Does the Russell Viper Venom time test provide a rapid estimation of the intensity of oral anticoagulation? A cohort study

Thromb Res. 2015 May;135(5):852-60. doi: 10.1016/j.thromres.2015.02.020. Epub 2015 Feb 26.

Abstract

Background: Dilute Russell Viper Venom Time (DRVV-T) might be useful in urgent settings for screening patients on Non-VKA Oral Anticoagulants (NOACs).

Aim: To compare the accuracy of DRVV-T with gold standard assays for the assessment of pharmacodynamics of dabigatran, rivaroxaban and vitamin K antagonist (VKA) in plasma samples from patients.

Methods: Sixty rivaroxaban, 48 dabigatran and 50 VKA samples from patients were included. DRVV-T was performed in all groups using STA®-Staclot®DRVV-Screen and -Confirm. For NOACs, PT and aPTT were performed using different reagents while plasma drug concentrations were measured by liquid mass-spectrometry (LC-MS/MS). For VKA, INR was performed using RecombiPlasTin 2G®.

Results: For NOACs, correlations between calibrated STA®-Staclot®DRVV-Confirm and LC-MS/MS (rs=0.88 and 0.97 for rivaroxaban and dabigatran, respectively) were higher than the ones obtained with STA®-Staclot®DRVV-Screen (rs=0.87 and 0.91), PT (rs=0.83 to 0.86) or aPTT (rs=0.84 to 0.89). Bland Altman analyses showed that calibrated DRVV-T methods tend to overestimate plasma concentrations of NOACs. ROC curves revealed that cut-off to exclude supra-therapeutic levels at Ctrough (i.e. 200ng/mL) are different for dabigatran and rivaroxaban. Neither STA®-Staclot®DRVV-Screen nor -Confirm correlated sufficiently with the intensity of VKA therapy (rs=0.35 and 0.52).

Conclusions: STA®-Staclot®DRVV-Confirm provides a rapid estimation of the intensity of anticoagulation with rivaroxaban or dabigatran without specific calibrators. At Ctrough, thresholds for rivaroxaban and dabigatran can be used to identify supra-therapeutic plasma level. However, this test cannot differentiate the nature of the NOACs. The development of a point-of-care device optimising this method would be of particular interest in emergency situations.

Publication types

  • Comparative Study

MeSH terms

  • Administration, Oral
  • Anticoagulants / administration & dosage
  • Anticoagulants / blood*
  • Anticoagulants / pharmacokinetics
  • Anticoagulants / therapeutic use
  • Dabigatran / administration & dosage
  • Dabigatran / blood
  • Dabigatran / pharmacokinetics
  • Dabigatran / therapeutic use
  • Drug Monitoring / methods*
  • Humans
  • International Normalized Ratio
  • Mass Spectrometry
  • Partial Thromboplastin Time
  • Prothrombin Time*
  • ROC Curve
  • Retrospective Studies
  • Rivaroxaban / administration & dosage
  • Rivaroxaban / blood
  • Rivaroxaban / pharmacokinetics
  • Rivaroxaban / therapeutic use
  • Sensitivity and Specificity
  • Thromboembolism / epidemiology
  • Thromboembolism / prevention & control
  • Time Factors
  • Vitamin K / antagonists & inhibitors

Substances

  • Anticoagulants
  • Vitamin K
  • Rivaroxaban
  • Dabigatran