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Pexelizumab for the Reduction of Infarction and Mortality in Coronary Artery Bypass Graft ll (PRIMO-CABG II) Trial

PRIMO-CABG ll Trial. Pexelizumab for the Reduction of Infarction and Mortality in Coronary Artery Bypass Graft ll (PRIMO-CABG II) Trial. Presented at The American College of Cardiology Scientific Session 2006 Presented by Dr. Peter K. Smith. PRIMO-CABG ll Trial: Background.

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Pexelizumab for the Reduction of Infarction and Mortality in Coronary Artery Bypass Graft ll (PRIMO-CABG II) Trial

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  1. PRIMO-CABG ll Trial Pexelizumab for the Reduction of Infarction and Mortality in Coronary Artery Bypass Graft ll (PRIMO-CABG II) Trial Presented at The American College of Cardiology Scientific Session 2006 Presented by Dr. Peter K. Smith

  2. PRIMO-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

  3. PRIMO-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 Matching placebo Pexelizumab 2.0 mg/kg bolus + 24 hour infusion • 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

  4. PRIMO-CABG ll Trial: Primary Endpoint Primary endpoint of death or MI (%) p=0.201 • 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%, p=0.201). • 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

  5. PRIMO-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%, p=0.177). • Myocardial Infarction occurred in 12.6% of patients given pexelizumab and 13.3% of patients given placebo • (p=0.311). • Results of the primary endpoint were similar in the different risk factor subgroups. p=0.311 13.3% 12.6% p=0.177 % of patients 4.6% 3.8% Presented at ACC 2006

  6. PRIMO-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 (p=0.043). Presented at ACC 2006

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