Rivaroxaban, compared with dabigatran or apixaban, was found to be associated with increased rates of gastrointestinal (GI) bleeding, according to study findings published in the Annals of Internal Medicine.

For the nationwide population-based cohort study, researchers sourced data from the Icelandic Medicine Registry, The National University Hospital of Iceland, and Iceland’s 4 regional hospitals. All patients who received a novel prescription for a direct oral anticoagulant (DOAC) between 2008 and 2019 were assessed for medical interventions for GI bleeding. To account for cohort imbalances, groups were compared using inverse probability weighting on the basis of propensity matching scores.

A total of 5868 new users of DOACs were included, among whom, 3217 received rivaroxaban, 2157 apixaban, and 494 dabigatran.


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There were 241 GI bleeding events after an average follow-up between 1.2-1.8 years. The bleeding occurred in the lower GI tract (56%), upper tract (30%), or were not classified (14%). Most events were major (61%).

GI bleeding rates were higher for rivaroxaban compared with apixaban (hazard ratio [HR], 1.42; 95% CI, 1.04-1.93) as were risk for major events (HR, 1.50; 95% CI, 1.00-2.24). Between rivaroxaban and dabigatran, there was a trend for higher risk for GI bleeding (HR, 1.63; 95% CI, 0.91-2.92) and major events (HR, 1.39; 95% CI, 0.67-2.88) among the rivaroxaban recipients.

For upper tract bleeds, risk was associated with rivaroxaban compared with dabigatran (HR, 3.75; 95% CI, 1.32-10.71) and for lower tract bleeds, risk was associated with rivaroxaban compared with apixaban (HR, 1.53; 95% CI, 1.00-2.33).

Among only patients with atrial fibrillation (AF; rivaroxaban: n=2463, apixaban: n=1787, dabigatran: n=420), GI bleeding risk was increased among the rivaroxaban cohort compared with apixaban (HR, 1.40; 95% CI, 1.01-1.94) or dabigatran (HR, 2.04; 95% CI, 1.17-3.55). Rivaroxaban also increased risk for major bleeds (HR, 1.95; 95% CI, 1.02-3.73) and upper tract bleeds (HR, 2.85; 95% CI, 1.01-8.04) compared with dabigatran.

This study was limited by not having access to confounding factors, such as socioeconomic status of lifestyle habits.

These data indicated there was an increased risk for GI bleeding among new users of the anticoagulant rivaroxaban compared with either apixaban or dabigatran. These trends were observed among all patients and the subset of individuals with AF.

“This may help guide oral anticoagulant selection, especially for patients at high risk for GI [bleeding],” the researchers said.

Disclosure: Multiple authors declared affiliations with industry. Please refer to the original article for a full list of disclosures.

Reference

Ingason AB, Hreinsson JP, Ágústsson AS, et al. Rivaroxaban is associated with higher rates of gastrointestinal bleeding than other direct oral anticoagulants: a nationwide propensity score–weighted study. Ann Intern Med. Published online October 12, 2021. doi:10.7326/M21-1474