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Axel Haverich
Stanton K. Shernan
Jerrold H. Levy
John C. Chen
Michel Carrier
Kenneth M. Taylor
Mark F. Newman
Peter X. Adams
Edward D. Verrier
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Right arrow Cardiac - other

Ann Thorac Surg 2006;82:486-492
© 2006 The Society of Thoracic Surgeons

Original article: Cardiovascular

Pexelizumab Reduces Death and Myocardial Infarction in Higher Risk Cardiac Surgical Patients

Axel Haverich, MDa,*, Stanton K. Shernan, MDb, Jerrold H. Levy, MDc, John C. Chen, MDd, Michel Carrier, MDe, Kenneth M. Taylor, MDf, Frans Van de Werf, MD, PhDg, Mark F. Newman, MDh, Peter X. Adams, MDi, Thomas G. Todaro, MD, JDj, Michael van der Laan, MDk, Edward D. Verrier, MDl

a Hannover Medical School, Hannover, Germany
b Brigham and Women's Hospital, Boston, Masschusetts
c Emory University Hospital, Atlanta, Georgia
d University of Hawaii, Honolulu, Hawaii
e Montreal Heart Institute, Montreal, Quebec, Canada
f Imperial College of Medicine, London, United Kingdom
g University Hospital Gasthuisberg, Leuven, Belgium
h Duke University Medical School, Durham, North Carolina
i Alexion Pharmaceuticals, Cheshire, Connecticut
j Procter & Gamble Pharmaceuticals, Cincinnati, Ohio
k Procter & Gamble Pharmaceuticals, Egham, United Kingdom
l University of Washington, Seattle, Washington

Accepted for publication December 1, 2005.

* Address correspondence to Dr Haverich, Klinik fur Thorax Herz und Gefasschirurgie, Konstanty-Gutschow-Str 8, Hannover, 30623, Germany (Email: haverich{at}thg.mh-hannover.de).

BACKGROUND: Morbidity and mortality after coronary artery bypass graft surgery are directly related to specific preoperative risk factors. We assessed the influence of preoperative risk factors on the effect of pexelizumab, a C5 complement inhibitor, to reduce postoperative morbidity and mortality in this post hoc analysis of the Pexelizumab for Reduction in Myocardial Infarction and MOrtality in Coronary Artery Bypass Graft surgery (PRIMO-CABG) trial, a phase III double-blind, placebo-controlled study of 3,099 patients undergoing coronary artery bypass graft surgery with cardiopulmonary bypass.

METHODS: The composite endpoint of death or myocardial infarction or both through postoperative day 30 was examined in subpopulations of patients with pre-specified risk factors, which included diabetes mellitus, prior coronary artery bypass graft, urgent intervention, female sex, history of neurologic event, history of congestive heart failure, and two or more previous myocardial infarctions or a recent myocardial infarction. Stratified post hoc analyses were also performed on patients presenting with two or more and three or more of those risk factors.

RESULTS: Pexelizumab significantly reduced the incidence of the composite endpoint of death or myocardial infarction through postoperative day 30 by 28% in patients with two or more risk factors (p = 0.004) and 44% in patients with three or more risk factors (p < 0.001).

CONCLUSIONS: The C5 complement inhibitor, pexelizumab, reduced morbidity and mortality among high-risk patients undergoing coronary artery bypass grafting with cardiopulmonary bypass.




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