Bifurcation Disease:
Sidebranch Occlusion, Restenosis, And Angiographic Challenges
Simulation Training Curriculum
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
Multiple Classification System
IVUS Predictors of Side Branch Occlusion in Bifurcation Lesions After PCI
• Ostial lesion location • Plaque distribution
Furukawa et al . Circ J. 2005; 69(3):325-30.
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
Multiple Overlap Stenting in TAXUS V
All Patients (n=1156)
Received no stents (n=8)
Multiple Stents in Target Vessel (n=379) No overlap (n=53) QCA-confirmed Overlapping Stents (n=326)
Single Stents (n=769)
Planned Procedures (n=281) Emergent Procedures (n=98)
Planned Procedures (n=248) Emergent Procedures (n=78)
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
MACE in QCA Analysis Subgroup
Control n=184
30-Day MACE Cardiac Death MI TVR 3.3% 0.0% 3.3% 0.5%
TAXUS n=188
8.6% 0.0% 8.6% 1.6%
P value
0.0457
0.0457 0.62
9-Month MACE
Cardiac Death MI
32.0%
0.6% 3.9% 29.8%
20.7%
0.5% 8.7% 16.3%
0.0172
1.00 0.08
TVR
0.0027
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
Side Branch Analysis in Multiple Stenting
Control n=184 pts TAXUS n=188 pts
P value
Total Sidebranches (n)
% pts with Sidebranch
268
87.5
289
89.1 0.74
# Branches (per pt.)
Sidebranch RVD (mm)
1.60±1.01
1.40±0.36
1.66±0.99
1.42±0.37
0.55
0.45
Side Branch Analysis in Multiple Stenting
Sidebranch Occlusion Side Branch Narrowing (Δ ≥ 70% 100%)
TIMI Flow Reduction
Impact of the Overlap Region (per side branch)
Control
Any Sidebranch Occlusion
p=0.74 p=0.23
TAXUS
Any TIMI Flow Reduction
p=0.10 p=0.025
47.3 32.9
Any Sidebranch Narrowing
p=1.00 p=1.00
43.8 43.6
27.3 18.2 16.4 16.7
27.6
28.0
25.1
25.0
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 region
Non-overlap region
Overlap region
Non-overlap region
Overlap region
SIRIUS. C-SIRIUS, E-SIRIUS, DIRECT N = 1735 No Stent N=3 Multiple Stents in Target Vessel N=656 Single Stent N = 1076
QCA Not Available (N=38)
Multiple Long Stents in ≥ 2 stents with each stent ≥ 18 mm in each target vessel (N=271)
Multiple Long Stent QCA Analysis (N=233)
SES (N=133)
BMS (N=94)
Impact of the Overlap Region (per side branch)
CYPHER 60 50
P = 0.11 P = 0.30 P = 0.24 P = 0.56
BMS
P = 0.47 P = 1.00
% of Patients
40 30 20
11.0 19.3 12.5 0.0 14.3 10.5 5.8
11/189 16/145 0/19 1/8 27/189 28/145 2/19 2/8
25.0 9.8 12.9
26.7 28.6
10 0
17/173 18/140
4/15
2/7
Non-Overlap
Overlap
Non-Overlap
Overlap
Non-Overlap
Overlap
Side Branch Occlusion
Side Branch Narrowing
TIMI Flow Reduction
Side Branch Analysis in Multiple Stenting Patients with and without CK-MB>3x ULN
+ no Myonecrosis Myonecrosis n=106 n=451 branches branches 35.6 % 41.3 % 42.3 % 9.9 % 20.5 % 20.0 %
Myonecrosis
P Value
Occlusion Narrowing ↓ Branch TIMI Flow
<0.0001 <0.0001 <0.0001
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
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
One Stent is Preferred With Bare Metal Stents
Yamashita et al JACC 2000; 35:1145
One Stent is Preferred
One Stent
Two Stents
Intracoronary Stent Implantation for True Bifurcation Lesion
Suwaidi et al JACC 2000;35:929
DES Bifurcation Approaches
Author
Colombo et al
Circ 2004; 109:1244
n
MV Only Both MV Only Both Crush Crush Crush 22 63 57 117 130 101 120
Stent Type
Cypher Cypher Cypher Cypher Cypher Taxus Cypher
RR (%)
18.7 28 9.5 23 36.4 31.6 ---
PB (%)
4.8 5.7 4.8 9.6 9.3 8.9 ---
SB (%)
14.2 21.8 4.8 13.5 27.1 22.8 ---
TLR (%)
4.5 9.5 5.4 8.9 6.2 14.5 11.3
MACE (%)
13.6 19 5.4 13.3 12.3 22 13.0
Ge et al
AJC 2005; 95:757
Hoye et al
JACC 2006; 47:1949
Moussa et al *
AJC 2006; 97:1317
*Restenosis was focal in all patients and localized at the sidebranch ostium in 69% of patients
No Kiss
Importance of Final Kissing Ballon PostDilatation
Final Kiss
Ge et al J Am Coll Cardiol. 2005 Aug 16;46(4):613-20.
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
Ostial – Follow-up branch vessel
Prox RVD
QCA Challenges: Determining Precise Regional Changes for Bifurcated Stents
Distal RVD 5 mm Ostium
Branch RVD
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