1. Bifurcation Disease: Simulation Training Curriculum
Sidebranch Occlusion, Restenosis,
And Angiographic Challenges
Simulation Training Curriculum

2. Unresolved Bifurcation Issues For Evaluation of New Strategies
“True” Bifurcation Disease
Sidebranch occlusion with DES bifurcation and its impact on MACE
Restenosis Rates:
Main Vessel
Sidebranch
Regional Angiographic Analysis to Evaluate Dedicated Stents

3. Multiple Classification System

4. IVUS Predictors of Side Branch Occlusion in Bifurcation Lesions After PCI
Ostial lesion location
Plaque distribution
Furukawa et al . Circ J. 2005; 69(3):

5. Unresolved Bifurcation Issues For Evaluation of New Strategies
“True” Bifurcation Disease
Sidebranch occlusion with DES bifurcation and its impact on MACE
Restenosis Rates:
Main Vessel
Sidebranch
Regional Angiographic Analysis to Evaluate Dedicated Stents

6. Multiple Overlap Stenting in TAXUS V
All Patients
(n=1156)
Received no stents (n=8)
Single Stents (n=769)
Planned Procedures
(n=281)
Multiple Stents in
Target Vessel
(n=379)
Emergent Procedures
(n=98)
No overlap
(n=53)
What happened to those other 53 patients?
- There are 326 patients in the database with overlap. Of these 326 patients, 324 do not have gap, and 2 have gap.
- There are 53 patients in the database without overlap. Of these 53 patients, 45 do not have gap, and 8 have gap.
- There are 10 patients (2+8) that have gap, and 369 patients (324+45) that do not have gap.
TAXUS V 9 Month Report :
Multiple (N=379): Exhibit 93
Single (N=769): Exhibit 101
Overlap (N=326): Exhibit 96
Planned Overlap (N=248): Exhibit 97
Unplanned Overlap (N=78): Exhibit 98
Planned Multiple: Exhibit 94
Unplanned Multiple: Exhibit 95
Planned Procedures
(n=248)
QCA-confirmed
Overlapping Stents
(n=326)
Emergent Procedures
(n=78)

7. Objective: Multiple Stent Analysis
TAXUS V Multiple Stent Patients:
62.7% Lesions >26mm
86.0% QCA-confirmed overlapping stents
44.0% 2.25 and 2.5 mm stents
34.3% Patients with diabetes
73.1% Type C lesions
Multiple Stent Report – EM – , Exhibit 1-2 (N=379)
QC02Mar05KLH

8. MACE in QCA Analysis Subgroup
Control n=184
TAXUS n=188
P value
30-Day MACE
3.3%
8.6%
0.0457
Cardiac Death
0.0% MI
TVR
0.5%
1.6%
0.62
9-Month MACE
32.0%
20.7%
0.0172
0.6%
1.00
3.9%
8.7%
0.08
29.8%
16.3%
0.0027
9 Month Report ,
Clinical Procedural Success: Exhibit 1
PCI in non-targ. vessel: Exhibit 1, pg. 2
GP inhibitors during procedure: Exhibit 14
Maximum Inflation Pressure: Exhibit 6, line 2 (confirm that this is correct variable to report)
Max. Balloon:Artery Ratio: Exhibit 6, line 4
IVUS: Exhibit 6, Pg. 1, line 6.

9. TAXUS V Multiple Stent Analysis Methodology
Blinded core lab analysis of all multiple stent patients
Main Vessel Analysis:
Main vessel No Reflow, TIMI flow, Dissection, Distal Embolization, Abrupt Closure
Side Branch Analysis (for branches >1 mm):
Branch occlusion (total occlusion)
Branch narrowing (Δ≥70%  100%)
Branch TIMI flow

10. Side Branch Analysis in Multiple Stenting
Control n=184 pts
TAXUS n=188 pts
P value
Total Sidebranches (n)
268
289
% pts with Sidebranch
87.5
89.1
0.74
# Branches (per pt.)
1.60±1.01
1.66±0.99
0.55
Sidebranch RVD (mm)
1.40±0.36
1.42±0.37
0.45
Multiple Stent Report – EM – , Exhibit 6

11. Side Branch Analysis in Multiple Stenting
Sidebranch Occlusion
Side Branch Narrowing (Δ ≥ 70%  100%)
TIMI Flow Reduction

