1. Techniques, Outcome and New Devices
CRT 2012
Washington, February 8, 2012
Bifurcation Lesions:
Techniques, Outcome and
New Devices
Eberhard Grube MD, FACC, FSCAI
University Bonn, School of Medicine, Bonn, Germany
Hospital Alemão Oswaldo Cruz - Dante Pazzanese, São Paulo, Brazil
Stanford University, Palo Alto, California, USA

2. Disclosure Statement of Financial Interest
Within the past 12 months, the presenter or their spouse/partner have had a financial interest/arrangement or affiliation with the organization(s) listed below.
Physician Name Company/Relationship
Eberhard Grube, MD Medtronic, CoreValve: C, SB, AB, OF
Sadra Medical: E, C, SB, AB
Direct Flow: C, SB, AB
Mitralign: AB, SB, E
Symetis: AB
Boston Scientific: C, SB, AB
Biosensors: E, SB, C, AB
Cordis: AB
Abbott Vascular: AB
Capella: SB, C, AB
InSeal Medical: AB
Valtec: E, SB
Claret, SB
Key
G – Grant and or Research Support E – Equity Interests S – Salary, AB – Advisory Board
C – Consulting fees, Honoraria R – Royalty Income I – Intellectual Property Rights
SB – Speaker’s Bureau O – Ownership OF – Other Financial Benefits‘ 2 2

3. Types of Involvement of Coronary Bifurcations by Atherosclerosis
Atherosclerosis occur predominantly close to bifurcation
Carinal involvement by atherosclerosis is extremely unusual.
Renu Virmani

4. Bifurcation Stenting: Not all Bifurcations are created equal!
LM Stenting
Peripheral Bifurcations 4 4

5. Bifurcation stenting: Questions to be answered
Two stents or one?
Types of bifurcations
Should I have kissing stents?
What is plaque shifting?
What Technique..
IVUS/OCT…? 5

6. Need for treating Bifurcations.
Bifurcations are a high risk region for the formation of atherosclerotic plaque.
>20% of all PCI involve treatment of Bifurcations:
cannot be avoided!!
Procedural and clinical success rates are inferior to non-complex treatments.
Drugs have helped greatly but still not solved the underlying problem.
Restenosis
Simple Strategy
Complex Strategy MB
2% -7.3%
3.1% % SB
4% -15%
9% - 21%
Combined
6% %
15.4% - 27%
MACE
Simple Strategy
Complex Strategy
At 6mths
9.6%
12.6%
Meta Analysis: Hakeem et al 2009 (BBC,Nordic,Cactus,Colombo,Pan,Ferenc)

7. Evolution in the efficacy of Bifurcation treatments.
Note: Review of significant peer review articles from 2000 to 2008, (BBC,Nordic,Cactus,Colombo,Pan,Ference bad Krosigen, Gallassi etc

8. Bifurcation Stent Techniques
More Complex Technique
Culotte
Crush
Kissing
Less Ostial Coverage
More Ostial Coverage
T-Stent
Provisional
Less Complex Technique

9. Issues with 2 Stent Techniques
Images from in vivo provisional stent studies at 180 days:
PTCA in SB
distortion, fracture
dissection at SB ostium
PV Cypher 3x23 + SB PTCA
PV Cypher 3x23 + SB Stent
Excessive overlap,
obstructed
lumen
Ostial gaps,
persistent flow restriction, restenosis 9

10. Optimal performance of 2 stent techniques important in reducing
event rates
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11. 1 vs. 2 vs. Dedicated Bifurcation Stent Approach…

12. 1 Stent ?
2 Stents ? 12

13. Ideal Bifurcation Stent Design Requirements
Coverage of Full Bifurcation
Effective at all angles.
Simple to deliver.
Nitinol is an important characteristic for the stent, but there are other factors which are necessary to create an optimal design for the sidebranch stent.
Correct radial force is needed to trigger remodeling.
The cell design provides appropriate scaffolding & permits crossing the stent with the main vessel stent. The design will also have an impact on the anchoring in the vessel & assure appropriate fixation.
The delivery system needs to adapt to tortuous & calcified lesions & therefore should provide ease in delivering the stent to the lesion site.
It is also important to see the device for optimal placement.
The shape memory is important for the variability of the sidebranch ostium as well as the scaffolding.
All of these points help to create the optimal design for a sidebranch stent.
Optimal Design
< 5%
Simple selection criteria. 13

14. Design Approach Fundamentally there exist two design philosophies:
Modified Provisional:
Objective: Provide sidebranch access without main branch compromise.
e.g. BSC petal, Abbott Frontier, Trireme Antares, Stentys.
Dedicated devices:
Objective: Provide treatment of the bifurcation segment using an
anatomically considered design.
e.g. Cappella Sideguard, Tryton, Devax Axxess.

15. 1. Modified Provisional:
Pros:
Simplest design concept.
Cost effective, single stent for majority.
Conceptually easy to use.
Cons:
Deliverability.
Guidewire twist, guidewire bias, delivery-system rotation.

