Pavia………… Pavia………… - Emoclinic Symposium

Pavia…………
Ezio
Bramucci,
2011
Ezio Bramucci,
NovaraNovara
2011
TRATTAMENTO DEL TRONCO
COMUNE
E DELLE BIFORCAZIONI COMPLESSE
EZIO BRAMUCCI, MD
Laboratorio di Emodinamica
Divisione di Cardiologia
Fondazione Policlinico San Matteo - Pavia
Novara, venerdì 14 Gennaio 2011
Ezio Bramucci, Novara 2011
Ezio Bramucci, Novara 2011
Ezio
Bramucci,
2011
Ezio Bramucci,
NovaraNovara
2011
Ezio
Bramucci,
2011
Ezio Bramucci,
NovaraNovara
2011
Ezio
Bramucci,
2011
Ezio Bramucci,
NovaraNovara
2011
Ezio
Bramucci,
2011
Ezio Bramucci,
NovaraNovara
2011
Ezio
Bramucci,
2011
Ezio Bramucci,
NovaraNovara
2011
Ezio
Bramucci,
2011
Ezio Bramucci,
NovaraNovara
2011
Ezio
Bramucci,
2011
Ezio Bramucci,
NovaraNovara
2011
www.escardio.org
Ezio
Bramucci,
2011
Ezio Bramucci,
NovaraNovara
2011
Ezio
Bramucci,
2011
Ezio Bramucci,
NovaraNovara
2011
SYNTAX Trial Design
62 EU Sites
+
23 US Sites
Heart Team (surgeon & interventionalist)
Total enrollment N=3075
Amenable for both
treatment options
Amenable for only one
treatment approach
Stratification:
Stratification:
St tifi ti
LM
LM and
and Diabetes
Diabetes
Randomized Arms
Two Registry Arms
N=1800
N=1275
Randomized Arms
CABG
n=897
3VD
66.3%
n=1800
LM
33.7%
vs
vs
TAXUS*
TAXUS
n=903
n=903
3VD
65.4%
LM
34.6%
Two Registry Arms
CABG
CABG
2500
n=1077
n=1077
50 w// f/u
750
5yr f/u
n=649
no f/u
n=428
PCI
all captured
n=198 w/
follow
fo
o up
*
TAXUS Express
Patient Characteristics (II)
Left Main Subset: Randomized Cohort
Patient-based
Total SYNTAX Score
Diffuse disease or small vessels, %
N lesions,
No.
l i
mean ± SD
CABG
n=348
26.7
± 11.5
12.9
32
3.2
± 1.9
TAXUS
n=357
28.1
± 12.4
11.8
33
3.3
± 1.8
P value
0.13
0.64
0 89
0.89
Left main disease type, %
Left Main only
14.1
11.8
0.36
Left Main + 1 vessel
20.4
18.8
0.58
Left Main + 2 vessel
essel
30 5
30.5
31 4
31.4
0 79
0.79
Left Main + 3 vessel
35.1
38.1
0.40
Total occlusion
occlusion, %
14 7
14.7
17 9
17.9
0 24
0.24
Bifurcation, %
62.4
63.6
0.74
Trifurcation %
Trifurcation,
12 6
12.6
13 2
13.2
0 84
0.84
Site-reported data
Ezio Bramucci, Novara 2011
Death (All(All-cause) to 12 Months
Left Main Subset
CABG (N=348)
Cu
umulativee Event R
Rate (%)
40
TAXUS (N=357)
P=0.88*
20
4.4%
4
4%
4.2%
0
0
Event rate ± 1.5 SE, *Fisher exact test
Ezio Bramucci, Novara 2011
6
Months Since Allocation
12
ITT population
CVA (Stroke) to 12 Months
Left
f Main Subset
b
CABG (N=348)
Cum
mulative
e Event R
Rate (%)
40
TAXUS (N=357)
P=0.009*
20
2.7%
0.3%
0
0
Event rate ± 1.5 SE, *Fisher exact test
Ezio Bramucci, Novara 2011
6
Months Since Allocation
12
ITT population
MACCE to 12 Months
L f M
Left
Main
i Subset
S b
CABG (N=348)
(N 348)
P=0.44*
40
Cum
mulative Event Raate (%)
TAXUS (N=357)
(N 357)
20
15.8%
13.6%
0
0
Event rate ± 1.5 SE, *Fisher exact test
Ezio Bramucci, Novara 2011
6
Months Since Allocation
12
ITT population
MACCE to 12 Months by SYNTAX Score Tertile
Low Scores (0-22) LM Subset
CABG (N=103)
(N 103)
Cu
umulativee Event R
Rate (%)
40
Mean baseline
SYNTAX Score
CABG
15.5 ± 4.3
TAXUS 15.7 ± 4.4
TAXUS (N=118)
(N 118)
P=0.19*
20
13.0%
7.7%
0
0
Event rate ± 1.5 SE, *Fisher exact test
Ezio Bramucci, Novara 2011
6
Months Since Allocation
12
Calculated by core laboratory; ITT population
MACCE to 12 Months by SYNTAX Score Tertile
