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Intracoronary Compared with Intravenous Bolus Abciximab Application During Primary Percutaneous Coronary Intervention Cardiac Magnetic Resonance Substudy of the AIDA STEMI trial. Holger Thiele, MD; Jochen Wöhrle, MD Henning Suenkel, BSc; Josephine Meissner, MD; Sebastian Kerber, MD;

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slide1

Intracoronary Compared with Intravenous Bolus Abciximab Application

  • During Primary
  • Percutaneous Coronary Intervention
  • Cardiac Magnetic Resonance Substudy of the
  • AIDA STEMI trial

Holger Thiele, MD; Jochen Wöhrle, MD

Henning Suenkel, BSc; Josephine Meissner, MD; Sebastian Kerber, MD;

Bernward Lauer, MD; Matthias Pauschinger, MD; Ralf Birkemeyer, MD; Christoph Axthelm, MD;

Rainer Zimmermann, MD; Petra Neuhaus, PhD; Oana Brosteanu, PhD; Steffen Desch, MD;

Matthias Gutberlet, MD; Gerhard Schuler, MD; Ingo Eitel, MD

on behalf of the AIDA STEMI Investigators

slide2

Disclosures

Off-label use of IC abciximab

Funding:

Unrestricted grant by Lilly, Germany

University of Leipzig – Heart Center

University of Leipzig, Clinical Trial Centre Leipzig: supported by the Federal Ministry of Education and Research (BMBF) FKZ 01KN1102

  • Potential Conflict of Interest:
  • Research Funding:
    • Terumo, Lilly. Maquet Cardiovascular, Teleflex Medical
    • Consulting:Maquet Cardiovascular, Avidal
    • Speaker Honoraria:
    • Lilly, Astra Zeneca, Daiichi Sankyo, Boehringer Ingelheim, Maquet Cardiovascular, Medicines Company
combined clinical endpoint

Background

Combined Clinical Endpoint

p=0.54

Cumulative event free survival from death, reinfarction and

congestive heart failure [%]

Intracoronary Abciximab

Intravenous Abciximab

Time from randomization [days]

Thiele et al. Lancet 2012;379:923-31

congestive heart failure

Background

Congestive Heart Failure

p=0.03

Intracoronary Abciximab

Intravenous Abciximab

Cumulative event free survival of congestive heart failure [%]

Time from randomization [days]

Thiele et al. Lancet 2012;379:923-31

aida stemi cmr substudy
AIDA-STEMI CMR Substudy
  • CMR enables investigation of mechanistic and pathophysiological effects of intracoronary + intravenous abciximab application on myocardial damage and reperfusion injury.
  • To determine potential benefits of intracoronary abciximab application on infarct size, myocardial salvage, microvascular obstruction and ventricular function to further evaluate the benefit with respect to congestive heart failure.

Thiele et al. Am Heart J 2010;159:547-554

slide6

Methods

Study Organization and Study Sites

Investigator Initiated Trial

22 study sites in Germany

8 CMR study sites

CMR core laboratory:Ingo Eitel (Coordinator)

Josephine Meissner

Henning Sünkel

Holger Thiele

DSMB:Uwe Zeymer

Hans-Richard Arntz

Christoph BodeKarl Wegscheider

Steering Committee:

Holger Thiele

Jochen Wöhrle

Oana Brosteanu

Gerhard Schuler

CRO:

Clinical Trial Center Leipzig

slide7

CMR Protocol

Contrast-Injection 1,5 mmol/kg/BW Bolus Gd i.v.

Area at risk +

Hemorrhage

late MO + IS

EF, EDV, ESV

Methods

35

40

0

5

10

15

20

25

30

Time (min)

Delayed enhancement 4CH + 2CH + SA

T2

SA

Function 4CH+2 CH

FunctionShort axes

Survey

Thiele et al. Am Heart J 2010;159:547-554

area at risk infarct size

Infarct size

50

Median [IQR]

16% [9, 25]

Median [IQR]

17% [8, 25]

40

p=0.52

30

Infarct size, %LV

20

10

0

IC abciximab

N=385

IV abciximab

N=389

Results

Area at Risk + Infarct Size

Area at risk

Median [IQR]

35% [25, 48]

Median [IQR]

35% [26, 48]

p=0.97

Area at risk, %LV

IC abciximab

N=344

IV abciximab

N=354

reperfusion injury

Hemorrhage

p=0.19

37%

32%

Presence Hemorrhage, %

IC abciximab

N=346

IV abciximab

N=353

Results

Reperfusion Injury

Microvascular obstruction

p=0.19

52%

47%

Presence MO, %

IC abciximab

N=384

IV abciximab

N=390

slide11

Results

Infarct Size - Subgroups

Mean

Difference

(95% CI)

Infarct size (%LV)

Baseline variable

N

Mean

Difference

(95% CI)

p-value

for

interaction

IC

abciximab

IV

abciximab

All Patients

Male sex

Female sex

Age < 75 years

Age ≥ 75 years

Anterior MI

Non-anterior MI

Killip-class II to IV

Killip-class I

TIMI flow post PCI 0 to II

TIMI-flow post PCI III

Symptom onset-randomization < 3 h

Symptom onset-randomization 3-6 h

Symptom onset-randomization > 6h

Thrombectomy

No thrombectomy

Prasugrel

No prasugrel

774

586

188

656

118

353

388

91

683

89

685

334

296

136

187

587

173

419

18 (13)

18 (13)

18 (12)

18 (13)

18 (12)

21 (14)

15 (10)

28 (16)

16 (11)

24 (14)

17 (12)

17 (13)

19 (13)

18 (12)

20 (12)

17 (13)

18 (13)

19 (13)

18 (13)

18 (12)

19 (12)

18 (12)

21 (12)

21 (14)

15 (10)

25 (13)

17 (12)

19 (9)

18 (13)

15 (12)

20 (13)

20 (12)

19 (13)

18 (12)

17 (11)

19 (13)

-0.2 (-2.9;1.5)

0.1 (-2.0;2.1)

-1.4 (-4.9;2.1)

0.2 (-1.7;2.1)

-3.1 (-7.6;1.3)

0.1 (-2.8;3.0)

-0.7 (-2.7;1.3)

3.0 (-3.1;9.0)

-0.9 (-2.8; 0.8)

4.4 (-0.5;9.3)

-0.9 (-2,8;1.0)

2.0 (-0.7;4.6)

-1.6 (-4.5;1.3)

-1.2 (-5.3;2.8)

1.4 (-2.2;5.0)

-0.8 (-2.9;1.2)

0.6 (-3.0;4.3)

0.2 (-2.2;2.7)

0.52

0.49

0.46

0.11

0.79

0.42

0.50

0.71

0.96

0.50

0.85

0.37

0.60

0.47

0.78

0.84

0.89

-6 -4 -2 0 2 4 6

IV better

IC better

summary conclusions
Summary + Conclusions
  • This largest multicenter CMR study in STEMI patients to date demonstrates that IC as compared to IV abciximab did not result in a difference in myocardial damage and/or reperfusion injury.
  • The results of the AIDA STEMI CMR substudy therefore confirm the lack of difference in the combined endpoint of death, reinfarction or congestive heart failure of the AIDA STEMI trial.
slide14

Acknowledgement

AIDA STEMI Investigators from 22 sites in Germany

Steering Committee

Clinical Trial Center

at University Leipzig

ECG Core Lab

MRI Core Lab

Sponsors

Study Sites

DSMB

CEC

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