12. Impact of the Overlap Region (per side branch)
Control
TAXUS
Any Sidebranch
Occlusion
Any Sidebranch
Narrowing
Any TIMI Flow
Reduction
p=0.74
p=0.23
p=1.00
p=0.10
p=0.025
37/203
34/207
8/48
15/55
56/203
58/207
21/48
24/55
51/203
68/207
12/48
26/55
Non-overlap
region
Overlap
Non-overlap
region
Overlap
Non-overlap
region
Overlap

13. SIRIUS. C-SIRIUS, E-SIRIUS, DIRECT N = 1735
Single Stent
N = 1076
No Stent
N = 3
Multiple Stents in
Target Vessel
N=656
Multiple Long Stents in
≥ 2 stents with each stent ≥ 18 mm
in each target vessel (N=271)
QCA
Not Available
(N=38)
Multiple Long Stent
QCA Analysis
(N=233)
BMS (N=94)
SES (N=133)

14. Impact of the Overlap Region (per side branch)
11/189
16/145
0/19
1/8
27/189
28/145
2/19
2/8
17/173
18/140
4/15
2/7
Side Branch Occlusion
Side Branch Narrowing
TIMI Flow Reduction

15. Side Branch Analysis in Multiple Stenting Patients with and without CK-MB>3x ULN
+ Myonecrosis n=106 branches
no Myonecrosis n=451 branches
P Value
Occlusion
35.6 %
9.9 %
<0.0001
Narrowing
41.3 %
20.5 %
↓ Branch TIMI Flow
42.3 %
20.0 %
Myonecrosis
Multistent analysis
Multistent report Compare – EM
QC02Mar05KLH

16. Sidebranch Occlusions
Sidebranch occurs more often in regions of stent overlap with both CYPHER and TAXUS
Although the many sidebranches that occlude are small (1.4 mm), SBO is associated with periprocedural CK MB elevations
Reduced TIMI flow is associated with myonecrosis
Newer stent designs should minimize the degree of overlap in regions important sidebranch

17. Unresolved Bifurcation Issues For Evaluation of New Strategies
“True” Bifurcation Disease
Sidebranch occlusion with DES bifurcation and its impact on MACE
Restenosis Rates with BMS and DES:
Main Vessel
Sidebranch
Regional Angiographic Analysis to Evaluate Dedicated Stents

18. One Stent is Preferred With Bare Metal Stents
Yamashita et al JACC 2000; 35:1145

19. One Stent is Preferred One Stent Two Stents
Intracoronary Stent Implantation for True Bifurcation Lesion
Suwaidi et al JACC 2000;35:929

20. DES Bifurcation Approaches
Author n
Stent Type RR
(%)
PB (%)
SB (%)
TLR
MACE
Colombo et al
MV Only 22
Cypher
18.7
4.8
14.2
4.5
13.6
Circ 2004; 109:1244
Both 63 28
5.7
21.8
9.5 19
Ge et al 57
5.4
AJC 2005; 95:757
117 23
9.6
13.5
8.9
13.3
Hoye et al
Crush
130
36.4
9.3
27.1
6.2
12.3
JACC 2006; 47:1949
101
Taxus
31.6
22.8
14.5
Moussa et al *
120
---
11.3
13.0
AJC 2006; 97:1317
*Restenosis was focal in all patients and localized at the sidebranch ostium in 69% of patients

21. Importance of Final Kissing Ballon Post-Dilatation
No Kiss
Final Kiss
Importance of Final Kissing Ballon Post-Dilatation
Ge et al J Am Coll Cardiol Aug 16;46(4):

22. Unresolved Bifurcation Issues For Evaluation of New Strategies
“True” Bifurcation Disease
Sidebranch occlusion with DES bifurcation and its impact on MACE
Restenosis Rates:
Main Vessel
Sidebranch
Regional Angiographic Analysis to Evaluate Dedicated Stents

26. Ostial – Follow-up branch vessel

27. QCA Challenges: Determining Precise Regional Changes for Bifurcated
Stents
Prox RVD
Distal RVD
Branch RVD
5 mm Ostium

28. Setting the Stage: Conclusions
Current bifurcation stent strategies are insufficient to provide safe and predictable long term results – and they are a lot of work
With the evaluation of new technologies:
- Dedicated or sidebranch salvage techniques
- Periprocedural MI  preservation of large and
small branch flow
- Regional restenosis rates and failure analysis –
angiographic follow-up will be essential but may
lead to oculostenotic TLR