[Efficacy and safety of direct oral anticoagulants for the treatment of non-triple-positive antiphospholipid syndrome-associated pulmonary thromboembolism].

Objective: To evaluate the efficacy and safety of direct oral anticoagulants (DOAC) in the treatment of non-triple-positive antiphospholipid syndrome (APS)-associated pulmonary thromboembolism (PTE). Methods: A retrospective analysis was conducted on APS patients who were definitively diagnosed with PTE at the First Affiliated Hospital of Chongqing Medical University from July 2016 to July 2021 and met the Sapporo diagnostic criteria. Patients were divided into a DOAC group (n=34; 19 males, 16 females, mean age 57.0±17.7 years) and a warfarin group (n=9; 3 males, 6 females, mean age 37.7±15.0 years) based on the type of oral anticoagulant. Baseline data and laboratory findings were collected for both groups. Efficacy and safety outcomes, including venous thromboembolism (VTE) recurrence, death, and anticoagulation-related bleeding, were compared between the two groups. Results: No statistically significant differences were observed in baseline data between the two groups except for age. In terms of efficacy, thrombosis recurrence occurred in 2 patients (5.9%) in the DOAC group, while no recurrence occurred in the warfarin group; there was no statistically significant difference in VTE recurrence between the 2 groups (P=1.000). No deaths occurred in either group during follow-up, with no statistically significant difference in mortality. Regarding safety, bleeding occurred in 4 patients (4/34, 11.8%) in the DOAC group and 3 patients in the warfarin group, with a risk ratio of 0.353 (95% confidence interval: 0.096-1.301); the difference was not statistically significant (P=0.147). Conclusion: DOAC may be non-inferior to warfarin in both efficacy and safety for the treatment of non-triple-positive APS-associated PTE.