16. AntaresTM Family Treating Main Vessel with Side Branch Access
AntaresTM II Continuous SB Access, Single balloon
MV stent engineered for ostial scaffolding
Continuous SB access and no wire crossing by design
Can be considered for all anatomies and lesion types at or near bifurcations
AntaresTM Lite Single wire, Single balloon
Ultra-low profile, single wire system (No SB wire required)
Stent crossing profile smaller than most regular stents (0.037”)

17. Disconnectors along the stent
STENTYS® Technology
Nitinol, self-apposing stent (BMS and DES)
6F single-wire, rapid exchange, CE-marking
Disconnectable struts over full length*
Disconnectable
interconnector
Disconnection
Disconnectors along the stent 17
* Except the first and last 2mm 17

18. Deploying a STENTYS® Self-Apposing Stent in an AMI patient
1. Position the STENTYS® stent over the lesion
2. Retract the outer sheath to deploy the stent from distal to proximal
3. The stent is fully deployed in the vessel of the AMI patient with perfect apposition
4. The STENTYS® stent expands with the vessel during vasodilation and as thrombus resolves ensuring perfect apposition.

19. Opening the STENTYS® Self-Apposing Stent at a Bifurcation
1. Position the guidewire into the side branch at the most distal point close to the carina.
2. Inflate a regular PTCA balloon at 8 atm at the side branch opening to disconnect the struts.
3. Deflate and withdraw the balloon allowing the stent to expand fully to create the opening to the side branch.
4. The STENTYS® stent expands with the vessel during vasodilation and as thrombus resolves ensuring perfect apposition.

20. APPOSITION II
DESIGN: International, prospective, randomized, two-arm multi-center trial
OBJECTIVE: To compare the STENTYS® Stent with balloon-expandable stents in AMI
ENDPOINTS:
Stent strut apposition and expansion at 3 days (measured by OCT)
days and 6 months
Independent monitoring: Genae
Core Lab: Cardialysis
80 STEMI patients enrolled between 12/09 and 06/10 in 9 European sites
STENTYS® stent
Clinical follow-up at 30 days and 6 months
Invasive follow-up at 3 days (QCA, OCT)
VISION / Driver
Balloon Expandable Stent - Day 3
Stentys Stent - Day 3
p<0.001
Results (patients with severe malapposition )

21. 2. Dedicated Devices: Pros:
Effective treatment of entire bifurcation anatomy.
Minimal main branch impact.
Cons:
Cost (price and time) since 2 stents required.
More complex design than modified provisional.

22. Current Stent Design Options (Provisional).
While simple in concept they fail to deal with the complexity of the anatomy.

23. Current Stent Design Options (Dedicated)

24. Current Stent Design Inputs
Their simplicity lies in their ability to treat the complexity of the anatomy in a repeatable and effective way.

25. Cappella Sidebranch Stent (ostial protection device)
Sideguard address the complexities
associated with ostial and bifurcated lesions
Precise BE Delivery System
Bare Metal Sidebranch Stent
Peel-away Split Sheath,
Balloon Expandable Delivery
Self-Expanding (SE) Stent
Sideguard is a self-expanding, anatomically-shaped stent
Target is a balloon-release delivery system for SE stents 25 25

26. Tryton Side Branch Stent
Side Branch Region
Standard Design
Transition Zone
Coverage
Hoop Strength
Main Vessel
Main Vessel Region
3 Fronds - Minimal Coverage
Wedding Band
Cobalt Chromium
Strut Thickness: 0.003”
Diameter: 2.5 mm 26

27. Dedicated bifurcation stents
Cappella
sideguard
6 month FU
At the moment for true bifurcation with short lesions on the side branch when the operator feel unconfident to recross an unprotected side branch
Tryton

28. AXXESS PLUS LM System Flared Distal-End Stent Design
Self Expanding Nitinol Material
6, 8, 10, or 12 mm
flare diameter
Biolimus A9
antiproliferative
strut coating
4.8F Rx Delivery System

29. Complete Ostial Coverage
Stent flares to cover ostia of
Both branching vessels
Carina area is covered
By stent struts

30. Example of Stent Conformity
Stent Boost Imaging shows
SB ostial coverage 30

31. Example of Stent Conformity
Stent Boost Imaging shows
SB ostial coverage
Final Angiogram
PV: Axxess + Cypher
SB: PTCA 31

32. Angiographic Outcome (DIVERGE)
Any in-bifurcation restenosis:
6.4% (9/140 at 9 months)
Proximal edge:
2.8%
SB stent:
4.8%
(105 SB stents)
Distal PV Cypher:
2.1%
AXXESS:
0.7%
Location Analysis:
Parent Vessel RS
2 pts
Side Branch RS
3 pts
Both
4 pts
Lowest restenosis rates
ever reported in a bifurcation
study of any kind 32

33. Summary of Ideal Stent Design.
Must not impact on main vessel treatment.
Must scaffold ostium entirely and effectively.
Easy and quick to deliver.
Allows further treatment of SB if required
Reduces the need for further interventions.
Will treat wide variety of Bifurcations lesions.

34. Conclusions 1
Stenting coronary bifurcations requires more than deciding to implant 1 or 2 stents
The most important decisions should be taken by examining:
the clinical setting (age of the patient, general conditions, extent of ischemia),
the extent of the disease of both branches,
their size,
the territory of distribution and
how confident is the operator with a specific approach

35. Conclusions 2
Dedicated bifurcation stents address ideally the specific needs of bifurcation lesions
Due to the variable anatomy of bifurcation lesions, variable stent designs or deployment techniques are most likely needed
Dedicated bifurcation DES are needed to combine the benefits of both technologies

36. Thank you

37. Tryton Side Branch Stent: Complex Bifurcation Lesions
Wide Angle
Narrow Angle
Prox LAD
Baseline
Final 37