title: Failure of investigator adherence to electrocardiographic entry criteria is frequent and influences clinical outcomes: lessons from APEX-AMI.
abstract: OBJECTIVE
  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.
  
  
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Division of Cardiology, Department of Medicine, University of Alberta, 2-51 Medical Sciences Building, Edmonton, Alberta T6G 2H7, Canada.
authors.forename: Michael C
authors.initials: MC
authors.lastname: Tjandrawidjaja
authors.forename: Yuling
authors.initials: Y
authors.lastname: Fu
authors.forename: Hussein
authors.initials: H
authors.lastname: Al-Khalidi
authors.forename: Thomas G
authors.initials: TG
authors.lastname: Todaro
authors.forename: Peter
authors.initials: P
authors.lastname: Adams
authors.forename: Frans
authors.initials: F
authors.lastname: Van de Werf
authors.forename: Christopher B
authors.initials: CB
authors.lastname: Granger
authors.forename: Paul W
authors.initials: PW
authors.lastname: Armstrong
mesh_terms: D000368:Aged; D000911:Antibodies, Monoclonal / Q000627:therapeutic use; D061067:Antibodies, Monoclonal, Humanized; D002317:Cardiovascular Agents / Q000627:therapeutic use; D004562:Electrocardiography / Q000379:methods*; D005260:Female; D019983:Guideline Adherence / Q000592:standards*; D006801:Humans; D008297:Male; D008875:Middle Aged; D015337:Multicenter Studies as Topic; D009203:Myocardial Infarction / Q000188:drug therapy / Q000401:mortality*; D018579:Patient Selection; D011237:Predictive Value of Tests; D016032:Randomized Controlled Trials as Topic; D018570:Risk Assessment; D012307:Risk Factors; D057127:Single-Chain Antibodies; D016896:Treatment Outcome
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D002317:Cardiovascular Agents; D057127:Single-Chain Antibodies; C402724:pexelizumab