https://doi.org/10.4081/btvb.2022.37
Evaluation of Coaguchek®Pro II coagulation testing device performance to assess direct oral anticoagulant action. The DOAC-CHECK study
Submitted: 8 July 2022
Accepted: 3 November 2022
Published: 1 December 2022
Accepted: 3 November 2022
Abstract Views: 1401
PDF: 281
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All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.
Authors
Direct oral anticoagulants (DOAC) measurement is recommended in specific conditions. A point-of-care testing should be used in emergency to qualitatively rule out relevant DOAC concentrations. The DOAC-CHECK Study aims to evaluate whether the use of CoaguChek® Pro II (Roche Diagnostics International Ltd, Rotkreuz, Switzerland) coagulation testing device can provide reliable information in patients treated with DOAC. The study was carried out in two FCSA (Italian Federation of Thrombosis Centers) centers. We choose 3 different concentration thresholds for our analysis (30, 50 and 100 ng/mL) and by ROC curves the ideal cut-off point was selected to be the one that yielded a sensitivity of at least 95% associated with the highest possible specificity. 512 patients were enrolled. For Edoxaban and Rivaroxaban, both CoaguChek® Pro II prothrombin time (PT) and activated partial thromboplastin time (aPTT) tests showed a sensitivity >95% corresponding to satisfying specificity values; negative predictive values resulted in the range 90-100%. At variance, CoaguChek® Pro II PT and aPTT tests did not seem to be useful for identifying Apixaban and Dabigatran concentrations higher than the pre-defined thresholds. Our results suggest that CoaguChek® Pro II coagulation testing device can be used to qualitatively identify relevant concentrations of Edoxaban or Rivaroxaban, but not of Apixaban or Dabigatran.
Douxfils J, Gosselin RC. Laboratory Assessment of Direct Oral Anticoagulants. Semin Thromb Hemost 2017;43:277-90.
DOI: https://doi.org/10.1055/s-0036-1597296
Douxfils J, Adcock D, Bates SM, et al. 2021 Update of the International Council for Standardization in Haematology Recommendations for Laboratory Measurement of Direct Oral Anticoagulants. Thromb Haemost 2021;121:1008-20.
DOI: https://doi.org/10.1055/a-1450-8178
Iapichino GE, Bianchi P, Ranucci M, Baryshnikova E. Point-of-Care Coagulation Tests Monitoring of Direct Oral Anticoagulants and Their Reversal Therapy: State of the Art. Semin Thromb Hemost 2017;43:423-32.
DOI: https://doi.org/10.1055/s-0037-1599157
Wool GD. Benefits and Pitfalls of Point-of-Care Coagulation Testing for Anticoagulation Management: An ACLPS Critical Review. Am J Clin Pathol 2019;151:1-17.
DOI: https://doi.org/10.1093/ajcp/aqy087
Favaloro EJ, Lippi G. Laboratory testing in the era of direct or non-vitamin k antagonist oral anticoagulants: a practical guide to measuring their activity and avoiding diagnostic errors. Semin Thromb Hemost 2015;41:208-27.
DOI: https://doi.org/10.1055/s-0035-1546827
Pernod G, Albaladejo P, Godier A, et al. Management of major bleeding complications and emergency surgery in patients on long-term treatment with direct oral anticoagulants, thrombin or factor-Xa inhibitors: proposals of the working group on perioperative haemostasis (GIHP) - March 2013. Arch Cardiovasc Dis 2013;106:382-93.
DOI: https://doi.org/10.1016/j.acvd.2013.04.009
Steiner T, Bohm M, Dichgans M, et al. Recommendations for the emergency management of complications associated with the new direct oral anticoagulants (DOACs), apixaban, dabigatran and rivaroxaban. Clin Res Cardiol 2013;102:399-412.
DOI: https://doi.org/10.1007/s00392-013-0560-7
Levy JH, Ageno W, Chan NC, et al. When and how to use antidotes for the reversal of direct oral anticoagulants: guidance from the SSC of the ISTH. J Thromb Haemost 2016;14:623-7.
DOI: https://doi.org/10.1111/jth.13227
Ebner M, Birschmann I, Peter A, et al. Limitations of Specific Coagulation Tests for Direct Oral Anticoagulants: A Critical Analysis. J Am Heart Assoc 2018;7:e009807.
DOI: https://doi.org/10.1161/JAHA.118.009807
Touze E, Gruel Y, Gouin-Thibault I, et al. Intravenous thrombolysis for acute ischaemic stroke in patients on direct oral anticoagulants. Eur J Neurol 2018;25:747-e52.
DOI: https://doi.org/10.1111/ene.13582
Bossuyt PM, Reitsma JB, Bruns DE, et al. STARD 2015: An Updated List of Essential Items for Reporting Diagnostic Accuracy Studies. Clin Chem 2015;61:1446-52.
