Abstract 13313: First Report of the New Point-of-Care TEG: a Multicenter Validation Study of the CORA® System

Abstract

Background: Thrombelastography (TEG) is an established but labor intensive method for assessing global hemostasis for the management of bleeding and thrombotic risk in surgical, cardiovascular, and trauma patients. We performed the initial validation study of the first true point-of-care TEG, the CORA® (COagulation Resonance Analyzer or TEG-6S system). CORA uses resonance-frequency viscoelasticity measurements and a disposable multi-channel microfluidic cartridge to assess hemostasis and response to antiplatelet therapy. Methods: TEG assays (n=5,100) were performed from the blood of healthy volunteers (n=160) and patients undergoing coronary revascularization (n=300) collected at 3 hospitals. Quality controls were also assayed. The performance of the TEG-6S system was compared with the conventional TEG 5000 system in accordance with Clinical Laboratory Standards Institute Guidelines. Results: Regression analysis demonstrated a strong correlation (R) between the two systems by all standard measures and a lower coefficient of variation (CV %) with the CORA system at all hospitals (Table). Receiver operating characteristic (ROC) curve analysis showed an excellent correlation between platelet mapping methods (AUC≥0.90, p<0.001) and there was a substantial agreement for measuring antiplatelet response to aspirin (k=0.67, agreement=87%) and P2Y12 inhibitors (k=0.69, agreement=86%). Conclusion: The new point-of-care TEG-6S system is associated with improved precision, greater ease of use, and a strong correlation as compared to the conventional TEG 5000 system. The TEG-6S will facilitate future trials of personalized antiplatelet therapy and improve the assessment of bleeding and thrombotic risk in cardiovascular, surgical, and trauma patients.