title: Incidence of a first thromboembolic event in asymptomatic carriers of high-risk antiphospholipid antibody profile: a multicenter prospective study.
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-β(2)-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.
authors.affiliation: Departments of Clinical Cardiology, University Hospital, Padova, Italy. vittorio.pengo@unipd.it
authors.forename: Vittorio
authors.initials: V
authors.lastname: Pengo
authors.forename: Amelia
authors.initials: A
authors.lastname: Ruffatti
authors.forename: Cristina
authors.initials: C
authors.lastname: Legnani
authors.forename: Sophie
authors.initials: S
authors.lastname: Testa
authors.forename: Tiziana
authors.initials: T
authors.lastname: Fierro
authors.forename: Francesco
authors.initials: F
authors.lastname: Marongiu
authors.forename: Valeria
authors.initials: V
authors.lastname: De Micheli
authors.forename: Paolo
authors.initials: P
authors.lastname: Gresele
authors.forename: Marta
authors.initials: M
authors.lastname: Tonello
authors.forename: Angelo
authors.initials: A
authors.lastname: Ghirarduzzi
authors.forename: Elisa
authors.initials: E
authors.lastname: Bison
authors.forename: Gentian
authors.initials: G
authors.lastname: Denas
authors.forename: Alessandra
authors.initials: A
authors.lastname: Banzato
authors.forename: Seena
authors.initials: S
authors.lastname: Padayattil Jose
authors.forename: Sabino
authors.initials: S
authors.lastname: Iliceto
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D017152:Antibodies, Antiphospholipid / Q000097:blood* / Q000378:metabolism; D016736:Antiphospholipid Syndrome / Q000097:blood / Q000150:complications* / Q000175:diagnosis* / Q000453:epidemiology; D004198:Disease Susceptibility / Q000097:blood / Q000175:diagnosis / Q000209:etiology; D042241:Early Diagnosis; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D015994:Incidence; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D012307:Risk Factors; D013923:Thromboembolism / Q000175:diagnosis* / Q000453:epidemiology / Q000209:etiology*; D055815:Young Adult
chemical_list: D017152:Antibodies, Antiphospholipid