Liu Shuqian, Li Xiaoyan, Shi Qian, Hamilton Melissa, Friend Keith, Zhao Yingnan, Horblyuk Ruslan, Hede Shalini, Shi Lizheng
a Tulane University School of Public Health and Tropical Medicine , New Orleans , LA , USA.
b Bristol-Myers Squibb , Lawrence , NJ , USA.
Curr Med Res Opin. 2018 Mar;34(3):415-421. doi: 10.1080/03007995.2017.1384370. Epub 2017 Oct 3.
Poor quality of warfarin control (time in therapeutic range [TTR] < 65%) can lead to increased risk of adverse events. The objective of this study was to examine the overall quality of international normalized ratio (INR) control and the association of TTR with clinical outcomes including stroke, major bleeding, and all-cause mortality among US warfarin users.
This retrospective observational cohort study utilized the US Veterans Affairs electronic medical records database (VA EMR). Patients with NVAF who newly initiated warfarin from 1 January 2005 to 31 December 2015 were grouped into two cohorts based on TTR <65% or ≥65%. TTR was computed from INR test results. Clinical outcomes assessed were stroke/systemic embolism (SE), hemorrhagic stroke, ischemic stroke, and major bleeding, defined based on hospitalization with those conditions as primary diagnosis, as well as all-cause mortality. Patients were followed from warfarin initiation to the first occurrence of an outcome or censoring. Propensity score weighted time-varying Cox regression was used to evaluate the risk of the clinical events. A total of 127,385 NVAF patients with mean TTR of 51% were included. TTR <65% was observed in 65% of patients. Mean CHADS-VAS score (SD) was 2.9 (1.5) in the low TTR cohort and 2.7 (1.4) in the high TTR cohort. Patients with TTR <65% had a higher risk for any stroke/SE (HR: 1.57; 95% CI: 1.41-1.75), major bleeding (HR: 2.78; 95% CI: 2.55-3.03) and all-cause mortality (HR: 1.73; 95% CI: 1.67-1.79).
The observed quality of warfarin control in VA EMR suggests room for improvement given the association with elevated risk of adverse clinical outcomes.
华法林控制质量不佳(治疗范围内时间[TTR]<65%)会导致不良事件风险增加。本研究的目的是检验国际标准化比值(INR)控制的总体质量,以及TTR与美国华法林使用者的临床结局(包括中风、大出血和全因死亡率)之间的关联。
这项回顾性观察性队列研究利用了美国退伍军人事务部电子病历数据库(VA EMR)。2005年1月1日至2015年12月31日新开始使用华法林的非瓣膜性房颤(NVAF)患者根据TTR<65%或≥65%分为两个队列。TTR根据INR检测结果计算。评估的临床结局包括中风/全身性栓塞(SE)、出血性中风、缺血性中风和大出血,根据以这些疾病为主要诊断的住院情况进行定义,以及全因死亡率。患者从开始使用华法林随访至首次出现结局或截尾。倾向评分加权时变Cox回归用于评估临床事件的风险。共纳入127385例平均TTR为51%的NVAF患者。65%的患者TTR<65%。低TTR队列的平均CHADS-VAS评分(标准差)为2.9(1.5),高TTR队列的平均CHADS-VAS评分为2.7(1.4)。TTR<65%的患者发生任何中风/SE(风险比:1.57;95%置信区间:1.41-1.75)、大出血(风险比:2.78;95%置信区间:2.55-3.03)和全因死亡率(风险比:1.73;95%置信区间:1.67-1.79)的风险更高。
鉴于VA EMR中观察到的华法林控制质量与不良临床结局风险升高相关,提示仍有改进空间。