Items | Description | |
---|---|---|
Demographics | Sex, race, age, duration of followup | |
Diagnosis | According to the most recent international classification criteria | |
APS clinical manifestations | As previously described5. Non-criteria manifestations defined as those not included in the updated classification criteria4, including cardiac: valvular disease, systolic dysfunction, pulmonary hypertension; pulmonary: acute respiratory distress syndrome, hemorrhagic alveolitis; central nervous system: transient ischemic attack, severe headache, epileptic seizures, cognitive dysfunctions, white matter lesions, transverse myelitis, movement disorders; renal: renal arterial stenosis, thrombotic microangiopathy; cutaneous: livedo reticularis, ulcers, digital gangrene, subungual splinter hemorrhages; ocular: ischemic optical neuritis; endocrinological: hyperprolactinemia, hyposurrenalism; hematological: thrombocytopenia, hemolytic anemia; osteoarticular: osteonecrosis, bone infarct. | |
Serologic changes* | LA | By coagulation assay |
IgG-IgM aCL | By ELISA | |
IgG-IgM anti-β2-GPI | By ELISA | |
ANA | By indirect immunofluorescence on Hep-2 cells substrate (≥ 1:160) | |
Anti-dsDNA | By Farr ammonium sulfate precipitation technique, ELISA, and/or indirect immunofluorescence on Crithidia luciliae substrate | |
Anti-ENA | By ELISA or by homemade counter-immunoelectrophoresis using calf and rabbit thymus and human spleen extracts | |
C3, C4 | By nephelometry and/or immunoturbidimetry and/or radial immunodiffusion | |
Cardiovascular risk factors | Hormonal therapy | Estroprogestinic pill or hormonal replacement therapy |
Obesity | Body mass index ≥ 30 | |
Smoking | Present use of cigarettes | |
Diabetes mellitus | Any previous diagnosis of diabetes or 2 glycemia tests ≥ 126 mg/dl | |
Hypercholesterolemia | Total cholesterol blood levels ≥ 200 mg/dl | |
Hyperhomocysteinemia | Blood homocysteine above the normal limit | |
Systemic arterial hypertension | Arterial blood pressure ≥ 140/90 mmHg | |
Inherited thrombophilia | Antithrombin or protein C or protein S deficiency, factor V Leiden or prothrombin or methylenetetrahydrofolate reductase mutation | |
Cancer | Any solid or hematological neoplasm diagnosis | |
Therapy | Each drug taken for at least 3 mos at any point during followup | |
Severe comorbidities | Severe infections | Requiring hospitalization |
Severe hemorrhages | Fatal or requiring hospitalization/treatment withdrawal | |
Cancer | Any solid or hematological neoplasm diagnosis | |
Functional damage | Permanent loss of function in any organ or system because of APS |
↵* Only confirmed serological positivity was considered (at least 2 determinations, for antiphospholipid antibodies at least 12 weeks apart). APS: antiphospholipid syndrome; LA: lupus anticoagulant; Ig: immunoglobulin; aCL: anticardiolipin antibodies; anti-β2-GPI: anti-β2 glycoprotein I antibodies; ANA: antinuclear antibodies; anti-ENA: antiextractable nuclear antigens antibodies; C3 and C4: complement fractions.