Patients with antiphosholipid syndrome and thrombotic recurrences: A real world observation (the Piedmont cohort study)
Open accessAbstract
Background: Patients with antiphospholipid syndrome (APS) often have thrombotic recurrences, sometimes despite appropriate ongoing anticoagulant treatment. Identifying APS vascular patients at high risk for thrombotic recurrences is still an unsolved issue. Objectives: To report the real-life experience of thrombotic recurrences in APS patients included in the Piedmont observational cohort study, and evaluate clinical and laboratory risk factors for thrombotic recurrences. Patients: A multi-centre observational study was performed by enrolling 177 patients with vascular APS (primary APS in 99 subjects (56%)); the median follow-up was five years (range 1–26 years). Results: The observed thrombotic recurrence rate was about 7.5/100 patient years in the first five years after the first thrombotic event. While the first recurrence often occurred (45%) in patients who were not on oral anticoagulant therapy (OAT), the second recurrence mainly occurred despite ongoing OAT (80%). However, due to the real-life observational nature of this study, treatment was based on the treating physician’s judgement, and no structured therapeutic protocol was applied. Moreover, compliance with OAT was not available. No differences in antiphospholipid antibodies (aPL) profile were observed between patients with or without thrombotic recurrences, but a high risk aPL profile (Miyakis type 1 and 2a) was present in 96% of our patients, 26% of whom had triple positivity. Diabetes ( p < 0.01, OR 10), inherited thrombophilia ( p < 0.0078, OR 4) and OAT withdrawal were independent risk factors for recurrences. Conclusions: With the limit of a real-life observational cohort study, the thrombotic recurrence rate in APS was as high as 7.5/100 patient years in the first five years after the first thrombotic event. OAT discontinuation, diabetes and inherited thrombophilia, when associated with a high-risk aPL profile, are risk factors for thrombotic recurrences.
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The 10-year cumulative TE incidence of 24.3% compares well to the thrombotic risk observed in the WAPS study and the Euro-Phospholipid Project registry, but was lower than the value in the Piedmont cohort study and higher than that in the study by Pengo et al.
“The 10-year cumulative TE incidence of 24.3% compares well to the thrombotic risk observed in the WAPS study [31] and the very large Euro-Phospholipid Project registry [6], but was lower than the value in the recently published Piedmont cohort study [32] and higher than that in the recently published study by Pengo et al. [30].”
From Cardiovascular risk factors are major determinants of thrombotic risk in patients with the lupus anticoagulant (2017) · cites this paper as [32]
While triple positivity has been shown to be a significant thrombotic risk factor in the WAPS study, several more recent prospective cohorts have also observed a lack of association between triple positivity or other LA-related autoantibodies and thrombosis.
“While triple positivity has been shown to be a significant thrombotic risk factor in the WAPS study [7], several more recent prospective cohorts have also observed a lack of association between triple positivity or other LA-related autoantibodies and thrombosis [30, 32, 33].”
From Cardiovascular risk factors are major determinants of thrombotic risk in patients with the lupus anticoagulant (2017) · cites this paper as [32]
The recently published results from the Piedmont cohort study found a tenfold increased thrombotic risk in LA patients with diabetes.
“This is consistent with the recently published results from the Piedmont cohort study, which found a tenfold increased thrombotic risk in LA patients with diabetes [32].”
From Cardiovascular risk factors are major determinants of thrombotic risk in patients with the lupus anticoagulant (2017) · cites this paper as [32]
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- Authors
- Bazzan, M., Vaccarino, A., Stella, S., Sciascia, S., Montaruli, B., Bertero, M. T., Carignola, R., Roccatello, D., & for the Piedmont APS Consortium
- Affiliations
- Ospedale San Giovanni Bosco (IT)
- Haemostasis Laboratory, Umberto I Hospital, Torino, Italy
- Clinical Immunology, Umberto I Hospital, Torino, Italy
- Ospedale San Luigi Gonzaga (IT)
- Venue
- Lupus
- Publisher
- SAGE Publications
- Published
- 2015-12-08
- Volume
- 25
- Issue
- 5
- Pages
- 479-485
- ISSN
- 0961-2033 (ISSN-L)
- 1477-0962
- OpenAlex
- W2391816831
- Cited by
- 56
- References
- 26
- Citations by year
- 2026: 2 · 2025: 6 · 2024: 5 · 2023: 5 · 2022: 3 · 2021: 7 · 2020: 5 · 2019: 4 · 2018: 8 · 2017: 8 · 2016: 3
- FWCI
- 5.32
- Type
- journal article
- Language
- en
- Open access
- green
- hdl.handle.net
- Locations
- Lupus (publishedVersion)
- PubMed (publishedVersion)
- Institutional Research Information System University of Turin (University of Turin) (submittedVersion, other-oa)
- Topics
- Health Sciences › Medicine › Rheumatology › Systemic Lupus Erythematosus Research
- Health Sciences › Medicine › Hematology › Blood Coagulation and Thrombosis Mechanisms
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Vasculitis and related conditions
- Keywords
- antiphospholipid syndrome, oral anticoagulation, antiphospholipid antibodies, risk factors, diabetes mellitus, inherited thrombophilia, anticoagulant withdrawal, primary antiphospholipid syndrome, recurrence rate
- MeSH terms
- Administration, Oral, Adolescent, Adult, Aged, Anticoagulants, Female, Humans, Italy, Male, Middle Aged, Prospective Studies, Recurrence, Risk Factors, Thrombosis, Time Factors, Biomarkers, Incidence, Logistic Models, Odds Ratio, Antiphospholipid Syndrome, Treatment Outcome, Antibodies, Antiphospholipid, Risk Assessment, Thrombophilia, Diabetes Complications, Young Adult
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