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Infarct Size after Primary Angioplasty Patients With Bivalirudin Compared to Unfractionated Heparin Plus Abciximab in ST

Infarct Size after Primary Angioplasty Patients With Bivalirudin Compared to Unfractionated Heparin Plus Abciximab in STEMI: The HORIZONS-AMI MRI Substudy.

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Infarct Size after Primary Angioplasty Patients With Bivalirudin Compared to Unfractionated Heparin Plus Abciximab in ST

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  1. Infarct Size after Primary Angioplasty Patients With Bivalirudin Compared to Unfractionated Heparin Plus Abciximab in STEMI: The HORIZONS-AMI MRI Substudy Jochen Wöhrle, Nico Merkle, Thorsten Nusser, Markus Kunze, Eugenia Nikolsky, AkikoMaehara, Alexandra J Lansky, Roxana Mehran, Gregg W Stone

  2. Disclosures Jochen Wöhrle None Nico Merkle None Thorsten Nusser None Markus Kunze None Eugenia Nikolsky None Akiko Maehara None Alexandra J Lansky Grant support: The Medicines Company Roxana Mehran Grant support, Lecture fees: The Medicines Company Gregg W. Stone Advisory Board: Boston Scientific; Abbott

  3. Background Primary PCI is the preferred reperfusion strategy in patients with ST elevation myocardial infarction In the HORIZONS-AMI trial, 3602 pts were randomized to treatment with bivalirudin or unfractionated heparin + glycoprotein IIb/IIIa inhibitor (UFH+GPI). Within 12 months, there was a significant reduction of bleeding events and cardiac death in pts treated with bivalirudin as compared to UFH+GPI (eptifibatide or abciximab).

  4. Background Abciximab has been reported to reduce microvascular obstruction and infarct size in STEMI. Cardiac magnetic resonance imaging (CMRI) is a powerful tool to assess infarct size, microvascular obstruction and left ventricular function and volumes. Whether there are differences in infarct size, LV ejection fraction and volumes determined in CMRI between STEMI patients with primary PCI treated with bivalirudin or UFH+abciximab has not been addressed so far.

  5. Successful primary PCI with stent implantation CMRI: within 7 days and after 6 months UFH + Abciximab + CMRI N=23 Bivalirudin + CMRI N=28 Harmonizing Outcomes with Revascularization and Stents in AMI Patients with STEMI with symptom onset ≤12 hours ASA 500mg i.v. Clopidogrel 600mg loading dose R 1:1 Bivalirudin monotherapy (± provisional abciximab) UFH + Abciximab

  6. Baseline Characteristics (i)

  7. Baseline Characteristics (ii)

  8. TIMI Flow pre and post PCI

  9. Study Drugs and Stents * P<0.001; **P<0.05 Bailout for giant thrombus or refractory no reflow after PCI. CCL = cardiac catheterization laboratory

  10. Acetylsalicylic acid Clopidogrel Discharge medication % % % 100 100 100 100 100 100 100 100 100 100 100 96.4 96.4 96.4 95.7 95.7 92.3 91.3 30.4 25.0 discharge 30 days 6 months discharge 30 days 6 months Beta- blocker ACE/ ARB Statin Diuretics Drug therapy

  11. CMRI Baseline Data

  12. p = 0.09 p = 0.28 % % p = 0.73 Difference baseline -6 months Baseline 6 months median 9.3 [4.9;26.6] 20.0 [5.9;28.2] 6.7 [3.8;20.0] 8.2 [1.8;16.5] -3.7 [-7.7;0.0] -6.5 [-12.8;-1.9] mean 15.4 ± 13.7 19.8 ± 14.0 12.1 ± 10.9 12.2 ± 13.9 -4.3 ± 5.1 -8.0 ± 6.9 CMRI – Infarct size

  13. p = 0.23 p = 0.84 % % p = 0.42 Baseline 6 months Difference baseline -6 months median 53.6 [47.8;70.7] 60.1 [53.7;67.4] 65.5 [55.4;73.1] 66.7 [54.8;69.6] 4.5 [-0.4;9.9] 0.2 [-4.1;7.7] mean 58.4 ± 12.4 60.7 ± 8.9 63.6 ± 11.6 62.2 ± 12.6 5.7 ± 10.1 1.5 ± 9.3 CMRI – LVEF

  14. p = 0.40 p = 1.00 mL/m² mL/m² p = 0.32 Baseline 6 months Difference baseline -6 months median 64.5 [57.7;74.5] 66.7 [59.0;81.9] 70.2 [63.3;81.0] 76.9 [62.0;82.8] 6.8 [-0.4;14.4] 6.3 [-1.9;26.2] mean 65.5 ± 12.7 69.2 ± 13.6 73.8 ± 14.1 80.0 ± 23.2 8.5 ± 10.5 10.3 ± 19.7 CMRI – LVEDVI

  15. p = 0.54 p = 0.84 mL/m² mL/m² p = 0.95 Baseline 6 months Difference baseline -6 months median 27.7 [16.6;39.8] 27.4 [18.0;35.5] 25.1 [15.7;32.1] 24.9 [22.6;37.7] -0.4 [-3.6;3.7] -0.8 [-5.8;12.3] mean 27.9 ± 11.5 27.9 ± 10.2 27.9 ± 13.6 31.9 ± 20.6 -0.4 ± 9.6 3.7 ± 16.0 CMRI – LVESVI

  16. CMRI – LVSVI p = 0.76 p = 0.21 mL/m² mL/m² p = 0.15 Baseline 6 months Difference baseline -6 months median 38.4 [31.3;43.6] 40.5 [34.5;49.1] 44.4 [40.1;49.8] 45.1 [39.6;55.1] 9.8 [3.6;12.8] 5.8 [-0.5;11.4] mean 37.6 ± 8.1 41.3 ± 7.0 45.9 ± 7.6 48.0 ± 11.3 8.9 ± 8.1 6.4 ± 9.9

  17. Conclusions In the prospective randomized HORIZONS-AMI trial including patients with primary PCI with stent implantation for STEMI, treatment with bivalirudin as compared to UFH+abciximab did not show a difference in CMRI parameters at baseline and at 6 months, including microvascular obstruction, infarct size, LV-EF and LV volumes.

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