Ochsner Clinic Foundation, New Orleans, Louisiana.
Clin Ther. 2013 Oct;35(10):1536-45.e1. doi: 10.1016/j.clinthera.2013.08.013. Epub 2013 Sep 26.
Patients with nonvalvular atrial fibrillation (NVAF) are at increased risk for stroke and bleeding events, but bleeding as an outcome has not been extensively studied in this patient population.
The goal of this study was to estimate the incidence of bleeding events among patients with NVAF enrolled in managed care, investigate the relationships between bleeding incidence and bleeding and stroke risks, and estimate health care costs for patients who had a major bleeding event.
Adults with commercial insurance or Medicare Advantage coverage and health care claims related to AF between January 2005 and June 2009 but with no evidence of valvular disease were included in this retrospective claims data analysis. Baseline stroke risk (CHADS2 [Congestive Heart Failure, Hypertension, Age >75 Years, Diabetes Mellitus, and Prior Stroke or Transient Ischemic Attack]) and bleeding risk (HAS-BLED [Hypertension, Abnormal Renal/Liver Function, Stroke, Bleeding History or Predisposition, Labile International Normalized Ratios, Elderly, Drugs/Alcohol]) were estimated. Bleeding events were identified during the variable follow-up period, which lasted from the date of the first qualifying AF visit until the earlier of death, disenrollment from the health plan, or June 30, 2010. Bleeding events were classified as major, serious nonmajor, or minor. Health care costs for patients with major bleeding events were calculated.
Among 48,260 patients with NVAF (mean age, 67 years), 34% had an incident bleeding event during a mean (SD) follow-up period of 802 (540) days. Incidence rates for bleeding events of any severity and major events were 29.6 and 10.4 per 100 patient-years, respectively. Bleeding incidence rates increased with greater CHADS2 and HAS-BLED risk scores. All-cause health care costs for patients during a major bleeding event averaged $16,830. Average costs per patient with a major event increased from approximately $52 per day in the prebleeding period to approximately $63 per day in the postbleeding period. Costs for patients who did not experience a major bleeding event averaged approximately $38 per day.
Bleeding incidence among patients with NVAF in a real-world setting was high and increased with greater stroke and bleeding risk scores. Health care costs for patients with major bleeding events were elevated. All rights reserved.
非瓣膜性心房颤动（NVAF）患者发生中风和出血事件的风险增加，但在该患者人群中，尚未广泛研究出血作为结局的情况。
本研究的目的是评估在接受管理护理的 NVAF 患者中出血事件的发生率，调查出血发生率与出血和中风风险之间的关系，并估算发生重大出血事件的患者的医疗保健费用。
本回顾性理赔数据分析纳入了 2005 年 1 月至 2009 年 6 月期间具有商业保险或医疗保险优势覆盖范围且有房颤相关理赔记录但无瓣膜疾病证据的成年人。在基线时估计中风风险（CHADS2[充血性心力衰竭、高血压、年龄＞75 岁、糖尿病和既往中风或短暂性脑缺血发作]）和出血风险（HAS-BLED[高血压、肾功能或肝功能异常、中风、出血史或倾向、不稳定的国际标准化比值、高龄、药物/酒精]）。在从首次合格的房颤就诊日期到死亡、从健康计划中除名或 2010 年 6 月 30 日较早的时间内的可变随访期间确定出血事件。出血事件分为主要、严重非主要和轻微。计算发生重大出血事件的患者的医疗保健费用。
在 48260 例 NVAF 患者（平均年龄，67 岁）中，34%在平均（SD）802（540）天的随访期间发生了一次出血事件。任何严重程度和主要事件的出血事件发生率分别为 29.6 和 10.4 例/100 患者-年。出血发生率随 CHADS2 和 HAS-BLED 风险评分的增加而升高。在重大出血事件期间，每位患者的全因医疗保健费用平均为 16830 美元。在出血前期间，每位发生重大事件患者的平均费用约为每天 52 美元，在出血后期间，平均费用约为每天 63 美元，而未发生重大出血事件患者的平均费用约为每天 38 美元。
在真实环境中，NVAF 患者的出血发生率较高，且随中风和出血风险评分的增加而升高。发生重大出血事件的患者的医疗保健费用较高。版权所有。
