Identifying Temporal Pattern of Adverse Events in Drug-Eluting Stents Studies

• Activity Number: 289
• Type: Topic Contributed
• Date/Time: Tuesday, August 3, 2010 : 8:30 AM to 10:20 AM
• Sponsor: Biopharmaceutical Section
• Author(s): Aijun Song*+ and Huyuan Yang and Hsini Terry Liao and Jeff Hersh
• Companies: Boston Scientific Corporation and Boston Scientific Corporation and Boston Scientific Corporation and Boston Scientific Corporation
• Keywords: instantaneous incidence rate ; Kaplan-Meier method ; Cox regression models

Abstract

It is common to use Kaplan-Meier method or Cox regression models to analyze time to event data. Usually information shown is cumulative event rate. Cumulative event rate is helpful; at the same time, it can be frustrating as well. Clinicians are interested in knowing the instantaneous incidence rate besides the cumulative event rate. With instantaneous incidence rate, clinician can identify where the risks are concentrated, when the risks reach the peak level, how one kind of event relates to another in a temporal pattern. A graph of instantaneous incidence rate is more intuitive and informative to clinicians than KM curves only. This exercise will introduce methods to calculate and present the instantaneous incidence risk as well as how it should be interpreted. Examples will be provided using drug eluting stent studies.