Abstract Number: PB0612
Meeting: ISTH 2020 Congress
Background: Adverse drug events from anticoagulants including direct oral anticoagulants (DOACs) are the major cause of emergency department admissions in the United States (1). Bleeding remains the main adverse event during DOAC use. Routine laboratory monitoring of DOACs plasma level is not recommended, but may be useful among certain patient groups, especially in emergency situations.
In 2019 study examining relationship between chromogenic anti-FXa assay and LC-MS/MS for detecting rivaroxaban (RXN) plasma concentration (P-RXN) was conducted in North Estonia Medical Centre (2). During this, data about 43 patients: demographics, vital signs, utilisation of medicines, adverse events and laboratory results at 4 visits (days 0, 7, 30 and 180), was collected.
Aims: The aim of this analysis was to describe differences between patient groups with and without bleeding complications in this dataset.
Methods: 43 patients were divided into two groups- patients with and without bleeding complications. Baseline characteristics of all patients at first visit (day 0) are presented in Table 1. P-RXN values used were detected by LC-MS/MS. Bleeding complications were classified by International Society on Thrombosis and Haemostasis (ISTH) definitions (3). We also conducted drug interaction review in Inxbase drug-drug interaction database.
With bleeding | Without bleeding | |
Patients (n) | 11 | 32 |
Male sex (n; %) | 7 (64) | 22 (69) |
Age (years; mean; min- max) | 61.4 (40- 79) | 57.9 (24- 81) |
Weight (kg; median; min- max) | 83.9 (72.5- 143.3) | 88.4 (51.5- 169.8) |
eGFR (mL/min; mean; min- max) | 88.3 (68- 107) | 82.9 (40- 117) |
Hemoglobin (g/L; mean; min- max) | 133.9 (110- 162) | 138.9 (106- 155) |
RXN indication (VTE/AF) | 8/ 3 | 25/ 7 |
[Table 1. Baseline characteristics of patients]
Results: There were 11 patients with bleeding complications including 2 patients with 2 visits with bleeding (in total we recorded 12 minor and 1 major bleeding). P-RXN trough levels ranged from < 2 to 440 ng/ml (median 51 ng/ml; SD 108.7) in patients with bleeding and from 2.2 to 240 ng/ml (median 33 ng/ml; SD 48.9) in patients without bleeding. 2 patients with minor bleeding complications used non-steroidal anti-inflammatory drugs.
Conclusions: P-RXN levels in both groups had a very high variability, but tended to be higher in patients with bleeding. Bleeding events were mostly minor in patients using RXN.
(1) JAMA 2016;316(20):2115-2125 |
(2) Eur J Clin Pharmacol (2019) 75(Suppl 1): 1. https://doi.org/10.1007/s00228-019-02685-2 |
(3) J Thromb Haemost 2015;13: 2119-26 |
[References]
To cite this abstract in AMA style:
Arjakse J, Malmström RE, Gustafsson L, Ilumets H, Kostjuk J, Märk M, Pikta M, Pohanka A, Rönquist Y, Marandi T. Rivaroxaban Plasma Concentration Values and Risk Factors for Adverse Events in Patients Experiencing Bleeding: Results from a Prospective Study [abstract]. Res Pract Thromb Haemost. 2020; 4 (Suppl 1). https://abstracts.isth.org/abstract/rivaroxaban-plasma-concentration-values-and-risk-factors-for-adverse-events-in-patients-experiencing-bleeding-results-from-a-prospective-study/. Accessed March 21, 2024.« Back to ISTH 2020 Congress
ISTH Congress Abstracts - https://abstracts.isth.org/abstract/rivaroxaban-plasma-concentration-values-and-risk-factors-for-adverse-events-in-patients-experiencing-bleeding-results-from-a-prospective-study/