DOI: https://doi.org/10.1373/clinchem.2015.246280
Swets JA. Measuring the accuracy of diagnostic systems. Science 1988;240:1285-93.
DOI: https://doi.org/10.1126/science.3287615
Tripodi A, Ageno W, Ciaccio M, et al. Position Paper on laboratory testing for patients on direct oral anticoagulants. A Consensus Document from the SISET, FCSA, SIBioC and SIPMeL. Blood Transfus 2018;16:462-70.
Dunois C. Laboratory Monitoring of Direct Oral Anticoagulants (DOACs). Biomedicines 2021;9:
DOI: https://doi.org/10.3390/biomedicines9050445
Siegal DM, Crowther MA. Acute management of bleeding in patients on novel oral anticoagulants. Eur Heart J 2013;34:489-98b.
DOI: https://doi.org/10.1093/eurheartj/ehs408
Tran H, Joseph J, Young L, et al. New oral anticoagulants: a practical guide on prescription, laboratory testing and peri-procedural/bleeding management. Australasian Society of Thrombosis and Haemostasis. Intern Med J 2014;44:525-36.
DOI: https://doi.org/10.1111/imj.12448
Seiffge DJ, Traenka C, Polymeris A, et al. Feasibility of rapid measurement of Rivaroxaban plasma levels in patients with acute stroke. J Thromb Thrombolysis 2017;43:112-6.
DOI: https://doi.org/10.1007/s11239-016-1431-7
Douxfils J, Ageno W, Samama CM, et al. Laboratory testing in patients treated with direct oral anticoagulants: a practical guide for clinicians. J Thromb Haemost 2018;16:209-19.
DOI: https://doi.org/10.1111/jth.13912
Gosselin RC, Adcock DM, Bates SM, et al. International Council for Standardization in Haematology (ICSH) Recommendations for Laboratory Measurement of Direct Oral Anticoagulants. Thromb Haemost 2018;118:437-50.
DOI: https://doi.org/10.1055/s-0038-1627480
Gosselin RC, Adcock DM, Douxfils J. An update on laboratory assessment for direct oral anticoagulants (DOACs). Int J Lab Hematol 2019;41 Suppl 1:33-9.
DOI: https://doi.org/10.1111/ijlh.12992
Kepplinger J, Prakapenia A, Barlinn K, et al. Standardized use of novel oral anticoagulants plasma level thresholds in a new thrombolysis decision making protocol. J Thromb Thrombolysis 2016;41:293-300.
DOI: https://doi.org/10.1007/s11239-015-1229-z
Härtig F, Birschmann I, Peter A, et al. Point-of-care testing for emergency assessment of coagulation in patients treated with direct oral anticoagulants including edoxaban. Neurol Res Pract 2021;3:9.
DOI: https://doi.org/10.1186/s42466-021-00105-4
Ebner M, Peter A, Spencer C, et al. Point-of-Care Testing of Coagulation in Patients Treated With Non-Vitamin K Antagonist Oral Anticoagulants. Stroke 46:2741-7.
DOI: https://doi.org/10.1161/STROKEAHA.115.010148
Fontana P, Alberio L, Angelillo-Scherrer A, et al. Impact of rivaroxaban on point-of-care assays. Thromb Res 2017;153:65-70.
DOI: https://doi.org/10.1016/j.thromres.2017.03.019
Padayattil Jose S, Banzato A, Carraro P, et al. Point of Care Testing (POCT) to assess drug concentration in patients treated with non-vitamin K antagonist oral anticoagulants (NOACs). Thromb Res 2018;163:100-4.
DOI: https://doi.org/10.1016/j.thromres.2018.01.044
Ebner M, Birschmann I, Peter A, et al. Point-of-care testing for emergency assessment of coagulation in patients treated with direct oral anticoagulants. Crit Care 2017;21:32.
DOI: https://doi.org/10.1186/s13054-017-1619-z
Cuker A, Siegal DM, Crowther MA, Garcia DA. Laboratory measurement of the anticoagulant activity of the non-vitamin K oral anticoagulants. J Am Coll Cardiol 2014;64:1128-39.
DOI: https://doi.org/10.1016/j.jacc.2014.05.065
Douxfils J, Tamigniau A, Chatelain B, et al. Measurement of non-VKA oral anticoagulants versus classic ones: the appropriate use of hemostasis assays. Thromb J 2014;12:24.
DOI: https://doi.org/10.1186/1477-9560-12-24
How to Cite
Legnani, C., Cini, M., Testa, S., Tosetto, A., Dellanoce, C., Bellesso, S., … Palareti, G. (2022). Evaluation of Coaguchek®Pro II coagulation testing device performance to assess direct oral anticoagulant action. The DOAC-CHECK study. Bleeding, Thrombosis and Vascular Biology, 1(3). https://doi.org/10.4081/btvb.2022.37
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