1. A prospective, randomized trial of
TATORT-NSTEMI:
A prospective, randomized trial of
Thrombus Aspiration in ThrOmbus containing culPriT lesions in
Non-ST-Segment Elevation Myocardial Infarction
Holger Thiele, MD
Ingo Eitel, MD; Suzanne de Waha, MD; Steffen Desch, MD;
Bruno Scheller, MD; Bernward Lauer, MD; Meinrad Gawaz, MD;
Tobias Geisler, MD; Oliver Gunkel, MD; Leonhard Bruch, MD;
Norbert Klein, MD; Dietrich Pfeiffer, MD;
Gerhard Schuler, MD; Uwe Zeymer, MD
on behalf of the TATORT-NSTEMI Investigators

2. Disclosures Funding: Unrestricted grants by
Terumo Europe, Leuven, Belgium
Lilly Germany, Bad Homburg, Germany
Potential Conflict of Interest:
Research Funding:
Terumo, Lilly, Medicines Company, Maquet Cardiovascular, Teleflex Medical
Speaker Honoraria:
Lilly, Astra Zeneca, Daiichi Sankyo, Boehringer Ingelheim, Maquet Cardiovascular, Medicines Company

3. Thrombectomy Guidelines
Background
Thrombectomy Guidelines
STEMI
2008
2010
2012 I I I I I I I I I
IIa
IIa
IIa
IIa
IIa
IIa
IIa
IIa
IIa
IIa
IIa
IIa
IIb
IIb
IIb
IIb
IIb
IIb
IIb
IIb
IIb
IIb
IIb
IIb
III
III
III
III
III
III
III
III
III
III
III
III I I I I I I I I I
IIa
IIa
IIa
IIa
IIa
IIa
IIa
IIa
IIb
IIb
IIb
IIb
IIb
IIb
IIb
IIb
III
III
III
III
III
III
III
III I I I
IIa
IIa
IIa
IIa
IIb
IIb
IIb
IIb
III
III
III
III
IIa
IIa
IIa
IIa
IIb
IIb
IIb
IIb
III
III
III
III I I I I I I
IIa
IIa
IIa
IIa
IIa
IIa
IIa
IIa
IIb
IIb
IIb
IIb
IIb
IIb
IIb
IIb
III
III
III
III
III
III
III
III
ESC B A B
2009
2013 I I I I I I I I I
IIa
IIa
IIa
IIa
IIa
IIa
IIa
IIa
IIa
IIa
IIa
IIa
IIb
IIb
IIb
IIb
IIb
IIb
IIb
IIb
IIb
IIb
IIb
IIb
III
III
III
III
III
III
III
III
III
III
III
III I I I I I I I I I
IIa
IIa
IIa
IIa
IIa
IIa
IIa
IIa
IIa
IIa
IIa
IIa
IIb
IIb
IIb
IIb
IIb
IIb
IIb
IIb
IIb
IIb
IIb
IIb
III
III
III
III
III
III
III
III
III
III
III
III
ACC/AHA B B
NSTEMI
Might be considered, no data!
Hamm et al. Eur Heart J 2011; 32:
O‘Gara et al. Circulation 2013;127:e362-e425
Kushner et al. JACC 2009;54;
Steg et al. Eur Heart J 2012;33:2569–2619
Wijns et al Eur Heart J 2010;31:
Van de Werf et al. Eur Heart J 2008; 29, 2909–2945

4. Inclusion Criteria Grade Thrombus Description Methods NSTEMI with
Ischemic symptoms > 20 minutes
Last symptoms within 72 h pre randomization
Elevated cardiac troponin T or I above 99. percentile
Identifiable culprit lesion with relevant thrombus (TIMI thrombus-grade 2-5 in lesion) with intended PCI
Grade
Thrombus
Description
No Thrombus
No angiographic characteristics for thrombus 1
Possible thrombus
Angiography demonstrates thrombus characteristics such as reduced contrast density, haziness, irregular lesion contour or a smooth convex (meniscus) at the site of total occlusion suggestive but not diagnostic of thrombus 2
Thrombus present
(small size)
Definitive thrombus with greatest dimension ≤ ½ vessel diameter 3
(medium size)
Definitive thrombus with greatest dimensions > ½ vessel diameter but < 2 vessel diameter 4
(large size)
Definitive thrombus with greatest dimension > 2 vessel diameter 5
Total occlusion

5. Study Endpoints Primary Study Endpoint:
Methods
Study Endpoints
Primary Study Endpoint:
Microvascular obstruction day 1-4 in CMR
Secondary Study Endpoints:
Infarct size measured by delayed enhancement CMR day 1-4
“Myocardial salvage” by CMR
Combined clinical endpoint: Mortality, reinfarction, TVR, and congestive heart failure 6 months after randomization
Individual clinical endpoints of combined endpoint
TIMI-flow post PCI
Myocardial blush grade post PCI
Enzymatic infarct size measured by Troponin T at 24 and 48 h
de Waha et al. Trials. 2013;14:110

