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Inhibition of complement activation by pexelizumab reduces death in patients undergoing combined aortic valve
M Carrier1, P Ménasché, J H Levy
1Montreal Heart Institute, Montreal, Quebec, Canada. michel.carrier@icm-mhi.org
Insights
Pexelizumab, a C5 complement inhibitor, showed a trend toward reduced mortality in patients undergoing combined aortic valve replacement and coronary artery bypass grafting surgery. Further research is needed to confirm these findings for this specific surgical procedure.
Area of Science:
- Cardiovascular Surgery
- Immunology
- Pharmacology
Background:
- Combined aortic valve replacement and coronary artery bypass grafting (AVR+CABG) is a complex procedure.
- Complement activation may contribute to perioperative injury during cardiac surgery.
- Pexelizumab is a C5 complement inhibitor investigated for cardioprotection.
Purpose of the Study:
- To evaluate the efficacy of pexelizumab in reducing death and myocardial infarction (MI) in patients undergoing AVR+CABG.
- To analyze outcomes in a specific subgroup of patients from a larger clinical trial.
Main Methods:
- A subgroup analysis of 218 patients undergoing AVR+CABG from a phase III randomized, double-blind, placebo-controlled trial.
- Patients received either pexelizumab or placebo.
- Primary end points were death and MI at postoperative days 30 and 180.
Main Results:
- Mortality at 180 days was 5.7% with pexelizumab versus 14.4% with placebo (P=.043).
- No significant difference in myocardial infarction incidence was observed at 30 days.
- The study was not powered to detect differences in MI for this specific patient cohort.
Conclusions:
- Pexelizumab demonstrated a statistically significant reduction in 180-day mortality in patients undergoing AVR+CABG.
- The findings suggest a potential benefit of complement inhibition in this high-risk surgical population.
- Further studies are warranted to confirm these results and explore the role of pexelizumab in AVR+CABG procedures.
Objective:
We sought to evaluate the effects of pexelizumab, a C5 complement inhibitor, on death and myocardial infarction in patients undergoing combined aortic valve replacement and coronary artery bypass grafting surgery.
Methods:
The Pexelizumab for Reduction in Myocardial Infarction and Mortality in Coronary Artery Bypass Graft surgery trial, a phase III prospective, randomized, double-blind, placebo-controlled study, enrolled 3099 patients at 205 centers. The primary end point was the composite of death, myocardial infarction, or both at postoperative day 30 in patients undergoing coronary artery bypass grafting without valve surgery. Postoperative myocardial infarction was defined as a creatine kinase MB fraction value of 100 ng/mL or greater, Q-wave myocardial infarction with a creatine kinase MB fraction value of 70 ng/mL or greater, or new Q-wave evidence of myocardial infarction by postoperative day 30. Because patients undergoing coronary artery bypass grafting with a valve procedure were not included in the primary population, separate analysis of death and myocardial infarction was conducted in 218 patients undergoing combined aortic valve replacement and coronary artery bypass grafting surgery.
Results:
Of the 353 patients randomized to any valve procedure, 106 (61%) underwent combined aortic valve replacement and coronary artery bypass grafting in the pexelizumab treatment group compared with 112 (63%) patients in the placebo group. Coronary artery bypass grafting was performed with 1 or more internal thoracic artery grafts in 139 (64%) patients and with 1 or more saphenous vein grafts in 179 (82%) patients. There were 4 (3.8%) deaths in the pexelizumab group versus 11 (9.9%) in the placebo group by postoperative day 30 and 6 (5.7%) deaths in the active group versus 16 (14.4%) in the placebo group by postoperative day 180 (P =.107 and P =.043, respectively, Fisher exact test). The incidence of myocardial infarction 30 days after surgical intervention was identical in the 2 groups, but the study was not designed to detect differences in this cohort of patients.
Conclusions:
Inhibition of complement activation by pexelizumab resulted in a decreased mortality at 180 days among 218 patients who underwent combined aortic valve replacement and coronary artery bypass grafting surgery. Additional studies are warranted to confirm this decrease in mortality with pexelizumab in combined aortic valve replacement and coronary artery bypass grafting procedures.
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