Cited by 184Systemic Lupus Erythematosus ResearchBlood Coagulation and Thrombosis MechanismsVenous Thromboembolism Diagnosis and Management

The DOI matches its Crossref record; 24 of the 24 references it cites were found in a registry or an index; 3 of the 19 sources its claims cite were checked for support.

Risk factors for a first thrombotic event in antiphospholipid antibody carriers: a prospective multicentre follow-up study.

Open access
Ruffatti, Amelia, Del Ross, Teresa, Ciprian, Manuela, Bertero, Maria T, Salvatore, Sciascia, Scarpato, Salvatore, Montecucco, Carlomaurizio, Rossi, Silvia, Caramaschi, Paola, Biasi, Domenico, Doria, Andrea, Rampudda, Mariaelisa, Monica, Nuzzo, Fischetti, Fabio, Picillo, Ugo, Brucato, Antonio, Salvan, Elisa, Vittorio, Pengo, Meroni, Pierluigi, Tincani, Angela·2011·Annals of the Rheumatic Diseases

Abstract

Objectives To assess risk factors for a first thrombotic event in confirmed antiphospholipid (aPL) antibody carriers and to evaluate the efficacy of prophylactic treatments.Methods Inclusion criteria were age 18-65 years, no history of thrombosis and two consecutive positive aPL results. Demographic, laboratory and clinical parameters were collected at enrolment, once a year during the follow-up and at the time of the thrombotic event, whenever that occurred.Results 258 subjects were prospectively observed between October 2004 and October 2008. The mean ± SD follow-up was 35.0 ± 11.9 months (range 1-48). A first thrombotic event (9 venous, 4 arterial and 1 transient ischaemic attack) occurred in 14 subjects (5.4%, annual incidence rate 1.86%). Hypertension and lupus anticoagulant (LA) were significantly predictive of thrombosis (both at p<0.05) and thromboprophylaxis was significantly protective during high-risk periods (p<0.05) according to univariate analysis. Hypertension and LA were identified by multivariate logistic regression analysis as independent risk factors for thrombosis (HR 3.8, 95% CI 1.3 to 11.1, p<0.05, and HR 3.9, 95% CI 1.1 to 14, p<0.05, respectively).Conclusions Hypertension and LA are independent risk factors for thrombosis in aPL carriers. Thromboprophylaxis in these subjects should probably be limited to high-risk situations.

Overview

AI snapshot

Written from the paper’s full text.

TL;DR

In 258 confirmed antiphospholipid antibody carriers without prior thrombosis, hypertension and lupus anticoagulant were independent risk factors for a first thrombotic event. Thromboprophylaxis appeared protective only when given during high-risk periods.

Key findings

  • A first thrombotic event occurred in 14/258 subjects (5.4%; annual incidence rate 1.86 per 100 patients per year): 9 venous thromboses, 4 arterial thromboses, and 1 transient ischaemic attack.
  • Multivariate Cox analysis identified hypertension (HR 3.8, 95% CI 1.3 to 11.1, p<0.05) and lupus anticoagulant (HR 3.9, 95% CI 1.1 to 14, p<0.05) as independent risk factors for thrombosis.
  • Univariate analysis found hypertension and lupus anticoagulant significantly associated with thrombosis (both p<0.05); Kaplan-Meier analysis showed higher cumulative incidence with hypertension (p<0.01) and lupus anticoagulant (p<0.05).
  • Thromboprophylaxis during high-risk periods was significantly protective (OR 0.1, 95% CI 0.01 to 0.9, p<0.05), whereas continuous prophylaxis was not associated with reduced thromboembolic events.

Methods

  • Prospective multicentre follow-up study of 258 Caucasian confirmed aPL carriers (223 women, 35 men; mean±SD age 40.9±11.1 years) aged 18–65 with no history of thrombosis and at least two consecutive positive aPL results no less than 12 weeks apart, recruited from 11 Italian rheumatology centres between 15 October 2004 and 15 October 2008.
  • Mean±SD follow-up was 35.0±11.9 months; clinical and laboratory parameters were collected at enrolment, once a year, and at any thrombotic event; aPL testing included lupus anticoagulant, IgG/IgM anticardiolipin, and IgG/IgM anti-β2-glycoprotein I.
  • Analyses included univariate tests, Kaplan-Meier survival analysis with log-rank tests, McNemar test, and multivariate Cox proportional hazards modelling adjusted for age, sex, aPL antibodies, hypertension, autoimmune diseases, pregnancy/puerperium, smoking, hypercholesterolaemia, body mass index, pill/hormone replacement therapy, and diabetes mellitus.

