Patel Manesh R, Peacock W Frank, Tamayo Sally, Sicignano Nicholas, Hopf Kathleen P, Yuan Zhong
Duke University Health System and Duke Clinical Research Institute, Durham, NC, USA.
Department of Emergency Medicine, Baylor College of Medicine, Houston, TX, USA.
Clin Exp Emerg Med. 2018 Mar 30;5(1):43-50. doi: 10.15441/ceem.17.216. eCollection 2018 Mar.
Patients with nonvalvular atrial fibrillation (AF) and renal disease (RD) who receive anticoagulation therapy appear to be at greater risk of major bleeding (MB) than AF patients without RD. As observed in past studies, anticoagulants are frequently withheld from AF patients with RD due to concerns regarding bleeding. The objective of this study was to evaluate the incidence and pattern of MB in those with RD, as compared to those without RD, in a population of rivaroxaban users with nonvalvular AF.
Electronic medical records of over 10 million patients from the Department of Defense Military Health System were queried to identify rivaroxaban users with nonvalvular AF. A validated algorithm was used to identify MB-related hospitalizations. RD was defined through diagnostic codes present within 6 months prior to the bleeding date for MB cases and end of study participation for non-MB patients. Data were collected on patient characteristics, comorbidities, MB management, and outcomes.
Overall, 44,793 rivaroxaban users with nonvalvular AF were identified. RD was present among 6,921 patients (15.5%). Patients with RD had a higher rate of MB than those without RD, 4.52 per 100 person-years versus 2.54 per 100 person-years, respectively. The fatal bleeding outcome rate (0.09 per 100 person-years) was identical between those with and without RD.
In this post-marketing study of 44,793 rivaroxaban users with nonvalvular AF, RD patients experienced a higher MB rate than those without RD. The higher rate of MB among those with RD may be due to the confounding effects of comorbidities.
接受抗凝治疗的非瓣膜性心房颤动（AF）和肾病（RD）患者似乎比无RD的AF患者发生大出血（MB）的风险更高。正如过去研究所观察到的，由于担心出血，RD的AF患者经常停用抗凝剂。本研究的目的是评估在使用利伐沙班的非瓣膜性AF人群中，与无RD的患者相比，RD患者MB的发生率和模式。
查询来自国防部军事卫生系统的1000多万患者的电子病历，以识别使用利伐沙班的非瓣膜性AF患者。使用经过验证的算法来识别与MB相关的住院情况。通过MB病例出血日期前6个月内以及非MB患者研究参与结束时出现的诊断代码来定义RD。收集了患者特征、合并症、MB管理和结局的数据。
总体而言，共识别出44793名使用利伐沙班的非瓣膜性AF患者。6921名患者（15.5%）存在RD。RD患者的MB发生率高于无RD的患者，分别为每100人年4.52例和每100人年2.54例。有RD和无RD患者的致命出血结局发生率（每100人年0.09例）相同。
在这项对44793名使用利伐沙班的非瓣膜性AF患者的上市后研究中，RD患者的MB发生率高于无RD的患者。RD患者中较高的MB发生率可能是由于合并症的混杂效应。
