Is the Debate Over? Routine
Thrombus Aspiration in STEMI (From
TAPAS to INFUSE-AMI to TASTE to
TOTAL)
Stefan James
Professor of Cardiology
Uppsala Clinical Research Centre
Uppsala University Uppsala, Sweden
Potential conflicts of interest
•
AstraZeneca Pharmaceuticals
Institutional Research grants/ consultant/Honoraria
•
The Medicines Company
Research grant/ consultant/ Honoraria
•
Jansen
consultant/ Honoraria
•
Bayer
consultant/ Honoraria
•
Thermo Fisher
Consultant/ Honoraria
•
Swedish Research Council
Research grant
•
Swedish Heart and Lung Foundation
Research grant
•
Strategic Research Council
Research grant
Impact of Macroscopic Distal Emboli
Proximal LCX filling
defect at primary PCI
site
Distal embolization
occurred in 15%
patients after primary
PCI

↓ ST resolution
↑ Infarct size
↑ Mortality
Distal thromboemboli
Henriques JPS et al. EHJ 2002;23:1112-7
Macroscopic embolic debris is
retrieved in >75% of primary PCI cases
The concept of thrombus aspiration prior to primary PCI in
STEMI is intuitive and “feels right”
No evidence of reduction in Infarct Size
Control
Aspiration
100
20
15
15
10
5
11
7.5
9
CPK-MB
Infarct size (% LV)
25
75
63
58
50
25
P=0.004
P=0.20
0
P=0.46
0
Kaltoft et al (n=225)
Expira (n=175)
Rescue catheter
Export catheter
Kaltoft A et al.
Circ 2006;114:40-47
Sardella G et al.
JACC 2009;53:309–15
TAPAS (n=1071)
Export catheter
Svilaas T et al.
NEJM 2008;358;-557-67
INFUSE-AMI
Infarct size, %LV
- Primary powered endpoint Median [IQR]
Median [IQR]
17.0%
17.3%
[9.0, 22.8]
[7.1, 25.5]
P=0.51
Aspiration
N=229
Stone GW et al. JAMA 2012;307:1817-26
No aspiration
N=223
N=452
All anterior MI
Sx-hosp <4 hrs
TIMI 0-2
TAPAS: 1,071 pts
12
10
Mortality (%)
Conventional PCI
Thrombus-Aspiration
30 days
4.0% vs. 2.1%
P=0.07
1 year
7.6% vs. 4.0%
P=0.04
8
A large confirmatory trial is needed (small trials with
6
unexpected large effect sizes, need to be replicated)
4
2
0
0
100
200
Time (days)
Vlaar et al. Lancet 2008;371:1915-20
300
400
1,071 pts
All-cause mortality
HR up to 1 year 0.94 (0.78 – 1.15), P=0.57
HR up to 30 days 0.94 (0.72 - 1.22), P=0.63
N Engl J Med. 2013 Oct 24;369(17):1587-97
N Engl J Med. 2014 Sep 18;371(12):1111-20
TASTE, N= 7.244
Stent thrombosis
Reinfarction
2.7
2.7
HR 1 year 0.97 (0.73 – 1.28), P=0.81
HR 30 days 0.61 (0.34 - 1.07), P=0.09
N Engl J Med. 2013 Oct 24;369(17):1587-97
N Engl J Med. 2014 Sep 18;371(12):1111-20
HR 1 year 0.84 (0.50 – 1.40), P=0.51
HR 30 days 0.47 (0.20 - 1.02), P=0.06
All-cause mortality at 1 year
Sub-group
All patients
Female
Male
Age > 65 yr
Age ≤ 65 yr
Diabetes
No Diabetes
Smoker
Not smoker
Previous MI
No previous MI
Previous PCI
No previos PCI
Symptom to PCI time > 2h
Symptom to PCI time ≤ 2h
ECG to PCI time > median
ECG to PCI time ≤ median
LAD
LCx
RCA
Proximal Lesion
No proximal lesion
Thrombus grade G4-G5
Thrombus grade G0-G3
TIMI 2-3 grade before PCI
TIMI 0-1 grade before PCI
Bivalirudin therapy
No Bivalirudin therapy
GP IIb/IIIa blocker
No GP IIb/IIIa blocker
Low including Operator
High including Operator
Low including Hospital
