An observational study of international normalized ratio control according to NICE criteria in patients with non-valvular atrial fibrillation: the SAIL Warfarin Out of Range Descriptors Study (SWORDS).

An observational study of international normalized ratio control according to NICE criteria in patients with non-valvular atrial fibrillation: the SAIL Warfarin Out of Range Descriptors Study (SWORDS).
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DOI:
10.1093/ehjcvp/pvz071
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发表时间:
2021-01-16
期刊:
European heart journal. Cardiovascular pharmacotherapy
影响因子:
--
通讯作者:
Halcox J
Halcox J
中科院分区:
其他
文献类型:
--
作者:
Harris DE;Thayer D;Wang T;Brooks C;Murley G;Gravenor M;Hill NR;Lister S;Halcox J

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在服用华法林的非瓣膜性心房颤动患者中,英国国家健康与护理卓越研究所(NICE)将抗凝不良定义为治疗范围内时间(TTR) <65%, 6个月内任意两个国际标准化比率(INR)≤1.5(“低”),6个月内任意两个INR≥5,或任何INR≥8(“高”)。我们的目标是(i)量化INR控制差的患者数量,(ii)描述与INR控制差相关的人口学和临床特征。英国威尔士(2006-2017)的关联匿名健康记录数据用于评估至少有6个月INR数据的华法林患者。纳入32380例患者。总共有13913例(43.0%)患者至少有一项NICE标记物表明INR控制不良。重要的是,在可接受的TTR(≥65%)的24123名(74.6%)队列中,5676名(23.5%)在其历史上的某个时间点具有低或高的INR读数。在多变量回归中,女性、年龄(≥75岁)、过量饮酒、糖尿病心力衰竭、缺血性心脏病和呼吸系统疾病与INR控制不良的所有标志物独立相关。根据NICE标准可接受的INR控制较差。在TTR可接受(约65%)的患者中,根据NICE标准,四分之一的患者的INR水平仍低或高得不可接受。因此,仅使用TTR来评估华法林的有效性有可能错过大量非治疗性inr患者,这些患者的风险可能会增加。
In patients with non-valvular atrial fibrillation prescribed warfarin, the UK National Institute of Health and Care Excellence (NICE) defines poor anticoagulation as a time in therapeutic range (TTR) of <65%, any two international normalized ratios (INRs) within a 6-month period of ≤1.5 (‘low’), two INRs ≥5 within 6 months, or any INR ≥8 (‘high’). Our objectives were to (i) quantify the number of patients with poor INR control and (ii) describe the demographic and clinical characteristics associated with poor INR control. Linked anonymized health record data for Wales, UK (2006–2017) was used to evaluate patients prescribed warfarin who had at least 6 months of INR data. 32 380 patients were included. In total, 13 913 (43.0%) patients had at least one of the NICE markers of poor INR control. Importantly, in the 24 123 (74.6%) of the cohort with an acceptable TTR (≥65%), 5676 (23.5%) had either low or high INR readings at some point in their history. In a multivariable regression female gender, age (≥75 years), excess alcohol, diabetes heart failure, ischaemic heart disease, and respiratory disease were independently associated with all markers of poor INR control. Acceptable INR control according to NICE standards is poor. Of those with an acceptable TTR (>65%), one-quarter still had unacceptably low or high INR levels according to NICE criteria. Thus, only using TTR to assess effectiveness with warfarin has the potential to miss a large number of patients with non-therapeutic INRs who are likely to be at increased risk.
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