Publication:

Safety and efficacy of rivaroxaban compared to standard anticoagulant therapy in the treatment of deep vein thrombosis in Indian population

Background Pulmonary embolism (PE) is relatively a common cardiovascular complication following acute deep vein thrombosis (DVT). Around 10% of DVT patients exhibit clinical manifestations of PE. Oral drugs with adequate efficacy and safety are preferred over parenteral medications in long term prevention of PE. Our study compared rivaroxaban (factor XA inhibitor) with standard therapy (acetrom) in terms of efficacy and safety in the Indian population.

Methods Patients presenting to department of general surgery at S. S. institute of medical science and research centre during the period from March 2018 to September 2020 with clinical signs and venous duplex study proven acute DVT were included in the study. Total of 64 patients were randomized into rivaroxaban group (N=28) and control group (N=36). Treatment included for rivaroxaban group was rivaroxaban (p/o) 15 mg twice daily for 21 days, followed by 20 mg once daily for 6 months. Treatment included for control group was enoxaparin (SC) overlapping with and followed by acitrom (p/o) for 6 months. The patients were looked for symptomatic recurrent PE and major or minor clinically relevant bleeding.

Results Recurrent vein thrombosis noted in 1 (3.57%) patient of the rivaroxaban group and 4 (11.10%) patients in the control group. Minor bleeding seen in 3 (10.70%) patients in the rivaroxaban group and in 7 (19.40%) patients in the control group. No major bleeding was observed in rivaroxaban group and in 1 patient in the control group.

Conclusions In patients with acute DVT, rivaroxaban is as efficacious as enoxaparin followed by acetram therapy, with a significantly lower rate of bleeding.