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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
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
Agenda
 Insights from intravascular imaging
 IVUS: IUVANT Study
 OCT
 Clinical Cases
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
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
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
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
 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
 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
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
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
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
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
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
6-month F/U
December 14, 2009
9-month follow-up
 No symptoms
 No restenosis in LAD or D1
Monzino Case 1
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
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
OCT Evaluation
D1 ostium
Distal LAD
Prox LAD
POC
Dragonfly OPTIS
OCT catheter
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
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
Final Result
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
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
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
Thank You

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Stent Expansion and Lesion Coverage Insights From Intravascular Imaging | 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
  • 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

Editor's Notes

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