tryton deployment @12 atm
SB post-dilation
Accuforce 2.75 x 6 mm @18 atm

20. BVS Implantation in Main Vessel (LAD)
Absorb BVS 3.5 x 28 mm
@ 14 atm
POT in LAD
Accuforce 3.5 x 6 @ 16 atm
Mini-KBPD
LAD: Accuforce 3.0 x 5 mm @ 10 atm
D1: Accuforce 2.75 x 5 mm @ 10 atm
BVS cell dilation
Accuforce 3.0 x 8 mm @ 10 atm

21. Final Result

22. Final Angiographic and OCT Result
Pull back
from LAD
D1 LAD
Prox LAD
POC
D1
LAD Pull back
from D1
POC
Distal LAD
D1
Prox
LAD
Distal
LAD

23. Complex Bifurcation Lesions
When Do I Use the Tryton Stent?
Key questions (in doubt ask IVUS!)
 SB size: Diameter and territory supplied?
 SB disease: Severity and length of disease?
 Angle of bifurcation?
 SB accessibility: Ease of wiring (and re-wiring)
 Bailout complexity
 MV lesion severity

24. Conclusions
 Bifurcation lesions:
 Increased complication/reduced success (with both single- or two-DES
approach) when compared to straight (non-bifurcation) lesions
 Poorer outcomes with standard stents and techniques:
 Reduced stent expansion and lesion coverage
 Tryton Side-Branch Stent:
 Preserves SB
 Accommodates broad spectrum of bifurcation angle
 Provides impressive carinal expansion
 Provides good coverage in all bifurcation segments with minimal stent strut
overlap in proximal MV
 Preserves high performance of “state-of-the-art” main vessel DES
 Implantation technique:
 Straightforward and central to success

25. Thank You