OBJECTIVES: The use of factor Xa inhibitors is associated with an increased risk of major bleeds. Aim of this study was to assess the number of patients with major and life-threatening bleeds under therapy with apixaban or rivaroxaban in Germany and to analyze associated outcomes.

METHODS: We conducted a retrospective claims data analysis using the InGef Research Database. Patients hospitalized with a major bleed under therapy with apixaban or rivaroxaban were identified in 2017 based on the algorithm by Cunningham. Major intracranial bleeds and those resulting in death were classified as life-threatening. Patient counts were extrapolated to the German population. Patients were described regarding age, gender, and bleed localization. Outcomes of interest included mortality, risk of thrombotic event, and length of hospitalization.

RESULTS: Our analysis identified 31,484 [95% CI 29,857 – 33,177] patients with a major bleed and 4,745 [95% CI 4,126 – 5,430] patients with a life-threatening bleed under therapy with apixaban or rivaroxaban in Germany in 2017. Most patients were aged ≥70 years for both major and life-threatening bleeds (83% and 86%). Slightly more than half of the patients were male (53% and 51%). Most major bleeds were located in the gastrointestinal tract (64%), followed by other (13%), intracranial (12%), and genitourinary (11%) bleeds. In-hospital mortality reached 7% among all major bleeds and 31% among intracranial bleeds. Thirty-day mortality reached 9% and 35%, respectively. Thirty-day risk of a thrombotic event after bleed onset was 8% for all major bleeds. The average length of hospitalization was 9 days [±11 days] with a major bleed.

CONCLUSIONS: To our knowledge, this is the first study estimating the number of patients with major and life-threatening bleeds under anticoagulation therapy with apixaban or rivaroxaban in Germany. Additionally, it underlines the severity and mortality risk of major bleeds under anticoagulation therapy using real-world data.