Apixaban significantly reduces bleeding risk compared with rivaroxaban in patients with acute venous thromboembolism, according to findings from a large international randomised trial.
Study Design and Treatment Regimens
An international, prospective, randomised, open label trial with blinded end point assessment evaluated bleeding risk in patients with acute symptomatic pulmonary embolism or proximal deep vein thrombosis. A total of 2760 patients were assigned in a 1:1 ratio to receive either apixaban or rivaroxaban over a 3-month period.
Apixaban was administered at 10 mg twice daily for 7 days, followed by 5 mg twice daily. Rivaroxaban was given at 15 mg twice daily for 21 days, followed by 20 mg once daily. The primary outcome focused on clinically relevant bleeding, defined as a composite of major bleeding or clinically relevant non major bleeding according to international criteria. Secondary outcomes included death from any cause.
Bleeding Risk Outcomes
The data show a clear difference in bleeding risk between the two treatment groups. A primary outcome event occurred in 44 of 1345 patients in the apixaban group compared with 96 of 1355 patients in the rivaroxaban group. This corresponded to a significantly lower relative risk with apixaban: (relative risk: 0.46; 95% CI: 0.33–0.65; p<0.001).
These findings indicate that apixaban nearly halved the risk of clinically relevant bleeding during the 3-month treatment period. With regard to mortality, death from any cause was rare in both groups, occurring in one patient receiving apixaban and four patients receiving rivaroxaban: (relative risk: 0.25; 95% CI: 0.03–2.26).
Safety And Clinical Implications
Serious adverse events unrelated to bleeding or venous thrombosis were reported in 36 patients in the apixaban group and 30 patients in the rivaroxaban group, suggesting comparable safety profiles beyond bleeding outcomes.
Overall, these data demonstrate that apixaban is associated with a significantly lower bleeding risk than rivaroxaban in patients undergoing treatment for acute venous thromboembolism over 3 months. The findings provide clinically relevant evidence to inform anticoagulant selection, particularly in patients where bleeding risk is a key consideration.
Reference
Castellucci LA et al. Bleeding risk with apixaban vs. rivaroxaban in acute venous thromboembolism. N Engl J Med. 2026;394:1051-60.
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