Increased Incident Ischemic Stroke Risk in Advanced Kidney Disease: A Large-Scale Real-World Data Study
Increased Incident Ischemic Stroke Risk in Advanced Kidney Disease: A Large-Scale Real-World Data Study
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晚期肾脏疾病中缺血性中风风险增加：一项大规模真实世界数据研究
DOI：
10.1159/000509567
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发表时间：
2020
影响因子：
4.2
通讯作者：
Arima Hisatomi
中科院分区：
文献类型：
--
作者：
Maeda Tosihki;Nishi Takumi;Funakoshi Shunsuke;Tada Kazuhiro;Tsuji Masayoshi;Satoh Atsushi;Kawazoe Miki;Yoshimura Chikara;Arima Hisatomi
关于口服抗凝剂（OACs）对肾脏疾病患者的影响，使用真实数据的证据很少。本研究的目的是研究肾脏疾病对服用OAC的患者缺血性卒中（IS）或全身性栓塞（SE）的影响，使用日本的大规模真实世界数据。方法本研究是一项回顾性队列研究，使用了2005年1月至2017年6月日本健康保险协会的索赔数据和健康检查数据。我们招募了21,581名诊断为心房颤动（AF）的患者。在总人口中，11,848例（54.9%）患者服用OAC。采用Cox比例风险模型检查肾脏疾病对有无OAC的IS/SE的影响。结果随访期间，未服用OAC的208例（平均随访2.6年）和服用OAC的200例（平均随访3.0年）出现IS/SE。有肾脏疾病组和无肾脏疾病组的IS/SE %发生率分别为2.42/人/年和0.63/人/年，未使用OAC组为3.66/人/年和0.76/人/年，使用OAC组为1.52/人/年和0.55/人/年。与OAC无关，IS/SE患者肾脏疾病的风险比（HR）和95%可信区间（CI）都很高，即使在校正后也是如此：无OAC的校正HR为2.62 (95% CI: 1.72-3.99)，有OAC的校正HR为2.03 (95% CI: 1.20-3.44)；无OAC与OAC相互作用p= 0.193。尽管与使用OAC无关，肾脏疾病的出血风险也很高（总体人群的HR为2.93 [95% CI: 2.27-3.77]，未使用OAC组的HR为3.08 [95% CI: 2.15-4.43]，使用OAC组的HR为2.73 [95% CI: 1.90-3.91]），但临床净获益表明，使用OAC的获益超过了出血风险：肾病患者的HR为4.50 (95% CI: 0.76-8.23)，无肾病患者的HR为0.35 （95% CI: 0.04-0.66）。结论：虽然我们发现OAC对AF患者有效且推荐使用，但晚期肾脏疾病仍然是is /SE的独立危险因素，即使在服用OAC的患者中也是如此。无论使用何种OAC，医生都应意识到这种风险，并严格控制可改变的风险因素。
IntroductionEvidence using real-world data is sparse regarding the effects of oral anticoagulants (OACs) among patients with kidney disease. The aim of this study was to investigate the effects of kidney disease on ischemic stroke (IS) or systemic embolism (SE) among patients taking OAC, using large-scale real-world data in Japan.MethodsThis was a retrospective cohort study using claims data and health checkup data from health insurance associations in Japan, from January 2005 to June 2017. We enrolled 21,581 patients diagnosed with atrial fibrillation (AF). Of the total population, 11,848 (54.9%) patients were taking OAC. A Cox proportional hazards model was used to examine the effect of kidney disease on IS/SE with or without OAC.ResultsDuring follow-up, 208 participants who were not taking OAC (mean follow-up 2.6 years) and 200 who were taking OAC (mean follow-up 3.0 years) experienced IS/SE. The% IS/SE incidence rates with and without kidney disease were 2.42/person-year and 0.63/person-year in the total population, 3.66/person-year and 0.76/person-year in the group without OAC use, and 1.52/person-year and 0.55/person-year in patients with OAC use, respectively. Hazard ratios (HRs) and 95% confidence intervals (CIs) of kidney disease for IS/SE were high, irrespective of OAC, even after adjustment: adjusted HR 2.62 (95% CI: 1.72–3.99) without OAC and adjusted HR 2.03 (95% CI: 1.20–3.44) with OAC; p= 0.193 for interaction between no OAC and OAC. Although bleeding risk was also high for kidney disease irrespective of OAC use (HR 2.93 [95% CI: 2.27–3.77] in the total population, HR 3.08 [95% CI: 2.15–4.43] in the group without OAC, and HR 2.73 [95% CI: 1.90–3.91] in the group with OAC use), net clinical benefit indicated that the benefit of OAC use exceeded the risk of bleeding: HR 4.50 (95% CI: 0.76–8.23) among those with kidney disease and HR 0.35 (95% CI: 0.04–0.66) among those without kidney disease.ConclusionAlthough we found that OAC use was effective and recommended for patients with AF, advanced kidney disease is still an independent risk factor for IS/SE, even in patients taking OAC. Physicians should be aware of this risk and strictly control modifiable risk factors, regardless of OAC use.