Postthrombotic Syndrome

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.

This trial is a prospective, multicenter, randomized controlled, superiority study. According to the inclusion and exclusion criteria for clinical research subjects, 104 patients with acute deep vein thrombosis involving the iliac and femoral veins were recruited. Qualified subjects were randomly (1:1) assigned to either the experimental group or the control group. The experimental group received thrombus aspiration, with or without balloon dilation, stent implantation, and other accompanying surgical treatments, combined with standard anticoagulant therapy, while the control group received only standard anticoagulant therapy. The efficacy and safety of the experimental group in treating acute iliac and femoral vein thrombosis were compared. The main efficacy endpoint of this study is the 24 month postoperative composite endpoint, with the following hierarchical order: 1. in-hospital mortality or treatment upgrade; 2. Recurrent venous thrombosis or newly developed pulmonary embolism of the target lesion within 24 months; 3. Severity of Villalta score at 24 months; 4. Change in VEINES score after 24 months. Simultaneously observe other secondary efficacy endpoints and safety endpoints. Clinical follow-up was conducted before discharge, 30 days after surgery, 6 months after surgery, 12 months after surgery, and 24 months after surgery.

Ongoing registration of patients with venous thromboembolism treated by means of antithrombotic therapy, thrombolisys, open surgery, endovenous desobstruction and stenting.