JSM 2005 Online Program

Abstract #304313

This is the preliminary program for the 2005 Joint Statistical Meetings in Minneapolis, Minnesota. Currently included in this program is the "technical" program, schedule of invited, topic contributed, regular contributed and poster sessions; Continuing Education courses (August 7-10, 2005); and Committee and Business Meetings. This on-line program will be updated frequently to reflect the most current revisions.

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Activity Number:	53
Type:	Topic Contributed
Date/Time:	Sunday, August 7, 2005 : 4:00 PM to 5:50 PM
Sponsor:	Section on Statistics in Epidemiology
Abstract - #304313
Title:	Establishment of a Surrogate Marker Application to Cardiovascular Drug Eluting Stent Trial
Author(s):	Roseann White*+
Companies:	Guidant Corporation
Address:	3200 Lakeside Drive, Santa Clara, CA, 95054, United States
Keywords:	surrogate marker ; roc ; logistic regression
Abstract:	As the ischemic driven target vessel revascularization (ID-TVR) rates improve for the treatment of coronary artery lesions, it becomes more challenging to demonstrate efficacy or noninferiority to the approved product. The regulations suggest that a clinically meaningful surrogate endpoint can be used to demonstrate efficacy or noninferiority of the product. This paper compares several possible angiographic surrogates: in-segment late loss, in-segment % diameter stenosis at followup, and the ratio of late loss and acute gain. The choice of the best surrogate remains controversial partly because the models used to predict the probability based on these markers did not account for the lack of homogeneity of variance. In this assessment, an additional parameter was added to the model to account for the changes in the variance with increasing probability of an event. The ROC curves before and after the added parameter show the improvement in the prediction. The resulting models were then "validated" by comparing predicted values to the actual for six drug-eluting stent trials.

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