Role of IVUS in Guiding Bifurcation Stenting: Utility in the DES Era?

Role of IVUS in Guiding
Bifurcation Stenting:
Utility in the DES Era?
Myeong-Ki Hong, MD, PhD.
Professor of Medicine,
Division of Cardiology, Severance Cardiovascular Hospital,
Yonsei University College of Medicine, Seoul, Korea
Potential conflicts of interest
❏ I have the following potential conflicts of interest to
report:
❏ Consulting
❏ Employment in industry
❏ Stockholder of a healthcare company
❏ Owner of a healthcare company
❏ Other(s)
× ❘ I do not have any potential conflict of interest
The Potential Clinical Utility of IVUS Guided
PCI with DES: reduced ST & TLR
Propensity score matching
P=0.013
IVUS
(n=884)
No IVUS
(n=884)
p-Value
In-hospital outcomes, n(%)
Death
11(1.2%)
20(2.3%)
0.11
Q-wave MI
1(0.1%)
8(0.9%)
0.02
30 Day outcomes, n(%)
MACE
25(2.8%)
46(5.2%)
0.01
Death
15(1.7%)
29(3.3%)
0.03
TLR
6(0.7%)
15(1.7%)
0.05
Cumulative ST
4(0.5%)
12(1.4%)
0.046
or pl avi vr us eerf T S
12 Month outcomes, n(%)
Survival Time (month)
MACE
128(14.5%)
143(16.2%)
0.33
Death
50(5.7%)
62(7.1%)
0.24
TLR
43(5.1%)
61(7.2%)
0.07
Definite ST
6(0.7%)
18(2.0%)
0.013
Roy P, Eur Heart J 2008;29:1851-1857
What about IVUS data in
bifurcation stenting?
Published data to compare the longterm clinical outcomes between angiographyand IVUS-guided stenting in bifurcation
lesions was quite limited.
Long-term Outcomes of IVUS Guidance
Stenting in non-LMCA Bifurcation Lesions
Asan Medical Center
758 patients between January 1998 and February 2006
IVUS-guidance
473 patients
Angiography-guidance
285 patients
4 years follow-up
BMS (n=338)
DES (n=420)
Primary end-point: All cause mortality
Secondary end-point: Stent thrombosis, TLR
Kim SH, et al, Am J Cardiol 2010;106:612-618
Baseline Characteristics
IVUS
guidance
(n=473)
Angiography
guidance
(n=285)
P Value
Age (years)
59 ± 10
60 ± 11
0.08
Male (%)
344 (73)
204 (72)
0.73
Acute coronary syndrome (%)
248 (52)
181 (64)
0.003
Drug-eluting stent implantation (%)
308 (65)
112 (39)
< 0.001
Simple stenting (%)
386 (82)
263 (92)
< 0.001
Ostial lesion (%)
61 (13)
9 (3)
< 0.001
Long lesion (≥ 30 mm, %)
279 (59)
131 (46)
< 0.001
Total stent length per lesion (mm)
34 ± 19
26 ± 14
< 0.001
Stents used per lesion (number)
1.4 ± 0.7
1.2 ± 0.5
< 0.001
Hazard Ratios of death after IVUS-guided
compared with angiography-guided
stenting
Death
Unadjusted
Overall
DES group
HR (95% CI)
P Value
HR (95% CI)
P Value
HR (95% CI)
P Value
0.22
< 0.001
0.21
0.01
0.27
0.02
(0.10-0.50)
Multivariable
adjusted
Propensity score
adjusted
BMS group
0.31
(0.06-0.72)
0.008
(0.13-0.74)
0.13
(0.03-0.66)
0.24
(0.09-0.81)
0.03
(0.06-0.86)
0.01
0.21
(0.06-0.73)
0.41
0.12
(0.13-1.26)
0.01
0.4
(0.1-1.2)
0.11
Hazard Ratios of stent thrombosis after
IVUS-guided compared with
angiography-guided stenting
Stent
thrombosis
Unadjusted
Overall
DES group
HR (95% CI)
P Value
HR (95% CI)
P Value
HR (95% CI)
P Value
0.45
0.14
0.27
0.09
0.78
0.74
(0.16-1.30)
Multivariable
adjusted
Propensity score
adjusted
BMS group
0.48
(0.06-1.22)
0.19
(0.16-1.43)
0.30
(0.07-1.32)
0.35
(0.17-3.48)
0.18
(0.08-1.64)
0.11
0.28
(0.06-1.25)
1.09
0.92
(0.22-5.34)
0.10
1.0
(0.2-4.9)
0.98
Hazard Ratios of TLR after IVUS-guided
compared with angiography-guided
stenting
TLR
Unadjusted
Overall
DES group
HR (95% CI)
P Value
HR (95% CI)
