Rivaroxaban associated with increased risk for GI bleeding compared to other DOACs

A study in Iceland of direct oral anticoagulants (DOACs) found a higher risk for overall and major GI bleeding with rivaroxaban than with either apixaban or dabigatran.

Rivaroxaban was associated with higher GI bleeding rates than apixaban and dabigatran, regardless of treatment indication, a cohort study comparing direct oral anticoagulants (DOACs) found.

Researchers used data from the Icelandic Medicine Registry to compare rates of GI bleeding among new users of apixaban, dabigatran, and rivaroxaban from 2014 to 2019. There were 5,668 patients included in the analysis: 3,217 receiving rivaroxaban, 2,157 receiving apixaban, and 494 receiving dabigatran. Results were published Oct. 12 by Annals of Internal Medicine.

For all patients, rivaroxaban was associated with higher overall rates of GI bleeding (3.2 vs. 2.5 events per 100 person-years; hazard ratio [HR], 1.42 [95% CI, 1.04 to 1.93]). Rates of major GI bleeding were higher with rivaroxaban versus apixaban (1.9 vs. 1.4 events per 100 person-years; HR, 1.50 [95% CI, 1.00 to 2.24]). Rivaroxaban also had higher GI bleeding rates than dabigatran, with similar point estimates, although the authors noted that the confidence intervals were wider and included the possibility of a null effect. Rivaroxaban was also associated with higher rates of overall bleeding than apixaban (HR, 1.40; 95% CI, 1.01 to 1.94) or dabigatran (HR, 2.04; 95% CI, 1.17 to 3.55) when only patients with atrial fibrillation were analyzed.

The authors noted that their findings may be used to guide oral anticoagulant selection, especially for patients at high risk for GI bleeding. “Why the risk for GI [bleeding] increased for patients receiving rivaroxaban is not clear, but this may at least partly be due to the different pharmacokinetics of rivaroxaban, which is administered once daily, as opposed to the other 2 drugs, which are given twice daily,” they wrote.