Definitions of high-risk venous thromboembolism (VTE) and cardiovascular disease (CVD) profiles based on general population guidelines

To determine if a thrombotic event occurred in a patient with a high-risk VTE or high-risk CVD profile, investigators should make every effort to collect and review risk factor data based on patient report or medical record review. If clinically relevant VTE or CVD risk factors at the time of an historical thrombotic event are unknown in the data source, then the lowest possible non-zero weight should be assigned to the macrovascular event to avoid overestimation of antiphospholipid antibody (aPL) contribution to thrombosis.

High-risk VTE profile is defined based on 1 or more major or 2 or more minor VTE risk factors, if timeline/severity is associated with the event based on investigator's judgment (timelines based on general population guidelines are provided when available).
1. Major VTE risk factors (any of the following at the time of the event):
  - Active malignancy with no or noncurative treatment received, ongoing curative treatment including hormonal therapy, or recurrence/progression despite curative treatment at the time of the event.
  - Hospital admission confined to bed (only bathroom privileges) with an acute illness for at least 3 days within 3 months prior to the event.
  - Major trauma with fractures or spinal cord injury within 1 month prior to the event.
  - Surgery with general/spinal/epidural anesthesia for >30 minutes within 3 months prior to the event.
1. Minor VTE risk factors (2 or more of the following at the time of the event):
  - Active systemic autoimmune disease or active inflammatory bowel disease using disease activity measures guided by current recommendations.
  - Acute/active severe infection according to guidelines, eg, sepsis, pneumonia, SARS-CoV-2.
  - Central venous catheter in the same vascular bed.
  - Hormone replacement therapy, estrogen containing oral contraceptives, or ongoing in vitro fertilization treatment.
  - Long distance travel (≥8 hours).
  - Obesity (body mass index [BMI] ≥30 kg/m²).
  - Pregnancy or postpartum period within 6 weeks after delivery.
  - Prolonged immobilization not counted above, eg, leg injury associated with reduced mobility, or confined to bed out of hospital for at least 3 days.
  - Surgery with general/spinal/epidural anesthesia for <30 minutes within 3 months prior to the event.

High-risk CVD profile is defined based on 1 or more high CVD risk factors or 3 or more moderate CVD risk factors, if timeline/severity is associated with the event based on investigator's judgment (timelines based on general population guidelines are provided when available).
1. High CVD risk factors (any of the following at the time of the event):
  - Arterial hypertension with systolic blood pressure (BP) ≥180 mmHg or diastolic BP ≥110 mmHg.
  - Chronic kidney disease with estimated glomerular filtration rate ≤60 mL/minute for more than 3 months.
  - Diabetes mellitus with organ damage^* or long disease duration (type 1 for ≥20 years; type 2 for ≥10 years).
  - Hyperlipidemia (severe) with total cholesterol ≥310 mg/dL (8 mmol/L) or low-density lipoprotein (LDL) cholesterol >190 mg/dL (4.9 mmol/L).
1. Moderate CVD risk factors (3 or more of the following at the time of the event):
  - Arterial hypertension on treatment, or with persistent systolic BP ≥140 mmHg or diastolic BP ≥90 mmHg.
  - Current tobacco smoking.
  - Diabetes mellitus with no organ damage^* and short disease duration (type 1 <20 years; type 2 <10 years).
  - Hyperlipidemia (moderate) on treatment, or with total cholesterol above normal range and <310 mg/dL (8 mmol/L), or LDL cholesterol above normal range <190 mg/dL (4.9 mmol/L).
  - Obesity (BMI ≥30 kg/m²).

* Diabetes mellitus diagnosis based on a hemoglobin A1c ≥6.5%, or a fasting plasma glucose ≥126 mg/dL (7.0 mmol/L), or symptoms of diabetes (eg, polyuria, polydipsia, or unexplained weight loss) with a random plasma glucose concentration ≥200 mg/dL (11.1 mmol/L). According to the 2019 ESC/EASD guidelines on diabetes, organ damage is defined by proteinuria, chronic kidney disease, left ventricular hypertrophy, or retinopathy.

From: Barbhaiya M, Zuily S, Naden R, et al. The 2023 ACR/EULAR Antiphospholipid Syndrome Classification Criteria. Arthritis Rheumatol 2023; 75:1687. https://acrjournals.onlinelibrary.wiley.com/doi/10.1002/art.42624. Copyright © 2023 American College of Rheumatology. Reproduced with permission of John Wiley & Sons Inc. This image has been provided by or is owned by Wiley. Further permission is needed before it can be downloaded to PowerPoint, printed, shared or emailed. Please contact Wiley's permissions department either via email: [email protected] or use the RightsLink service by clicking on the 'Request Permission' link accompanying this article on Wiley Online Library (https://onlinelibrary.wiley.com/).

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Definitions of high-risk venous thromboembolism (VTE) and cardiovascular disease (CVD) profiles based on general population guidelines