Treatment strategies and pregnancy outcomes in antiphospholipid syndrome patients with thrombosis and triple antiphospholipid positivity: A European multicentre retrospective study
Abstract
Previous thrombosis, diagnosis of systemic lupus erythematosus (SLE) and triple antiphospholipid (aPL) antibody positivity have recently been found to be independent factors associated to pregnancy failure during conventional therapy in women with antiphospholipid syndrome (APS). This study aimed to assess the effect of various treatment strategies on pregnancy outcomes in women with APS and the risk factors for pregnancy failure. One hundred ninety-six pregnancies of 156 patients diagnosed with APS were analysed: 118 (60.2%) of these had previous thrombosis, 81 (41.3%) were diagnosed with SLE, and 107 (54.6%) had triple aPL positivity. One hundred seventy-five (89.3%) were treated with conventional therapies (low-dose aspirin [LDA] or prophylactic doses of heparin + LDA or therapeutic doses of heparin + LDA), while 21 (10.7%) were prescribed other treatments in addition to conventional therapy. The pregnancies were classified into seven risk profiles depending on the patients' risk factors - thrombosis, SLE, and triple aPL positivity - and their single, double or triple combinations. It was possible to find significant difference in outcomes correlated to treatments only in the thrombosis plus triple aPL positivity subset, and logistic regression analysis showed that additional treatments were the only independent factor associated to a favourable pregnancy outcome (odds ratio=9.7, 95% confidence interval=1.1-88.9, p-value<0.05). On the basis of this retrospective study, we found that APS pregnant patients with thrombosis and triple aPL positivity treated with additional therapy had a significant higher live-birth rate with respect to those receiving conventional therapy alone.
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In women with a history of fetal loss, LDA plus heparin was associated with higher likelihood of live birth than LDA alone.
“For women with a history of fetal loss, combination treatment with LDA and heparin was associated with a higher likelihood of live birth compared with treatment with LDA alone.”
From EULAR recommendations for the management of antiphospholipid syndrome in adults (2019) · cites this paper as [52]
Pooled data from one RCT in women with first-trimester losses and eight observational studies not exclusively early losses indicated higher likelihood of live births with LDA plus prophylactic heparin versus LDA alone.
“Pooled data from one RCT including only patients with a history of first trimester losses46 and eight supporting observational studies47–54 that did not exclusively study women with early pregnancy losses indicated a higher likelihood of live births with combination treatment with LDA and heparin at prophylactic dosage versus LDA alone.”
From EULAR recommendations for the management of antiphospholipid syndrome in adults (2019) · cites this paper as [52]
The studies on fetal loss included women with histories of both early and mid-pregnancy losses.
“However, these studies included women with histories of both early and mid-pregnancy losses.48–52”
From EULAR recommendations for the management of antiphospholipid syndrome in adults (2019) · cites this paper as [52]
In observational studies, LDA plus therapeutic dose heparin was associated with live births in 79% of pregnancies on average.
“In observational studies, treatment with LDA and therapeutic dose heparin was associated with live births in 79% of pregnancies on average.52 61–64”
From EULAR recommendations for the management of antiphospholipid syndrome in adults (2019) · cites this paper as [52]
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References 41 · Cited by 108
- Authors
- Salvan, E., Ross, T. D., Gerosa, M., Andreoli, L., Maina, A., Alijotas-Reig, J., Carolis, S. D., Mekinian, A., Bertero, M. T., Canti, V., Brucato, A., Bremme, K., Ramoni, V., Mosca, M., Poi, E. D., Caramaschi, P., Galeazzi, M., Tincani, A., Meroni, P. L., & Ruffatti, A.
- Affiliations
- Azienda Ospedale - Università Padova (IT)
- University of Milan (IT)
- University of Turin (IT)
- Università Cattolica del Sacro Cuore (IT)
- A. O. Ordine Mauriziano di Torino (IT)
- Karolinska Institutet (SE)
- University of Pavia (IT)
- University of Pisa (IT)
- University of Udine (IT)
- Azienda Ospedaliera Universitaria Integrata Verona (IT)
- University of Siena (IT)
- University of Padua (IT)
- Corresponding author
- Ruffatti, Amelia
- ORCID
- Venue
- Thrombosis and Haemostasis
- Publisher
- Georg Thieme Verlag KG
- Published
- 2014
- Volume
- 112
- Issue
- 10
- Pages
- 727-735
- ISSN
- 0340-6245 (ISSN-L)
- 2567-689X
- OpenAlex
- W1930926314
- Cited by
- 108
- References
- 41
- Citations by year
- 2026: 3 · 2025: 1 · 2024: 3 · 2023: 2 · 2022: 5 · 2021: 7 · 2020: 6 · 2019: 14 · 2018: 17 · 2017: 13 · 2016: 18 · 2015: 14 · 2014: 5
- FWCI
- 13.82
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Thrombosis and Haemostasis (publishedVersion)
- PubMed (publishedVersion)
- Institutional Research Information System (Università degli Studi di Brescia) (submittedVersion)
- Use Siena air (University of Siena) (submittedVersion)
- Padua Research Archive (University of Padova) (submittedVersion)
- Topics
- Health Sciences › Medicine › Rheumatology › Systemic Lupus Erythematosus Research
- Life Sciences › Immunology and Microbiology › Immunology › Reproductive System and Pregnancy
- Health Sciences › Medicine › Hematology › Blood Coagulation and Thrombosis Mechanisms
- Keywords
- antiphospholipid syndrome, pregnancy outcomes, miscarriage, thrombosis, systemic lupus erythematosus, low-dose aspirin, heparin prophylaxis, live birth rate, risk factors
- MeSH terms
- Adult, Aspirin, Europe, Female, Heparin, Humans, Immunoglobulin G, Immunoglobulin M, Lupus Erythematosus, Systemic, Middle Aged, Pregnancy, Pregnancy Complications, Cardiovascular, Pregnancy Outcome, Retrospective Studies, Risk Factors, Thrombosis, Odds Ratio, Antiphospholipid Syndrome, Antibodies, Antiphospholipid
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