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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

ClinicalTrials.gov · COMPLETED, 2021

564 participants

Abstract

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.

Conditions: Venous Thrombosis Deep (Limbs), Venous Insufficiency (Chronic)(Peripheral), Varicose Veins Leg, Venous Thrombosis.

Primary outcome: Number of Limbs With Clinically Significant EHIT (AVF Class ≥II).

Enrollment: 564 participants.

How strong is the evidence?

Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 564 participants or records.

How the five levels of evidence work. The level is assigned automatically from the abstract and can be wrong, so check the paper.

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