Title: Pexelizumab for the Reduction of Infarction and Mortality in Coronary Artery Bypass Graft ll (PRIMO-CABG II) Trial
1Pexelizumab for the Reduction of Infarction and
Mortality in Coronary Artery Bypass Graft ll
(PRIMO-CABG II) Trial
PRIMO-CABG ll Trial
Presented at The American College of Cardiology
Scientific Session 2006 Presented by Dr. Peter
K. Smith
2PRIMO-CABG ll Trial Background
- To evaluate if treatment with pexelizumab will be
associated with a reduction in death or
myocardial infarction (MI) at 30 days compared
with placebo among patients undergoing coronary
artery bypass graft (CABG) surgery. - Patients who underwent CABG with or without
concomitant valve surgery were randomized in a
double-blind manner to pexelizumab or placebo
immediately prior to surgery
Presented at ACC 2006
3PRIMO-CABG ll Trial Study Design
4,254 patients undergoing CABG with or without
valve surgery, with at least two of the following
risk factors diabetes mellitus, prior CABG,
urgent intervention, female, history of
neurological event, history of CHF and 2 or more
previous MIs or a recent MI. Placebo controlled.
Randomized. Blinded. 40 female, mean age 66
years, mean follow-up 90 days
Pexelizumab 2.0 mg/kg bolus 24 hour infusion
Matching placebo
- Primary Endpoint Death or MI through 30 days
postoperative - Secondary Endpoints All-cause mortality through
90 days post-operative, new or worsening CHF
occurring during the index hospitalization or
re-hospitalization for CHF through 30 days
post-operative
Presented at ACC 2006
4PRIMO-CABG ll Trial Primary Endpoint
Primary endpoint of death or MI () p0.201
- The primary endpoint of death or MI at 30 days
occurred in 15.2 of the pexelizumab group and
16.3 of the placebo group (RRR 6.7, p0.201). - Urgent CABG was performed in 72 of patients.
- 60 of patients had diabetes.
- 40 of patients had a history of CHF.
Presented at ACC 2006
5PRIMO-CABG ll Trial Primary Composite Endpoint
Components of Primary Endpoint ()
- Death occurred in 3.8
- of patients given pexelizumab and in 4.6 of
patients given placebo - (RRR 17, p0.177).
- Myocardial Infarction occurred in 12.6 of
patients given pexelizumab and 13.3 of patients
given placebo - (p0.311).
- Results of the primary endpoint were similar in
the different risk factor subgroups.
p0.311
13.3
12.6
p0.177
of patients
4.6
3.8
Presented at ACC 2006
6PRIMO-CABG ll Trial Summary
- Among patients undergoing CABG surgery, treatment
with pexelizumab was not associated with a
difference in the primary endpoint of death or MI
at 30 days compared with placebo. - In the PRIMO-CABG l trial, it was also found that
treatment with pexelizumab was not associated
with a reduction in death or MI in the overall
trial population. - A meta-analysis of all CABG patients in the 3
randomized trials with pexelizumab demonstrated a
significant 21 risk reduction in mortality
(p0.043).
Presented at ACC 2006