About this Medicine article

Clinical End Points in Coronary Stent Trials: A Case for Standardized Definitions by Donald E. Cutlip; Stephan Windecker; Roxana Mehran; Ashley Boam; David J. Cohen; Gerrit-Anne van Es; P. Gabriel Steg; Marie-angèle Morel; Laura Mauri; Pascal Vranckx; Eugene McFadden; Alexandra Lansky; Martial Hamon; Mitchell W. Krucoff; Patrick W. Serruys is a Medicine article available to read on EtoBox.

**__Background—__** Although most clinical trials of coronary stents have measured nominally identical safety and effectiveness end points, differences in definitions and timing of assessment have created confusion in interpretation. **__Methods and Results—__** The Academic Research Consortium is an informal collaboration between academic research organizations in the United States and Europe. Two meetings, in Washington, DC, in January 2006 and in Dublin, Ireland, in June 2006, sponsored by the Academic Research Consortium and including representatives of the US Food and Drug Administration and all device manufacturers who were working with the Food and Drug Administration on drug-eluting stent clinical trial programs, were focused on consensus end point definitions for drug-eluting stent evaluations. The effort was pursued with the objective to establish consistency among end point definitions and provide consensus recommendations. On the basis of considerations from historical legacy to key pathophysiological mechanisms and relevance to clinical interpretability, criteria for assessment of death, myocardial infarction, repeat revascularization, and stent thrombosis were develop

Author

Donald E. Cutlip; Stephan Windecker; Roxana Mehran; Ashley Boam; David J. Cohen; Gerrit-Anne van Es; P. Gabriel Steg; Marie-angèle Morel; Laura Mauri; Pascal Vranckx; Eugene McFadden; Alexandra Lansky; Martial Hamon; Mitchell W. Krucoff; Patrick W. Serruys

Publisher

Ovid Technologies (Wolters Kluwer Health)

Published

2007

Language

EN

Field

Medicine (Health Sciences)