Coleman Craig I, Peacock W Frank, Antz Matthias
University of Connecticut School of Pharmacy, Storrs, CT, USA.
Department of Emergency Medicine, Baylor College of Medicine, Houston, TX, USA.
Heart Lung Circ. 2018 Mar;27(3):390-393. doi: 10.1016/j.hlc.2017.04.002. Epub 2017 May 3.
Scarce data comparing real-world outcomes between apixaban and vitamin K antagonist (VKA) users with nonvalvular atrial fibrillation (NVAF) are available. We sought to assess the effectiveness and safety of newly-initiated apixaban vs. VKA in German NVAF patients.
We performed a retrospective analysis in German outpatients using IMS Disease Analyzer data. Adults newly-initiated on apixaban or a VKA from January 2013 to March 2015 with a diagnosis of NVAF on the day of the first qualifying oral anticoagulant (OAC) prescription (index date) or any time during 1 year prior, and at least 1 year of follow-up were included. Patients experiencing a prior event in the composite endpoint, receiving an OAC before the index date, >1 OAC on the index date or switched to another OAC during follow-up were excluded. Apixaban and VKA users were 1:1 propensity-score matched. We evaluated the composite of ischaemic stroke, transient ischaemic attack (TIA), myocardial infarction (MI) or intracranial haemorrhage (ICH) in the year after OAC initiation. Cox regression was used to calculate hazard ratios (HRs) and 95% confidence intervals (CIs).
In total, 835 apixaban and 835 VKA users were matched. Forty-one composite events were identified. Hazard of the composite endpoint did not differ between apixaban and VKA users (HR=0.87, 95%CI=0.47-1.60). Ischaemic stroke and MI occurred at dissimilar (albeit not statistically significant) rates between apixaban and VKA therapy (HR=1.51, 95%CI=0.54-4.24) and (HR=0.33, 95%CI=0.11-1.03). Only two patients (both in the apixaban cohort) experienced an ICH.
Apixaban and VKA therapy were associated with a similar impact on the composite endpoint in real-world German practice. Additional investigation is needed to evaluate the numeric trends of ischaemic stroke and decreased number of MIs observed with apixaban, as well as the high rate of reduced dose apixaban use found in this analysis.
关于阿哌沙班与维生素K拮抗剂（VKA）用于非瓣膜性心房颤动（NVAF）患者的真实世界疗效对比数据稀缺。我们旨在评估德国NVAF患者中新启用阿哌沙班与VKA的有效性和安全性。
我们使用IMS疾病分析仪数据对德国门诊患者进行了一项回顾性分析。纳入2013年1月至2015年3月期间新启用阿哌沙班或VKA的成年人，在首次符合条件的口服抗凝剂（OAC）处方日（索引日期）或之前1年内的任何时间被诊断为NVAF，且至少随访1年。排除在复合终点事件中曾有过事件、在索引日期之前接受过OAC、在索引日期使用>1种OAC或在随访期间改用另一种OAC的患者。阿哌沙班和VKA使用者按1:1倾向评分匹配。我们评估了OAC启用后1年内缺血性卒中、短暂性脑缺血发作（TIA）、心肌梗死（MI）或颅内出血（ICH）的复合情况。使用Cox回归计算风险比（HRs）和95%置信区间（CIs）。
总共匹配了835名阿哌沙班使用者和835名VKA使用者。确定了41例复合事件。阿哌沙班和VKA使用者之间复合终点的风险无差异（HR = 0.87，95%CI = 0.47 - 1.60）。阿哌沙班和VKA治疗之间缺血性卒中和MI的发生率不同（尽管无统计学意义）（HR = 1.51，95%CI = 0.54 - 4.24）和（HR = 0.33，95%CI = 0.11 - 1.03）。仅2例患者（均在阿哌沙班队列）发生ICH。
在德国的实际应用中，阿哌沙班和VKA治疗对复合终点的影响相似。需要进一步研究以评估阿哌沙班观察到的缺血性卒中数值趋势和MI数量减少情况，以及本分析中发现的阿哌沙班低剂量使用率较高的情况。
