Key result
Rivaroxaban demonstrated a recurrent VTE rate of 3.57% compared to 11.10% with standard therapy, alongside a lower rate of minor bleeding (10.70% vs 19.40%) in patients with acute DVT.
Why the study?
Oral drugs with adequate efficacy and safety are preferred over parenteral medications for long-term prevention of pulmonary embolism following acute deep vein thrombosis, but comparisons in the Indian population were needed.
Does rivaroxaban reduce recurrent VTE and bleeding compared to standard anticoagulant therapy (enoxaparin followed by acitrom) in Indian patients with acute DVT?
RCT (n=64)
Randomized
No
Does rivaroxaban reduce recurrent VTE and bleeding compared to standard anticoagulant therapy (enoxaparin followed by acitrom) in Indian patients with acute DVT?
Absolute Event Rate: 3.57% vs 11.1%
p-value: p=<0.05
Rivaroxaban is as efficacious as standard therapy for acute DVT with a significantly lower rate of bleeding in this Indian cohort.
Supports rivaroxaban over VKA-based regimens for acute DVT in Indian patients; extends randomized evidence to this 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.
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Anantharaju et al. (2021) conducted an RCT in Acute deep vein thrombosis (DVT) (n=64). Rivaroxaban vs. Enoxaparin (SC) overlapping with and followed by acitrom (p/o) was evaluated on Recurrent venous thromboembolism (VTE) (p=<0.05). Rivaroxaban demonstrated a recurrent VTE rate of 3.57% compared to 11.10% with standard therapy, alongside a lower rate of minor bleeding (10.70% vs 19.40%) in patients with acute DVT.
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