Comparison of the Incidence of Major Bleeding With Rivaroxaban Use Among Nonvalvular Atrial Fibrillation Patients With Versus Without Diabetes Mellitus

Abstract

Diabetes mellitus (DM) is a common co-morbidity in those with nonvalvular atrial fibrillation (NVAF). Most patients with DM and NVAF have a CHADS-VASc score of ≥1 and should be considered for oral anticoagulation therapy for stroke prevention per treatment guidelines. The most important risk associated with anticoagulation is bleeding, which may be higher in those with NVAF plus DM. Our objective was to evaluate the incidence and characteristics of major bleeding (MB) in rivaroxaban users diagnosed with NVAF, further comparing those with DM versus those without DM, in a real-world clinical setting. Electronic medical records of >10 million patients from the Department of Defense Military Health System were queried to identify rivaroxaban users with NVAF over a 2.5-year period. Major bleeding-related hospitalization was identified by a validated case-finding algorithm. Patient characteristics, incidence and management of MB, and fatal outcomes were assessed by DM status. Of 44,793 rivaroxaban users with NVAF, 12,039 (26.9%) had DM, who were more likely men, younger, with more co-morbidity and higher CHADS-VASc scores. Major bleeding incidence was higher among those with DM compared with those without, 3.68 (95% confidence interval [CI] 3.37 to 4.03) versus 2.51 (95% CI 2.34 to 2.69) per 100 person-years, and intracranial bleeding incidence was 0.19 (95% CI 0.13 to 0.28) versus 0.25 (95% CI 0.20 to 0.31) per 100 person-years. Fatal outcomes were rare for both cohorts, 0.09 per 100 person-years. In conclusion, in this post-marketing study of 44,793 rivaroxaban users with NVAF, patients with DM had more co-morbidities and higher incidence of MB compared with those without DM.

Effectiveness and Safety of Oral Anticoagulants in Patients With Nonvalvular Atrial Fibrillation and Diabetes Mellitus

“…32 A study of US Department of Defense records found that rivaroxaban was associated with a higher incidence of MB in diabetic patients than in nondiabetic patients (3.7 events per 100 person-years vs 2.5 events per 100 person-years). 33 A study in Taiwan in diabetic patients with NVAF found that compared with those prescribed warfarin, patients prescribed dabigatran had a lower risk of allcause mortality and GI bleeding whereas those prescribed rivaroxaban had a similar risk of mortality, stroke, and bleeding. Also, compared with those prescribed rivaroxaban, patients prescribed dabigatran had significantly lower rates of all-cause mortality.…”

Type 2 Diabetes, Atrial Fibrillation, and Direct Oral Anticoagulation

“…Peacock et al [47] studied the impact of T2D on the incidence of major bleeding in rivaroxaban-treated patients with AF. Among the 44,793 rivaroxaban users enrolled in this analysis, 26.9% had T2D (12,039 patients).…”

Understanding the Value of Real-World Evidence: Focus on Stroke Prevention in Atrial Fibrillation with Rivaroxaban

“…An additional analysis of 44,793 patients revealed that patients with DM had more comorbidities and a higher incidence of major bleeding than those without DM. 39 A total of 12,039 (26.9%) had DM, and were more likely to be male, younger, and with more comorbidities and higher CHA 2 DS 2 -VASc scores. Major bleeding incidence in the DM versus the non-DM group was 3.68 (95% CI: 3.37-4.03) versus 2.51 (95% CI: 2.34-2.69), respectively per 100 person-years (ROCKET AF incidence of major bleeding: 3.79 in the DM group vs. 3.47 per 100 person-years in the non-DM group).…”