Lack of rivaroxaban influence on a prothrombinase‐based assay for the detection of activated C protein resistance: an Italian <i>ex vivo</i> and <i>in vitro</i> study in normal subjects and factor V Leiden carriers

Gessoni, Gianluca; Valverde, Sara; Valle, Letizia; Gessoni, Francesca; Caruso, Pierpaolo; Valle, Roberto La

doi:10.1111/ijlh.12647

Cited by 7 publications

(15 citation statements)

References 23 publications

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“…The APC-R methods based on the aPTT and using factor V–deficient plasma are mostly affected by all DOACs. 5 6 24 31 However, it is known that rivaroxaban does not interfere with the Pefakit APC-R factor V Leiden (prothrombinase-based assay) used in this study, 6 32 33 while the dabigatran and edoxaban do. 8 34 35 Accordingly, we found a significant decrease following the DOAC-Stop® procedure for dabigatran (ratio from 6.6 to 4.6, p < 0.0001) and to a lesser extent for edoxaban (ratio from 4.5 to 4.2, p = 0.001).…”

Section: Discussionmentioning

confidence: 86%

Evaluation of the DOAC-Stop® Procedure to Overcome the Effect of DOACs on Several Thrombophilia Screening Tests

Favresse

Lardinois

Sabor

et al. 2018

TH Open

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The impact of direct oral anticoagulants (DOACs) on laboratory assays used for thrombophilia testing (e.g., antithrombin, protein S, protein C, lupus anticoagulant and activated protein-C resistance) is a well-known issue and may cause false-positive and -negative results. Therefore, the correct interpretation of tests that are performed in patients taking DOACs is mandatory to prevent misclassification and the subsequent clinical consequences. We aimed at evaluating the efficiency of a new and simple procedure (DOAC-Stop®; Haematex Research, Hornsby, Australia) to overcome the effect of all DOACs in real-life settings and to assess the percentage of erroneous results due to the presence of DOACs on thrombophilia screening tests. For this purpose, 135 DOAC-treated patients (38 apixaban, 40 dabigatran, 15 edoxaban, and 42 rivaroxaban) and 20 control patients were enrolled. A significant drop in apixaban, dabigatran, edoxaban, and rivaroxaban plasma concentrations following the DOAC-Stop® treatment was observed (74.8–8.2 ng/mL [p < 0.0001], 95.9–4.7 ng/mL [p < 0.0001], 102.1–8.8 ng/mL [p = 0.001], and 111.3–7.0 ng/mL [p < 0.0001], respectively). The DOAC-Stop® treatment was mostly effective to overcome the effect of DOACs on PTT-LA, dilute Russell's viper venom time (dRVVT) screen, and dRVVT confirm tests. Using our procedures, false-positive results due to DOACs were observed only with lupus anticoagulant tests (up to 75%) and fell to zero after the DOAC-Stop® procedure, regardless of the DOAC considered. In conclusion, the DOAC-Stop® adsorbent procedure appeared to be an effective and simple way to overcome the interference of DOAC on coagulation tests and should facilitate the interpretation of thrombophilia screening tests in patients taking DOACs.

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Section: Discussionmentioning

confidence: 86%

Evaluation of the DOAC-Stop® Procedure to Overcome the Effect of DOACs on Several Thrombophilia Screening Tests

Favresse

Lardinois

Sabor

et al. 2018

TH Open

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“…Assays for activated protein C resistance are typically overestimated in the presence of any DOAC. With certain methodologies, such as a prothrombinase‐based activated protein C resistance (APCr) assay, therapeutic levels of dabigatran can elevate results to the extent that an abnormal APCr result is falsely extended into the normal range . The main advantage of noscarin‐based or APTT‐based APC resistance assay is that these methods are not influenced by dXa agents.…”

