Gallagher Arlene M, van Staa Tjeerd P, Murray-Thomas Tarita, Schoof Nils, Clemens Andreas, Ackermann Diana, Bartels Dorothee B
Clinical Practice Research Datalink, London, UK.
BMJ Open. 2014 Jan 27;4(1):e003839. doi: 10.1136/bmjopen-2013-003839.
Atrial fibrillation (AF) is the most common cardiac rhythm disorder with a significant health burden. The aim of this study was to characterise patients with recently diagnosed AF and to estimate the rates of comorbidities and outcome events requiring hospitalisation in routine clinical practice.
Pharmacoepidemiological cohort study using observational data.
METHODS/SETTING: This study included 16 513 patients with a first diagnosis of AF between 1 January 2005 and 28 February 2010 (newly diagnosed patients) using data from the UK Clinical Practice Research Datalink (CPRD) linked to Hospital Episode Statistics (HES) and the Office for National Statistics mortality data. Exposure was stratified by vitamin K antagonist (VKA) exposure (non-use, current, recent and past exposure) based on prescriptions and/or international normalised ratio measurements, and followed for outcome events of interest based on diagnosis codes in the databases, that is, vascular outcomes, bleeding events and others. The main focus of the study was on outcome events requiring hospitalisation using the HES data.
The incidence of vascular outcome hospitalisations (myocardial infarction (MI), stroke or systemic arterial peripheral embolism) was 3.8 (95% CI 3.5 to 4.0)/100 patient-years. The incidence of stroke was 0.9 (0.8 to 1.1) during current VKA exposure, 2.2 (1.6 to 2.9) for recent, 2.4 (1.9 to 2.9) for past and 3.4 (3.1 to 3.7) during non-use. MI incidence was 0.7 (0.6 to 0.9) for current VKA exposure, 0.7 (0.4 to 1.2) for recent, 1.1 (0.8 to 1.5) for past and 1.9 (1.7 to 2.1) during non-use. The incidence of bleeding event hospitalisations was 3.8 (3.4 to 4.2) for current VKA exposure, 4.5 (3.7 to 5.5) for recent, 2.7 (2.2 to 3.3) for past and 2.9 (2.6 to 3.2) during non-use; 38% of intracranial bleeds and 6% of gastrointestinal bleeds were fatal.
This population-based study from recent years provides a comprehensive characterisation of newly diagnosed patients with AF and incidence estimates of common outcomes with a focus on hospitalised events stratified by VKA exposure. This study will help to place future data on new oral anticoagulants into perspective.
心房颤动（AF）是最常见的心律失常，对健康有重大负担。本研究的目的是描述近期诊断为AF的患者特征，并估计常规临床实践中合并症的发生率以及需要住院治疗的结局事件发生率。
使用观察性数据的药物流行病学队列研究。
方法/研究背景：本研究纳入了2005年1月1日至2010年2月28日期间首次诊断为AF的16513例患者（新诊断患者），使用了与医院事件统计（HES）以及国家统计局死亡率数据相链接的英国临床实践研究数据链（CPRD）中的数据。根据处方和/或国际标准化比值测量结果，将暴露情况按维生素K拮抗剂（VKA）暴露情况进行分层（未使用、当前使用、近期使用和既往使用），并根据数据库中的诊断编码对感兴趣的结局事件进行随访，即血管结局、出血事件及其他。本研究的主要重点是使用HES数据的需要住院治疗的结局事件。
血管性结局住院（心肌梗死（MI）、中风或系统性动脉外周栓塞）的发生率为3.8（95%CI 3.5至4.0）/100患者年。在当前VKA暴露期间，中风的发生率为0.9（0.8至1.1），近期使用为2.2（1.6至2.9），既往使用为2.4（1.9至2.9），未使用时为3.4（3.1至3.7）。MI发生率在当前VKA暴露时为0.7（0.6至0.9），近期使用为0.7（0.4至1.2），既往使用为1.1（0.8至1.5），未使用时为1.9（1.7至2.1）。出血事件住院的发生率在当前VKA暴露时为3.8（3.4至4.2），近期使用为4.5（3.7至5.5），既往使用为2.7（2.2至3.3），未使用时为2.9（2.6至3.2）；38%的颅内出血和6%的胃肠道出血是致命的。
这项近年来基于人群的研究全面描述了新诊断的AF患者特征，并对常见结局的发生率进行了估计，重点是按VKA暴露分层的住院事件。本研究将有助于正确看待未来关于新型口服抗凝剂的数据。
