Pexelizumab reduces death and myocardial infarction in higher risk cardiac surgical patients.
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.
Haverich
Axel
A
Hannover Medical School, Hannover, Germany. haverich@thg.mh-hannover.de
Shernan
Stanton K
SK
Levy
Jerrold H
JH
Chen
John C
JC
Carrier
Michel
M
Taylor
Kenneth M
KM
Van de Werf
Frans
F
Newman
Mark F
MF
Adams
Peter X
PX
Todaro
Thomas G
TG
van der Laan
Michael
M
Verrier
Edward D
ED
D000911:Antibodies, Monoclonal / Q000009:adverse effects / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized; D002315:Cardiopulmonary Bypass / Q000009:adverse effects*; D001026:Coronary Artery Bypass / Q000009:adverse effects* / Q000401:mortality; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D009203:Myocardial Infarction / Q000517:prevention & control*; D057127:Single-Chain Antibodies
D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D057127:Single-Chain Antibodies; C402724:pexelizumab