Cited by 468Systemic Lupus Erythematosus ResearchVenous Thromboembolism Diagnosis and ManagementBlood Coagulation and Thrombosis Mechanisms

The DOI matches its Crossref record; 28 of the 28 references it cites were found in a registry or an index; 4 of the 15 sources its claims cite were checked for support.

Incidence of a first thromboembolic event in asymptomatic carriers of high-risk antiphospholipid antibody profile: a multicenter prospective study

Open access

Abstract

Persistent antiphospholipid (aPL) antibodies are occasionally found in subjects without prior history of thromboembolic events (TEs), raising the dilemma of whether to initiate or not a primary thromboprophylaxis. A first TE is considered rare in aPL carriers, but previous studies did not consider the aPL profile nor was the test positivity confirmed in a reference laboratory. In this study, 104 subjects with high-risk aPL profile (positive lupus anticoagulant, anticardiolipin, and anti-β2–glycoprotein I antibodies, triple positivity) confirmed in a reference laboratory, were followed up for a mean of 4.5 years. There were 25 first TEs (5.3% per year): the cumulative incidence after 10 years was 37.1% (95% confidence interval [CI], 19.9%-54.3%). On multivariate analysis, male sex (hazard ratio = 4.4; 95% CI, 1.5-13.1, P = .007) and risk factors for venous thromboembolism (hazard ratio = 3.3; 95% CI, 1.3-8.5, P = .01) were independent predictors for TEs. Aspirin did not significantly affect the incidence of TE. In conclusion, the occurrence of a first TE in carriers of high-risk aPL profile is considerable; it is more frequent among male subjects and in the presence of additional risk factors for venous TE. These data can help in the decision to initiate primary thromboprophylaxis in these subjects.

Overview

AI snapshot

Written from the paper’s full text.

TL;DR

In 104 asymptomatic carriers of triple-positive antiphospholipid antibodies confirmed in a reference laboratory, first thromboembolic events occurred at 5.3% per year, with a 10-year cumulative incidence of 37.1%. Male sex and venous thromboembolism risk factors independently predicted events, whereas aspirin did not significantly reduce them.

Key findings

  • During 469 patient-years of follow-up, there were 25 first thromboembolic events (5.3% per year); cumulative incidence was 9.8% (95% CI, 3.7%-15.9%) at 2 years, 27.3% (95% CI, 17.1%-37.5%) at 5 years, and 37.1% (95% CI, 19.9%-54.3%) at 10 years.
  • On multivariate analysis, independent predictors of thromboembolism were male sex (hazard ratio 4.4; 95% CI, 1.5-13.1; P = .007) and presence of risk factors for venous thromboembolism (hazard ratio 3.3; 95% CI, 1.3-8.5; P = .01).
  • Aspirin prophylaxis did not significantly affect thromboembolic events on multivariate analysis (hazard ratio 0.5; 95% CI, 0.2-1.5; P = .2); it was close to significance on univariate analysis but did not achieve statistical significance.
  • Among the 25 events, there were 12 arterial and 11 venous thromboembolic events, 1 right atrial thrombosis, and 1 renal thrombotic microangiopathy.

Methods

  • Multicenter prospective cohort of 104 subjects with high-risk antiphospholipid antibody profile (triple positivity: lupus anticoagulant, anticardiolipin, and anti-β2-glycoprotein I antibodies) on 2 occasions at least 12 weeks apart, without clinical features of antiphospholipid syndrome; triple positivity was confirmed in a reference laboratory. Mean age was 45 years, 79% were female, and mean follow-up was 4.5 years.
  • Subjects were seen annually or earlier as clinically indicated; no long-term anticoagulant treatment was prescribed, and short-term low-molecular-weight heparin was given in high-risk thromboembolism scenarios. Data collected included demographic, laboratory, and clinical variables, autoimmune disease, arterial and venous risk factors, and aspirin treatment.
  • Kaplan-Meier survival analysis estimated cumulative incidence of thromboembolism; Cox regression survival analysis identified predictors among demographic factors, autoimmune diseases, anticardiolipin isotype, arterial and venous risk factors, and aspirin treatment. Statistical significance was set at P < .05; analyses used SPSS.

