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

Vittorio Pengo, Amelia Ruffatti, Cristina Legnani, Sophie Testa, Tiziana Fierro, Francesco Marongiu, Valeria De Micheli, Paolo Gresele, Marta Tonello, Angelo Ghirarduzzi, Elisa Bison, Gentian Denas, Alessandra Banzato, Seena Padayattil Jose and Sabino Iliceto

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  • Table 1

    Demographic and clinical characteristics

    CharacteristicsValue
    No.104
    Age, y (mean ± SD)45 ± 15
    Female, no. (%)82 (79)
    IgG isotype, no. (%)86 (83)
        dRVVT mixing (mean ± SD)1.78 ± 0.5
        IgG aCL, GPL units (mean ± SD)102 ± 91
        IgG aβ2GPI, units (mean ± SD)123 ± 154
    IgM isotype, no. (%)
        dRVVT mixing18 (17)
        IgM aCL, GPL units (mean ± SD)1.42 ± 0.3
        IgM aβ2GPI, units (mean ± SD)81 ± 58
    Reason for initial testing, no. (%)
        Prolonged aPTT55 (53)
        Autoimmune disorder39 (37)
        Family history for thrombosis4 (4)
        Migraine2 (2)
    Autoimmune disorders, no. (%)
        SLE14 (13)
        Other35 (34)
    Risk for arterial thrombosis* no. (%)34 (33)
    Risk for venous thrombosis no. (%)30 (29)
    • dRVVT indicates diluted Russell viper venom time; and aPTT, activated partial thromboplastin time.

    • * Considered risk factors for arterial thrombosis: diabetes mellitus, hypertension, hypercholesterolemia, obesity, smoking habit, and family history.

    • Considered risk factor for venous thrombosis: recent surgical intervention, perioperative immobilization, oral estroprogestinic treatment, pregnancy, malignancy, family history, thrombophilia, and previous VTE.

  • Table 2

    Details of subjects affected by thromboembolism in the follow-up period

    Patient no.Age, ySexIg isotype (G or M)Time lag,* yPrimary prophylaxisType of event
    113FemaleG5.4ASAStroke
    261MaleG0.9Stroke
    324FemaleG18.4ASARenal thrombotic microangiopathy
    456FemaleG2.5Proximal DVT
    554MaleG4ASAProximal DVT
    625FemaleG1.8Stroke
    743FemaleG1.5Proximal DVT
    830FemaleG2.6PE
    933FemaleG2Stroke
    1054MaleG4Stroke
    1122MaleM1.2Proximal DVT + PE
    1257FemaleG2.1Myocardial infarction
    1348MaleG2.4Stroke
    1444FemaleG3.1Proximal DVT + PE
    1538MaleG1.8Proximal DVT
    1650MaleG1Proximal DVT + PE
    1740MaleG3PE
    1865FemaleG9TIA
    1922FemaleG1.7Right atrial thrombosis
    2057FemaleG5ASATIA
    2141FemaleM11.5ASARetinal artery thrombosis
    2255FemaleG4.8Proximal DVT
    2345FemaleM2ASAProximal DVT
    2453FemaleG3.2ASAStroke
    2531FemaleG2.8Stroke
    • — indicates no primary prophylaxis; ASA, aspirin 100 mg 4 times a day; DVT, deep vein thrombosis; PE, pulmonary embolism; and TIA, transient ischemic attack.

    • * Time interval from laboratory finding to the thromboembolic event.

    • All the clinical events had a pertinent area of ischemia at cerebral imaging.

  • Table 3

    Risk factors for thrombosis in the follow-up period

    Risk factorThrombosis (N = 25)Controls (N = 79)Hazard ratio
    Univariate95% CIMultivariate95% CI
    Age, y (mean ± SD)42.4 ± 14.245.3 ± 14.71.00.97-1.02
    Male sex no. (%)8 (32)14 (18)3.31.4-8.04.41.5-13.1
    aCL titre, GPL units (mean ± SD)95 ± 8584 ± 911.00.99-1.01
    G isotype, no. (%)22 (88)64 (81)1.70.5-5.6
    Associated autoimmune diseases, no.(%)10 (40)39 (49)0.60.2-1.1
    Arterial risk factors, no. (%)8 (32)26 (33)0.90.4-2.2
    Venous risk factors, no. (%)10 (40)12 (15)2.71.2-6.33.31.3-8.5
    Aspirin prophylaxis, no. (%)7 (28)30 (38)0.40.1-1.1
    • — indicates not significant.