Superficial Vein Thrombosis (SVT) Treated With Rivaroxaban Versus Fondaparinux

Inclusion Criteria

• acute symptomatic supragenual superficial vein thrombosis of the leg
• at least one of the following major risk factor for VTE:
• age > 65 years or
• male sex or
• history of DVT/PE/SVT or
• history of cancer or active cancer or
• autoimmune disease or
• SVT of a non-varicose vein
• thrombus extension of at least 5 cm
• proximal thrombus end with more than 3 cm distance to the saphenofemoral junction (SFJ)
• age > 18 years
• written informed consent

Exclusion Criteria

• other indication for therapeutic anticoagulation such as acute deep vein thrombosis, acute pulmonary embolism, atrial fibrillation with indication for anticoagulant therapy
• any PE or DVT within last 6 months before inclusion
• clinical signs of PE without objective exclusion (CT or VQ scan, angiography)
• SVT without signs of thrombotic/inflammatory activity (activity signs: diameter > 4 mm, pain, redness, elevated local or systemic temperature)
• SVT after sclerotherapy
• Duration of symptoms > 3 weeks
• pretreatment of more than 72 h with therapeutic dosages of oral or parenteral anticoagulants
• pretreatment of more than 5 days with subtherapeutic oral or parenteral anticoagulants
• indication for escalated antiplatelet therapy (monotherapy with aspirin > 325 g/d and any dual antiplatelet therapy)
• SVT closer than 3 cm to saphenofemoral junction (SVJ)
• anticipated superficial vein surgery within 90 days
• anticipated thrombolytic therapy within 90 days
• manifest clinically relevant bleeding
• clinically relevant bleeding in the last 30 days before study inclusion
• major surgery within last 30 days before inclusion
• ophthalmic, spinal or cerebral surgery within last 90 days
• severe head trauma within last 90 days
• hemorrhagic stroke within last 12 months
• hereditary or acquired severe hemorrhagic diathesis
• gastrointestinal bleeding within last 90 days requiring endoscopy
• uncontrolled arterial hypertension (systolic > 180 mm Hg, diastolic > 110 mm Hg)
• acute endocarditis
• low platelet count (< 100 x 109/l)
• Prothrombin time < 50 %
• calculated creatinine clearance < 30 ml/min
• significant liver disease such as acute hepatitis, chronic active hepatitis, cirrhosis
• life expectancy < 3 months
• any contraindications listed for rivaroxaban or fondaparinux
• women of child bearing potential without safe contraception method
• pregnant or breastfeeding women
• participation in another trial with pharmacological intervention