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| ID | Type | Description | Link |
|---|---|---|---|
| 18001 - Type: Other; | Other Identifier | Saint Agnes Medical Center IRB |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| apixaban | Experimental | Experimental · apixaban 5 mg orally twice daily for 5 days from the day of the procedure |
|
| rivaroxaban | Experimental | Experimental · rivaroxaban 20 mg orally once daily for 5 days from the day of the procedure |
|
| No anticoagulant | No Intervention | "No anticoagulant" · No Intervention · no post-procedural anticoagulant |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Apixaban | Drug | 5 mg orally twice daily for 5 days |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Limbs With Clinically Significant EHIT (AVF Class ≥II) | Incidence of clinically significant EHIT (AVF class ≥II) | Up to 1 week after the ablation procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Limbs With Any EHIT (AVF Class I-IV) | Any EHIT (AVF class I-IV) - first post-ablation duplex | Up to 1 week after the ablation procedure |
| Number of Limbs With Remote (Non-contiguous) Deep Vein Thrombosis |
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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
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| Name | Affiliation | Role |
|---|---|---|
| Sanjay S Srivatsa, MD | Heart, Artery, and Vein Center of Fresno | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Heart Artery and Vein Center of Fresno | Fresno | California | 93722 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36592692 | Background | Yang J, Chung S, Srivatsa S. Prospective randomized trial of antithrombotic strategies following great saphenous vein ablation using injectable polidocanol endovenous microfoam (Varithena). J Vasc Surg Venous Lymphat Disord. 2023 May;11(3):488-497.e4. doi: 10.1016/j.jvsv.2022.12.008. Epub 2022 Dec 31. |
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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)
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Who is masked: Outcomes Assessor (duplex read by blinded technologists)
| Rivaroxaban | Drug | 20 mg orally once daily for 5 days |
|
|
Remote (non-contiguous) deep vein thrombosis
| Up to 1 week after the ablation procedure |
| Number of Limbs With Treated Great Saphenous Vein Closure | Treated great saphenous vein closure | Up to 3 years after the ablation procedure |
| Number of Limbs With Bleeding (ISTH Major, CRNM, or Minor) | Bleeding (ISTH major / clinically relevant non-major / minor) | Up to 30 days after the ablation procedure |
| ID | Term |
|---|---|
| D020246 | Venous Thrombosis |
| D014689 | Venous Insufficiency |
| ID | Term |
|---|---|
| D013927 | Thrombosis |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C522181 | apixaban |
| D000069552 | Rivaroxaban |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D009025 | Morpholines |
| D010078 | Oxazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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