The Investigation Of Concordance Of The Diagnosis Of Coronary Stent Thrombosis Among The Clinical Event Committee,Angiographic Core Lab And Site

Aim:To investigate the concordance of the diagnosis of stent thrombosis among clinical events committee, angiographic core laboratories and sites.Background:Stent thrombosis (ST) is an important endpoint in cardiovascular clinical trials, and adjudication is based on clinical event committee (CEC) review of case report forms (CRFs) and source documentation. However, the degree to which the CEC adjudication is concordant with the review of an independent angiographic core laboratory (ACL) has not been established. Objects and Method:The purpose of this study was to evaluate the degree to which concordance between site investigators, a CEC, and an ACL exists in the assessment of ST. Serial angiograms of 327 non-ST segment elevated acute coronary syndrome patients who underwent percutaneous coronary intervention at study entry in the TRACER trial who met criteria for possible ST were reviewed by an ACL. The ACL was blinded to the assessment by both investigator sites and the CEC of the presence or absence of ST. CEC adjudication was based upon the Academic Research Consortium (ARC) definition of ST, using CRF data and source documents, including catheterization laboratory reports.Result:The ACL, CEC and local investigators agreed on the presence or absence of ST in 52.9%of potential events (κ= 0.32; 95% CI:0.26,0.39). The ACL and CEC agreed on 82.7% of potential events (κ= 0.57; 95% CI:0.47,0.67), the ACL and sites agreed on 61.1% of potential events (κ= 0.25; 95% CI:0.16,0.34), and the CEC and sites agreed on 62% of potential events (κ= 0.28; 95% CI:0.21,0.36).Conclusion:The discordance observed in this study went mostly to one direction; stent thrombosis was detected by the ACL but not by CEC. Examination of the documentation used by the event committee suggests that there was underreporting of the stent thrombosis in the catheterization laboratory and discharge reports.The result also suggested that the site researcher should be more careful when the diagnosis of ST was made because the low specificity was observed in our research.