Key result
Rivaroxaban significantly reduced the risk of recurrent VTE compared to placebo after 6-12 months of treatment, at the cost of a moderate increase in bleeding complications.
Why the study?
Does rivaroxaban reduce recurrent VTE in patients who completed standard treatment for VTE?
RCT
Does rivaroxaban reduce recurrent VTE in patients who completed standard treatment for VTE?
Rivaroxaban is an effective alternative for long-term secondary prevention of VTE after standard treatment, though it carries a moderate increase in bleeding risk.
Answers are grounded in this paper and cite their sources.
May inform extended rivaroxaban use for secondary VTE prevention; leaves open individualized bleeding risk assessment.
Over recent years, research on anticoagulant drugs has been guided by the requirement for convenient administration and a wide therapeutic window to allow fixed dosing without the need for coagulation monitoring. Rivaroxaban is the first of a new class of anticoagulant drugs, the direct, selective inhibitors of Factor Xa. The EINSTEIN-extension study compared rivaroxaban with placebo in patients who completed their standard treatment course after venous thromboembolism (VTE), in whom there was equipoise with respect to the need for continued anticoagulation. After 6-12 months of treatment, rivaroxaban significantly reduced the risk of recurrent VTE at the cost of a moderate increase in bleeding complications. Overall, these results suggest that rivaroxaban can be a valid alternative to warfarin for patients requiring long-term secondary prevention of VTE. However, additional data are needed for special populations including the elderly, patients with cancer, renally impaired patients and morbidly obese patients, all of whom were scarcely represented in this trial.
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Romualdi et al. (2011) conducted an RCT in Venous thromboembolism (VTE). Rivaroxaban vs. Placebo was evaluated on Recurrent VTE. Rivaroxaban significantly reduced the risk of recurrent VTE compared to placebo after 6-12 months of treatment, at the cost of a moderate increase in bleeding complications.
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