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

My Hanh Bui; Nguyen Truong  Son; Pham Thanh  Viet; Nguyen Hoang  Hiep; Toi  Chu Dinh

doi:10.3889/oamjms.2019.370

Authors

My Hanh Bui Tuberculosis and Lung Disease Department, Hanoi Medical University, Hanoi, Vietnam; Scientific Research & International Cooperation Department, Hanoi Medical University Hospital, Hanoi, Vietnam
Nguyen Truong Son Director Board, Cho Ray Hospital, Ho Chi Minh City, Vietnam
Pham Thanh Viet Department of General Administration, Bach Mai Hospital, Hanoi, Cho Ray Hospital, Ho Chi Minh, Vietnam
Nguyen Hoang Hiep Center for Development of Curriculum and Human Resource in Health, Hanoi Medical University, Hanoi, Vietnam
Toi Chu Dinh 4Faculty of Biology, Hanoi National University of Education, Hanoi, Vietnam; School of Odonto Stomatology, Hanoi Medical University, Hanoi, Vietnam

DOI:

https://doi.org/10.3889/oamjms.2019.370

Keywords:

Oral rivaroxaban, Standard therapy, Acute venous thromboembolism, 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.

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