Iliofemoral Venous Thrombosis
Conditions
Brief summary
* Iliofemoral DVTs (IF DVTs) are vascular disorders associated with high morbidity and mortality, which can be complicated by long-term post-thrombotic syndrome (PTS). * Pharmaco mechanical thrombolysis (PMT) is an innovative endovascular technique involving in situ fibrinolysis of the thrombus in the acute phase of thrombosis, followed by mechanical extraction by fragmenting the thrombus. * The American ATTRACT study showed that management by catheter-directed thrombolysis and/or PMT in the acute phase is safe and effective at 2 years in a subgroup of DVTif compared with anticoagulation (18% moderate or severe SPT with thrombolysis vs. 28% without thrombolysis). * PMT-DVT will be the first study to assess the medium (30 months) and long-term (60 months) efficacy of PMT in the French context, using data from the French National Health Data System.
Detailed description
Patients with acute iliofemoral thrombosis will be included in the study after consent. They will be randomized to pharmaco-mechanical thrombolysis combined with anticoagulant therapy with direct oral anticoagulant versus direct anticoagulant therapy alone. They will be monitored, and patients in the anticoagulation-only group may undergo stenting angioplasty in the chronic phase if they present a moderate post-thrombotic syndrome or venous claudication. At the end of 30 months, a medico-economic analysis will be carried out.
Interventions
DEVICEpharmaco mechanical thrombolysis
arm with the pharmaco mechanical thrombolysis intervention combined with anticoagulant treatment with direct oral anticoagulants
Sponsors
Nantes University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients who agreed to participate in the study and gave oral consent. * Patient affiliated to a social security scheme * Iliac and/or common femoral venous thrombosis * Recent thrombosis less than or equal to 14 days since qualifying imaging or less than or equal to 21 days since onset of symptoms And at least 1 of the following criteria: * Visual analog scale greater than or equal to 5 and/or * Venous claudication and/or * Increase in thigh circumference greater than or equal to 5% compared with contralateral thigh.
Exclusion criteria
* Patients with superficial femoral or popliteal venous thrombosis without involvement of the common femoral or iliac veins. * Patients with isolated thrombosis of the inferior vena cava, without extension to the iliac veins. * Thrombosis of inferior vena cava proximal to the renal veins. * Minors, pregnant women, adults under guardianship. * Chronic renal failure with creatinine clearance below 30ml/min according to Cockroft. * Ischaemic phlebitis: proximal venous thrombosis associated with limb ischemia and impaired arterial flow.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cost-utility analysis | 30 month | Cost-utility analysis of the economic efficiency of the PMT strategy compared with the anticoagulation strategy for the treatment of DVT from a collective perspective and a 30-month time horizon |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with Villalta score greater than or equal to 10 | 30 month | Number of patients with Villalta score greater than or equal to 10 |
| Number of patients with Villalta score greater than or equal to 15, or presence of ulceration | 30 month | Number of patients with Villalta score greater than or equal to 15, or presence of ulceration |
| Number of major hemorrhages and number of clinically relevant non-major hemorrhages according to ISTH criteria | 1, 30 and 60 month | Number of major hemorrhages and number of clinically relevant non-major hemorrhages according to ISTH criteria |
| Number of patients with pain greater than or equal to 7 as assessed by the visual analog scale, or the presence of venous claudication, or lower-limb edema with a circumference greater than 20% of the contralateral leg, or failure to return to work. | 1 month | Number of patients with pain greater than or equal to 7 as assessed by the visual analog scale, or the presence of venous claudication, or lower-limb edema with a circumference greater than 20% of the contralateral leg, or failure to return to work. |
| VEIN-QOL | 1,30 and 60 month | overall assessment by questionnaire |
| CIVIQ 20 | 1,30 and 60 month | score 0 to 100 |
| SF36 scores | 1,30 and 60 month | score 0 to 100 |
| Number of patients with onset of venous claudication | 30 month | Number of patients with onset of venous claudication |
| Number of patients with a trophic disorder, assessed by clinical examination | 60 month | Number of patients with a trophic disorder, assessed by clinical examination |
| Incremental cost-utility ratio of MPT compared with anticoagulation strategy | 60 month | Incremental cost-utility ratio of MPT compared with anticoagulation strategy |
| Net financial impact over 5 years of TPM distribution | 60 month | Net financial impact over 5 years of TPM distribution |
Countries
France
Contacts
CONTACTOlivier Espitia, Dr
Outcome results
None listed