DVT Burden and the Risk of Post-thrombotic Syndrome

Overview

Post-thrombotic syndrome (PTS) is the most common chronic complication of deep vein thrombosis (DVT), with major consequences for patient quality of life and cost of management. Identifying patients at high risk of developing PTS could be useful for its prevention and may lead to more appropriate therapeutic strategies to reduce its incidence and severity.

Prognostic tools for predicting risk are very useful for choosing the optimum treatment and improving patient management and are a preliminary step before developing predictive models useful for determining sensitivity to treatment. At present, although several prognostic markers and models have been proposed, it is still difficult to predict who will develop a PTS or a moderate to severe PTS. The development of PTS is multifactorial and depends largely on the extent and severity of venous obstruction which supports the theory of thrombosis burden (DVT-Burden) as a potential prognostic marker for PTS. It therefore seems important to study the association between thrombosis burden and the occurrence of PTS.

The Venous Volumetric Index or VVI (Ouriel 1999) will be used for quantifying DVT-Burden. The VVI was constructed by calculating the volume from the diameter and length of 14 venous segments from the calf veins to the inferior vena cava. The VVI has been validated for its ability to discriminate between symptomatic and asymptomatic DVT and has shown superior performance to other methods for quantifying DVT.

This study aim to assess the performance of baseline DVT-burden estimated by the VVI score on ultrasound for predicting the occurrence and the severity of PTS as assessed by the Villalta scale at 6 months.

Description

This is a multicenter prospective cohort study aiming at assessing baseline DVT-Burden and other prognostic factors for predicting the occurrence and the severity of PTS.

Patients diagnosed with a first episode of unprovoked DVT of the lower limbs are recruited in offices and departments of vascular medicine. They will be informed of the study by their physician. If patients agree to take part and meet the eligibility criteria, they will be included consecutively in the study after signing an informed consent form.

The study will include follow-up visits at one week (D7±2), 1 month (D30±5), 3 months (D90±5) and 6 months (D180±5).

At each visit, the following examinations will be carried out:

• Assessment of symptoms and clinical signs to evaluate the Villalta score.
• Venous ultrasound evaluation of the lower limbs by colour Doppler ultrasound (CDUS). Data collected will be useful to calculate the VVI score planned at the study analysis phase.

At the D0, D7, D30 and D90 visits, blood samples will be taken for research purposes to assess factors of inflammation, coagulation and fibrinolysis.

At the D90 and D180 visits, the patient will also be asked to complete the VEINES-QOL and SF-36 quality of life questionnaires.

The patient's participation in the research will end at the end of the D180 visit.

Eligibility

Inclusion Criteria:

1. Age ≥ 18 years
2. Outpatients with acute deep venous thrombosis of the lower limbs confirmed by ultrasound on the criteria of venous incompressibility and direct image of the thrombus
3. Affiliates or beneficiaries of a social security scheme.

Exclusion Criteria:

1. Pregnant women, women in labour or breastfeeding mothers.
2. Suspected or confirmed pulmonary embolism.
3. Asymptomatic venous thrombosis.
4. Bilateral venous thrombosis.
5. History of ipsilateral or contralateral venous thrombosis of the lower limb.
6. DVT caused by a major transient risk factor (surgery with general anaesthetic > 30 minutes in the last 3 months; fracture of the lower limbs in the last 3 months; immobilisation > 3 days for acute medical reasons in the last 3 months; oestroprogestogenic contraception, pregnancy, post-partum, menopausal hormone treatment).
7. DVT caused by a minor risk factor (Surgery with general anaesthetic < 30 minutes in the last 2 months; Trauma to a non-plastered lower limb with reduced mobility ≥ 3 days; Immobilisation < 3 days for acute medical reason in the last 2 months; Travel > 6 hours in the last 2 months).
8. Active cancer defined as cancer for which treatment is ongoing, treatment has not been effective (recurrence or progression) or treatment is palliative.
9. Chronic inflammatory bowel disease.
10. Time between onset of symptoms and diagnosis > 14 days.
11. Prophylactic or therapeutic anticoagulant treatment > 48 hours.
12. Expected duration of anticoagulant treatment < 3 months (all patients must have a minimum treatment of 3 months).
13. Known contraindication to anticoagulant treatment (chronic renal insufficiency defined by creatinine clearance < 30 ml/min according to the Cockcroft-Gault formula; platelets < 100,000/mm3; active bleeding or high risk of bleeding (gastric ulcer, recent haemorrhagic stroke, etc.); known liver disease (Child Pugh class B and class C)).
14. Treatment with antiplatelet agents other than Aspirin ≤ 160 mg/ 24H or Clopidogrel ≤ 75 mg, non-steroidal anti-inflammatory drugs.
15. Indication for interruption of the inferior vena cava or venous recanalisation (endovascular, thrombolysis or surgery).
16. Refusal or inability to give written informed consent to participate in the study.
17. Life expectancy < 6 months.
18. Patients under legal protection (guardianship, curatorship, etc.) or safeguard of justice.
19. Patients taking part in a therapeutic trial for venous thromboembolism.