Document Detail

Evaluation of early percutaneous coronary intervention vs. standard therapy after fibrinolysis for ST-segment elevation myocardial infarction: contribution of weighting the composite endpoint.
MedLine Citation:
PMID:  23257948     Owner:  NLM     Status:  Publisher    
AimsThe 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 resultsWe 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).ConclusionThis analysis highlights the importance of considering the relative severity and multiple events in the evaluation of a clinical trial.
Jeffrey A Bakal; Cynthia M Westerhout; Warren J Cantor; Francisco Fernández-Avilés; Robert C Welsh; David Fitchett; Shaun G Goodman; Paul W Armstrong
Related Documents :
2438498 - Beneficial effects of the converting enzyme inhibitor, ramipril, in ischemic rat hearts.
7828308 - Left ventricular performance and remodeling in rabbits after myocardial infarction. eff...
17127098 - Laser doppler flowmetry for assessment of myocardial microperfusion in the beating rat ...
1999008 - Contractility and stiffness of noninfarcted myocardium after coronary ligation in rats....
1378108 - Effects of captopril on metabolic and hemodynamic alterations in global ischemia and re...
19277768 - Epicardial control of myocardial proliferation and morphogenesis.
Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2012-12-19
Journal Detail:
Title:  European heart journal     Volume:  -     ISSN:  1522-9645     ISO Abbreviation:  Eur. Heart J.     Publication Date:  2012 Dec 
Date Detail:
Created Date:  2012-12-21     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  8006263     Medline TA:  Eur Heart J     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
Division of Cardiology, 2-132 Li Ka Shing Centre for Health Research Innovation, University of Alberta, Edmonton, Alberta, Canada T6G 2E1.
Export Citation:
APA/MLA Format     Download EndNote     Download BibTex
MeSH Terms

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

Previous Document:  Incremental value of high-sensitive troponin T in addition to the revised cardiac index for peri-ope...
Next Document:  Functional assessment of coronary stenoses: can we live without it?