Oral Rivaroxaban Versus Standard Therapy in Acute Venous Thromboembolism Treatment for Vietnamese Patients.

Abstract

BACKGROUND:Direct oral anticoagulant-rivaroxaban may provide a simple, fixed-dose therapy for the management of hospital-acquired, acute venous thromboembolism (VTE) and for extended treatment, its use could skip lab observation and/or parenteral treatment.AIM:Compare the efficacy and safety (EAS) of RIV vs. standard therapy (SDTD) in a cohort of Vietnamese patients diagnosed with symptomatic, acute VTE.METHODS:An open-label, case-control, prospective study was conducted to check the efficacy and safety (EAS) of oral rivaroxaban (RIV) alone (15 mg 2 times/day for 3 weeks, then 20 mg 1 time/day) in a comparison to the standard therapy (STDT) (enoxaparin 1.0 mg/kg 2 times/day combining with vitamin K antagonist). Patients were treated for 6 months and followed-up for suspect reoccurring VTE and bleeding.RESULTS:A total 187 patients were enrolled into study. 83 were provided rivaroxaban and 104 received enoxaparin overlapping with vitamin K antagonist (VKAs). Recurrent VTE occurred in 3 (3.6%) rivaroxaban-received patients compared with 5 (4.8%) standard-treatment received patients (OR: 0.74, 95% CI, 0.17 to 3.20, p > 0.05). Major bleeding events were found in 1 (1,8%) and 4 (3.9%) cases in the RIV treated and STDT cohort, respectively (OR: 0.30, 95% CI, 0.03 to 2.76, p > 0.05).CONCLUSION:The finding of this study in Vietnamese patients with acute VTE presented comparable EAS profile with RIV versus STDT, consistent with those found in global population.