Abstract:
Background and Aims
Urgent assessment of direct oral anticoagulation (DOAC) is inevitable in decision making with regards to thrombolysis and DOAC-reversal in emergency medicine. We studied the safety and clinical applicability of activated partial thromboplastin time (aPTT)-based CoaguChek® Point-of-Care testing system (POCT) in guiding decision-making during acute ischemic and hemorrhagic stroke in patients under DOAC.
Methods
80 patients (20 each for apixaban, dabigatran, edoxaban and rivaroxaban) were enrolled. Blood sampling and bed-side POCT were conducted simultaneously: before (baseline), and after DOAC-intake (30 minutes, 1h, 2h, 8h and immediately before next DOAC-intake). For each DOAC, the correlation between CoaguChek®-aPTT and the exact DOAC plasma concentrations, measured using ultra-performance liquid chromatography-tandem mass spectrometry, was assessed. Furthermore, sensitivity and specificity of POCT in identifying DOAC plasma concentrations above the currently recommended treatment thresholds for thrombolysis (30 and 50 ng/mL) were analyzed. ClinicalTrials.gov Identifier: NCT04679298.
Results
80 patients were enrolled, 20 for each DOAC. 459 out of the 480 samples were collected, dabigatran n = 115, apixaban n = 113, edoxaban n = 116 and rivaroxaban n = 115. Correlations between CoaguChek®-aPTT and UPLC-MS/MS were weak for dabigatran (r = 0.489; p< 0.001) and apixaban (r = 0.497; p< 0.001) but high for edoxaban (r = 0.837; p< 0.001) and rivaroxaban (r = 0.786; p< 0.001. A cut-off of 31.8s and 30.1s, edoxaban and rivaroxaban yielded a sensitivity of 95.7% (95%-CI 89.1–98.9) and 95.3% (95%-CI 89.5–98.5) respectively, with a corresponding specificity of 74.5% (95%-CI 60.9–85.4) and 62.1% (95%-CI 43.9–78.2) respectively, all p < 0.00 at ≥ 30 ng/ml threshold. At ≥ 50 ng/ml threshold, a cut-off of 33.7s and 30.6s, edoxaban and rivaroxaban yielded a sensitivity of 95.2% (95%-CI 88.1–98.8) and 94.7% (95%-CI 88.2–98.3) respectively, with a corresponding specificity of 79.2% (95%-CI 67.1–88.6) and 51.3% (95%-CI 35.9–66.5) respectively, all p < 0.00.
Conclusion
CoaguChek®-aPTT is capable of qualitatively detecting edoxaban and rivaroxaban plasma levels above the recommended treatment thresholds of ≥ 30 and 50 ng/ml for thrombolysis and DOAC-reversal. Similar to results obtained with the INR test strips, aPTT is likewise not applicable for apixaban and dabigatran and therefore the does not extend the spectrum of DOAC assessment for CoaguChek®.
