Impact of Thromboaspiration during Primary PCI on
Microvascular Damage and Infarct Size: Acute and Long term
CE-MRI Evaluation.
GENNARO SARDELLA, MD, FACC ,FESC;
MASSIMO MANCONE, MD; RAFFAELE SCARDALA, MD; CHIARA BUCCIARELLI
DUCCI,MD;ANGELO DI ROMA,MD; IACOPO CARBONE,MD*;GIULIA BENEDETTI
GIULIA CONTI,MD ; FRANCESCO FEDELE, MD.
O.U. of Invasive Cardiology, Dept. of Cardiovascular Sciences
*Dept.of Radiology
Policlinico Umberto I - University “La Sapienza
ROME
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GENNARO SARDELLA,MD;
MASSIMO MANCONE,MD;
RAFFAELE SCARDALA, MD;
CHIARA BUCCIARELLI DUCCI,MD;
ANGELO DI ROMA,MD;
IACOPO CARBONE,MD*;
GIULIA BENEDETTI MD,
GIULIA CONTI,MD;
FRANCESCO FEDELE, MD.

No relationship to disclose
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Background
Myocardial Perfusion After Primary PCI is Strongest
Predictor of Mortality independently from IRA reopening
Cumulative Survival (%)
100
PPCI Hardest point
Final Blush Score (patients with
final TIMI 3 flow)
95
3
90
2
85
Blush 1-Year Mortality
3 6.8%
2 13.2% P=0.004
0/1 18.3%
80
75
0
2
4
6
8
10
“ Open Artery ...but
Closed Myocardium !!
0/1
12
Stone GW, et al. J Am Coll Cardiol. 2002;39:591-597.
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( Courtesy of M.Gibson)
Impact of Thrombectomy with EXPort catheter in Infarct Related
Artery on procedural and clinical outcome in patients with AMI
( EXPIRA Trial ).
(G.Sardella et al presented at TCT 2007)
256 pts.
(STEMI, at 6.8 ± 2.3 h from symptoms onset)
Design
Prospective, randomized,
double-arm, mono-centric study.


Primary end-point :

Final MBG ≥ 2 ;
90’ ST resolution

175 pts. eligible for 1:1
randomization
(Heparin 7.500 U/I, GPIIb/IIIa,
Aspirin, Clopidogrel 300 mg)

MACE at 9 month clinical f-u

Principal investigator
G.Sardella MD
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Cardiogenic shock
 3-vessel / Left Main
 TIMI >0-1
 TS < 3
 Contra to GPIIb/IIIa
(> 70% decrease of ST segment after PCI)
Secondary end-point :
81 pts.excluded:
87 pts
88 pts
randomized to
Standard PCI
randomized to
Thrombectomy
+ PCI
9 months clinical f-u
Impact of Thrombectomy with EXPort catheter in Infarct Related Artery on
procedural and clinical outcome in patients with AMI
( EXPIRA Trial ).
Procedural Results
MYOCARDIAL BLUSH GRADE
*p=<0.0001
100
90
80
70
%
28.7*
60
50
40
70.3*
MBG 3
MBG 2
MBG 0/1
30
20
39.5*
10
0
11.8*
Basal
Post- POBA
Final
Basal
Post-Thr.
CONVENTIONAL
EXPORT GROUP
GROUP
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(G.Sardella et al ,TCT 2007)
Final
Impact of Thrombectomy with EXPort catheter in Infarct Related Artery on
procedural and clinical outcome in patients with AMI
( EXPIRA Trial ).
90’ ST resolution after PCI (%)
( > 70% decrease of ST segment)
p=<0.01
100
90
80
70
60
% 50
40
30
20
10
0
OR 6.36
(95% CI 3.23-12.50)
80.0
37.5
CONVENTIONAL
GROUP
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EXPORT
GROUP
(G.Sardella et al ,TCT 2007)
Impact of Thrombectomy with EXPort catheter in Infarct Related
Artery on procedural and clinical outcome in patients with AMI
( EXPIRA Trial ).
9 months Composite Cardiac
Event Rates
12
p=ns
10,3
10
Pts %
p=0.059
8
6
4,6
4,5
4
2
0
0
DEATH
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MACE
(G.Sardella et al ,TCT 2007)
CONTR.
EXPORT
Aim of the Study
We sought to evaluate the impact of thromboaspiration on
procedural and long term outcomes in terms of microascular
damage and infarct size by contrast enhanced-MRI (ce-MRI) as
compared to conventional primary PCI.
Export® aspiration catheter (Medtronic, Minneapolis, Minnesota)
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Methods
Design

Prospective, randomized,
double-arm, mono-centric study.
75 patients eligible for 1:1 randomization
(Anterior STEMI, at 6.8 + 2.3 h from symptoms
onset)

End-points (MRI evaluation)

Microvascular damage (grams/g) in
terms of Hypoenhancement .

