Varicose Veins Leg, Venous Insufficiency (Chronic)(Peripheral), Venous Thrombosis, Venous Thrombosis Deep (Limbs)
Conditions
Keywords
EHIT, Endothermal heat-induced thrombosis, Endovenous laser ablation, Great saphenous vein, Apixaban, Rivaroxaban, Thromboprophylaxis
Brief summary
Endothermal heat-induced thrombosis (EHIT) is a thrombotic complication specific to endovenous thermal ablation of the great saphenous vein (GSV), for which no prophylactic regimen is standardized. This single-centre, single-operator randomized trial compared a brief 5-day post-procedural course of the direct oral anticoagulants apixaban and rivaroxaban against no anticoagulation for the prevention of EHIT after GSV endovenous laser ablation performed with concurrent below-knee foam sclerotherapy. Treated limbs were randomly allocated 2:1:1 (no anticoagulant : rivaroxaban : apixaban), and EHIT was graded on post-ablation duplex by the American Venous Forum (AVF) classification.
Detailed description
The unit of randomization was the treated limb, assigned by a computer-generated random sequence. Some participants underwent bilateral procedures and could contribute limbs to different arms; within-participant correlation was addressed with patient-clustered robust standard errors and a one-limb-per-patient sensitivity analysis. The primary endpoint was clinically significant (AVF class ≥II) EHIT on the first post-ablation duplex, which was performed and interpreted by two registered vascular technologists blinded to treatment allocation, with adjudication by the treating physician.
Interventions
DRUGApixaban
5 mg orally twice daily for 5 days
DRUGRivaroxaban
20 mg orally once daily for 5 days
Sponsors
Heart, Artery, and Vein Center of Fresno
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
Who is masked: Outcomes Assessor (duplex read by blinded technologists)
Intervention model description
Parallel Assignment · Number of Arms: 3 Allocation: Randomized Masking: Single → Who is masked: Outcomes Assessor (duplex read by blinded technologists) 564 - Actual participants (723 treated limbsanalyzed units)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Adults aged 18 years or older Undergoing great saphenous vein endovenous laser ablation for symptomatic reflux Concurrent below-knee foam sclerotherapy
Exclusion criteria
Known thrombophilia Current oestrogen or hormone-replacement therapy Family history of venous thromboembolism or thrombophilia Active malignancy Prior ipsilateral ablation Deep venous reflux or obstruction
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Limbs With Clinically Significant EHIT (AVF Class ≥II) | Up to 1 week after the ablation procedure | Incidence of clinically significant EHIT (AVF class ≥II) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Limbs With Any EHIT (AVF Class I-IV) | Up to 1 week after the ablation procedure | Any EHIT (AVF class I-IV) - first post-ablation duplex |
| Number of Limbs With Remote (Non-contiguous) Deep Vein Thrombosis | Up to 1 week after the ablation procedure | Remote (non-contiguous) deep vein thrombosis |
| Number of Limbs With Treated Great Saphenous Vein Closure | Up to 3 years after the ablation procedure | Treated great saphenous vein closure |
| Number of Limbs With Bleeding (ISTH Major, CRNM, or Minor) | Up to 30 days after the ablation procedure | Bleeding (ISTH major / clinically relevant non-major / minor) |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORSanjay S Srivatsa, MD
Heart, Artery, and Vein Center of Fresno
Outcome results
None listed