The Role of Recurrent Event Analysis in Cardiovascular Trials: A Trialist's Perspective

• Activity Number: 117
• Type: Topic Contributed
• Date/Time: Monday, August 5, 2013 : 8:30 AM to 10:20 AM
• Sponsor: Biopharmaceutical Section
• Author(s): Scott Solomon*+
• Companies: Harvard University

Abstract

Cardiovascular clinical outcomes trials have generally utilized the time to first event approach to determine the benefit of a tested therapy. This approach is most appropriate when studying diseases in which the time to an endpoint is accurately reflective of the burden of disease or when censoring events, such as death, occur with high enough frequency to represent a likely first event. However, for many diseases in cardiovascular and other disciplines in medicine, the burden of disease is best described not just by the time to the first event, but by the cumulative number of events over a period of time. Heart failure with preserved ejection fraction represents one such disease entity with a relatively low mortality rate, combined with a relatively high hospitalization frequency. Utilizing data from recurrent hospitalizations in this population has the potential advantage of increasing power to demonstrate a treatment effect Post hoc analysis of several cardiovascular clinical trials, including in patients with heart failure with preserved ejection fraction, suggests potential benefits of recurrent event approaches.