Skip Navigation

European Heart Journal 1997 18(Supplement F):22-27; doi:10.1093/eurheartj/18.suppl_F.22
Copyright © 1997 by the European Society of Cardiology.
This Article
Right arrow FREE Full Text (PDF) Freely available
Right arrow E-letters: Submit a response
Right arrow Alert me when this article is cited
Right arrow Alert me when E-letters are posted
Right arrow Alert me if a correction is posted
Services
Right arrow Email this article to a friend
Right arrow Similar articles in this journal
Right arrow Alert me to new issues of the journal
Right arrow Add to My Personal Archive
Right arrow Download to citation manager
Right arrowRequest Permissions
Right arrow Disclaimer
Google Scholar
Right arrow Articles by Hampton, J. R.
Right arrow Search for Related Content
PubMed
Right arrow Articles by Hampton, J. R.
Social Bookmarking
Add to CiteULike   Add to Connotea   Add to Del.icio.us  
What's this?

© 1997 The European Society of Cardiology

The concept of equivalence and its application to the assessment of thrombolytic effects

J. R. Hampton

Cardiovascular Medicine, University Hospital Nottingham, United Kingdom

Correspondence: J. R. Hampton, DM, MA, DPhil, FRCP, FFPM, Professor of Cardiology, Cardiovascular Medicine, University Hospital, Nottingham NG7 2UH, U.K.

Very large clinical trials have become the norm in the evaluation of thrombolytic agents, and these ‘megatrials’ are administratively complex and expensive. It remains to be seen whether new thrombolytics will lead to further large reductions in fatality from an acute myocardial infarction, but new agents may well have advantages in areas such as safety and ease of administration, in addition to other clinical benefits (i.e. fewer cases of cardiac shock, heart failure and atrial fibrillation). The problem is how to introduce such new agents without a megatrial for each one.

Endpoints other than fatality have some advantages and, in thrombolysis, angiographic studies are a necessary step in the development of new agents. However, such studies may not always correlate precisely with the results of mortality endpoint studies. Measurements of the resolution of ST segment elevation in myocardial infarction seem to provide a very useful method of assessing thrombolysis, but although such a technique can be applied to large numbers of patients, it cannot totally replace mortality endpoint trials.

The ‘equivalence’ of two treatments is a clinical, not a statistical, concept, although statistical principles that allow equivalence to be investigated with medium-sized trials should be applied. Demonstrating equivalence in outcome between the new thrombolytic reteplase and streptokinase was the aim of the INJECT study.

Key Words: Reteplase • thrombolysis • clinical trials • endpoints • equivalence


Add to CiteULike CiteULike   Add to Connotea Connotea   Add to Del.icio.us Del.icio.us    What's this?


This article has been cited by other articles:


Home page
 Eur Heart JHome page
E Lesaffre, E Bluhmki, F Wang-Clow, S Berioli, T Danays, N.L Fox, and F Van de Werf
The general concepts of an equivalence trial, applied to ASSENT-2, a large-scale mortality study comparing two fibrinolytic agents in acute myocardial infarction
Eur. Heart J., June 1, 2001; 22(11): 898 - 902.
[PDF]


Disclaimer: Please note that abstracts for content published before 1996 were created through digital scanning and may therefore not exactly replicate the text of the original print issues. All efforts have been made to ensure accuracy, but the Publisher will not be held responsible for any remaining inaccuracies. If you require any further clarification, please contact our Customer Services Department.