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European Heart Journal Advance Access published online on May 4, 2005
European Heart Journal, doi:10.1093/eurheartj/ehi292
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European Heart Journal © The European Society of Cardiology 2005; All rights reserved
Received November 26, 2004
Revised March 7, 2005
Accepted March 24, 2005

Clinical research

Prognostic significance of blood markers of inflammation in patients with ST-segment elevation myocardial infarction undergoing primary angioplasty and effects of pexelizumab, a C5 inhibitor: a substudy of the COMMA trial

Pierre Théroux 1*, Paul W. Armstrong 2, Kenneth W. Mahaffey 3, Judith S. Hochman 4, Kevin J. Malloy 5, Scott Rollins 6, Jose C. Nicolau 7, Joel Lavoie 8, The Minh Luong 8, Jeb Burchenal 9, and Christopher B. Granger 3

1 Montreal Heart Institute, Montreal, 5000 Belanger E, Montreal, Quebec, Canada H1T 1C8
2 University of Alberta, Edmonton, Alberta, Canada
3 Duke Clinical Research Institute, Durham, NC, USA
4 New York University School of Medicine, New York, NY, USA
5 Procter & Gamble Pharmaceuticals, Mason, OH, USA
6 Alexion Pharmaceuticals, Inc., Cheshire, CT, USA
7 Heart Institute, University of Sao Paulo Medical School, Sao Paulo, Brazil
8 Montreal Heart Institute, Montreal, 5000 Belanger E, Montreal, Quebec, Canada H1T 1C8
9 South Denver Cardiology Associates, Denver, CO, USA

* To whom correspondence should be addressed.
Pierre Théroux, E-mail: pierre.theroux{at}icm-mhi.org


  Abstract

Aims Pexelizumab, a monoclonal antibody inhibiting C5, reduced 90 day mortality and shock in the COMplement inhibition in Myocardial infarction treated with Angioplasty (COMMA) trial without apparent reductions in infarct size. Inflammation is a critical component of ST-elevation myocardial infarction (STEMI); this substudy examines prognostic values of selected markers and treatment effects.

Methods and results C-reactive protein, interleukin-6 (IL-6), and tumour necrosis factor-{alpha} (TNF-{alpha}) serum levels were assessed in 337 patients enrolled in either the placebo or the pexelizumab 24 h infusion group. Higher C-reactive protein and IL-6 levels at baseline, 24 h, and 72 h were strongly associated with increased subsequent death (P<0.002 at baseline and 24 h, P<0.02 at 72 h); and all baseline marker levels with death or cardiogenic shock (P<0.03) within 90 days. C-reactive protein and IL-6 levels were similar at baseline, but significantly lower 24 h later with pexelizumab, when compared with placebo (17.1 vs. 25.5 mg/L, P=0.03 and 51.0 vs. 63.8 pg/mL, P=0.04, respectively). At 72 h, corresponding levels were similar, whereas TNF-{alpha} was slightly higher (P=0.04) in the treated group.

Conclusion Inflammation markers and their serial changes predict death and shock in patients with STEMI undergoing primary angioplasty. Pexelizumab reduced C-reactive protein and IL-6, suggesting treatment benefits mediated through anti-inflammatory effects.

Keywords: Myocardial infarction; Primary angioplasty; Complement inhibition; Pexelizumab; C-reactive protein; Interleukin-6; Tumour necrosis factor.
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