Limitations

  • The paper does not include a formal limitations section. It states that larger clinical trials are definitely needed to test hypotheses about aspirin and hydroxychloroquine.
  • Evident from the text: treatment with aspirin was observational rather than randomized, so confounding by indication cannot be excluded; the cohort had 104 subjects and 25 events, yielding wide confidence intervals for some estimates.

Model-written summary. Check it against the paper before relying on it.

Integrity signals

Registry

Crossref · 10.1182/blood-2011-03-340232

Cites

28 of 28 references verified0 citation errors · 0 not checkable

Statistics

Nothing to recompute.

Verification

Claims the paper makes

8 Own result · 7 No full text of the sources · 4 Own interpretation · 3 Own method · 2 Partly supported · 1 Supported so far · 1 Couldn’t confirm · accuracy not yet measured

Show all 18 claims

  • Probably not a substantial claim. 7
  • It may state two separate claims as one. 3
8 of 8
  • The paper relies on this without support.

    The clinical course of persons carrying a high-risk antiphospholipid antibody profile (triple positivity) is not known.

    “The clinical course in persons with high-risk aPL antibody profile (triple positivity) is not known, casting a shadow on the need for primary prophylaxis to avoid TEs.”
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Metadata

Authors
Pengo, V., Ruffatti, A., Legnani, C., Testa, S., Fierro, T., Marongiu, F., De Micheli, V., Gresele, P., Tonello, M., Ghirarduzzi, A., Bison, E., Denas, G., Banzato, A., Padayattil Jose, S., & Iliceto, S.
Affiliations
  • Departments of Clinical Cardiology and
  • University of Padua (IT)
  • University of Bologna (IT)
  • District Hospital, Cremona, Italy;
  • University of Perugia (IT)
  • University of Cagliari (IT)
  • Transfusion Medicine, District Hospital, Merate, Italy; and
  • Santa Maria Nuova Hospital (IT)
Venue
Blood
Published
2011-10-27
Volume
118
Issue
17
Pages
4714-4718
ISSN
  • 0006-4971 (ISSN-L)
  • 1528-0020
OpenAlex
W1975074770
Cited by
468
References
28
Citations by year
2026: 13 · 2025: 14 · 2024: 35 · 2023: 36 · 2022: 18 · 2021: 41 · 2020: 46 · 2019: 42 · 2018: 39 · 2017: 38 · 2016: 29 · 2015: 23 · 2014: 33 · 2013: 28 · 2012: 28
FWCI
18.65
Type
journal article
Language
en
Open access
Licence
other-oa
Locations
  • Blood (publishedVersion)
  • PubMed (publishedVersion)
  • UNICA IRIS Institutional Research Information System (University of Cagliari) (submittedVersion, other-oa)
  • Padua Research Archive (University of Padova) (submittedVersion)
Topics
  • Health Sciences › Medicine › Rheumatology › Systemic Lupus Erythematosus Research
  • Health Sciences › Medicine › Internal Medicine › Venous Thromboembolism Diagnosis and Management
  • Health Sciences › Medicine › Hematology › Blood Coagulation and Thrombosis Mechanisms
Keywords
antiphospholipid antibodies, thromboembolic events, lupus anticoagulant, anticardiolipin antibodies, anti-beta2-glycoprotein I antibodies, triple positivity, venous thromboembolism, aspirin, primary thromboprophylaxis, risk factors, male sex, incidence
MeSH terms
Adolescent, Adult, Aged, Disease Susceptibility, Female, Follow-Up Studies, Humans, Male, Middle Aged, Prospective Studies, Risk Factors, Thromboembolism, Incidence, Antiphospholipid Syndrome, Antibodies, Antiphospholipid, Early Diagnosis, Young Adult

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