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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
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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.
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Vlaar P. et al, Lancet 2008 371 191520
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Thrombectomy Trials
Trial MBG 2 TIMI 3 No-reflow Slow flow MACE Infarct size STR MVO
AIMI jacc 2006 91.8 P0.02 6.7 P0.01 12.5 P0.03
EMERALD Jama 2006 10.0 P0.66 12.0 P0.15 63.3 P0.78 31.5 P0.0005
DEAR-MI Jacc 2006 88 p0.0001 89 Pgt0.20 3 P0.04 68 p 0.05
EXPIRA Jacc 2009 88 p0.001 64 p 0.001
JETSTENT Jacc 2010 80.6 Pgt0.20 11.2 p 0.011 11.8 Pgt0.20 85.8 p 0.043
VAMPIRE Jacc Card Int 2011 46.0 P0.001 12 P0.07 12.9 P0.05
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Study design

• First MI with high thrombotic burden
• Randomization 11 to thrombectomy
  (Rheolityc/Manual)
• Clopidogrel 600 mg oral load before PCI
• Abciximab administration during PCI
• Stratification for anterior wall MI

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C a t h L a b s
Cardiothoracic Dept, University of Pisa
M R I
Monasterio Foundation-CNR, Pisa
Cardiology Unit, Pisa General Hospital
Monasterio Foundation-CNR, Massa
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Inclusion criteria

• STEMI with symptom onset lt12 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

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Exclusion criteria

• Previous MI in the same ventricular wall
• Recent PCI (lt2 weeks)
• STEMI with cardiogenic shock
• Contraindications to abciximab
• Contraindications to MRI

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Primary endpoints

1. Infarct size at 3 months (assessed with
   delayed-enhancement MRI)
2. ST-segment elevation resolution gt70 at 60
   minutes after primary PCI

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Secondary endpoints

1. Microvascular obstruction (3-month MRI)
2. Infarct transmurality (3-month MRI)
3. DysHomogeneous scar (3-month MRI)
4. Postprocedural TIMI flow grade
5. Postprocedural TIMI myocardial perfusion grade
6. MACE-free survival at 1 year

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MRI quantitative analysis of infarct size and
transmurality
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Microvascular obstruction (no-reflow)
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Homogeneous transmural necrosis w/o microvascular
obstruction
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dysHomogeneous transmural necrosis w/o
microvascular obstruction
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Post-processing of dysHomogeneous transmural
necrosis
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Randomized (n208)
Aspiration (n104)
No aspiration (n104)
Rheolytic (n54)
Manual (n50)
No MRI (n29) Dead (n2) Refused MRI (n25)
Lost at f-up (n1) Claustrofobia (n1)
No MRI (n25) Dead (n3) Refused MRI (n21)
Lost at f-up (n1)
3-month MRI (n41)
3-month MRI (n75)
3-month MRI (n38)
Primary endpoint analysis (n75)
Primary endpoint analysis (n79)
1-year follow-up n68
1-year follow-up n73
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Baseline profile
Control (N104) Thrombectomy (N104) P
Age 61.514.9 63.011.2 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
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Baseline profile
Control Thrombectomy p
Painto-balloon time, m 241161 260132 0.07
Max ST elevation, mm 4.12.1 4.21.7 0.21
Total ST elevation, mm 11.77.3 12.77.8 0.18
N of leads with ST elevation 4.31.5 4.61.7 0.34
Anterior wall MI 48 (46.2) 49 (47.1) 0.89
Three-vessel disease 9 (8.7) 14 (13.5) 0.27
Area at risk (angiography) 23.58.4 24.98.9 0.19
Killip Class 3 9 (8.7) 4 (3.8) 0.10
LVEF, 4610 468 0.90
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Diagnostic Angiography
Control Thrombectomy P
Thrombus Grade      
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
Initial TIMI flow      
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 8628 9517 0.004
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Procedural results
Control Thrombectomy P
Final TIMI flow 0-1 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
Final cTFC 2821 2417 0.17
Final MBG 0-1 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
STE resolution gt70 38 (37.3) 58 (57.4) 0.004
cTnI peak, ng/mL 7382 5262 0.37
CK-MB peak, mg/dL 245290 2922111 0.60
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MRI results
Control (N75) Thrombectomy (N79) P
DE area, 19.310.6 20.410.5 0.54
DE area gt20 41 (54.7) 44 (55.7) 0.90
Transmurality, 11.612.7 11.912.0 0.91
MVO 14 (19.4) 4 (5.1) 0.01
Dyshomogeneous scar 2 (2.7) 28 (35.4) lt0.0001
EDVi, mL/m2 8020 8224 0.79
Stroke Volume, mL/m2 4512 4511 0.80
LVEF, 5911 5612 0.10
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Feasibility of thrombectomy

• 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)

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Rheolytic vs manual thrombectomy
Procedural results Rheolytic (N54) Manual (N50) P
Angiographic success 51 (94.4) 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 gt70 34 (63.0) 27 (54.0) 0.47

MRI results Rheolytic (N41) Manual (N38) P
DE area, 17.59.6 21.311.3 0.10
DE area gt20 21 (51.2) 23 (60.5) 0.40
Transmurality, 11.912.3 11.811.7 0.97
MVO 3 (7.3) 1 (2.7) 0.62
Dyshomogeneous scar 18 (43.9) 10 (27.0) 0.16
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1-year freedom from MACEs
93.92.4
92.32.8
P0.57
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Conclusions

• 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

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Conclusions

• 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

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Conclusions

• The lack of benefit in terms of infarct size
  might be related to
• little role of the prevention of
  thrombo-embolization 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)