Section: Doac Laboratory Interferencementioning

confidence: 99%

“…With certain methodologies, such as a prothrombinase-based activated protein C resistance (APCr) assay, therapeutic levels of dabigatran can elevate results to the extent that an abnormal APCr result is falsely extended into the normal range. 25,26 The main advantage of noscarin-based or APTTbased APC resistance assay is that these methods are not influenced TA B L E 1 DOAC characteristics [1][2][3][4][5][6][7][8]14,16,17…”

Section: Doac L Abor Atory Interferen Cementioning

confidence: 99%

An update on laboratory assessment for direct oral anticoagulants (DOACs)

Gosselin

Adcock²,

Douxfils

2019

Int J Lab Hematology

108

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The first direct oral anticoagulant (DOAC) to be approved for clinical use was dabigatran, a direct thrombin inhibitor, in 2010. Since that time, four additional DOACs, all direct anti‐Xa inhibitors, have been approved, including rivaroxaban, apixaban, edoxaban and betrixaban. Our knowledge about the effect of DOACs on laboratory testing, as well as the use of the laboratory for measuring DOACs has been an evolving process. These drugs are not routinely monitored in the same fashion as coumadin, but there is an increasing demand on the laboratory to have the capacity to adequately assess DOAC anticoagulant effect (pharmacodynamics) or levels (pharmacokinetics) in either emergent or the routine situations. This manuscript provides an update on laboratory guidance and progress of methods for measuring DOACs.

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“…These DOAC concentrations may not be reflective of all reagents or methods. Notes: Data on plasma concentrations were extracted from Douxfils et al, 11 Favaloro et al, 1 Gessoni et al, 35 Bonar et al 12 and Gosselin et al 2 …”

Section: Impact Of Doacs On Specialized Hemostasis Testsmentioning

confidence: 99%

Comprehensive review of the impact of direct oral anticoagulants on thrombophilia diagnostic tests: Practical recommendations for the laboratory

Siriez

Dogné

Gosselin

et al. 2020

Int J Lab Hematology

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There is a laboratory and clinical need to know the impact of direct oral anticoagulants (DOACs) on diagnostic tests to avoid misinterpretation of results. Although the regulatory labelling documents provide some information about the influences of each DOAC on diagnostic tests, these are usually limited to some of the most common tests and no head to head comparison is available. In this paper, we report the impact of DOACs on several thrombophilia tests, including assessment of antithrombin, protein S and protein C activity assays, detection of activated protein C resistance and assays used for lupus anticoagulant. Results are compared and discussed with data obtained from literature. The final goal of this comprehensive review is to provide practical recommendations for laboratories to avoid misdiagnosis due to oral direct factor Xa (FXa) or IIa (FIIa) inhibitors. Overall, oral direct FXa (apixaban, betrixaban, edoxaban and rivaroxaban) and FIIa (dabigatran) antagonists may affect clot‐based thrombophilia diagnostic tests resulting in false‐positive or false‐negative results. An effect on FIIa‐based thrombophilia diagnostic tests is observed with dabigatran but not with anti‐FXa DOACs and conversely for FXa‐based thrombophilia diagnostic tests. No impact was observed with antigenic/chromogenic methods for the assessment of protein S and C activity. In conclusion, interpretation of thrombophilia diagnostic tests results should be done with caution in patients on DOACs. The use of a device/chemical compound able to remove or antagonize the effect of DOACs or the development of new diagnostic tests insensitive to DOACs should be considered to minimize the risk of false results.

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Lack of rivaroxaban influence on a prothrombinase‐based assay for the detection of activated C protein resistance: an Italian ex vivo and in vitro study in normal subjects and factor V Leiden carriers

Cited by 7 publications

References 23 publications

Evaluation of the DOAC-Stop® Procedure to Overcome the Effect of DOACs on Several Thrombophilia Screening Tests

Evaluation of the DOAC-Stop® Procedure to Overcome the Effect of DOACs on Several Thrombophilia Screening Tests

An update on laboratory assessment for direct oral anticoagulants (DOACs)

Comprehensive review of the impact of direct oral anticoagulants on thrombophilia diagnostic tests: Practical recommendations for the laboratory

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