Centre for Observational Research and Data Sciences/Worldwide Health Economics and Outcomes Research, Bristol-Myers Squibb, Uxbridge, UB8 1DH, UK.
Health Economics and Outcomes Research, CliCon S.r.l. Health, Economics & Outcomes Research, Ravenna, 48121, Italy.
J Comp Eff Res. 2018 Nov;7(11):1063-1071. doi: 10.2217/cer-2018-0054. Epub 2018 Aug 13.
This study aimed to evaluate the risk of major bleeding among two cohorts of nonvalvular atrial fibrillation patients newly initiating a vitamin K antagonist (VKA) or apixaban in a real-world setting in Italy.
PATIENTS & METHODS: A retrospective study using a large administrative database of Italian local health units was performed, using data from ten local health units and patients were included from the date of new initiation of apixaban or VKAs from January 2012 to June 2015.
Risk of major bleeding was calculated using an adjusted Cox regression model. Compared with VKA, apixaban had a significantly lower risk of major bleeding (hazard ratio = 0.44 [95% CI: 0.12-0.97]).
In this analysis, apixaban was associated with a lower risk of major bleeding compared with VKA.
本研究旨在评估意大利真实世界环境中，新使用维生素 K 拮抗剂（VKA）或阿哌沙班的非瓣膜性心房颤动患者的两组人群中主要出血的风险。
使用意大利地方卫生单位的大型行政数据库进行回顾性研究，数据来自十个地方卫生单位，纳入的患者自 2012 年 1 月至 2015 年 6 月新开始使用阿哌沙班或 VKA 时起算。
使用调整后的 Cox 回归模型计算主要出血风险。与 VKA 相比，阿哌沙班的主要出血风险显著降低（风险比=0.44 [95% CI：0.12-0.97]）。
在本分析中，与 VKA 相比，阿哌沙班与较低的主要出血风险相关。
