Disclosures: Icelandic Centre for Research and Landspítali — The National University Hospital of Iceland provided funding for this study. Björnsson reports no relevant financial disclosures. Please see the study for all other authors’ relevant financial disclosures.
October 12, 2021
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GI bleeding more common with rivaroxaban than other direct oral anticoagulants

Disclosures: Icelandic Centre for Research and Landspítali — The National University Hospital of Iceland provided funding for this study. Björnsson reports no relevant financial disclosures. Please see the study for all other authors’ relevant financial disclosures.
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Rivaroxaban appeared associated with a higher rate of gastrointestinal bleeding than other direct oral anticoagulants, according to study results published in Annals of Internal Medicine.

Patients treated with rivaroxaban (Xarelto, Janssen) demonstrated a 40% higher overall risk for GI bleeding and a 50% higher risk for major GI bleeding than those treated with apixaban (Eliquis; Bristol Myers Squibb, Pfizer).

GI bleeding risk.
Data derived from Ingason AB, et al. Ann Intern Med. 2021;doi:10.7326/M21-1474.

“[The findings of this study] may help guide oral anticoagulant selection, especially for patients at high risk for GI bleeding,” Einar S. Björnsson, MD, PhD, professor in the department of gastroenterology and hepatology at Landspítali — The National University Hospital of Iceland, and colleagues wrote.

Patients who receive oral anticoagulation can experience potentially life-threatening GI bleeding.

A meta-analysis of randomized phase 3 trials showed higher GI bleeding rates with direct oral anticoagulants than warfarin. However, no randomized controlled trial has directly compared GI bleeding rates between direct oral anticoagulants, according to study background.

Björnsson and colleagues conducted a population-based cohort study to assess GI bleeding risks among patients who received rivaroxaban, apixaban or dabigatran (Pradaxa, Boehringer Ingelheim).

The analysis included 5,868 patients treated at Landspítali and four other regional hospitals in Iceland.

All study participants began using rivaroxaban (54.8%), apixaban (36.7%) or dabigatran (8.4%) between 2014 and 2019. The most common treatment indications for those receiving apixaban included atrial fibrillation (82.8%), venous thromboembolism (10.9%) and ischemic stroke (3.5%), with similar percentages for the other anticoagulants.

Mean follow-up was 1.6 years for patients who received rivaroxaban, 1.2 years for those who received apixaban and 1.8 years for those who received dabigatran.

A comparison of patients who received rivaroxaban or apixaban showed a higher overall rate of GI bleeding (3.2 events vs. 2.5 events per 100 person-years; HR = 1.42; 95% CI, 1.04-1.93) and higher major GI bleeding rate (1.9 events vs. 1.4 events per 100 person-years; HR = 1.5; 95% CI, 1-2.24) with rivaroxaban.

A comparison of patients who received rivaroxaban or dabigatran showed a 63% to 104% higher risk for GI bleeding and a 39% to 95% higher risk for major GI bleeding with rivaroxaban. However, researchers noted these findings must be considered in the context of relatively wide confidence intervals and the possibility of a null effect.

When researchers limited their analysis to patients with atrial fibrillation, results showed a higher rate of overall GI bleeding with rivaroxaban than apixaban (HR = 1.4; 95% CI, 1.01-1.94) or dabigatran (HR = 2.04; 95% CI, 1.17-3.55).

Analyses of bleeding types showed a higher rate of upper GI bleeding (1 event vs. 0.3 event per 100 person-years; HR = 3.75; 1.31-10.71) with rivaroxaban than dabigatran.

Researchers acknowledged limitations to their study, including their inability to exclude residual confounding factors, short follow-up and its smaller sample size compared with prior registry studies.