High including Hospital
Hospital < 500 PPCI
Hospital > 500 PPCI
191/3621
63/900
128/2721
166/1955
25/1666
40/448
148/3155
29/1083
134/2336
32/402
151/3172
17/337
97/3284
128/2308
28/801
107/1772
84/1816
100/1467
22/494
48/1436
202/3623
81/920
121/2703
169/1875
33/1748
42/453
157/3155
43/1173
134/2211
36/440
159/3137
25/362
101/3261
139/2309
25/805
109/1730
93/1852
102/1449
22/471
61/1443
164/2903
27/718
69/1138
119/2451
31/792
160/2821
154/2874
37/746
19/558
172/3063
66/1265
114/1904
70/1352
121/2146
66/1153
125/2468
170/2935
32/688
79/1078
118/2499
39/809
163/2811
174/2835
28/782
28/630
174/2993
59/1248
125/1921
61/1351
135/2148
631/1161
139/2462
0.25
0.94 (0.78-1.15)
0.79 (0.57-1.10)
1.05 (0.82-1.35)
0.94 (0.76-1.17)
0.79 (0.47-1.33)
0.97 (0.63-1.49)
0.94 (0.75-1.18)
0.73 (0.45-1.17)
0.94 (0.74-1.20)
0.97 (0.60-1.57)
0.94 (0.75-1.17)
0.72 (0.39-1.34)
0.98 (0.79-1.20)
0.92 (0.72-1.17)
1.13 (0.66-1.93)
0.96 (0.73-1.25)
0.92 (0.68-1.23)
0.97 (0.73-1.27)
0.95 (0.53-1.72)
0.79 (0.54-1.15)
0.97 (0.79-1.21)
0.81 (0.48-1.34)
0.82 (0.60-1.14)
1.03 (0.80-1.33)
0.81 (0.50-1.30)
0.97 (0.78-1.22)
0.87 (0.70-1.08)
1.39 (0.85-2.27)
0.76 (0.47-1.36)
0.97 (0.78-1.19)
1.10 (0.78-1.57)
0.92 (0.71-1.18)
1.15 (0.82-1.62)
0.89 (0.70-1.14)
1.06 (0.75-1.50)
0.89 (0.70-1.14)
0.5
TA+PCI better
N Engl J Med. 2013 Oct 24;369(17):1587-97
Interaction P
Hazard Ratio (95% CI)
PCI+TA
PCI only
no. of death/total no. of patients
1
2
4
PCI only better
N Engl J Med. 2014 Sep 18;371(12):1111-20
0.17
0.55
0.92
0.34
0.89
0.37
0.39
0.84
0.69
0.50
0.29
0.48
0.09
0.46
0.41
0.24
0.42
TOTAL, N=10.732
 Patients
with STEMI were assigned to primary PCI with or without thrombectomy
 At 180 days: there
was no significant between-group difference in the primary
outcome of death or cardiovascular events.
N Engl J Med; Volume 372(15):1389-1398, 2015
TOTAL, N=10.732
 Patients
in the thrombectomy group had a higher rate of stroke at 30 days.
N Engl J Med; Volume 372(15):1389-1398, 2015
TOTAL, N=10.732
TASTE and TOTAL
TASTE, N= 7.244
TOTAL, N=10.732
CV death, recurrent myocardial infarction, cardiogenic shock, or heart
failure within 180 days
Residual thrombus burden
Johnson, Vizzi, Strange Baumbach
EuroIntervention 2014;10:167-168
TOTAL OCT-substudy
Culprit lesion thrombus burden after thrombus aspiration
16
P=0.24
14
12
10
Primary
outcome
P=0.37
8
P=0.33
6
P=0.37
4
P=0.14
P=0.14
2
0
Thrombus burden
Absolute
thrombus volume
Pre-stent
max thrombus
area
Athero throbotic
Absolute
Max
burden
Atherothrombotic atherothrombotic
burden
area
Post-stent
Bhindi et al European Heart Journal (2015) 36, 1892–1900
Conclusions
The concept of thrombus aspiration prior to primary PCI in
STEMI is intuitive and “feels right”
Data from two major RCT 18000 patients show that routine
aspiration does not reduce infarct size, MI, stent thrombosis,
heart failure or mortality
Routine thrombus aspiration is not beneficial in any
investigated subgroup
Thrombus aspiration is associated with an increased risk of
stroke
Routine aspiration should not be performed