Why the study?
Traditional Calibrated Automated Thrombogram assays are labor-intensive, motivating an assessment of coagulation using the automated ST Genesia compared with CAT in anticoagulated patients.
Does the automated ST Genesia thrombin generation assay correlate with the Calibrated Automated Thrombogram (CAT) in anticoagulated patients?
Does the automated ST Genesia thrombin generation assay correlate with the Calibrated Automated Thrombogram (CAT) in anticoagulated patients?
The automated ST Genesia assay does not reliably correlate with the traditional CAT assay in anticoagulated patients, failing to capture ETP reduction with DOACs and failing at high anticoagulation levels.
ST Genesia enables automated TG assessment in anticoagulated patients; leaves open equivalence to CAT for routine use.
Background The thrombin generation (TG) assay is a feasible but labor‐intensive method for detecting global coagulation. It enables comprehensive assessment of anticoagulation, while drug‐specific assays assess only exposure. Traditionally, the Calibrated Automated Thrombogram (CAT) has been used, however the ST Genesia (Diagnostica Stago) allows automated evaluation. Objective We aimed to observe coagulation using the ST Genesia and compare the data with those of CAT in anticoagulated patients. Patients and methods In total, 43 frozen‐thawed samples were studied using DrugScreen to assess direct oral anticoagulants (DOACs), warfarin, and low‐molecular‐weight heparin. Twenty samples (nine rivaroxaban, five apixaban, three warfarin, and three heparin) were also compared using CAT (5 pM tissue factor). Results TG reduction in DrugScreen depended on the specific drug and modestly correlated with DOAC levels (lag time R 2 = 0.36; peak R 2 = 0.50). The best correlation was observed with peak thrombin and rivaroxaban‐specified anti–activated factor X (anti‐Xa) activity (R 2 = 0.60). When comparing ST Genesia with CAT, only the results for apixaban concorded (R 2 = 0.97). Unlike CAT, ST Genesia yielded a normal endogenous thrombin potential (ETP) in 77% (24/31) activated factor X inhibitor cases, and it failed to give readouts at international normalized ratio (INR) ≥4.5 and at anti‐Xa ≥1.0 IU/mL. Conclusion The ST Genesia data did not correlate with CAT, but it was independently associated with INR, anti‐Xa, and DOAC concentrations. The lag time and peak responses were similar; the major differences were that ST Genesia showed no ETP effect of DOACs and failed to give readout at high INR or anti‐Xa activity.
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Helin et al. (2021) studied this question.
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