Comparative study of obstetric antiphospholipid syndrome (OAPS) and non-criteria obstetric APS (NC-OAPS): report of 1640 cases from the EUROAPS registry.

OBJECTIVES: 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). METHODS: This was a retrospective and prospective multicentre study from the European Registry on Obstetric Antiphospholipid Syndrome. RESULTS: 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). CONCLUSION: 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.

The European Registry on Obstetric Antiphospholipid Syndrome (EUROAPS): A survey of 1000 consecutive cases.

AIM: To analyse the clinical features, laboratory data and foetal-maternal outcomes, and follow them up on a cohort of 1000 women with obstetric antiphospholipid syndrome (OAPS). METHODS: The European Registry of OAPS became a registry within the framework of the European Forum on Antiphospholipid Antibody projects and was placed on a website in June 2010. Thirty hospitals throughout Europe have collaborated to carry out this registry. Cases with obstetric complaints related to antiphospholipid antibodies (aPL) who tested positive for aPL at least twice were included prospectively and retrospectively. The seven-year survey results are reported. RESULTS: 1000 women with 3553 episodes were included of which 2553 were historical and 1000 were latest episodes. All cases fulfilled the Sydney classification criteria. According to the laboratory categories, 292 (29.2%) were in category I, 357 (35.7%) in IIa, 224 (22.4%) in IIb and 127 (12.7%) in IIc. Miscarriages were the most prevalent clinical manifestation in 386 cases (38.6%). Moreover, the presence of early preeclampsia (PE) and early foetal growth restriction (FGR) appeared in 181 (18.1%) and 161 (16.1%), respectively. In this series, 448 (44.8%) women received the recommended OAPS treatment. Patients with recommended treatment had a good live-birth rate (85%), but worse results (72.4%) were obtained in patients with any treatment (low-dose aspirin (LDA) or low-molecular-weight heparin (LMWH) not on recommended schedule, while patients with no treatment showed a poor birth rate (49.6%). CONCLUSION: In this series, recurrent miscarriage is the most frequent poor outcome. To avoid false-negative diagnoses, all laboratory category subsets were needed. OAPS cases have very good foetal-maternal outcomes when treated. Results suggest that we were able to improve our clinical practice to offer better treatment and outcomes to OAPS patients.

The European Registry on Obstetric Antiphospholipid Syndrome (EUROAPS): A survey of 247 consecutive cases.

AIM: To analyse the clinical features, laboratory data, foetal-maternal outcomes, and follow-up in a cohort of 247 women with obstetric antiphospholipid syndrome (OAPS). METHODS: The European Registry on APS became a Registry within the framework of the European Forum on Antiphospholipid Antibody projects and placed on a website in June 2010. Cases with obstetric complaints related to aPL who tested positive for aPL prospectively and retrospectively were included. The three-year survey results are reported. RESULTS: 338 women with 1253 pregnancy episodes were included; 915 were historical and 338 were latest episodes. All these women tested positive for aPL. 247 of the 338 fulfilled the Sydney criteria. According to the laboratory categories, 84/247 were in category I, 42 in IIa, 66 in IIb and 55 in IIc. Obstetric complications other than foetal losses, appeared in 129 cases (52.2%). 192 (77.7%) had a live birth and 55 (22.3%) did not. The latter group of only 38 cases (69%) received adequate treatment and 17 (31%) did not. 177/247 (72%) women were put on heparin plus LDA. Thrombosis appeared in two during pregnancy and in 14 during the puerperium. 7 (3%) women evolved to complete SLE. CONCLUSIONS: OAPS shows differential characteristics than classical APS. All laboratory test categories are needed to avoid false-negative diagnoses. In some cases, complement levels could act as a serological marker. OAPS has very good foetal-maternal outcomes when treated. Thrombosis and progression to SLE in mothers with OAPS are scarce compared with "classical APS", suggesting that they have different aPL-mediated pathogenic mechanisms.

