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May 2, 2007

Pexelizumab and the APEX AMI Trial

JAMA. 2007;297(17):1881-1882. doi:10.1001/jama.297.17.1881-b

To the Editor: As authors of the Assessment of Pexelizumab in Acute Myocardial Infarction (APEX AMI) trial,1 and on behalf of the APEX AMI study group, we believe that the accompanying Editorial by Drs Eikelboom and O’Donnell2 raises 3 issues deserving clarification. First, the Editorial questions the rationale for targeting one half of the original number of anticipated events. Prior to unblinding the results, we reported3 that the rationale was based in part on the prior systematic overview.4 When combined with the results from Pexelizumab for Reduction of Infarction and Mortality in Coronary Artery Bypass Grafting surgery (PRIMO-CABG II) in a meta-analysis, there was an overall relative risk reduction of 24% (95% confidence interval, 0.61-0.93; log rank P = .009) in all-cause 30-day mortality.5 If that effect had been observed in APEX, it would have achieved statistical significance (P<.05).

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