Background: Deep vein thrombosis (DVT) poses a considerable burden on the affected patients, which triggers
the need for proper management and follow-up. This study aimed to evaluate the outcome of rivaroxaban versus
warfarin in the treatment of patients with acute lower limb DVT.
Patients and methods: This is a randomized controlled trial that included patients with ultrasound-proved acute
lower limb DVT. Patients were equally randomized to Group A (Treated with warfarin) and Group B (treated with
rivaroxaban). All patients received scheduled follow-up visits up to 6 months post-treatment, during which they
received clinical examination, routine laboratory analysis, and duplex ultrasound.
Results: Eighty patients were eligible to the study and enrolled in the two study groups. At the 6-month follow-up,
the median (IQR) recanalization rate was 100.0% (87.5%–100.0%) in Group A and 100.0% (90.0%–100.0%) in
Group B (P = 0.464). Valve incompetence was evident in eight patients in Group A (20.0%) and four patients in
Group B (10.0%) (p = 0.211). The Villalta Score (VS) median (IQR) values were 2 (1–3) in Group A and 1 (0–3.5)
in Group B (P = 0.340). Regression analysis demonstrated that predictors of 6-month post-thrombotic syndrome
(PTS) were the patients' age (OR = 1.46, p = 0.014) and dyslipidemia (OR = 11.6, p = 0.014).
Conclusion: This study highlights the potential benefits of rivaroxaban over warfarin in the management of DVT,
with trends suggesting better recanalization rates, lower valve incompetence, and a reduced Villalta score.