I t
Intermediate
di t Scores
S
(23-32)
(23 32) LM Subset
S b t
CABG (N=92)
(N 92)
Cu
umulativee Event R
Rate (%)
40
Mean baseline
SYNTAX Score
CABG
27.2 ± 3.0
TAXUS 27.0 ± 2.7
TAXUS (N=195)
(N 195)
P=0.54*
20
15.5%
15
5%
12.6%
0
0
Event rate ± 1.5 SE, *Fisher exact test
Ezio Bramucci, Novara 2011
6
Months Since Allocation
12
Calculated by core laboratory; ITT population
MACCE to 12 Months by SYNTAX Score Tertile
Hi h Scores
High
S
(≥33) Left
L ft Main
M i Subset
S b t
CABG (N=150)
(N 150)
Cu
umulativee Event R
Rate (%)
40
Mean baseline
SYNTAX Score
CABG
42.1 ± 7.6
TAXUS 43.8 ± 9.1
TAXUS (N=135)
(N 135)
P=0.008*
25 3%
25.3%
20
12.9%
0
0
Event rate ± 1.5 SE, *Fisher exact test
Ezio Bramucci, Novara 2011
6
Months Since Allocation
12
Calculated by core laboratory; ITT population
1-year MACCE by baseline SINTAX score terzile
LM disease
Circulation 2010; 121: 2645-53
Ezio
Bramucci,
2011
Ezio Bramucci,
NovaraNovara
2011
SYNTAX Trial – Left Main
36 M th MACCE Results
36-Month
R lt
C
Cumulative
e Event Rate (%)
40%
Before
B
f 1 year*
13.7% vs 15.8%
p=0.44
11-22 years*
7.5% vs 10.3%
p=0.22
22-33 years*
5.2% vs 5.7%
p=0.78
20%
26.8%
22.3%
p=0.20
0%
0
12
24
M th Si
Months
Since All
Allocation
ti
CABG
(n=348)
Cumulative KM Event Rate ± 1.5 SE; log-rank P value; *Binary rates; ITT population
MACCE: Death, MI, CVA, any Revasc.
Ezio Bramucci, Novara 2011
TAXUS™ Express2™ Stent
(n=357)
36
SYNTAX Trial – Left Main
36 M th MACCE Results
36-Month
R lt
Low SYNTAX Score (0
(0-22)
22)
Intermediate SYNTAX
Score (23-32)
High SYNTAX Score (≥33)
CABG (n=104)
CABG (n=92)
CABG (n=149)
TAXUS™
TAXUS™ Express22™
Stent (n=103)
TAXUS™ Express22™
Stent (n=135)
Express2™
Stent (n=118)
Cumulative KM Event Rate ± 1.5
1 5 SE; log-rank P value
Site-reported Data; ITT population
MACCE: Death, MI, CVA, any Revasc.
Ezio Bramucci, Novara 2011
Multivariate baseline predictors of 1year MACCE in patients with LM
disease
Baseline variable
Coefficient
OR (95% CI)
P
value
1.84
6.27 (1.62-24.22)
0.008
0.17
0.92
0 72
0.72
1.19 (1.04-1.35)
2.52 (0.94-6.73)
2 05 (0.91-4.62)
2.05
(0 91 4 62)
0.009
0.07
0 08
0.08
CABG predictors (n=348)
• Emergent
revascularization priority
• Additive euro score
• COPD
• Medically
M di ll treated
t t d DM
Circulation 2010; 121: 2645-53
Ezio Bramucci, Novara 2011
Multivariate baseline predictors of 1year MACCE in patients with LM
disease
Baseline variable
Coefficient
OR (95% CI)
P
value
1.16
0.11
0.03
1.82
3.19 (1.03-9.86)
1.12 ((1.00-1.25))
1.03 (1.01-1.05)
6.17 (0.92-41.5)
0.04
0.045
0.01
0.06
PCI predictors (n
(n=357)
357)
• Prior TIA
• Additive euroSCORE
• SYNTAX score (corelab)
• Creatinine > 200 mcmol/L
Circulation 2010; 121: 2645-53
Ezio Bramucci, Novara 2011
SPIRIT III TRIAL
Stone et al, Circulation 2009; 119: 680-686
Ezio
Bramucci,
2011
Ezio Bramucci,
NovaraNovara
2011
Ezio
Bramucci,
2011
Ezio Bramucci,
NovaraNovara
2011
Ezio
Bramucci,
2011
Ezio Bramucci,
NovaraNovara
2011
Conclusion
• In selected patients with LM disease PCI can be considered
as safe and effective as CABG
g patient
p
evaluation with SYNTAX score and
• In everyy single
euroSCORE are of paramount importance for decision
makingg
• LM PCI should be considered a complex lesion to be done
in high volume center by experieced operator
Ezio
Bramucci,
