Abstract
BACKGROUND
The patients with venous thromboembolism (VTE) and thrombophilia have historically been treated with vitamin K antagonist (VKA) therapy. Nowadays, direct oral anticoagulants (DOAC) are broadly used in the treatment and prevention of VTE. However, the use of DOAC in the treatment of inherited and acquired thrombophilia remains unclear.
AIMS
To assess the safety and effectiveness in both cohorts according to DOAC or VKA treatment in a cohort of patients with VTE and thrombophilia.
METHODS
We included adult patients with VTE and thrombophilia treated with DOAC or VKA (2016-2018) from the beginning of treatment. Patients in the VKA group received acenocoumarol. Demographic, laboratory, thrombophilia diagnosis data and clinical presentation of VTE were collected. All patients with history of at least one VTE episode were included. The diagnosis of VTE was established by a positive finding of duplex sonography. Pulmonary embolism was diagnosed based on positive results of high resolution computed tomography. Inherited trombophilia included homozygous and heterozygous Factor V Leiden and prothrombin G20210A, natural anticoagulant deficiencies (protein C, protein S, or antithrombin) or combined defects. Patients with antiphospholipid syndrome (APS) were considered to have acquired thrombophilia. Bleeding events were classified according to ISTH criteria.
RESULTS
Among 181 patients, 96 (45.5%) were treated with DOAC (6 Dabigatran, 45 Rivaroxaban, 12 Apixaban and 33 Edoxaban) and 85 were treated with VKA. Among patients receiving VKA, the time in therapeutic range was 58.5%. Mean Follow - Up (FU) were 8.1 and 6.8 months (DOAC vs VKA, p:0.77). Demographic characteristics, thrombophilia subtypes and clinical features of VTE are summarised in table 1. The most frequent previous anticoagulant treatment was low molecular weight heparin (DOAC 71.6% vs VKA 98%, p:0.15). During FU, 9 recurrent VTE episodes were reported: 2 (2.1%) vs 5 (5.9%) [DOAC vs VKA, p: 0.57] and 5 (5.2%) vs 17 (20%) major and clinically relevant non-major bleeding events [DOAC vs VKA, p: 0.001] occurred. There were 2 arterial thromboembolic events in the VKA group (APS and antithrombin deficiency patient's in the periprocedural setting).
CONCLUSIONS
In our study, the effectiveness of DOAC treatment for VTE in patients with thrombophilia had a similar profile to VKA and caused significantly less major and clinically relevant non-major bleeding. This suggests that DOAC could be a good treatment option in this clinical setting. However, additional evaluation of DOAC use in patients with thrombophilia is necessary in order to provide more evidence.
No relevant conflicts of interest to declare.
