Receiver Operating Characteristic Curve Method for Surrogate Endpoints for Predicting Target Lesion Revascularization in TAXUS Stent Clinical Trials

• 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
• Author(s): Hong Wang*+ and Peter Lam and Joerg Koglin and Mary Russell
• Companies: Boston Scientific Corporation and Boston Scientific Corporation and Boston Scientific Corporation and Boston Scientific Corporation
• Keywords: Clinic Trial ; Receiver Operation Characteristic ; Surrogate Endpoint

Abstract

Receiver operating characteristic (ROC) curves and the area under the curve (AUC) are widely used to examine the effectiveness of diagnostic markers. In TAXUS stent randomized trials, quantitative coronary angiography (QCA) parameters were measured by a core reading laboratory and compared with the clinical outcome of Target Lesion Revascularization (TLR). ROC method was performed to measure the effectiveness of several QCA parameters to correlate TLR from the TAXUS stent meta-analysis database. Of the six QCA parameters studied (in-stent and in-segment measures of percent diameter stenosis, minimum lumen diameter and late loss), in-segment percent diameter stenosis was identified as the QCA surrogate marker with the highest correlation to clinical TLR by the use of AUC statistics of the ROC curve. The ROC analysis was performed using a logistic regression model in SAS. The in-segment percent diameter stenosis is a candidate for a surrogate endpoint to predict clinical TLR in coronary stent trials.