Limitations

  • The paper states that there was no central laboratory for aPL testing and that the follow-up period was short.
  • Evident from the text: only 14 thrombotic events occurred, limiting statistical power and precision.
  • Evident from the text: prophylaxis was not randomized, long-term low-dose aspirin was initiated arbitrarily for specified reasons, and drug compliance was monitored by self-report, so confounding by indication is possible.

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

Integrity signals

Registry

Crossref · 10.1136/ard.2010.142042

Cites

24 of 24 references verified0 citation errors · 0 not checkable

Statistics

Nothing to recompute.

Verification

Claims the paper makes

10 Own result · 4 No full text of the sources · 3 Own interpretation · 2 Own method · 1 Mixed support · 1 Not checked yet · accuracy not yet measured

Show all 16 claims

  • Probably not a substantial claim. 2
  • It may state two separate claims as one. 3
5 of 5
  • The paper relies on this without support.

    Drug compliance self-reports accurately reflect actual compliance.

    “Drug compliance was monitored on the basis of self-reports by participants.”
  • The paper relies on this without support.

    The study cohort is representative of confirmed antiphospholipid antibody carriers without a history of thrombosis.

    “A cohort of 258 Caucasian confirmed aPL carriers (223 women and 35 men, mean±SD age 40.9±11.1 years, range 18-65) without a history of thrombosis were prospectively evaluated between 15 October 2004 and 15 October 2008 for a mean±SD follow-up of 35.0±11.9months (range 1-48).”
  • The paper relies on this without support.

    The association between high-risk prophylaxis and reduced thrombosis is not due to confounding by indication or other unmeasured confounders.

    “Thromboembolic events were significantly reduced only when antithrombotic prophylaxis was administered in high-risk situations (OR 0.1, 95% CI 0.01 to 0.9, p<0.05).”
3 of 3

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Metadata

Authors
Ruffatti, A., Del Ross, T., Ciprian, M., Bertero, M. T., Salvatore, S., Scarpato, S., Montecucco, C., Rossi, S., Caramaschi, P., Biasi, D., Doria, A., Rampudda, M., Monica, N., Fischetti, F., Picillo, U., Brucato, A., Salvan, E., Vittorio, P., Meroni, P., & Tincani, A.
Affiliations
  • University of Padua (IT)
  • A. O. Ordine Mauriziano di Torino (IT)
  • University of Pavia (IT)
  • University of Verona (IT)
  • University of Brescia (IT)
  • University of Campania "Luigi Vanvitelli" (IT)
Corresponding author
Ruffatti, Amelia
Venue
Annals of the Rheumatic Diseases
Publisher
Elsevier BV
Published
2011-06
Volume
70
Issue
6
Pages
1083-1086
ISSN
0003-4967 (ISSN-L)
OpenAlex
W2104266044
Cited by
184
References
24
Citations by year
2026: 2 · 2025: 2 · 2024: 7 · 2023: 19 · 2022: 17 · 2021: 15 · 2020: 13 · 2019: 17 · 2018: 8 · 2017: 12 · 2016: 16 · 2015: 9 · 2014: 11 · 2013: 14 · 2012: 13
FWCI
9.57
Type
journal article
Language
en
Update notices
erratum (2011-08-01)
Open access
Locations
  • Annals of the Rheumatic Diseases (publishedVersion)
  • PubMed (publishedVersion)
  • Institutional Research Information System University of Turin (University of Turin) (submittedVersion, other-oa)
  • ArTS Archivio della ricerca di Trieste (University of Trieste https://www.units.it/) (submittedVersion)
  • HighWire Press Open Archive (submittedVersion)
  • Padua Research Archive (University of Padova) (submittedVersion)
Topics
  • Health Sciences › Medicine › Rheumatology › Systemic Lupus Erythematosus Research
  • Health Sciences › Medicine › Hematology › Blood Coagulation and Thrombosis Mechanisms
  • Health Sciences › Medicine › Internal Medicine › Venous Thromboembolism Diagnosis and Management
Keywords
antiphospholipid antibodies, thrombosis, thromboprophylaxis, hypertension, lupus anticoagulant, risk factors, venous thrombosis, arterial thrombosis, transient ischemic attack, thrombosis incidence
MeSH terms
Adult, Autoantibodies, Epidemiologic Methods, Female, Humans, Hypertension, Male, Middle Aged, Thrombosis, Lupus Coagulation Inhibitor, Antiphospholipid Syndrome, Antibodies, Antiphospholipid, Young Adult

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