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. 2024 Sep 23;39(36):e252.
doi: 10.3346/jkms.2024.39.e252.

Direct Oral Anticoagulants in Antiphospholipid Syndrome-Associated Venous Thromboembolism: Real World Evidence

Hun-Gyu Hwang  1 , Ju Hyun Lee  2 , Sang-A Kim  2 , Yang-Ki Kim  3 , Myung-Shin Kim  1 , Junshik Hong  4 , Ho-Young Yhim  5 , Soo-Mee Bang  6
Affiliations

Direct Oral Anticoagulants in Antiphospholipid Syndrome-Associated Venous Thromboembolism: Real World Evidence

Hun-Gyu Hwang et al. J Korean Med Sci. .

Abstract

Background: The efficacy and safety of direct oral anticoagulants (DOACs) versus warfarin in patients with antiphospholipid syndrome-associated venous thromboembolism (APS-VTE) remain uncertain. We aimed to evaluate efficacy and safety of DOACs in patients with APS-VTE.

Methods: Using the Korean Health Insurance Review and Assessment Service database, we retrospectively identified all APS-VTE cases. We examined the VTE recurrence, arterial thrombosis, death and bleeding in patients who received DOACs compared with warfarin for therapeutic anticoagulation.

Results: Of all the VTE cases (n = 84,916) detected between 2014 and 2018, patients with APS-VTE (n = 410) accounted for 0.48%. Most patients with APS-VTE (73%) were aged < 60 years. The recurrent VTE occurred in 8 of 209 patients (3.8%) who received DOACs and in 7 of 201 (3.5%) who received warfarin (relative risk [RR], 1.099; 95% confidence interval [CI], 0.41-2.98; P = 1.000). The arterial thrombosis (ATE) occurred in 8 of 209 patients (3.8%) who received DOAC and in 20 of 201 (10%) who received warfarin (RR, 0.385; 95% CI, 0.17-0.85; P = 0.024). The composite outcomes of VTE recurrence, ATE, or mortality were significantly lower in patients (9.1%) on DOAC than in those (16.3%) on warfarin (RR, 0.537; 95% CI, 0.32-0.91; P = 0.028). The bleeding outcome occurred in 7 of 209 (3.4%) patients in the DOACs group and 7 of 201 (3.5%) patients in the warfarin group (RR, 0.96; 95% CI, 0.34-2.69; P = 0.840).

Conclusion: In patients with APS-VTE, DOACs group showed comparable rates of recurrent VTE, bleeding, and deaths, but a significantly lower incidence of ATE and composite outcomes compared with the warfarin group in Korea.

Keywords: Antiphospholipid Antibody; Antiphospholipid Syndrome; Arterial Thrombosis; Direct Oral Anticoagulants; Venous Thromboembolism; Vitamin K Antagonist.

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Conflict of interest statement

The authors have no potential conflicts of interest to disclose.

Figures

Fig. 1
Fig. 1. Overall flow of analysis.
VTE = venous thromboembolism, UFH = unfractionated heparin, LMWH = low-molecular weight heparin, AF = atrial fibrillation, DOAC = direct oral anticoagulant.
Fig. 2
Fig. 2. The proportion of subgroups by age in APS-VTE versus non-APS-VTE. The numbers in bars represent the count of patients. The Y-axis in the graph is displayed as a cumulative percentage of the total (100%).
APS = antiphospholipid syndrome, VTE = venous thromboembolism.
See this image and copyright information in PMC

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