P Value
HR (95% CI)
P Value
1.36
0.29
0.94
0.88
2.13
0.05
(0.77-2.41)
Multivariable
adjusted
Propensity score
adjusted
BMS group
1.47
(0.39-2.24)
0.21
(0.79-2.71)
0.63
(0.23-1.72)
0.92
(1.00-4.55)
0.86
(0.38-2.25)
0.36
0.90
(0.33-2.54)
2.27
0.05
(0.99-5.25)
0.84
1.67
(0.75-3.72)
0.21
DES, Angiography
BMS, Angiography
DES, IVUS
BMS, IVUS
p=0.03*, among DES group
p=0.16, among BMS group
A landmark analysis: unadjusted cumulative incidence of very late stent
thrombosis in patients implanted with drug-eluting stents under IVUS
guidance and angiography guidance
Impact of IVUS-Guidance on
Long term Clinical Outcomes in
Patients Treated with DES for
Bifurcation Lesions: Data from
a Korean Multi-center
Bifurcation Registry
Study Design
The Korean multi-center bifurcation registry
1,668 patients with non-LM de novo bifurcation lesions who underwent
DES implantation between Jan. 2004 and June 2006:
IVUS (n=532) and angiography (n=1136)
Propensity score matching
IVUS-guidance
487 patients
Angiography-guidance
487 patients
3 years follow-up
Primary end-point: Death or MI
Secondary end-point: TLR, stent thrombosis, MACEs (Death, MI or TLR)
Baseline Clinical Characteristics
IVUS
guidance
(n=487)
Angiography
guidance
(n=487)
P Value
62.0±9.6
61.8±10.2
0.72
Male
324 (66.5%)
326 (66.9%)
0.89
Diabetes mellitus
155 (31.8%)
162 (33.3%)
0.63
Acute coronary syndrome
259 (53.2%)
275 (56.4%)
0.43
Triple anti-platelet therapy
65 (13.3%)
65 (13.3%)
1.00
Use of glycoprotein IIb/IIIa inhibitor
17 (3.5%)
18 (3.7%)
0.86
Age, years
Angiographic findings
IVUS
guidance
(n=487)
Angiography
guidance
(n=487)
P Value
True bifurcation*
319 (65.5%)
324 (66.5%)
0.74
Two-stent technique
128 (26.3%)
79 (16.2%)
<0.001
Final kissing ballooning
260 (53.4%)
165 (33.9%)
<0.001
Main vessel
3.2±0.3
3.1±0.3
<0.001
Side branch
2.8±0.3
2.7±0.3
0.05
Maximal stent diameter
Type of stents
0.33
Sirolimus-eluting stent
337 (69.2%)
321 (65.9%)
Paclitaxel-eluting stent
148 (30.4%)
161 (33.1%)
Other drug-eluting stent
2 (0.4%)
5 (1.0%)
Hazard Ratio (HR) of IVUS-guidance
compared to angiography guidance
HR
95% CI
P Value
Death
0.58
0.21-1.61
0.30
Myocardial infarction
0.32
0.09-1.18
0.09
Death or myocardial infarction
0.44
0.12-0.96
0.04
Target lesion revascularization
0.91
0.52-1.62
0.76
Stent thrombosis*
0.33
0.04-3.21
0.34
Major adverse cardiac events†
0.73
0.44-1.19
0.20
Impact of IVUS-Guidance on 3-Year Clinical Outcomes in Patients
Treated with Drug-Eluting Stent for Bifurcation Lesions
20
Angiography guidance
IVUS guidance
15
Death or MI
IVUS-guidance
) e%
(viIt M
tu
aeC
alr uo hm
Df o ec nedi c nI
10
Patients at risk
P=0.03
7.8 % (5.7-9.9 %)
5
3.8 % (2.1-5.5 %)
0
0
487
Angiography-guidance 487
180
360
480
720
Follow-Up Duration (Days)
900
1080
467
281
118
469
346
124
Impact of IVUS-Guidance on 3-Year Clinical Outcomes in Patients
Treated with Drug-Eluting Stent for Bifurcation Lesions
4
Angiography guidance
IVUS guidance
( TCSf o ec nedi c nI
evi t al u) m%u
3
Stent thrombosis
2
P=0.29
1
0.6 % (0.2-1.0 %)
0.2 % (0-0.4 %)
0
0
Patients at risk
IVUS-guidance
487
Angiography-guidance 487
180
360
480
720
Follow-Up Duration (Days)
900
1080
470
281
120
471
348
126
Double vs. Single stenting (meta-analysis)
The provisional technique should remain the preferred strategy in the majority of cases.