Infarct size (grams/g) in terms of
Hyperenhancement.
(Heparin 7.500 U/I, GPIIb/IIIa,
Aspirin, Clopidogrel 300 mg)
37 pts
38 pts
randomized to
Standard PCI
randomized to
Thrombectomy
+ PCI
3 – 90 Day MRI follow-up
Microvascular damage
Infarct size
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Methods
Methods
Inclusion Criteria
 Age >18 yrs
 STEMI within 9 hrs from symptoms
onset
 “De novo” coronary artery lesions
Native IRA ≥2.5 mm diameter
Exclusion Criteria
Previous AMI or CABG
 Cardiogenic shock
 3-vessel / Left Main CAD
Severe valvular heart disease
 Unsuccessful PCI (no antegrade
flow or 50% residual stenosis in the
 Angiographically identifiable occlusive
IRA)
thrombus (TS grade ≥ 3)
 Rescue / Facilitaded PCI
 TIMI 0-1 at time of initial angiography
 Contraindication to GP IIb/IIIa
inhibitors
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CLINICAL CHARACTERISTICS
Total
Population
(n=75)
Age, yrs±SD
Males (%)
Risk factors
Hypertension (%)
Diabetes (%)
Smoking (%)
Obesity (%)
Family History of CAD (%)
Cholesterol (mg/dl±SD)
Triglycerides (mg/dl±SD)
Renal Failure (%)
Killip class III (%)
Previous PCI (%)
Symptoms to balloon, (hrs±SD)
LVEF (%±SD)
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Conventional Thrombectomy
Group
Group
(n=38)
(n=37)
66.310.6
65.813.1
67.414.1
47 (62.7)
24 (64.7)
23 (60.5)
43 (57.8)
17 (22.7)
26 (34.7)
2 (2.7)
27 (36.0)
16413
12035
4 (5.3)
19 (25.3)
10 (13.3)
7.90.7
24 (64.9)
9 (24.3)
11 (29.8)
2 (5.4)
12 (32.4)
16510
12223
19 (50.0)
8 (21.1)
15 (39.5)
0
15 (39.5)
16311
12127
3 (8.1)
12 (32.4)
4 (10.8)
7.71.2
1 (2.6)
7 (18.4)
43.1 ±12
40.8 ±7.5
41.9 ±0.9
6 (15.8)
6.51.4
PROCEDURAL CHARACTERISTICS 1
IABP (%)
Lesion length, mm±SD
Total
Conventional Thrombectomy
Population
Group
Group
(n=75)
(n=37)
(n=38)
7 (9.3)
4 (10.8)
3 (7.9)
13.85.7
14.15.6
14.94.9
Vessel size, mm±SD
2.90.6
2.80.5
2.90.6
MLD pre, mm±SD
0.90.4
0.70.3
GPIIb/IIIa Inhibhitors
0.80.4
75 (100)
37 (100)
38 (100)
Direct stenting
32 (42.6)
2 (5.4)*§
28 (74.3)§
Post-dilatation
7 (9.3)
3 (8.1)
4 (10.5)
MLD post, mm±SD
2.90.7
2.80.5
2.90.3
Post-PCI diameter
stenosis, (%±SD)
3.45.2
3.53.9
3.45.4
29 (38.7)
46 (61.3)
17 (45.9)
20 (54.0)
12 (31.5)
Stent Type (%)
Bare-metal Stent
Drug-eluting Stent
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26 (68.4)
* 2 pts with recanalized IRA after guide-wire placement
§ p= <.0001
PROCEDURAL RESULTS 1
TIMI FLOW GRADE
p=0.0005
100
90
80
70
60
% 50
40
30
20
10
0
p=ns
45.9
97.8
Basal
Post POBA
CONVENTIONAL GROUP
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Final
TIMI 0/1
Basal
TIMI 2
TIMI 3
PostThromb
Final
THROMBECTOMY GROUP
PROCEDURAL RESULTS 2
MYOCARDIAL BLUSH GRADE
*p=<0.0001
100
90
%
32.4*
80
70
76.3*
60
50
40
MBG 3
MBG 2
MBG 0/1
30
20
10
0
Basal Post- POBA
Final
CONVENTIONAL
GROUP
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Basal
Post-Thr.
Final
THROMBECTOMY GROUP
In-Hospital Outcome
90’ ST resolution after PCI
( > 70% decrease of ST segment)
p=.0001
OR 7.2
(95% CI 2.5-20.9)
100
90
80
70
60
%
50
40
84.2
30
40.5
20
10
0
CONVENTIONAL
GROUP
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THROMBECTOMY
GROUP
MRI Results-1
MRI evaluation
Thrombectomy
(n=38)
Standard PCI
(n=37)
3d
3m
3d
╪
Hypoenhancement (gr)
3.7±5.04
2.7±2.3
3m
╪
*
0.12±0.4
4.04±5.87*
§
Hyperenhancement (gr)
§
14.02±7.5 13.6+ 12,7 17.39±15.6 11.01±8.07
╪
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p
p=.001 between the groups
the same group
*§ p=.004 within
within the same group
p=.004
<.001
MRI Results-2
p=0.004
20
18
16
P<0.001
14
12
10
gr
8
Standard PCI
17.39
p=0.004
Thrombectomy
g
6
11.01
4
2
4.04
0
2.7
0.12
Hypo33Days
Days
Hypo33Months
Months
Hyper3 days
Hyper 33Months
Hypo
Hypo
Hyper
Days Hyper
Months
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Conclusion
 In this study Thrombectomy has been demonstrated to be safe and effective
in AMI setting during Primary PCI.
 Compared with conventional stenting, in patients with intracoronary visible
and occlusive thrombus, pretreatment with manual aspiration thrombectomy
during primary PCI improves acutely the parameters of myocardial tissue
perfusion and ST resolution in a well selected population.
MRI long term evaluation showed a reduction of microvascular damage in
the Thrombectomy group compared with the Control group.
 In the Thrombectomy group setting resulted a reduction of microvascular
damage and infarct size in long term compared with acute evaluation.
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Thank You !
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