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Pexelizumab for the Reduction of Infarction and Mortality in Coronary Artery Bypass Graft ll (PRIMO-CABG II) Trial Presented at The American College of.

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Presentation on theme: "Pexelizumab for the Reduction of Infarction and Mortality in Coronary Artery Bypass Graft ll (PRIMO-CABG II) Trial Presented at The American College of."— Presentation transcript:

1 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

2 www. Clinical trial results.org 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.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 surgeryPatients who underwent CABG with or without concomitant valve surgery were randomized in a double-blind manner to pexelizumab or placebo immediately prior to surgery 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.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 surgeryPatients 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 www. Clinical trial results.org PRIMO-CABG ll Trial: Study Design Presented at ACC 2006  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  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 Pexelizumab 2.0 mg/kg bolus + 24 hour infusion Pexelizumab 2.0 mg/kg bolus + 24 hour infusion Matching placebo 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 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

4 www. Clinical trial results.org PRIMO-CABG ll Trial: Primary Endpoint Presented at ACC 2006 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).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.Urgent CABG was performed in 72% of patients. 60% of patients had diabetes.60% of patients had diabetes. 40% of patients had a history of CHF.40% of patients had a history of CHF. Primary endpoint of death or MI (%) p=0.201

5 www. Clinical trial results.org PRIMO-CABG ll Trial: Primary Composite Endpoint Death occurred in 3.8%Death occurred in 3.8% of patients given pexelizumab and in 4.6% of patients given placebo 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 placeboMyocardial Infarction occurred in 12.6% of patients given pexelizumab and 13.3% of patients given placebo (p=0.311). (p=0.311). Results of the primary endpoint were similar in the different risk factor subgroups.Results of the primary endpoint were similar in the different risk factor subgroups. % of patients Presented at ACC 2006 Components of Primary Endpoint (%) p=0.177 p= % 4.6% 12.6% 13.3%

6 www. Clinical trial results.org 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.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.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).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). 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.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.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).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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