Background: Increasing age is associated with more comorbidity and higher congestive heart failure, hypertension, age ≥75 years, diabetes, stroke, vascular disease, age 65–74 years, and sex category (CHA2DS2-VASc) scores. The estimated stroke risk for patients with CHA2DS2-VASc scores of 1 to ≥4 is 1.3%–6.4% per year, respectively. Many older adults receive anticoagulant therapy for stroke prevention and may be at greater risk of bleeding when anticoagulants are used. This study aimed to evaluate the incidence of major bleeding (MB) by age group and CHA2DS2-VASc scores in patients taking rivaroxaban, a direct factor Xa inhibitor anticoagulant approved to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation (NVAF).
Methods: The United States Department of Defense database electronic medical records for all beneficiaries (a population of nearly 10 million unique patients) were queried from the period of January 1, 2013, to June 30, 2016, to identify rivaroxaban users with NVAF. CHA2DS2-VASc scores were calculated for each patient. MB was identified using a validated case-finding algorithm that required, at minimum, one of a series of bleeding-related diagnosis codes within the primary diagnosis field on an inpatient hospitalization record. The incidence of MB was calculated by age group and by CHA2DS2-VASc score and presented per 100 person-years. Fatal bleeding was considered if the patient died during the MB hospitalization.
Results: 1914 of 57,070 patients experienced MB. Bleeding rates increased with CHA2DS2-VASc scores. Gastrointestinal bleeding was the most common bleed site across all groups, followed by intracranial hemorrhage (ICH), 85.1% and 8.7% of MB events, respectively. Those <65 years with a CHA2SD2-VASc score of ≥4 had the highest rate of ICH, 0.57 (95% confidence interval [CI] 0.18–1.77) per 100 person-years. Fatal MB was uncommon, the highest rate was in those 85+ years old and with CHA2SD2VASc scores of ≥4, a rate of 0.15 (95% CI 0.09–0.25) per 100 person-years.
Conclusion: The rate of MB in rivaroxaban users treated for stroke prevention increases as CHA2DS2-VASc score increases, though the risk and impact of MB may not exceed the risk of stroke. Those <65 years with higher CHA2DS2-VASc scores had the highest rate of MB, though patients over age 85 experienced higher rates of fatal MB.
Keywords: Atrial fibrillation, major bleed, nonvalvular, rivaroxaban, stroke