2011
Ezio Bramucci,
NovaraNovara
2011
Coronaryy Bifurcation
f
Lesions
• >20%
20% off all
ll existing
i i coronary lesions
l i
• ~10%
10% off routinely
ti l treated
t t d coronary lesions
l i
• Frequently observed in high risk patients (UA or
AMI)
• Poor outcome compared to non-bifurcated lesions
(high incidence of MACE, high restenosis rate)
• DES fatigue to provide as great results as in standard
stenting
• One
O
off the
th few
f
remaining
i i
areas where
h
patients
ti t are
referred to CABG
Ezio Bramucci, Novara 2011
Side Branch Occlusion during PCI
Generally clinical sequelae are transient chest pain
and ST-T wave changes
A small percentage of patients develop Q-wave
infarction or require emergency surgery as long as
main vessel remain patent
Non Q-wave myocardial infarction undoubtely
occurs frequently (serial systematic evaluation of
cardiac enzymes are not available, from the PTCA era)
Ezio Bramucci, Novara 2011
Ri k off acute
Risk
t side
id branch
b
h occlusion
l i
Occlusion rate (%)
Side branch with minimal disease
<4
Side branch with significant disease
> 27
Meier B et al. Am J Cardiol 1984; 53: 10-4
Ezio Bramucci, Novara 2011
A new classification of
coronary bifurcation lesions
Ezio Bramucci, Novara 2011
Medina et al Rev Esp Cardiol. 2006;59(2):183-4
Our proposed strategy to
bifurcation PCI
Ezio
Bramucci, Novara 2011
Ezio Bramucci, Novara 2011
Provisional T Stenting
1st Choice Approach in most BL
Bifurcation Treatment Stategies with DES
“Culotte” technique V stenting
Systematic T stenting
±2
1
Modified T or
“Mini Crush”
1
Modified T with
“Crush”
Crush technique
with or without
balloon “step”
2
1
2
1
1
1
Provisional T stenting
2
2
1
±2
“Kissing
Kissing stents
stents”
technique
1
1
Yves Louvard et al Heart 2004;90:713–722
Ezio
Bramucci,
2011
Ezio Bramucci,
NovaraNovara
2011
The T-stenting with protrusion
technique (TAP) as a cross-over from
the provisional approach
Ezio
Bramucci,
2011
Ezio Bramucci,
NovaraNovara
2011
The T-stenting with protrusion
technique (TAP) as a cross
cross-over
over from
the provisional approach
Ezio
Bramucci,
2011
Ezio Bramucci,
NovaraNovara
2011
Ezio
Bramucci,
2011
Ezio Bramucci,
NovaraNovara
2011
Ezio
Bramucci,
2011
Ezio Bramucci,
NovaraNovara
2011
Ezio Bramucci, Novara 2011
Ezio
Bramucci,
2011
Ezio Bramucci,
NovaraNovara
2011
Ezio Bramucci, Novara 2011
Circulation 2011; 123: 79-86
Ezio
Bramucci,
2011
Ezio Bramucci,
NovaraNovara
2011
Circulation 2011; 123: 79-86
Ezio
Bramucci,
2011
Ezio Bramucci,
NovaraNovara
2011
Ezio
Bramucci,
2011
Ezio Bramucci,
NovaraNovara
2011
Ezio
Bramucci,
2011
Ezio Bramucci,
NovaraNovara
2011
Bifurcation Treatment in the Era of DES
Conclusions
• Treatments are not equivalent: Simple is better than Complex when
possible (in the majority of cases)
• Complex techniques with DES (Culotte, Kissing Stent and Crushing)
are associated
i t d with
ith a increased
i
d risk
i k off non-Q
Q wave MI
MI, TVR and
d postt
procedure stent thrombosis even after final “kissing balloon”
probablyy due to:
p
9
9
9
9
Ezio Bramucci, Novara 2011
Multiple layers of DES
y healingg
Delayed
Risk of incomplete stent apposition
Polymer damage
(after repeated inflations at high pressure)
BIG conclusions need BIG studies with BIG numbers!!
Ezio Bramucci, Novara 2011