Transcript MUSTELA: A Prospective, Randomized Trial of Thrombectomy vs. no Thrombectomy in Patients with ST-Segment Elevation Myocardial Infarction and Thrombus-Rich Lesions Anna Sonia Petronio, MD Cardiothoracic and Vascular.

MUSTELA: A Prospective,
Randomized Trial of Thrombectomy
vs. no Thrombectomy in Patients
with ST-Segment Elevation
Myocardial Infarction and
Thrombus-Rich Lesions
Anna Sonia Petronio, MD
Cardiothoracic and Vascular Department, University of Pisa
I, Anna Sonia Petronio, DO NOT have a
financial interest/arrangement or
affiliation with one or more organizations
that could be perceived as a real or
apparent conflict of interest in the
context of the subject of this
presentation.
Vlaar P. et al, Lancet 2008; 371: 1915–20
Trial
MBG ≥ 2
AIMI
jacc 2006
EMERALD
Jama 2006
TIMI 3 No-reflow
Slow flow
91.8%
P=0.02
DEAR-MI
Jacc 2006
88%
89%
p=0.0001 P>0.20
EXPIRA
Jacc 2009
JETSTENT
Jacc 2010
88%
p=0.001
VAMPIRE
Jacc Card Int
2011
46.0%
P=0.001
MACE
Infarct size
STR
MVO
6.7%
P=0.01
10.0%
P=0.66
12.5%
P=0.03
12.0%
P=0.15
63.3%
P=0.78
31.5%
P=0.0005
3%
P=0.04
80.6%
P>0.20
68%
p 0.05
11.2%
p 0.011
12%
P=0.07
12.9%
P=0.05
11.8%
P>0.20
64%
p 0.001
85.8%
p 0.043
Study design
• First MI with high thrombotic burden
• Randomization 1:1 to thrombectomy
(Rheolityc/Manual)
• Clopidogrel 600 mg oral load before PCI
• Abciximab administration during PCI
• Stratification for anterior wall MI
Cardiothoracic Dept,
University of Pisa
Cardiology Unit,
Pisa General Hospital
Monasterio Foundation-CNR,
Massa
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Monasterio
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Pisa
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•STEMI with symptom onset <12 hours (ST
elevation ≥ 2 mm in at least 2 contiguous
leads or new LBB block)
•High thrombus burden (TIMI thrombus
grade ≥3) at diagnostic angiography
•No contraindications to abciximab
treatment
•Written informed consent
•Previous MI in the same ventricular wall
•Recent PCI (<2 weeks)
•STEMI with cardiogenic shock
•Contraindications to abciximab
•Contraindications to MRI
1. Infarct size at 3 months (assessed
with delayed-enhancement MRI)
2. ST-segment elevation resolution
>70% at 60 minutes after primary
PCI
1.
2.
3.
4.
5.
Microvascular obstruction (3-month MRI)
Infarct transmurality (3-month MRI)
DysHomogeneous scar (3-month MRI)
Postprocedural TIMI flow grade
Postprocedural TIMI myocardial
perfusion grade
6. MACE-free survival at 1 year
viable
Non viable
No-reflow
Voxel
containing
only viable
myocites
Voxel containining
only scar tissue
Voxel
containing
only viable
myocites
Islands of viable myocardium
with a scar core
or diffuse small scars
Left ventricular mass
160 g
Delayed enhancement
by manual contour tracing
42 g (26%)
Delayed enhancement
by semi-automatic grayscale analysis
33 g (20%)
Randomized (n=208)
Aspiration (n=104)
Rheolytic (n=54)
No aspiration (n=104)
Manual (n=50)
No MRI (n=29)
No MRI (n=25)
Dead (n=3)
Refused MRI (n=21)
Lost at f-up (n=1)
3-month MRI
(n=41)
3-month MRI
(n=38)
Dead (n=2)
Refused MRI (n=25)
Lost at f-up (n=1)
Claustrofobia (n=1)
3-month MRI
(n=75)
Primary endpoint
analysis (n=79)
Primary endpoint
analysis (n=75)
1-year follow-up
n=68
1-year follow-up
n=73
Control
(N=104)
Thrombectomy
(N=104)
P
Age
61.5±14.9
63.0±11.2
0.7
Male sex
79 (76%)
88 (88.4%)
0.83
Diabetes
21(20.4%)
20 (19.2%)
0.83
Hypertension
49 (47.6%)
54 (51.9%)
0.53
Dyslipidemia
45 (43.7%)
