Rivaroxaban With Diosmin in Long-term Treatment of Deep Vein Thrombosis

The Efficacy of Rivaroxaban With Diosmin in the Long-term Treatment of Acute Proximal Deep Vein Thrombosis

The randomized clinical study aimed to assess the efficacy and safety of standard anticoagulation with rivaroxaban in combination with diosmin compared to the isolated use of standard rivaroxaban for prolonged therapy of acute femoro-popliteal deep vein thrombosis reflected the speed of deep vein recanalization and incidence of post-thrombotic syndrome.

Deep vein thrombosis is an acute inflammatory disease that affects vein wall and leads to the structural changes in the wall and valves reflected with chronic venous insufficiency that called postthrombotic syndrome (PTS).

Diosmin as a flavonoid agent has properties to reduce leukocyte-endothelial interaction and inflammatory response, that could reduce the damage to venous wall and valves.

The hypothesis of the study is based on assumption that diosmin combined with standard anticoagulation can improve outcomes of femoro-popliteal DVT due to increase speed of veins recanalization, decrease of vein wall inflammation and finally decrease the incidence of PTS at 6 month and 1 year after index DVT.

Inclusion Criteria:

• Age over 18 years
• The first episode of femoro-popliteal deep vein thrombosis (DVT)
• Verification of DVT by duplex ultrasound
• Informed consent signed

Exclusion Criteria:

• Suspicion of pulmonary embolism (PE)
• Verified PE
• Bilateral DVT
• Contraindications for rivaroxaban (in accordance with the official instructions)
• Contraindications for diosmin (in accordance with the official instructions)
• Active cancer
• Verified severe thrombophilia (antiphospholipid antibodies, deficiency of proteins C, S, antithrombin 3)
• Use of other anticoagulants for more than 7 days from the DVT verification
• Impossibility of using compression stocking after 3 days from DVT verification
• Performed surgical intervention on the superficial or deep veins of the lower extremities (thrombolysis, thrombectomy, vein ligation, implantation of the inferior cava filter)
• Continuous use of other drugs that affect the hemostasis system (except for acetylsalicylic acid in a dose of not more than 100 mg).
• Low compliance