Impact of rivaroxaban on point-of-care assays.
BACKGROUND
Point-of-care testing (POCT) is regularly used to assess haemostasis in various clinical settings. The impact of rivaroxaban on those POCT is still elusive. We aimed to study the effects of rivaroxaban on most commonly used POCT assays.


METHODS
Blood samples were taken before, 3h, and 24h after administration of 20mg rivaroxaban to 20 healthy volunteers as part of a prospective, multicenter validation study (clinicaltrials.govNCT01710267). Blood samples were analysed with thromboelastometry (ROTEM®), two platelet function assays (INNOVANCE® PFA-200 and Multiplate®), and the CoaguChek® XS. Rivaroxaban plasma levels were determined using liquid chromatography-mass spectrometry.


RESULTS
Rivaroxaban significantly modified some thromboelastometry parameters (CT INTEM: mean difference 56.1s, 95% CI: 41.8, 70.3; CT EXTEM: 47.5s, 95% CI: 37.8, 57.1; CT HEPTEM: 50.1s, 95% CI: 34.7, 65.6), and CoaguChek® XS parameters (prothrombin time: mean difference 3.8s, 95% CI: 3.3, 4.2; INR: 0.32, 95% CI: 0.27, 0.38; prothrombin ratio: -36.1%, 95% CI: -32.3, -39.9). CT EXTEM and INR showed a moderate correlation with rivaroxaban plasma levels (r=0.83; 95% CI 0.69, 0.9 and r=0.83; 95% CI 0.70, 0.91, respectively) and a high sensitivity to detect rivaroxaban treatment at peak levels (0.95; 95% CI: 0.76, 1.0 and 0.90, 95% CI 0.70, 0.99, respectively).


CONCLUSIONS
Rivaroxaban 20mg treatment significantly alters ROTEM® and CoaguChek® XS parameters. Even though POCT do not allow precise quantification of rivaroxaban plasma concentration, CT EXTEM and CoaguChek XS detect the presence of rivaroxaban at peak level with a high sensitivity.
Division of Angiology and Haemostasis, Laboratory of Haemostasis, University Hospitals of Geneva, CH-1211 Geneva, Switzerland.
Pierre
P
Fontana
Service and Central Laboratory of Haematology, Centre Hospitalier Universitaire Vaudois, University of Lausanne, CH-1011 Lausanne, Switzerland.
Lorenzo
L
Alberio
Department of Haematology, Inselspital, Bern University Hospital, Department of Clinical Research, University of Bern, CH-3010 Berne, Switzerland.
Anne
A
Angelillo-Scherrer
Unilabs Zurich, CH-8034 Zurich, Switzerland.
Lars M
LM
Asmis
Institute for Clinical Chemistry and Haematology, Cantonal Hospital St. Gallen, CH-9007 St. Gallen, Switzerland.
Wolfgang
W
Korte
Center for Laboratory Medicine, Cantonal Hospital Aarau, CH-5001 Aarau, Switzerland.
Adriana
A
Mendez
Division of Haematology, Central Haematology Laboratory, Luzerner Kantonsspital, CH-6000 Lucerne 16, Switzerland.
Pirmin
P
Schmid
Division of Surgery, Regional Hospital La Carita, CH-6600 Locarno, Switzerland.
Hans
H
Stricker
Division of Haematology, University Hospital and University of Zurich, CH-8091 Zurich.
Jan-Dirk
JD
Studt
Diagnostic Haematology, University Hospital of Basel, CH-4031 Basel, Switzerland.
Dimitrios A
DA
Tsakiris
Division of Haematology, Central Haematology Laboratory, Luzerner Kantonsspital, CH-6000 Lucerne 16, Switzerland; Department of Clinical Research, University of Berne, CH-3000 Berne, Switzerland.
Walter A
WA
Wuillemin
Department of Haematology, Inselspital, Bern University Hospital, Department of Clinical Research, University of Bern, CH-3010 Berne, Switzerland; Department of Clinical Research, University of Berne, CH-3000 Berne, Switzerland. Electronic address: michael.nagler@insel.ch.
Michael
M
Nagler
D000293:Adolescent; D000328:Adult; D000368:Aged; D001780:Blood Coagulation Tests / Q000379:methods*; D065427:Factor Xa Inhibitors / Q000097:blood*; D006801:Humans; D019934:International Normalized Ratio / Q000379:methods; D008297:Male; D008875:Middle Aged; D010979:Platelet Function Tests / Q000379:methods*; D000067716:Point-of-Care Testing; D011446:Prospective Studies; D011517:Prothrombin Time / Q000379:methods; D000069552:Rivaroxaban / Q000097:blood*; D013916:Thrombelastography / Q000379:methods; D055815:Young Adult
D065427:Factor Xa Inhibitors; D000069552:Rivaroxaban