|
Activity Number:
|
194
|
|
Type:
|
Topic Contributed
|
|
Date/Time:
|
Monday, July 30, 2007 : 2:00 PM to 3:50 PM
|
|
Sponsor:
|
Biopharmaceutical Section
|
| Abstract - #309963 |
|
Title:
|
What Have We Learned from Results of Primary Prevention Cardiovascular Medical Device Mortality Trials?
|
|
Author(s):
|
Kerry Lee*+ and Laura Thompson*+ and Andrew Mugglin*+ and David Breiter*+ and W. Jackson Hall*+
|
|
Companies:
|
Duke University and Food and Drug Administration and The University of Minnesota and Boston Scientific Corporation and University of Rochester
|
|
Address:
|
2400 Pratt Street, Durham, NC, 27705, 1350 Piccard Dr HFZ550, Rockville, MD, 20850, 2221 University Ave SE, Minneapolis, MN, 55414, 4100 Hamline Ave N, St Paul, MN, 55112, Department of Biostatistics, Rochester, NY, 14642-8630,
|
|
Keywords:
|
ICDs ; primary-prevention ; sequential ; medical-device ; endpoints ; trials
|
|
Abstract:
|
Sudden cardiac death claims about ½ million lives every year in the United States. The MADIT I, II, and SCD-HeFT trials demonstrated that implantable cardioverter defibrillators (ICDs) reduce total mortality in patients who have a high risk of experiencing SCD. These landmark trials raised many interesting statistical questions. Statistical methods for analyzing survival data and fully sequential (MADIT and MADIT-II) group sequential designs (SCD-HeFT) were employed. In addition to total mortality, trial endpoints included health outcomes measurements (e.g., cost-effectiveness). In this session, panelists will discuss their perspectives on statistical, clinical, public policy and regulatory issues associated with the results and wide-scale acceptability of these trials and uptake of ICDs. Panelists will also provoke discussion of future directions for endpoints.
|
- The address information is for the authors that have a + after their name.
- Authors who are presenting talks have a * after their name.
Back to the full JSM 2007 program |
