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非瓣膜性心房颤动患者治疗范围内时间控制不佳与不良临床结局相关:来自全国性COOL-AF注册研究的报告

Poor Time in Therapeutic Range Control is Associated with Adverse Clinical Outcomes in Patients with Non-Valvular Atrial Fibrillation: A Report from the Nationwide COOL-AF Registry.

作者信息

Krittayaphong Rungroj, Chantrarat Thoranis, Rojjarekampai Roj, Jittham Pongpun, Sairat Poom, Lip Gregory Y H

机构信息

Division of Cardiology, Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok 10700, Thailand.

Division of Cardiology, Department of Medicine, Phramongkutklao College of Medicine, Bangkok 10400, Thailand.

出版信息

J Clin Med. 2020 Jun 2;9(6):1698. doi: 10.3390/jcm9061698.

Abstract

BACKGROUND

Warfarin remains the most commonly used oral anticoagulant (OAC) in Thailand for stroke prevention among patients with non-valvular atrial fibrillation (NVAF). The aim of this study was to investigate the relationship between time in therapeutic range (TTR) after warfarin initiation and clinical outcomes of NVAF.

METHODS

TTR was calculated by the Rosendaal method from international normalized ratio (INR) data acquired from a nationwide NVAF registry in Thailand. Patients were followed-up every six months. The association between TTR and clinical outcomes was analyzed.

RESULTS

There was a total of 2233 patients from 27 hospitals. The average age was 68.4 ± 10.6 years. The average TTR was 53.56 ± 26.37%. Rates of ischemic stroke/TIA, major bleeding, ICH, and death were 1.33, 2.48, 0.76, and 3.3 per 100 person-years, respectively. When patients with a TTR < 65% were compared with those with TTR ≥ 65%, the adjusted hazard ratios (aHR) for the increased risks of ischemic stroke/TIA, major bleeding, ICH, and death were 3.07, 1.90, 2.34, and 2.11, respectively.

CONCLUSION

Poor TTR control is associated with adverse clinical outcomes in patients with NVAF who were on warfarin. Efforts to ensure good TTR (≥65%) after initiation of warfarin are mandatory to minimize the risk of adverse clinical outcomes.

摘要

背景

在泰国,华法林仍然是预防非瓣膜性心房颤动(NVAF)患者中风最常用的口服抗凝剂(OAC)。本研究的目的是调查华法林起始治疗后处于治疗范围内的时间(TTR)与NVAF临床结局之间的关系。

方法

采用Rosendaal法,根据从泰国全国NVAF登记处获取的国际标准化比值(INR)数据计算TTR。患者每六个月随访一次。分析TTR与临床结局之间的关联。

结果

共有来自27家医院的2233例患者。平均年龄为68.4±10.6岁。平均TTR为53.56±26.37%。缺血性中风/短暂性脑缺血发作(TIA)、大出血、颅内出血(ICH)和死亡的发生率分别为每100人年1.33、2.48、0.76和3.3例。将TTR<65%的患者与TTR≥65%的患者进行比较时,缺血性中风/TIA、大出血、ICH和死亡风险增加的调整后风险比(aHR)分别为3.07、1.90、2.34和2.11。

结论

TTR控制不佳与服用华法林的NVAF患者的不良临床结局相关。在华法林起始治疗后,必须努力确保良好的TTR(≥65%),以将不良临床结局的风险降至最低。

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