Key result
Apixaban reduces clinically relevant bleeding compared to rivaroxaban in acute venous thromboembolism.
Why the study?
Uncertainty remains about the difference in bleeding risk between apixaban and rivaroxaban for treating acute venous thromboembolism.
Does apixaban reduce clinically relevant bleeding compared to rivaroxaban in patients with acute symptomatic pulmonary embolism or proximal deep-vein thrombosis?
RCT
Open-label, blinded end-point
1:1
Yes
Does apixaban reduce clinically relevant bleeding compared to rivaroxaban in patients with acute symptomatic pulmonary embolism or proximal deep-vein thrombosis?
In patients with acute venous thromboembolism, apixaban resulted in significantly lower rates of clinically relevant bleeding compared to rivaroxaban over a 3-month period.
Captured external expert commentary on this paper, strongest first. Original sources are linked where available.
“For many patients with acute venous thromboembolism, the choice of anticoagulant is no longer a toss-up. Apixaban is a safer first-line option than rivaroxaban for minimizing the risk of bleeding without compromising the prevention of recurrent thrombosis.”
“From the safety side of things, we have seen that apixaban reduces the risk of clinically relevant bleeding events. That is a really important finding because, even if [apixaban] is a twice-daily dosed medication, that is a more than 50% reduction in bleeding rates, offsetting any inconvenience of the twice-daily dosing regimen. That is a reason to prescribe it first.”
“Of course, this doesn't mean we get rid of all the options because for some patients there may be a reason why one is preferred over the other. But I think for the general population in whom we're starting anticoagulation, these types of data are critical.”
May support apixaban preference to lower bleeding in acute VTE; leaves open confirmation before practice change.
Background: Apixaban and rivaroxaban are the oral anticoagulants most frequently used to treat acute venous thromboembolism. However, uncertainty remains about the difference in bleeding risk between the two medications. Methods: In an international trial with a prospective, randomized, open-label, blinded end-point design, we assigned, in a 1:1 ratio, eligible patients with acute symptomatic pulmonary embolism or proximal deep-vein thrombosis to receive apixaban or rivaroxaban for 3 months. Apixaban was given at a dose of 10 mg twice daily for 7 days followed by 5 mg twice daily, and rivaroxaban was given at a dose of 15 mg twice daily for 21 days followed by 20 mg daily. The primary outcome was clinically relevant bleeding, a composite of major bleeding or clinically relevant nonmajor bleeding, as defined according to the International Society on Thrombosis and Haemostasis, during the 3-month trial period. Secondary outcomes included death from any cause. Conclusions: Among patients with acute venous thromboembolism, the risk of clinically relevant bleeding was significantly lower with apixaban than with rivaroxaban during the 3-month treatment period. (Funded by the Canadian Institutes of Health Research and others; COBRRA ClinicalTrials.gov number, NCT03266783.).
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Castellucci et al. (2026) conducted an RCT in Acute venous thromboembolism (pulmonary embolism or proximal deep-vein thrombosis). Apixaban vs. Rivaroxaban (15 mg twice daily for 21 days followed by 20 mg daily) was evaluated on Clinically relevant bleeding (composite of major bleeding or clinically relevant nonmajor bleeding). Apixaban resulted in a significantly lower risk of clinically relevant bleeding compared to rivaroxaban over the 3-month treatment period in patients with acute venous thromboembolism.
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