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

Publication ,  Journal Article
Tjandrawidjaja, MC; Fu, Y; Al-Khalidi, H; Todaro, TG; Adams, P; Van de Werf, F; Granger, CB; Armstrong, PW; APEX-AMI Investigators,
Published in: Eur Heart J
December 2007

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.

Duke Scholars

Published In

Eur Heart J

DOI

ISSN

0195-668X

Publication Date

December 2007

Volume

28

Issue

23

Start / End Page

2850 / 2857

Location

England

Related Subject Headings

  • Treatment Outcome
  • Single-Chain Antibodies
  • Risk Factors
  • Risk Assessment
  • Randomized Controlled Trials as Topic
  • Predictive Value of Tests
  • Patient Selection
  • Myocardial Infarction
  • Multicenter Studies as Topic
  • Middle Aged
 

Citation

APA
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ICMJE
MLA
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Tjandrawidjaja, M. C., Fu, Y., Al-Khalidi, H., Todaro, T. G., Adams, P., Van de Werf, F., … APEX-AMI Investigators, . (2007). Failure of investigator adherence to electrocardiographic entry criteria is frequent and influences clinical outcomes: lessons from APEX-AMI. Eur Heart J, 28(23), 2850–2857. https://doi.org/10.1093/eurheartj/ehm453
Tjandrawidjaja, Michael C., Yuling Fu, Hussein Al-Khalidi, Thomas G. Todaro, Peter Adams, Frans Van de Werf, Christopher B. Granger, Paul W. Armstrong, and Paul W. APEX-AMI Investigators. “Failure of investigator adherence to electrocardiographic entry criteria is frequent and influences clinical outcomes: lessons from APEX-AMI.Eur Heart J 28, no. 23 (December 2007): 2850–57. https://doi.org/10.1093/eurheartj/ehm453.
Tjandrawidjaja MC, Fu Y, Al-Khalidi H, Todaro TG, Adams P, Van de Werf F, et al. Failure of investigator adherence to electrocardiographic entry criteria is frequent and influences clinical outcomes: lessons from APEX-AMI. Eur Heart J. 2007 Dec;28(23):2850–7.
Tjandrawidjaja, Michael C., et al. “Failure of investigator adherence to electrocardiographic entry criteria is frequent and influences clinical outcomes: lessons from APEX-AMI.Eur Heart J, vol. 28, no. 23, Dec. 2007, pp. 2850–57. Pubmed, doi:10.1093/eurheartj/ehm453.
Tjandrawidjaja MC, Fu Y, Al-Khalidi H, Todaro TG, Adams P, Van de Werf F, Granger CB, Armstrong PW, APEX-AMI Investigators. Failure of investigator adherence to electrocardiographic entry criteria is frequent and influences clinical outcomes: lessons from APEX-AMI. Eur Heart J. 2007 Dec;28(23):2850–2857.
Journal cover image

Published In

Eur Heart J

DOI

ISSN

0195-668X

Publication Date

December 2007

Volume

28

Issue

23

Start / End Page

2850 / 2857

Location

England

Related Subject Headings

  • Treatment Outcome
  • Single-Chain Antibodies
  • Risk Factors
  • Risk Assessment
  • Randomized Controlled Trials as Topic
  • Predictive Value of Tests
  • Patient Selection
  • Myocardial Infarction
  • Multicenter Studies as Topic
  • Middle Aged