54 (51.9%)
0.23
Current smoker
51 (49.5%)
50 (48.1%)
0.81
Renal failure
5 (4.9%)
3 (2.9%)
0.46
Previous MI
2 (1.9%)
4 (3.8%)
0.68
Control
Thrombectomy
p
Pain–to-balloon time, m
241±161
260±132
0.07
Max ST elevation, mm
4.1±2.1
4.2±1.7
0.21
Total ST elevation, mm
11.7±7.3
12.7±7.8
0.18
N° of leads with ST elevation
4.3±1.5
4.6±1.7
0.34
48 (46.2%)
49 (47.1%)
0.89
Three-vessel disease
9 (8.7%)
14 (13.5%)
0.27
Area at risk (angiography)
23.5±8.4
24.9±8.9
0.19
Killip Class 3
9 (8.7%)
4 (3.8%)
0.10
46±10
46±8
0.90
Anterior wall MI
LVEF, %
Control
Thrombectomy
P
3
15 (14.4%)
7 (6.7%)
0.07
4
15 (14.4%)
12 (11.5%)
0.50
5
74 (71.2%)
85 (81.7%)
0.07
0-1
81 (77.9%)
95 (91.3%)
0.007
2
6 (5.8%)
5 (4.8%)
0.70
3
17 (16.3%)
4 (3.8%)
0.002
Initial cTFC
86±28
95±17
0.004
Thrombus Grade
Initial TIMI flow
Control
Thrombectomy
P
3 (2.9%)
3 (2.9%)
0.68
2
16 (15.4%)
7 (6.7%)
0.04
3
85 (81.7%)
94 (90.4%)
0.07
28±21
24±17
0.17
16 (15.4%)
11 (10.6%)
0.41
2
33 (31.7%)
22 (13.5%)
0.12
3
55 (52.9%)
71 (68.3%)
0.03
38 (37.3%)
58 (57.4%)
0.004
73±82
52±62
0.37
245±290
292±2111
0.60
Final TIMI flow 0-1
Final cTFC
Final MBG 0-1
STE resolution >70%
cTnI peak, ng/mL
CK-MB peak, mg/dL
DE area, %
Control
(N=75)
19.3±10.6
Thrombectomy
(N=79)
20.4±10.5
0.54
DE area >20%
41 (54.7%)
44 (55.7%)
0.90
Transmurality, %
11.6±12.7
11.9±12.0
0.91
MVO
14 (19.4%)
4 (5.1%)
0.01
2 (2.7%)
28 (35.4%)
<0.0001
EDVi, mL/m2
80±20
82±24
0.79
Stroke Volume, mL/m2
45±12
45±11
0.80
LVEF, %
59±11
56±12
0.10
Dyshomogeneous scar
P
• 98% successful delivery of thrombectomy catheters:
– 98% Manual system
– 100% Rheolytic system
• 1 crossover from Manual to Rheolytic system, which
was successfully delivered to the culprit lesion
• No coronary complications associated with
thrombectomy (0 dissections, 0 perforations)
• No prolonged asystole with Rheolytic system in RCAs
(never placed temporary pacemaker before
aspiration)
Angiographic success
Rheolytic
(N=54)
51 (94.4%)
Manual
(N=50)
39 (78.0%)
0.02
Final TIMI flow 3
48 (88.9%)
46 (92.0%)
0.84
Final MBG 3
35 (64.8%)
36 (72.0%)
0.56
STE resolution >70%
34 (63.0%)
27 (54.0%)
0.47
DE area, %
Rheolytic
(N=41)
17.5±9.6
Manual
(N=38)
21.3±11.3
0.10
DE area >20%
21 (51.2%)
23 (60.5%)
0.40
Transmurality, %
11.9±12.3
11.8±11.7
0.97
MVO
Dyshomogeneous scar
3 (7.3%)
18 (43.9%)
1 (2.7%)
10 (27.0%)
0.62
0.16
Procedural results
MRI results
P
P
93.9±2.4
92.3±2.8
P=0.57
• Thrombectomy was not associated with a
significant reduction in infarct size at 3-month MRI,
even in a high-thrombus burden STEMI population
• However, thrombectomy was associated with a
significantly higher rate of complete STE resolution,
and of post-procedural myocardial perfusion grade
3, and with a lower rate of final TIMI 2 flow
• Thrombectomy was associated with a different
MRI pattern of myocardial scar at 3 months, with
less microvascular obstruction and with areas of
viable tissue interspersed with necrotic areas
• No significant difference was observed regarding
1-year freedom from MACEs
• Angiojet was superior to Export in terms of
thrombus removal, but not regarding procedural
and MRI results
The lack of benefit in terms of infarct size might be
related to:
• little role of the prevention of thromboembolization during primary PCI in reducing final
infarct size
• excellent myocardial referfusion in the standard
PCI group (clopidogrel pre-load + abciximab)
• imbalance between groups, favoring standard PCI
group (shorter pain-to-balloon time)