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Terminal complement blockade with pexelizumab during coronary artery bypass graft surgery requiring cardiopulmonary
Edward D Verrier1, Stanton K Shernan, Kenneth M Taylor
1Division of Cardiothoracic Surgery, University of Washington School of Medicine, Seattle 98195-6310, USA. edver@u.wash.edu
Insights
Pexelizumab, a C5 complement inhibitor, did not significantly reduce death or myocardial infarction (MI) in coronary artery bypass graft (CABG) surgery patients. However, it showed a statistically significant risk reduction in the overall study population.
Area of Science:
- Cardiology
- Immunology
- Surgical Innovation
Background:
- Coronary artery bypass graft (CABG) surgery with cardiopulmonary bypass can lead to inflammation and ischemia-reperfusion injury.
- These complications are associated with increased risk of postoperative myocardial infarction (MI) and mortality.
Purpose of the Study:
- To evaluate the efficacy and safety of pexelizumab, a C5 complement inhibitor, in mitigating perioperative MI and mortality in patients undergoing CABG surgery.
- To determine if pexelizumab can reduce adverse cardiovascular events following CABG procedures.
Main Methods:
- A randomized, double-blind, placebo-controlled trial involving 3099 adult patients undergoing CABG surgery (with or without valve surgery).
- Patients received either intravenous pexelizumab or a placebo before surgery.
- The primary composite endpoint was death or MI within 30 days in patients undergoing CABG surgery only; intent-to-treat analyses included all patients.
Main Results:
- In the CABG-only group (n=2746), pexelizumab did not significantly reduce the composite endpoint of death or MI (9.8% vs 11.8%, P=.07).
- In the intent-to-treat analysis of all patients (n=3099), pexelizumab was associated with a statistically significant reduction in death or MI at 30 days (11.5% vs 14.0%, P=.03).
- The trial was not powered to detect a significant reduction in mortality alone.
Conclusions:
- Pexelizumab did not demonstrate a significant reduction in the composite endpoint of death or MI for patients undergoing CABG surgery alone.
- However, pexelizumab showed a statistically significant benefit in reducing the composite endpoint of death or MI in the overall study population undergoing CABG with or without valve surgery.
- Further research may be needed to clarify the role of C5 inhibition in cardiac surgery outcomes.
Context:
Inflammation and ischemia-reperfusion injury during coronary artery bypass graft (CABG) surgery requiring cardiopulmonary bypass are associated with postoperative myocardial infarction (MI) and mortality.
Objective:
To determine the efficacy and safety of pexelizumab, a C5 complement inhibitor, in reducing perioperative MI and mortality in CABG surgery.
Design, Setting, And Participants:
A randomized, double-blind, placebo-controlled trial, including 3099 patients (> or = 18 years) undergoing CABG surgery with or without valve surgery at 205 hospitals in North America and Western Europe from January 2002 to February 2003.
Interventions:
Patients were randomly assigned to receive intravenous pexelizumab (2.0 mg/kg bolus plus 0.05 mg/kg per hour for 24 hours; n = 1553) or placebo (n = 1546) 10 minutes before undergoing the procedure.
Main Outcome Measures:
The primary composite end point was the incidence of death or MI within 30 days of randomization in those undergoing CABG surgery only (n = 2746). Secondary analyses included the intent-to-treat analyses of death or MI composite at days 4 and 30 in all 3099 study patients.
Results:
After 30 days, 134 (9.8%) of 1373 of patients receiving pexelizumab vs 161 (11.8%) of 1359 of patients receiving placebo (relative risk, 0.82; 95% confidence interval, 0.66-1.02; P =.07) died or experienced MI in the CABG surgery only population. In the intent-to-treat analyses, 178 (11.5%) of 1547 patients receiving pexelizumab vs 215 (14.0%) of 1535 receiving placebo died or experienced MI (relative risk, 0.82; 95% confidence interval, 0.68-0.99; P =.03). The trial was not powered to detect a reduction in mortality alone.
Conclusions:
Compared with placebo, pexelizumab was not associated with a significant reduction in the risk of the composite end point of death or MI in 2746 patients who had undergone CABG surgery only but was associated with a statistically significant risk reduction 30 days after the procedure among all 3099 patients undergoing CABG with or without valve surgery.
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