Apixaban vs Rivaroxaban vs No Anticoagulant to Prevent EHIT After Great Saphenous Vein Laser Ablation

Randomized Trial of Rivaroxaban (Xarelto) and Apixaban (Eliquis) for the Prevention of Endothermal Heat-Induced Thrombosis (EHIT) and Deep Vein Thrombosis After Great Saphenous Vein Endovenous Laser Ablation

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.

Study Overview

• Status: Completed
• Conditions: Venous Thrombosis; Varicose Veins Leg; Venous Thrombosis Deep (Limbs); Venous Insufficiency (Chronic)(Peripheral)
• Intervention / Treatment: Drug: Apixaban; Drug: Rivaroxaban

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.

• Study Type: Interventional
• Enrollment (Actual): 564
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • California
    • Fresno, California, United States, 93722
      • Heart Artery and Vein Center of Fresno

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion: Adults (≥18 y) undergoing great saphenous vein endovenous laser ablation for symptomatic reflux · concurrent below-knee foam sclerotherapy Exclusion: Known thrombophilia · current oestrogen/hormone-replacement therapy · family history of VTE or thrombophilia · active malignancy · prior ipsilateral ablation · deep venous reflux or obstruction

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: apixaban; Experimental · apixaban 5 mg orally twice daily for 5 days from the day of the procedure	Drug: Apixaban; 5 mg orally twice daily for 5 days; Other Names: ELIQUIS
Experimental: rivaroxaban; Experimental · rivaroxaban 20 mg orally once daily for 5 days from the day of the procedure	Drug: Rivaroxaban; 20 mg orally once daily for 5 days; Other Names: XARELTO
No Intervention: No anticoagulant; "No anticoagulant" · No Intervention · no post-procedural anticoagulant

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of clinically significant EHIT (AVF class ≥II)	Incidence of clinically significant EHIT (AVF class ≥II)	Up to 1 week after the ablation procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Any EHIT (AVF class I-IV) - first post-ablation duplex	Any EHIT (AVF class I-IV) - first post-ablation duplex	Up to 1 week after the ablation procedure
Remote (non-contiguous) deep vein thrombosis	Remote (non-contiguous) deep vein thrombosis	Up to 1 week after the ablation procedure
Treated great saphenous vein closure	Treated great saphenous vein closure	Up to 3 years after the ablation procedure
Bleeding (ISTH major / clinically relevant non-major / minor)	Bleeding (ISTH major / clinically relevant non-major / minor)	Up to 30 days after the ablation procedure

Collaborators and Investigators

• Sponsor: Heart, Artery, and Vein Center of Fresno
• Investigators: Principal Investigator: sanjay S srivatsa, MD, heart artery and vein of fresno

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 6, 2018
• Primary Completion (Actual): November 4, 2020
• Study Completion (Actual): June 15, 2021

Study Registration Dates

• First Submitted: July 1, 2026
• First Submitted That Met QC Criteria: July 7, 2026
• First Posted (Actual): July 13, 2026

Study Record Updates

• Last Update Posted (Actual): July 13, 2026
• Last Update Submitted That Met QC Criteria: July 7, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: RIVAROXABAN; ENDOTHERMAL HEAT-INDUCED THROMBOSIS; EHIT; ENDOVENOUS LASER ABLATION; GREAT SAPHENOUS VEIN; APIXABAN; THROMBOPROPHYLAXIS
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Embolism and Thrombosis; Thrombosis; Venous Thrombosis; Venous Insufficiency; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Morpholines; Oxazines; Thiophenes; Rivaroxaban; apixaban
• Other Study ID Numbers: SAMC-18001; 18001 - Type: Other; (Other Identifier: Saint Agnes Medical Center IRB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No