Cardiovascular

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

TL;DR

DOAC may be non-inferior to warfarin in both efficacy and safety for the treatment of non-triple-positive APS-associated pulmonary thromboembolism.

Key Findings

VTE recurrence rates did not differ significantly between the DOAC and warfarin groups in non-triple-positive APS-associated PTE.

  • Thrombosis recurrence occurred in 2 patients (5.9%) in the DOAC group and 0 patients in the warfarin group.
  • The difference in VTE recurrence between the two groups was not statistically significant (P=1.000).
  • DOAC group: n=34 (mean age 57.0±17.7 years); warfarin group: n=9 (mean age 37.7±15.0 years).
  • All patients met the Sapporo diagnostic criteria for APS and were definitively diagnosed with PTE.

No deaths occurred in either the DOAC or warfarin group during the follow-up period.

  • Mortality was zero in both groups throughout follow-up.
  • There was no statistically significant difference in mortality between the two groups.
  • The study was conducted at the First Affiliated Hospital of Chongqing Medical University from July 2016 to July 2021.

Bleeding rates did not differ significantly between the DOAC and warfarin groups.

  • Bleeding occurred in 4 patients (4/34, 11.8%) in the DOAC group and 3 patients in the warfarin group.
  • The risk ratio for bleeding was 0.353 (95% CI: 0.096–1.301).
  • The difference in bleeding rates was not statistically significant (P=0.147).

Baseline characteristics between the two groups were comparable except for age.

  • The DOAC group had a mean age of 57.0±17.7 years, compared to 37.7±15.0 years in the warfarin group.
  • All other baseline data and laboratory findings showed no statistically significant differences between groups (P>0.05).
  • This was a retrospective analysis of patients meeting Sapporo diagnostic criteria for APS with confirmed PTE.

DOACs may be non-inferior to warfarin for both efficacy and safety in treating non-triple-positive APS-associated pulmonary thromboembolism.

  • The study specifically focused on non-triple-positive APS patients, a subset considered at lower thrombotic risk than triple-positive patients.
  • Patients were divided into DOAC (n=34) and warfarin (n=9) groups based on type of oral anticoagulant received.
  • The retrospective design and small sample sizes, particularly in the warfarin group (n=9), limit generalizability of findings.

What This Means

This research suggests that newer blood thinners called direct oral anticoagulants (DOACs) may work just as well and be just as safe as the traditional blood thinner warfarin for treating a specific type of blood clot in the lungs (pulmonary thromboembolism) in patients with a condition called antiphospholipid syndrome (APS). APS is an autoimmune disorder where the immune system mistakenly attacks certain proteins in the blood, increasing the risk of dangerous blood clots. This study focused specifically on patients with a less severe form of APS called 'non-triple-positive' APS, meaning they tested positive for only one or two (rather than all three) of the antibody markers associated with the condition. The study followed 43 patients treated at a Chinese hospital between 2016 and 2021, with 34 receiving DOACs and 9 receiving warfarin. Researchers found no significant differences between the two groups in rates of blood clot recurrence (5.9% vs. 0%), death (0% in both groups), or bleeding complications (11.8% vs. 33% in the warfarin group, though this difference was also not statistically significant). The risk ratio for bleeding suggested DOACs may actually cause less bleeding, but the study was too small to confirm this with statistical confidence. This research matters because warfarin requires frequent blood monitoring and has many dietary and drug interactions, while DOACs are generally easier for patients to use. However, current guidelines generally recommend against DOACs for APS patients due to concerns about clot recurrence, particularly for high-risk 'triple-positive' patients. This small retrospective study suggests that for the lower-risk, non-triple-positive subset of APS patients, DOACs might be a viable alternative, though larger studies are needed before any firm conclusions can be drawn.

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Citation

Hu C, Wang X, Chen H. (2026). [Efficacy and safety of direct oral anticoagulants for the treatment of non-triple-positive antiphospholipid syndrome-associated pulmonary thromboembolism].. Zhonghua jie he he hu xi za zhi = Zhonghua jiehe he huxi zazhi = Chinese journal of tuberculosis and respiratory diseases. https://doi.org/10.3760/cma.j.cn112147-20251214-00789