Impact of Dabigatran Treatment on Rotation Thromboelastometry

Abstract

A rapid and reliable assessment of the dabigatran effect is desirable in dabigatran treated patients with uncontrolled bleeding or before acute surgery. The aim of this study was to study the anticoagulant effects of dabigatran in patients with atrial fibrillation (AF) as assessed by the whole blood assays ROTEM, and how data from these methods correlate to plasma dabigatran concentrations measured by Hemoclot. ROTEM was performed with ROTEM Gamma (Pentapharm GmbH, Munich, Germany). The assays used in our study were Ex-tem and In-tem assay. Plasma dabigatran concentrations were determined by hemoclot thrombin inhibitor assay (Hyphen BioMed, France) at trough and post-dose in 27 patients on dabigatran 150 mg BID. Median plasma dabigatran concentrations at trough were 74 ng/mL (11.2–250) and post-dose (2 h after ingestion) 120 ng/mL (31–282). The ROTEM clotting time (CT) and maximum clot firmnes (MCF) correlated strongly with dabigatran concentrations when activated with the reagents Ex-tem (p < 0.0001) and In-tem (p < 0.0001). In summary, in our study, we have found that the ROTEM variable CT and MCF, when activated with triggers Ex-tem and In-tem, has a strong and highly significant correlation with the plasma dabigatran concentration in a real-life population of AF-patients and could thereby be an alternative to estimate dabigatran concentration in emergency situations. However, additional studies are needed to further validate these findings.

Viscoelastic Hemostatic Assays: A Primer on Legacy and New Generation Devices

“…VHAs are not sensitive to the effects of FXa inhibitors (apixaban, rivaroxaban, edoxaban) or DTIs. Modified TEG ® and ROTEM ® systems have been described that measure the effects of FXa inhibitors, as well as DTIs [17,50,100,[109][110][111][112].…”

“In Less than No Time”: Feasibility of Rotational Thromboelastometry to Detect Anticoagulant Drugs Activity and to Guide Reversal Therapy

“…Several studies pointed out that thromboelastometric tests were applicable to qualitatively monitor the anticoagulant effect of DOACs [ 138 , 139 , 140 , 141 , 142 , 143 , 144 , 145 , 146 , 147 , 148 , 149 , 150 , 151 , 152 , 153 , 154 , 155 , 156 , 157 , 158 , 159 , 160 , 161 , 162 , 163 , 164 ] ( Table S3 in Supplementary Materials ) and the reversibility of their activity [ 165 , 166 , 167 , 168 , 169 , 170 , 171 , 172 , 173 , 174 , 175 , 176 , 177 ].…”

“…Regarding the detection of dabigatran anticoagulant activity with a ROTEM device, some studies evaluated ROTEM reagents in patients treated with dabigatran compared with healthy blood donors (controls) [ 138 , 139 , 140 ] or analyzed the correlations between ROTEM results and dabigatran plasma concentration [ 142 , 143 , 144 , 145 , 146 , 147 , 148 ].…”

“…They demonstrated that EXTEM and FIBTEM-CT correlated with dabigatran plasma concentrations measured with LC–MS/MS without differences between spikes and patient samples. Lastly, in a recent study, Sokol et al [ 147 ] found that INTEM-CT and INTEM-MCF as well as EXTEM-CT and EXTEM-MCF have a strong correlation with the plasma concentration of dabigatran in a real-life population with AF.…”

Rotational Thromboelastometry in High-Risk Patients on Dual Antithrombotic Therapy After Percutaneous Coronary Intervention

“…In vitro spiking studies demonstrated a DOAC dose-response effect in ROTEM CT, which was most pronounced for the EXTEM assay (35). Similar effects were observed in vivo in patients treated with a DOAC or VKA (36,39,(41)(42)(43), hinting that ROTEM may be suitable to monitor anticoagulant drug concentrations. Although EXTEM CT had almost perfect discriminatory ability in the current setting, the observed AUC (0.979) did not outperform the PT assay (Table 2).…”