Key result
Routine coagulation tests' ability to detect clinically relevant levels (≥30 ng/mL) of dabigatran or rivaroxaban is highly test and reagent dependent, though ROTEM may be a fast alternative.
Why the study?
Do routine coagulation tests and thromboelastography accurately detect clinically relevant levels of dabigatran or rivaroxaban in patients with non-valvular atrial fibrillation?
Observational (n=76)
No
Do routine coagulation tests and thromboelastography accurately detect clinically relevant levels of dabigatran or rivaroxaban in patients with non-valvular atrial fibrillation?
The ability of routine coagulation tests to detect clinically relevant levels of dabigatran or rivaroxaban is highly test- and reagent-dependent, highlighting the potential of ROTEM as a rapid whole-blood alternative in emergency settings.
Clinicians should not rely on routine coagulation tests to detect relevant dabigatran or rivaroxaban levels; review leaves open ROTEM validation in algorithms.
Background Traditional coagulation tests are included in emergency guidelines for management of patients on direct oral anticoagulants (DOACs) who experience acute bleeding or require surgery. We determined the ability of traditional coagulation tests and fast whole blood thromboelastography (ROTEM®) to screen for anticoagulation activity of dabigatran and rivaroxaban as low as 30 ng/mL. Methods One hundred eighty-four citrated blood samples (75 dabigatran, 109 rivaroxaban) were collected from patients with non-valvular atrial fibrillation (NVAF), to perform screening tests from different manufacturers, (diluted, D) PT, aPTT, TT and ROTEM®. The activity of DOACs was quantitatively determined by clot detection assays: Hemoclot DTT and DiXaI test (Biophen), on CS2100 (Siemens). The clotting time (CT) of INTEM and EXTEM ROTEM® (Werfen) were used as test parameters. Results Dabigatran, ≥ 30 ng/mL, was accurately detected by five coagulation tests: APTT Actin FSL (93%), PT Neoplastin (93%), APTT Cephascreen, Thromboclotin, and Thrombin (all 100%), but not by PT Innovin (49%). CT-EXTEM (91%) was sufficiently sensitive, but not CT-INTEM (52%). APTT Cephascreen and Thrombin showed good linearity (R2 = 0.71,R2 = 0.72). For the other tests linearity was moderate to poor. Rivaroxaban was accurately detected by PT Neoplastin (98%) and less so by APTT Cephascreen (85%). In addition, rivaroxaban was also accurately detected by CT-INTEM (96%). PT Neoplastin showed good linearity (R2 = 0.81), all other tests had moderate to poor linearity. Conclusion In patients with NVAF, the ability of routine coagulation tests to detect the presence of significant levels of DOACs is test and reagent dependent. CT-INTEM and CT-EXTEM may be fast whole blood alternatives. Trial registration The Institutional Review Board of the MUMC approved this study (December 2011, project number 114069).
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Henskens et al. (2018) conducted an observational in Non-valvular atrial fibrillation (n=76). Routine coagulation tests (PT, aPTT, TT) and ROTEM vs. Quantitative clot detection assays (Hemoclot DTT and DiXaI) was evaluated on Sensitivity of routine coagulation tests to detect clinically relevant DOAC levels (≥ 30 ng/mL). Routine coagulation tests' ability to detect clinically relevant levels (≥30 ng/mL) of dabigatran or rivaroxaban is highly test and reagent dependent, though ROTEM may be a fast alternative.