Receiver Operating Characteristic Curve Method for Evaluating Surrogate Endpoints for Predicting Target Lesion Revascularization in a Second-Generation Drug Eluting Stent Trial

• Activity Number: 138
• Type: Topic Contributed
• Date/Time: Monday, August 7, 2006 : 10:30 AM to 12:20 PM
• Sponsor: Biopharmaceutical Section
• Author(s): Hong Wang*+ and Sarah Bass and Peter S. Lam
• Companies: Boston Scientific Corporation and Boston Scientific Corporation and Boston Scientific Corporation
• Keywords: receiver operating characteristic ; c-statistics ; diagnostic test ; drug eluting stent ; surrogate endpoint

Abstract

In this paper, we used the receiver operating characteristic (ROC) curve and area under the ROC curve method to access the correlations of the quantitative coronary angiography (QCA) parameters with the clinical outcome of target lesion revascularization (TLR) in the second-generation drug eluting stent trial. The examined QCA surrogate endpoints included the analysis segment and stented region of late loss, percent diameter stenosis, and minimum lumen diameter. The c-statistics were computed with its 95% confidence interval for each QCA parameter. A threshold was determined by using the probability cutoff method, and a diagnostic test was performed to test the difference of the c-statistics of the paired QCA parameters for their correlation with TLR. The in-segment percent diameter stenosis was identified as the QCA surrogate endpoint with the highest correlation with TLR.