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European Heart Journal Advance Access originally published online on October 29, 2007
European Heart Journal 2007 28(23):2850-2857; doi:10.1093/eurheartj/ehm453
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Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2007. For permissions, please e-mail: journals.permissions@oxfordjournals.org

Failure of investigator adherence to electrocardiographic entry criteria is frequent and influences clinical outcomes: lessons from APEX-AMI

Michael C. Tjandrawidjaja1, Yuling Fu1, Hussein Al-Khalidi2, Thomas G. Todaro2, Peter Adams3, Frans Van de Werf4, Christopher B. Granger5, Paul W. Armstrong on behalf of the APEX-AMI Investigators1,*

1 Division of Cardiology, Department of Medicine, University of Alberta, 2-51 Medical Sciences Building, Edmonton, Alberta T6G 2H7, Canada
2 Procter & Gamble Pharmaceuticals, Mason, OH, USA
3 Alexion Pharmaceuticals, Cheshire, CT, USA
4 University Hospital Gasthuisberg, Leuven, Belgium
5 Duke Clinical Research Institute, Durham, NC, USA

Received 12 March 2007; revised 17 July 2007; accepted 12 September 2007; online publish-ahead-of-print 29 October 2007.

* Corresponding author. Tel: +1 780 492 0591; fax: +1 780 492 9486. E-mail address: paul.armstrong{at}ualberta.ca

Aims: To examine the extent and impact on clinical outcomes of adherence to electrocardiogram (ECG) entry criteria in ST-elevation myocardial infarction patients in the assessment of pexelizumab in acute myocardial infarction (APEX-AMI) trial.

Methods and results: We examined the frequency, characteristics, and outcomes of patients enrolled in APEX-AMI trial who did not meet the trial ECG entry criteria.

Among 5615 patients analysed, 28.8% did not meet ECG entry criteria: this occurred more than twice as frequently amongst those with high-risk inferior vs. those with other MI (42.3 vs. 19.3%, P < 0.001). Regardless of infarct location, patients who failed to meet ECG entry criteria had significantly lower mortality (2.5 vs. 4.5% at 30 days and 3.1 vs. 5.3% at 90 days; both P < 0.001) and the composite rate of death, cardiogenic shock, or CHF (5.8 vs. 10.3% at 30 days and 6.9 vs. 11.4% at 90 days; both P < 0.001) as compared to those who met criteria.

Conclusion: In APEX-AMI over one-quarter of enrolled patients did not meet ECG entry criteria and had better outcomes than eligible patients. Although the trial’s primary result was unaffected by alignment with the baseline ECG criteria, our findings may have important implications in designing future trials.

Key Words: Clinical trials • Myocardial infarction • ECG

This paper was guest edited by Prof. Elliott Marshall Antman, Brigham and Women's Hospital, Bostan, USA.


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