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Evaluation of early percutaneous coronary intervention vs. standard therapy after fibrinolysis for ST-segment elevation myocardial infarction: contribution of weighting the composite endpoint.

Publication ,  Journal Article
Bakal, JA; Westerhout, CM; Cantor, WJ; Fernández-Avilés, F; Welsh, RC; Fitchett, D; Goodman, SG; Armstrong, PW
Published in: Eur Heart J
March 2013

AIMS: The selection of optimal endpoints for cardiovascular clinical trials continues to be challenging. We examined an alternative interpretation of a series of trials when the individual event severity is considered. METHODS AND RESULTS: We analysed three contemporary myocardial infarction (MI) trials of early percutaneous coronary intervention after fibrinolysis, using a weighted composite method. This method allows the examination of the heterogeneity in the direction and magnitude of component endpoints, and multiple events (vs. first event). We incorporated a physician-assessed severity of each component endpoint in all patients for the five-item composite in the largest study, Trial of Routine Angioplasty and Stenting after Fibrinolysis to Enhance Reperfusion in Acute Myocardial Infarction (TRANSFER-AMI), which enrolled 1059 ST-elevation MI patients. The traditional approach yielded event-free survival probabilities of 0.89 [95% confidence interval (CI) 0.86-0.91] for the early invasive arm and 0.83 (95% CI 0.79-0.86) for the standard care arm (P = 0.004). After accounting for the clinician-investigator-determined weights, the effective survival probabilities were 0.93 (95% CI 0.91-0.95) for the early invasive arm and 0.93 (95% CI 0.90-0.95) with no significant difference (P = 0.54). The same pattern was observed in the three-trial cohort using a four-item composite with an observed improvement in event-free survival outcomes (P = 0.01), which was no longer apparent after the severity weights were considered (P = 0.44). CONCLUSION: This analysis highlights the importance of considering the relative severity and multiple events in the evaluation of a clinical trial.

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Published In

Eur Heart J

DOI

EISSN

1522-9645

Publication Date

March 2013

Volume

34

Issue

12

Start / End Page

903 / 908

Location

England

Related Subject Headings

  • Treatment Outcome
  • Thrombolytic Therapy
  • Percutaneous Coronary Intervention
  • Myocardial Infarction
  • Kaplan-Meier Estimate
  • Humans
  • Endpoint Determination
  • Disease-Free Survival
  • Combined Modality Therapy
  • Clinical Trials as Topic
 

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Bakal, J. A., Westerhout, C. M., Cantor, W. J., Fernández-Avilés, F., Welsh, R. C., Fitchett, D., … Armstrong, P. W. (2013). Evaluation of early percutaneous coronary intervention vs. standard therapy after fibrinolysis for ST-segment elevation myocardial infarction: contribution of weighting the composite endpoint. Eur Heart J, 34(12), 903–908. https://doi.org/10.1093/eurheartj/ehs438
Bakal, Jeffrey A., Cynthia M. Westerhout, Warren J. Cantor, Francisco Fernández-Avilés, Robert C. Welsh, David Fitchett, Shaun G. Goodman, and Paul W. Armstrong. “Evaluation of early percutaneous coronary intervention vs. standard therapy after fibrinolysis for ST-segment elevation myocardial infarction: contribution of weighting the composite endpoint.Eur Heart J 34, no. 12 (March 2013): 903–8. https://doi.org/10.1093/eurheartj/ehs438.
Bakal JA, Westerhout CM, Cantor WJ, Fernández-Avilés F, Welsh RC, Fitchett D, Goodman SG, Armstrong PW. Evaluation of early percutaneous coronary intervention vs. standard therapy after fibrinolysis for ST-segment elevation myocardial infarction: contribution of weighting the composite endpoint. Eur Heart J. 2013 Mar;34(12):903–908.
Journal cover image

Published In

Eur Heart J

DOI

EISSN

1522-9645

Publication Date

March 2013

Volume

34

Issue

12

Start / End Page

903 / 908

Location

England

Related Subject Headings

  • Treatment Outcome
  • Thrombolytic Therapy
  • Percutaneous Coronary Intervention
  • Myocardial Infarction
  • Kaplan-Meier Estimate
  • Humans
  • Endpoint Determination
  • Disease-Free Survival
  • Combined Modality Therapy
  • Clinical Trials as Topic