Registro de pacientes con síndrome antifosfolipídico / Registry of patients with antiphospholipid syndrome

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Anti-annexin A5 antibodies in women with spontaneous pregnancy loss

Background and Objective: The aim was to evaluate the role of anti-annexin A5 (anti-ANXA5) antibodies as risk factor for recurrent miscarriage (RM) and unexplained fetal loss (UFL). Patients and methods: Retrospective, cohort study. Setting: Vall d’Hebron University Hospital. Subjects: 122 women, in two groups: Study group: 54 women with RM/UFL and control group: 68 pregnant without RM/UFL. Intervention: Antiphospholipid, mainly anti-ANXA5 antibody analysis. Comparison of all antiphospholipid antibodies between groups. Results: Antiphospholipid antibody (aPL) prevalence in the study group was 10/54 (14.8%) and 5/68 (7.3%) in control group (p=0.09). In the RM subgroup, it was 3/25 and 9/34 in UFL versus 5/68 in controls (p=0.013). Lupus anticoagulant (LA) was present in 4 cases, all belonging to the study group (p=0.011). Four out of 34 women with UFL were positive for anticardiolipin antibodies-IgG (IgG-aCL) versus 1/68 in controls (p=0.041). In RM subgroup, anti-ANXA5 antibodies were positive in 2/25 versus 3/68 in controls, and in UFL subgroup, 3/34 versus 3/68 cases (p=1.000). Conclusion: According to our results, anti-ANXA5 antibodies should not be considered as a risk factor for RM/UFL (AU)

Fundamento y Objetivo: El objetivo principal fue evaluar el papel de los anticuerpos anti-anexina A5 (ac-anti-ANXA5) como factor de riesgo de abortos recurrentes (AR) y de la pérdida fetal inexplicada (PFI). Pacientes y Método: Se trata de un estudio de cohortes retrospectivo. Se desarrolló en el Hospital Universitario Vall d’Hebron de Barcelona. Se estudiaron un total de 122 mujeres, en dos grupos: grupo de estudio, formado por: 54 mujeres con AR/PFI y grupo control, constituido por 68 gestantes sin historia de AR/PFI. Se estudiaron los anticuerpos antifosfolípido (aFL), con especial interés para los ac-anti-ANXA5. Se compararon los resultados entre ambos grupos, estudio y control. Resultados: La prevalencia de positividad para los aFL fue de 10/54 (14,8%) en el grupo de estudio y de 5/68 (7,3%) en el grupo control (p=0,09). En el subgrupo de mujeres con AR, la prevalencia de los aFL fue de 3/25 y de 9/35 en el subgrupo afecto de PFI, versus 5/68 en el grupo control (p=0,013). El anticoagulante lúpico (AL) fue positivo en 4 casos, todos ellos pertenecientes al grupo de estudio (p=0,011). Cuatro de las 34 mujeres con historia de PFI tenían anticuerpos anti-cardiolipina isotipo IgG versus 1/68 en el grupo control (p=0,041). En el subgrupo de AR, los ac-anti-anexina A5 se detectaron en 2/25 casos versus 3/68 en el grupo control y 3/34 el subgrupo con PFI (p=1,000). Conclusiones: De acuerdo con los resultados de nuestro estudio, los anticuerpos anti-anexina A5 no deberían ser considerados como factores de riesgo de AR y/o de PFI (AU)

Anti-annexin A5 antibodies in women with spontaneous pregnancy loss.

BACKGROUND AND OBJECTIVE: The aim was to evaluate the role of anti-annexin A5 (anti-ANXA5) antibodies as risk factor for recurrent miscarriage (RM) and unexplained fetal loss (UFL). PATIENTS AND METHODS: Retrospective, cohort study. SETTING: Vall d'Hebron University Hospital. SUBJECTS: 122 women, in two groups: STUDY GROUP: 54 women with RM/UFL and control group: 68 pregnant without RM/UFL. INTERVENTION: Antiphospholipid, mainly anti-ANXA5 antibody analysis. Comparison of all antiphospholipid antibodies between groups. RESULTS: Antiphospholipid antibody (aPL) prevalence in the study group was 10/54 (14.8%) and 5/68 (7.3%) in control group (p=0.09). In the RM subgroup, it was 3/25 and 9/34 in UFL versus 5/68 in controls (p=0.013). Lupus anticoagulant (LA) was present in 4 cases, all belonging to the study group (p=0.011). Four out of 34 women with UFL were positive for anticardiolipin antibodies-IgG (IgG-aCL) versus 1/68 in controls (p=0.041). In RM subgroup, anti-ANXA5 antibodies were positive in 2/25 versus 3/68 in controls, and in UFL subgroup, 3/34 versus 3/68 cases (p=1.000). CONCLUSION: According to our results, anti-ANXA5 antibodies should not be considered as a risk factor for RM/UFL.