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The APEX AMI Investigators Published in JAMA January 3, 2007

Pexelizumab for Acute ST-Elevation Myocardial Infarction in Patients Undergoing Primary Percutaneous Coronary Intervention. Pexelizumab for Acute ST-Elevation Myocardial Infarction in Patients Undergoing Primary Percutaneous Coronary Intervention. The APEX AMI Investigators Published in JAMA

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The APEX AMI Investigators Published in JAMA January 3, 2007

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  1. Pexelizumab for Acute ST-Elevation Myocardial Infarction in Patients Undergoing Primary Percutaneous Coronary Intervention Pexelizumab for Acute ST-Elevation Myocardial Infarction in Patients Undergoing Primary Percutaneous Coronary Intervention The APEX AMI Investigators Published in JAMA January 3, 2007

  2. APEX AMI Trial: Background • Complement is known to be both activated and a potential mediator of inflammation following reperfusion / reperfusion injury. • The goal of this trial was to evaluate the effectiveness of pexelizumab, a humanized monoclonal antibody that binds the C5 component of complement, as an adjunct to PCI in improving 30 day mortality from STEMI. Armstrong et al., JAMA. 2007 Jan; 297(1):43 - 51.

  3. APEX AMI Trial: Study Design 5745 patients > 18 yrs with acute MI within 6 hours of symptom onset; high-risk anterior lateral or inferior MI; planned primary PCI; or new left-bundle branch block excluding those with prior fibrinolytic therapy for treatment of the index MI; complement deficiency; pregnant; breast-feeding; isolated, low-risk, inferior wall MI Prospective. Double-Blind. Placebo-Controlled. Randomized. Mean follow-up 90 days. 23% female, mean age 61 years, mean follow-up 90 days. R Placebo 2 mg/kg bolus + 0.05 mg/kg/hr for 24 hours n=2885 Pexelizumab 2mg/kg bolus + 0.05 mg/kg/hr for 24 hours n=2860 90 days follow-up • Primary Endpoint: All-cause mortality through 30 days. • Secondary Endpoint: Death at day 90 and the composite of death, cardiogenic shock, or congestive heart failure through days 30 or 90. Armstrong et al., JAMA. 2007 Jan; 297(1):43 - 51.

  4. APEX AMI Trial: Baseline Characteristics Armstrong et al., JAMA. 2007 Jan; 297(1):43 - 51.

  5. APEX AMI Trial: Baseline Characteristics (cont.) Armstrong et al., JAMA. 2007 Jan; 297(1):43 - 51.

  6. APEX AMI Trial: Primary Endpoint Primary endpoint of 30 day mortality • There was no difference in the primary endpoint (mortality at 30 days) between placebo and pexelizumab (3.9% vs 4.1% respectively), ie, each experiencing a low mortality. p = 0.78 % patients Armstrong et al., JAMA. 2007 Jan; 297(1):43 - 51.

  7. APEX AMI Trial: Secondary Endpoint Secondary composite endpoint of death, cardiogenic shock, or heart failure at 30 days p = 0.81 • The 30 day composite endpoing of death, cardiogenic shock, or congestive heart failure was similar between treatment groups (9.2% for placebo vs. 9.0% for pexelizumab). % Patients Placebo Pexelizumab Armstrong et al., JAMA. 2007 Jan; 297(1):43 - 51.

  8. APEX AMI Trial: Secondary Endpoint (cont.) Secondary endpoint of mortality at 90 days p = NS • The secondary endpoint of mortality at 90 days remained low and was similar between both treatment groups (4.5% for placebo vs. 4.9% for pexelizumab). % Patients Placebo Pexelizumab Armstrong et al., JAMA. 2007 Jan; 297(1):43 - 51.

  9. APEX AMI Trial: Secondary Endpoint (cont.) Secondary composite endpoint of death, shock, or heart failure at 90 days p = 0.91 • The secondary composite endpoint of death, shock, or heart failure at day 90 was similar between both treatment groups (10.2% for placebo vs. 10.2% for pexelizumab). % Patients Placebo Pexelizumab Armstrong et al., JAMA. 2007 Jan; 297(1):43 - 51.

  10. APEX AMI Trial: Sepsis Sepsis among treatment groups • In spite of the theoretical possibility of more infection with a complement inhibitor, sepsis, while uncommon in both groups, tended to be less common in patients treated with pexelizumab than with placebo (0.56 % vs. 0.90%; respectively, p=0.13) p = 0.13 % Patients Placebo Pexelizumab Armstrong et al., JAMA. 2007 Jan; 297(1):43 - 51.

  11. APEX AMI Trial: Summary • Among patients with ST elevation MI undergoing primary PCI, treatment with pexelizumab was not associated with a difference in mortality at 30 days compared with placebo. • Prior data from the COMMA study demonstrated a reduction in mortality at 6 months with pexelizumab compared with placebo in patients treated with primary PCI; however, the COMMA trial was designed specifically to address infarct size, not mortality at 30 days. Armstrong et al., JAMA. 2007 Jan; 297(1):43 - 51.

  12. APEX AMI Trial: Summary (cont.) • In addition to the present study, the PRIMO-CABG II trial also showed no significant benefit on death or MI with pexelizumab in the setting of bypass surgery. • Performance of PCI and bypass surgery can cause reperfusion injury and increase inflammation, which this compound was designed to inhibit. • Limited success has been reported to date for therapies that target reperfusion injury, although other agents are currently being investigated. Armstrong et al., JAMA. 2007 Jan; 297(1):43 - 51.

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