Katritsis DG et al. Circ Cardiovasc Intervent 2009;2:409-415
Double vs. Single stenting (random study)
Study
No. Pts (simple vs.
complex
True
bifurcation
Cross-over to complex
strategy
PostIVUS
CACTUS
350 (173:177)
94%
54 (31%)
2-4%
Colombo et al
86 (43:43)
NA
22 (51%)
All
Most random studies with larger number of patients were
performed
without
IVUS guidance…..
Ferenc
et al
202 (101: 101)
68%
19 (19%)
NA
Nordic provisional
413 (207: 206)
NAremain the 9preferred
(4%)
Should
technique
strategies in subgroup of true bifurcation ?
NA
Pan et al
91 (47: 44)
86%
1 (2%)
NA
BBC
500 (250: 250)
82%
7 (3%)
NA
Katritsis DG et al. Circ Cardiovasc Intervent 2009;2:409-415,
Hildick-Smith D et al. Circulation 2010;121:1235-1243
What about role of IVUS in
bifurcation stenting?
• Pre-procedural evaluation
- Severity of bifurcation; especially side branch ostium
• Procedural and post-procedural evaluation
- Stent apposition & expansion
- Stent carina
IVUS Predictors of SB occlusion
• 81 bifurcation lesions in 72 patients
Group 1
Group 2
SB occlusion (%)
Ostial plaque distribution as assessed by IVUS may
be one of the consistent predictors of side branch
occlusion after PCI.
Group 1
(n=61)
Group 21
(n=20)
Furukawa E, et al. Circ J 2005;69:325-330
Anatomic and functional evaluation of bifurcation
lesions undergoing percutaneous coronary intervention
• IVUS of 77 patients with bifurcation, before and after MB stenting.
Both plaque shift from the MB and carina shift
contribute to the creation/aggravation of an SB ostial
lesion after MB stent implantation.
In the proximal MB, the plaque volume
index decreased (9.1±3.0 to 8.4±2.4
mm3/mm, P=0.001);
 implicating Plaque shift.
However, in the distal MB, plaque
volume did not decrease (5.4±1.8 to
5.3±1.7 mm3/mm, P=0.227);
 implicating Carina shifting to account
for the change in vessel size.
Koo BK, et al. Circ Cardiovasc Interv 2010;3:113
IVUS analysis after crush stenting
 40 patients with bifurcation underwent crushing with SES. Postprocedural IVUS was performed in both branches (n=25) and only the
main vessel Minimum
(MV) in 15 stent
lesions
area was found at
the SB ostium in 68%.
“Incomplete crushing”—incomplete apposition of SB or MV
stent struts against the MV wall proximal to the carina—was
seen in 60% of non-left main lesions.
10% (2/20)
20% (4/20)
55% (11/20)
90% (18/20)
Costa RA et al. J Am Coll Cardiol 2005;46:599-605
A
B
C
Significance of radio-opaque markers
• Presence of radio-opaque makers is helpful to
guide the placement of stent struts for avoidance of
stent struts around or on the side branch ostium
before stent implantation.
• After stent implantation, correct passage of guidewire into possibly largest space among the several
stent cells is expected under the guidance of radioopaque markers
A
marker
Presence of Radio-opaque
radio-opaque
marker is
more useful to protect side branch
C
rather than Bideal stent platform
Before stenting
After stenting
After kissing balloon
A
B
Incidence of jailed side branch by
stent struts: 5 of 10 conventional
stent vs. 1 of 10 stent with radioopaque markers
Summary
IVUS would be an useful tool for the PCI of the lesions with
bifurcations to evaluate the severity of side branch, main
vessel and carina before PCI, and guidance for the occluded
side branch, stent apposition and expansion, especially in
side branch during and after PCI.
IVUS-guided stenting may be associated with reduction of
long-term mortality compared with conventional
angiography-guided stenting. In addition, IVUS guidance
may reduce the development of (very) late stent thrombosis
in patients receiving drug-eluting stents.
Take Home Messages
• Although IVUS would be expected to be an useful
tool for the evaluation and PCI of the bifurcation
lesions, data regarding the IVUS evaluation of the
bifurcation lesions are not still sufficient.
• Further IVUS studies with larger populations will
be needed.
Dreams will
come true