Abstract

Introduction Risk of bleeding is an important consideration among patients with nonvalvular atrial fibrillation (NVAF). Hypothesis We hypothesized that in a real-world managed care setting, bleeding incidence among NVAF patients is high and increases with higher bleeding risk HAS-BLED score. Methods Adults with healthcare claims related to AF between Jan 2005 and Jun 2009 but no evidence of valvular disease were included in this retrospective study. Follow-up lasted until the earliest of death, disenrollment from the health plan, or 30 Jun 2010. A claims-based approximation of HAS-BLED score was used to measure bleeding risk. Bleeding events were categorized as major, serious non-major, or minor. A bleeding event was considered major if it was associated with any of the following: inpatient care, blood transfusion, decreased hemoglobin or hematocrit, death, physician guided medical or surgical treatment, or intracranial bleed. Serious non-major events were those that involved vascular injury or critical site bleeding and were associated with outpatient hospital care or an emergency department visit. Minor events were those associated with noncritical anatomical sites and an emergency department, outpatient hospital, or office visit. Results Mean (SD) age of the study sample (N=48,260) was 67±13 years and 62% of the patients were male. Mean follow-up was 802±540 days (median 673 days). Approximately 34% of NVAF patients had an incident bleeding event; 43% of these had at least one subsequent event. Of all bleeding events, 35% were major, 14% serious non-major, and 51% minor. Death was associated with 270 (2%) major events (n=7908). Event rates for each bleeding category increased with greater scores (Table). Conclusions Patients with NVAF in a real-world managed care setting had a high incidence of bleed episodes, and approximately one-third of these events were major. High HAS-BLED scores were associated with a greater incidence of bleeding events.

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