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Intracoronary Compared with Intravenous Bolus Abciximab Application During Primary

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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Intracoronary Compared with Intravenous Bolus Abciximab Application During Primary

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  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. Results Patient Characteristics

  9. 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

  10. 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

  11. 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

  12. CMR and Outcome Results

  13. 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.

  14. 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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