Natural history and risk factors for thrombosis in 360 patients with antiphospholipid antibodies: a four‐year prospective study from the Italian Registry
Abstract
Purpose To assess the natural history and risk factors for thrombosis in a large cohort of unselected patients with antiphospholipid antibodies.Patients and methods Three hundred sixty consecutive patients (118 males, 242 females, median age 39 years [range 2 to 78]) fulfilling the currently accepted criteria for diagnosis of lupus anticoagulant (LAC) (n = 326) and/or raised immunoglobulin G anticardiolipin antibodies (IgG ACA) (n = 185) were collected from 16 Italian institutions and prospectively observed for a median of 3.9 years (range 0.5 to 5). Main endpoints were the occurrence of arterial or venous thrombosis, the outcome of pregnancies, and any severe complications leading to hospitalization or death.Results Thirty-four patients developed a thrombotic complication, with a total incidence of 2.5% patient-years. Multivariate logistic regression analysis identified two independent risk factors for thrombotic events: a previous thrombosis (RR 4.9; 95% CI, 1.76 to 13.7; P < 0.005) and IgG ACA titer above 40 units (RR 3.66; 95% CI, 1.24 to 10.8; P < 0.01). A total of 28 pregnancies were observed in 25 women and 11 (39%) were abortive. Adverse pregnancy outcomes were significantly more frequent in women with a history of miscarriage or vascular occlusion (9/16, 56%) than in asymptomatic women (2/12, 17%) (P = 0.035). Four patients developed non-Hodgkin's lymphoma during the follow-up. Eighteen patients died. Vascular events and hematological malignancies represented the most frequent causes of death (n = 5 for each).Conclusions The present study shows that: (a) previous thrombosis and ACA titer > 40 U are independent predictors of thrombosis; (b) history of miscarriage or vascular disease is significantly associated with adverse pregnancy outcome; (c) hematological malignancies can develop during follow-up in patients with antiphospholipid antibodies.
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The exclusion of patients with aCL <40 units was based on a prior study showing a strong correlation between aCL titer and thrombosis.
“This restriction criterion was introduced on the basis of the results of a previous clinical study showing a strong correlation between aCL titer and thrombosis [23].”
From Clinical course of high‐risk patients diagnosed with antiphospholipid syndrome (2010) · cites this paper as [23]
The authors' findings do not support prior suggestions that recurrence tends to occur in the same vascular district.
“Our findings do not confirm the findings of previous studies [23,27] that have suggested that the recurrence of an event is more likely to occur in the same vascular district (i.e.venous or arterial).”
From Clinical course of high‐risk patients diagnosed with antiphospholipid syndrome (2010) · cites this paper as [23]
Some prospective studies have failed to produce reliable results because patients with vascular antiphospholipid syndrome and carriers of aPL were considered together.
“Some prospective studies have likewise failed to produce reliable results since patients with vascular antiphospholipid syndrome (APS) and carriers of aPL were considered together.[16][17][18]”
From Risk factors for a first thrombotic event in antiphospholipid antibody carriers: a prospective multicentre follow-up study. (2011) · cites this paper as [16]
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- Authors
- Finazzi, G., Brancaccio, V., Moia, M., Ciavarella, N., Mazzucconi, M. G., Schinco, P., Ruggeri, M., Pogliani, E. M., Gamba, G., Rossi, E., Baudo, F., Manotti, C., D'Angelo, A., Palareti, G., Stefano, V. D., Berrettini, M., & Barbui, T.
- Affiliations
- Ospedale Antonio Cardarelli (IT)
- University of Milan (IT)
- Azienda Universitaria Ospedaliera Consorziale - Policlinico Bari (IT)
- Sapienza University of Rome (IT)
- University of Turin (IT)
- Ospedale San Bortolo (IT)
- Azienda Ospedaliera San Gerardo (IT)
- University of Pavia (IT)
- Luigi Sacco Hospital (IT)
- Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda (IT)
- Ospedale di Parma (IT)
- IRCCS Azienda Ospedliero-Universitaria di Bologna Policlinico di Sant'Orsola (IT)
- Università Cattolica del Sacro Cuore (IT)
- University of Perugia (IT)
- Corresponding author
- Finazzi, Guido
- ORCID
- Venue
- The American Journal of Medicine
- Publisher
- Elsevier BV
- Published
- 1996-05
- Volume
- 100
- Issue
- 5
- Pages
- 530-536
- ISSN
- 0002-9343 (ISSN-L)
- OpenAlex
- W2041297457
- Cited by
- 427
- References
- 38
- Citations by year
- 2025: 1 · 2024: 8 · 2023: 5 · 2022: 4 · 2021: 12 · 2020: 7 · 2019: 6 · 2018: 4 · 2017: 11 · 2016: 13 · 2015: 5 · 2014: 11 · 2013: 13 · 2012: 16
- FWCI
- 12.17
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- The American Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- IRIS Research product catalog (Sapienza University of Rome) (submittedVersion)
- 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 antibodies, lupus anticoagulant, anticardiolipin antibodies, thrombosis, thrombosis risk factors, antibody titers, adverse pregnancy outcomes, miscarriage, vascular occlusion, non-Hodgkin lymphoma, hematologic malignancies, natural history (disease)
- MeSH terms
- Adolescent, Adult, Aged, Anticoagulants, Cause of Death, Child, Child, Preschool, Female, Follow-Up Studies, Humans, Immunoglobulin G, Male, Middle Aged, Pregnancy, Prospective Studies, Risk Factors, Thrombosis, Time Factors, Warfarin, Cohort Studies, Incidence, Logistic Models, Antibodies, Antiphospholipid, Antibodies, Anticardiolipin
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