Comparative study of obstetric antiphospholipid syndrome (OAPS) and non-criteria obstetric APS (NC-OAPS): report of 1640 cases from the EUROAPS registry.
To compare clinical features, laboratory data and fetal-maternal outcomes between 1000 women with obstetric APS (OAPS) and 640 with aPL-related obstetric complications not fulfilling Sydney criteria (non-criteria OAPS, NC-OAPS).
This was a retrospective and prospective multicentre study from the European Registry on Obstetric Antiphospholipid Syndrome.
A total of 1650 women with 5251 episodes, 3601 of which were historical and 1650 latest episodes, were included. Altogether, 1000 cases (OAPS group) fulfilled the Sydney classification criteria and 650 (NC-OAPS group) did not. Ten NC-OAPS cases were excluded for presenting thrombosis during follow-up. All cases were classified as category I (triple positivity or double positivity for aPL) or category II (simple positivity). Overall, aPL laboratory categories showed significant differences: 29.20% in OAPS vs 17.96% in NC-OAPS (P < 0.0001) for category I, and 70.8% in OAPS vs 82% in NC-OAPS (P < 0.0001) for category II. Significant differences were observed when current obstetric complications were compared (P < 0.001). However, major differences between groups were not observed in treatment rates, livebirths and thrombotic complications. In the NC-OAPS group, 176/640 (27.5%) did not fulfil Sydney clinical criteria (subgroup A), 175/640 (27.34%) had a low titre and/or non-persistent aPL positivity but did meet the clinical criteria (subgroup B) and 289/640 (45.15%) had a high aPL titre but did not fulfil Sydney clinical criteria (subgroup C).
Significant clinical and laboratory differences were found between groups. Fetal-maternal outcomes were similar in both groups when treated. These results suggest that we could improve our clinical practice with better understanding of NC-OAPS patients.
Alijotas-Reig J
，Esteve-Valverde E
，Ferrer-Oliveras R
，Sáez-Comet L
，Lefkou E
，Mekinian A
，Belizna C
，Ruffatti A
，Hoxha A
，Tincani A
，Nalli C
，Marozio L
，Maina A
，Espinosa G
，Ríos-Garcés R
，Cervera R
，Carolis S
，Monteleone G
，Latino O
，Udry S
，LLurba E
，Garrido-Gimenez C
，Trespidi L
，Gerosa M
，Chighizola CB
，Rovere-Querini P
，Canti V
，Mayer-Pickel K
，Tabacco S
，Arnau A
，Trapé J
，Ruiz-Hidalgo D
，Sos L
，Farran-Codina I
，EUROAPS Study Group
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[Obstetric Antiphospholipid Syndrome: Insights on the Diagnosis, Treatment, and Hot Issues].
Obstetric antiphospholipid syndrome (OAPS) is an autoimmune disorder associated with various pathological pregnancies, such as recurrent miscarriage, stillbirth, severe pre-eclampsia and severe placental insufficiency. The persistent presence of antiphospholipid antibodies (aPLs) is the most important laboratory characteristic of OAPS. OAPS severely affects the reproductive health of women of childbearing age in China. Reports indicate that approximately 9.6% stillbirths, 11.5% severe pre-eclampsia, and 54% recurrent miscarriages are associated with OAPS or aPLs. However, the pathogenesis of OAPS remains unclear. Previously, thrombosis at the maternal-fetal interface (MFI) was considered the main mechanism of OAPS-related pathological pregnancies. Consequently, the use of low molecular weight heparin and aspirin throughout pregnancy was recommended to improve outcomes in OAPS patient. In recent years, many studies have found that thrombosis in MFI is uncommon, but various inflammatory factors are significantly increased in the MFI of OAPS patients. Based on these findings, some clinicians have started using anti-inflammatory treatments for OAPS, which have preliminarily improved the pregnancy outcomes. Nevertheless, there is no consensus on these second-line treatments of OAPS. Another troubling issue is the clinical diagnosis of OAPS. Similar to other autoimmune diseases, there are only classification criteria for OAPS, and clinical diagnosis of OAPS depends on the clinicians' experience. The present classification criteria of OAPS were established for clinical and basic research purposes, not for patient clinical management. In clinical practice, many patients with both positive aPLs and pathological pregnancy histories do not meet the strict OAPS criteria. This has led to widespread issues of incorrect diagnosis and treatment. Timely and accurate diagnosis of OAPS is crucial for effective treatment. In this article, we reviewed the epidemiological research progress on OAPS and summarized its classification principles, including: 1) the persistent presence of aPLs in circulation; 2) manifestations of OAPS, excluding other possible causes. For the first point, accurate assessment of aPLs is crucial; for the latter, previous studies regarded only placenta-related pregnancy complications as characteristic manifestations of OAPS. However, recent studies have indicated that adverse pregnancy outcomes related to trophoblast damage, such as recurrent miscarriage and stillbirth, also need to be considered in OAPS. We also discussed several key issues in the diagnosis and treatment of OAPS. First, we addressed the definition of non-standard OAPS and offered our opinion on defining non-standard OAPS within the framework of the 2023 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) APS criteria. Then, we discussed the advantages and disadvantages of different aPL testing methods, emphasizing that harmonizing results across platforms and establishing specific reference values are keys to resolving controversies in aPL testing results. We also introduced the application of non-criteria aPLs, especially anti-phosphatidylserine/prothrombin antibody (aPS/PT) and anti-β2 glycoprotein Ⅰ domain Ⅰ antibody (aβ2GPⅠDⅠ). Additionally, we discussed aPL-based OAPS risk classification strategies. Finally, we proposed potential treatment methods for refractory OAPS. The goal is to provide a reference for the clinical management of OAPS.
Gao R
，Qin L
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Clinical phenotype, treatment strategy and pregnancy outcome of non-criteria obstetric antiphospholipid syndrome.
To illustrate the clinical features, treatment strategy, and pregnancy outcome of patients with obstetric antiphospholipid syndrome (OAPS), non-criteria obstetric antiphospholipid syndrome (NC-OAPS) METHOD OF STUDY: A single-center nested case-control study was designed. Patients with a diagnosis of OAPS and NC-OAPS were enrolled. The medical history, coagulation status, and antibody profile data were collected. Patients were given standard anticoagulation therapy with or without glucocorticoids (GC) and/or hydroxychloroquine (HCQ) during pregnancy and were observed for their pregnancy outcome.
A total of 47 patients with OAPS and 120 patients with NC-OAPS were finally included, of whom 55 patients met the clinical criteria (subgroup C) and 65 met the laboratory criteria (subgroup L). Pregnancy morbidity showed significant differences: gravida, pregnancy loss in OAPS versus NC-OAPS. The coagulation function was not significantly different between OAPS and NC-OAPS groups, while TT and FIB were significantly higher in the subgroup C. Thromboelastography (TEG) results showed a significantly lower ANGEL in the NC-OAPS group, a higher ANGEL and lower EPL, LY30 in the subgroup L. No differences between groups were observed in treatment strategy. The pregnancy outcomes were not significantly different between NC-OAPS and OAPS groups.
Clinical and laboratory differences were found between OAPS and NC-OAPS groups in this study. Patients in different subgroups of NC-OAPS could be identified with different clinical phenotypes. A relatively hypercoagulable status existed in the OAPS group compared to NC-OAPS, and also in the subgroup L.
Li J
，Hou Y
，Zhang L
，Li F
，Liu Q
，Li Y
，Shen H
，Xiong Z
，Huang L
，Qiao C
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