D2227 g v01 rev. 1 d.rizik, tryton breakfast symposium introduction_the challenge of treating bifurcation lesions

1. Scottsdale-LincolnHealthNetwork
Tryton Breakfast Symposium
Session Introduction:
The Challenge of Treating
Bifurcation Lesions
David G. Rizik, M.D., F.A.C.C., F.S.C.A.I.
Chief Scientific Officer
Director of Structural & Coronary Interventions
HonorHealth and the Scottsdale-Lincoln
HealthNetwork
HonorHealth/Scottsdale-LincolnHealthNetwork

2. Disclosure
Statement
of
Financial
Interest
I, (David G Rizik, MD), DO NOT have a
financial interest/arrangement or
affiliation with one or more organizations
that could be perceived as a real or
apparent conflict of interest in the
context of the subject of this
presentation

3. Scottsdale-LincolnHealthNetwork
Q1: Why is stenting the standard for the
treatment of these lesions subsets?
• Discrete
• Long Segmental
• Calcified
• Eccentric
• Saphenous Vein Graphs
• CTO’s
• In-­Stent Restenosis
• Thrombotic
• Type A, B1, B2, C
A1: Stenting provides a wide variety of lesion
subsets predictable procedural
success with a durable result.

4. Scottsdale-LincolnHealthNetwork
Q2: What is the only major lesion subset which
stenting is not the current Standard?
A2: Bifurcation Lesions: Workhorse stents do not
provide the same predictable and durable results as
straight lesion

5. Scottsdale-LincolnHealthNetwork
Bifurcation Lesions are Common
“All Comers” Studies % Patients % Lesions
Leaders Trial1,2 29.1% 21.6%
Nobori 23 17.5% 16.9%
xSearch4 22.2% N/A
Average 22.9% 19.3%
1. Windecker et al. Lancet 2008;; 372: 1163–73
2. Wykrzykowska, EuroPCR ’09
3. Danzi, EuroPCR ‘09
4. Serruys, ACC ‘08

6. Scottsdale-LincolnHealthNetwork
Treatment of Branching Geometry Lesions Using
Currently Available Technology Yield Complications
• Thrombosis Rate
– Incidence: 3.6-­
3.9%
– Hazard Ratio: 4.6-­
6.5
• Restenosis Rates
– Angiographic 20-­
40%

7. Scottsdale-LincolnHealthNetwork
Bifurcation Lesions:
Large Variation: Extent of Disease, Angle & Diameter
Case Courtesy of Drs
Kutcher & Holland, USA
Courtesy of P Brunel,
France
Courtesy of Dr. Dumonteil,
France
Courtesy of Prof. R.
Kornowski, Israel
Courtesy of Dr. Th. Lefèvre,
France
Courtesy of Dr. Schulze,
Germany
Courtesy of Dr. M. Lesiak,
Poland
Courtesy of Drs. E. Grübe -­
R. Müller, Germany
Like finger prints: No two bifurcations are alike

8. Scottsdale-LincolnHealthNetwork
5 Year Follow-Up Nordic Bifurcation Study
Simple vs Complex Stenting Strategy in Non-­LM PCI
• MACE event were low and did not differ
significantly in patients treated with a
simple versus a complex bifurcation stenting
technique.
• Stent thrombosis rate was not increased in
patients treated with 2-stents.

9. Scottsdale-LincolnHealthNetwork Meta-Analysis: NORDIC I & BBC I (Non LM Bifurcations)
Probability of MACE (Death/MI/TVR)
Difference in MACE
favoring a simple strategy
What is the relevance of
peri-­procedural MI ?
25-­50% of patients in randomized
trials have little or no SB disease.
Most one vs two stent trials have focused
on bifurcations with diminutive SB diameters

10. Scottsdale-LincolnHealthNetwork
More Contemporary Trials Involving Large Side
Branches Favor 2- stent Strategy

11. Scottsdale-LincolnHealthNetwork
Key Points
• Bifurcation Lesions: Continues to be problem
Only Lesion Subset Not Routinely Stented
• Combined Literature:
Supports Provisional over 2 Stent Strategies
• Study Population Primarily Focused on Small SB
– BBC 1
– Nordic 1
• Studies with Large SB Favors 2 Stent Approach
– DK Crush
– 2 Stent ‘Simple’ Dedicated Stent
• Tryton is a Dedicated Side Branch Stent:
Focused on Providing Straight Forward 2 stent
solution

12. Scottsdale-LincolnHealthNetwork
Tryton Side Branch Stent
Product Features
• Cobalt Chromium (CoCr)
• Strut thickness: 84µm
• Delivery System: Rapid Exchange
• Side Branch Diameters: 2.5-­3.5 mm
• Guide Size: ≥ 5 Fr (Operator’s Choice)
• Guide Wire: 0.014” (Operator’s Choice)
• Main Vessel Stent: Workhorse DES (Operator’s
Choice)

13. Scottsdale-LincolnHealthNetwork
Tryton Side Branch Stent™
Main Branch Zone
& wedding band
8mm
*: 5.5mm for Large Vessel diameters
**: 18mm for Large Vessel diameters
Total stent
length:
19mm**
Transition Zone
4.5mm
Side Branch Zone
6.5mm*
Necessarily Employs a Save the Side Branch Strategy

14. Scottsdale-LincolnHealthNetwork
Tryton Deployment Sequence
1. Wire both vessels and pre-­dilate SB 2. Position Tryton
3. Perform P.O.T. 4. Position DES and remove ‘jailed’ wire
5. Deploy DES and re-­wire SB
6. Simultaneous Kissing Balloon

15. Scottsdale-LincolnHealthNetwork
Complex LAD-Diagonal Lesion
A2: Treated Electively via right radial 6 Fr.
Sheath with Tryton Side Branch Stent
Case Courtesy of Michael Kutcher, M.D.
Wake Forest Baptist Medical Center

16. Scottsdale-LincolnHealthNetwork
Tryton Breakfast Symposium