6. Late Microvascular Obstruction + Mortality
Background
Presence late MO
100
Extent late MO 80 60 40 20 10 30
Time to event (months)
Survival (%)
p=0.001
Tertile 3
Tertile 1
Tertile 2
100 80 60
Survival (%)
p=0.01 40 20
No MO MO 10 20 30 40
Time to event (months)
de Waha et al. Eur Heart J 2010; 31:

7. Contrast-Injection 1,5 mmol/kg/BW Bolus Gd i.v.
CMR Protocol
Methods
Contrast-Injection 1,5 mmol/kg/BW Bolus Gd i.v. 5 10 15 20 25 30 35 40
Time (min)
Delayed enhancement 4CH + 2CH + SA
Function 4CH + 2CH T2 SA
Function SA
Survey
Area at risk
EF, EDV, ESV
Late MO + infarct size
de Waha et al. Trials. 2013;14:110

8. Study Design, Flow, and Compliance
Methods
460 NSTEMI patients
20 not randomized
440 NSTEMI patients
221 assigned to thrombectomy
219 assigned to standard PCI
No CMR (n=40)
Claustrophobia (n=11)
PM/ICD (n=2)
Obesity (n=1)
Death (n=3)
Renal insuff. (n=0)
Other (n=23)
No CMR (n=27)
Claustrophobia (n=5)
PC/ICD (n=3)
Obesity (n=1)
Death (n=3)
Renal insuff. (n=1)
Others (n=14)
Primary endpoint analysis MO (n=181)
Secondary endpoint MBG (n=221)
Secondary endpoint TIMI-flow (n=221)
Clinical follow-up 6 months (n=218)
Primary endpoint analysis MO (n=192)
Secondary endpoint MBG (n=219)
Secondary endpoint TIMI-flow (n=219)
Clinical follow-up 6 months (n=216)

9. Primary Study Endpoint - MO
Results
Presence of MO
Extent of MO
Thrombectomy
Standard PCI
Median [IQR]
1.95% [0.80;4.10]
1.40%
[0.70;2.60]
Extent of MO, %LV
p=0.17 2 4 6 8 10
p=0.74
Presence MO, %
30.8%
29.2%
Thrombectomy
Standard PCI
Core lab assessed

10. MO – Predefined Subgroups Mean Difference in MO %LV
Results
MO – Predefined Subgroups
Baseline variable
P-value
for interaction
Mean Difference in MO %LV
(95% CI)
All Patients
Male sex
Female sex
Diabetes
No diabetes
TIMI thrombus grade 2-4
TIMI thrombus grade 5
TIMI-flow pre PCI 0-1
TIMI-flow pre PCI 2-3
Glycoprotein IIb/IIIa-inhibitor
No glycoprotein IIb/IIIa-inhibitor
0.78
0.83
0.76
0.92
0.70
0.97
0.64
0.73
0.91
0.20
0.46
Thrombectomy
better
Standard PCI
better

11. Myocardial Blush Grade
Results
p=0.63
62.6% %
Myocardial Blush Grade
Core lab assessed

12. Clinical Outcome 6 Months
Results
Clinical Outcome 6 Months
100
Thrombectomy
Cumulative incidence of death, reinfarction,
TVR, and new congestive heart failure
(%) 90
Standard PCI
p=0.20; log-rank test
Evtl. weglassen und nur die Kaplan Meier Kurven zeigen 80
Time after randomization (days)

13. Summary + Conclusions
In this first randomized, multicenter trial in patients with NSTEMI with thrombus containing lesions aspiration thrombectomy led to aspiration of thrombus material in 74%.
This led to a higher rate of primary stent implantation in comparison to standard PCI.
However, aspiration thrombectomy did not reduce the extent of microvascular obstruction in comparison to standard PCI without thrombectomy.
The results are also supported by a lack of benefit in secondary endpoints.

14. Acknowledgement TATORT-NSTEMI Investigators from 7 sites in Germany
Steering Committee
Angio Core Lab Homburg
H. Thiele (Chair)
B. Scheller
U. Zeymer
B. Scheller (Chair)
T. Dani
CRO at Institut für Herzinfarktforschung
S. Avsar (Chair)
M. Horack
M. Neumer
CMR Core Lab Leipzig
Sponsors
I. Eitel (Coordinator)
T. Arndt
Lilly Germany
Terumo Europe
Study Sites
Leipzig – Heart Center: H. Thiele
Leipzig – University: N. Klein, D. Pfeiffer
Berlin: L. Bruch
Frankfurt (Oder): O. Gunkel
Tübingen: T. Geisler, M. Gawaz
Ludwigshafen: U. Zeymer
Bad Berka: B. Lauer
CEC
S. Desch (Chair)
H. Thiele