J Korean Med Sci.  2024 Sep;39(36):e252. 10.3346/jkms.2024.39.e252.

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

• Hwang HG
• Lee JH
• Kim SA
• Kim YK
• Kim MS
• Hong J
• Yhim HY
• Bang SM

• KMID: 2559774
• DOI: http://doi.org/10.3346/jkms.2024.39.e252

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 APSVTE.
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.

Keyword

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

Figure

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  Fig. 1 Overall flow of analysis.VTE = venous thromboembolism, UFH = unfractionated heparin, LMWH = low-molecular weight heparin, AF = atrial fibrillation, DOAC = direct oral anticoagulant.

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  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.

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