接受抗凝治疗的日本非瓣膜性心房颤动患者的特征：达比加群酯日本监测研究和日本心房颤动（JAPAF）研究的描述性分析
Characteristics of Japanese Patients with Nonvalvular Atrial Fibrillation on Anticoagulant Treatment: A Descriptive Analysis of J-dabigatran Surveillance and JAPAF Study.
作者信息
Koretsune Yukihiro, Kusakawa Koichi, Harada Kouji H, Koizumi Akio, Uchiyama Shinichiro, Atarashi Hirotsugu, Okumura Ken, Yasaka Masahiro, Yamashita Takeshi, Taniguchi Atsushi, Fukaya Taku, Inoue Hiroshi
机构信息
National Hospital Organization Osaka National Hospital, Osaka, Japan.
Department of Health and Environmental Sciences, Kyoto University Graduate School of Medicine, Kyoto, Japan.
出版信息
Cardiol Ther. 2019 Jun;8(1):43-54. doi: 10.1007/s40119-019-0129-2. Epub 2019 Feb 11.
INTRODUCTION
Following approval of dabigatran and other antithrombotics in Japan, few studies have specifically evaluated the clinical characteristics of patients prescribed these antithrombotics for nonvalvular atrial fibrillation (NVAF) in real-world practice.
METHODS
We conducted a descriptive analysis of data from two real-world studies [J-dabigatran surveillance and Japanese study on current Anticoagulation therapies for Patients with nonvalvular Atrial Fibrillation (JAPAF); conducted at sites common to both studies] to determine the characteristics of patients with NVAF initiated on dabigatran etexilate [110 mg twice daily (BID; DE110) or 150 mg BID (DE150)], warfarin, rivaroxaban, or antiplatelets as their first antithrombotic treatment. Inferential statistical analyses were not performed, and no statistical hypothesis was tested.
RESULTS
Data for 1270 and 3011 eligible patients from the J-dabigatran surveillance (DE110, 976; DE150, 273) and JAPAF study (warfarin, 82.5%; rivaroxaban, 10.3%; antiplatelets, 21%), respectively, were extracted. In the J-dabigatran surveillance, 31.8% (full cohort, 28.1%) of patients had been switched from warfarin to dabigatran. Among patients prescribed DE110/DE150, 41.4%/57.5% and 41.5%/18.7% of patients had low-to-intermediate risk for ischemic stroke (CHADS score of 0 or 1) and high risk for bleeding (HAS-BLED score ≥ 3), respectively. Similarly, 33.7%/41.3%/40.2% and 48.7%/42.6%/75.7% of patients taking warfarin/rivaroxaban/antiplatelets had a CHADS score of 0 or 1 and HAS-BLED score ≥ 3, respectively. Dabigatran was favored in patients with creatinine clearance > 50 ml/min.
CONCLUSIONS
In Japan, physicians who attempt stroke prevention in patients with atrial fibrillation choose appropriate anticoagulant treatment, taking into consideration the individual patient backgrounds as well as the features of each antithrombotic agent.
TRIAL REGISTRATION
ClinicalTrials.gov Identifier, NCT01491178 and University Hospital Medical Information Network (UMIN) Clinical Trial Registry Identifier, UMIN000009644.
FUNDING
Nippon Boehringer Ingelheim Co., Ltd. Plain language summary available for this article.
引言
在达比加群及其他抗栓药物于日本获批后，几乎没有研究专门评估在实际临床中使用这些抗栓药物治疗非瓣膜性心房颤动（NVAF）患者的临床特征。
方法
我们对两项真实世界研究[J-达比加群监测研究以及日本非瓣膜性心房颤动患者当前抗凝治疗研究（JAPAF）；两项研究在共同的研究地点开展]的数据进行了描述性分析，以确定首次接受达比加群酯[110毫克每日两次（BID；DE110）或150毫克BID（DE150）]、华法林、利伐沙班或抗血小板药物作为抗栓治疗的NVAF患者的特征。未进行推断性统计分析，也未检验统计假设。
结果
分别从J-达比加群监测研究（DE110，976例；DE150，273例）和JAPAF研究（华法林，82.5%；利伐沙班，10.3%；抗血小板药物，21%）中提取了1270例和3011例符合条件患者的数据。在J-达比加群监测研究中，31.8%（整个队列，28.1%）的患者从华法林转换为达比加群。在接受DE110/DE150治疗的患者中，分别有41.4%/57.5%和41.5%/18.7%的患者发生缺血性卒中的风险为低至中度（CHADS评分为0或1）和出血风险高（HAS - BLED评分≥3）。同样，服用华法林/利伐沙班/抗血小板药物的患者中，分别有33.7%/41.3%/40.2%和48.7%/42.6%/75.7%的患者CHADS评分为0或1且HAS - BLED评分≥3。肌酐清除率>50毫升/分钟的患者更倾向于使用达比加群。
结论
在日本，试图预防心房颤动患者卒中的医生会考虑患者个体背景以及每种抗栓药物的特点，选择合适的抗凝治疗。
试验注册
ClinicalTrials.gov标识符，NCT01491178以及大学医院医学信息网络（UMIN）临床试验注册标识符，UMIN000009644。
资助
日本勃林格殷格翰株式会社。本文提供了通俗易懂的摘要。
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