From the Departments of Cerebrovascular Medicine (M.F.-D., M.K., S.Y., K.M., A.I., M.S., K.T.), Data Science (M.F.-D., H.Y., K.O.), and Neurology (M.I.), National Cerebral and Cardiovascular Center; Department of Nephrology (Y.D.), Osaka University Graduate School of Medicine, Suita, Japan; Zeenat Qureshi Stroke Institute (A.I.Q.), St. Cloud, MN; and Department of Neurology (A.I.Q.), University of Missouri, Columbia.
Neurology. 2021 Aug 31;97(9):e913-e921. doi: 10.1212/WNL.0000000000012442. Epub 2021 Jul 1.
The clinical effect of renal impairment on intracerebral hemorrhage (ICH) is unknown. This study sought to assess whether estimated glomerular filtration rate (eGFR) affects clinical outcomes or modifies the efficacy of intensive systolic blood pressure (BP) control (target, 110-139 mm Hg) against the standard (target, 140-179 mm Hg) among patients with ICH.
We conducted post hoc analyses of ATACH-2, a randomized, 2-group, open-label trial. The baseline eGFR of each eligible patient was calculated using the Chronic Kidney Disease Epidemiology Collaboration equation. The outcome of interest was death or disability at 90 days. Multivariate logistic regression models were used for analysis.
Among the 1,000 patients randomized, 974 were analyzed. The median baseline eGFR was 88 (interquartile range, 68, 99) mL/min/1.73 m; 451 (46.3%), 363 (37.3%), and 160 (16.4%) patients had baseline eGFR values of ≥90, 60-89, and <60 mL/min/1.73 m, respectively. Compared with normal eGFR (≥90 mL/min/1.73 m), higher odds of death or disability were noted among those with eGFR values of <60 mL/min/1.73 m (adjusted odds ratio [OR], 2.02; 95% confidence interval [CI], 1.25-3.26) but not among those with eGFR values of 60-89 mL/min/1.73 m (OR, 1.01; 95% CI, 0.70-1.46). The odds of death or disability were significantly higher in the intensive arm among patients with decreased eGFR; the ORs were 0.89 (95% CI, 0.55-1.44), 1.13 (0.68-1.89), and 3.60 (1.47-8.80) in patients with eGFR values of ≥90, 60-89, and <60 mL/min/1.73 m, respectively ( for interaction = 0.02).
Decreased eGFR is associated with unfavorable outcomes following ICH. The statistically significant interaction between the eGFR group and treatment assignment raised safety concerns for the intensive BP-lowering therapy among patients with renal impairment.
Clinicaltrials.gov identifier: NCT01176565.
This study provides Class II evidence that in spontaneous ICH, decreased eGFR identifies patients at risk of death or disability following intensive BP control.
肾损害对脑出血（ICH）的临床影响尚不清楚。本研究旨在评估估算肾小球滤过率（eGFR）是否会影响临床结局，或是否会改变强化收缩压（BP）控制（目标 110-139mmHg）相对于标准（目标 140-179mmHg）对ICH 患者的疗效。
我们对 ATACH-2 进行了事后分析，这是一项随机、2 组、开放性试验。每个合格患者的基线 eGFR 使用慢性肾脏病流行病学合作方程计算。主要终点为 90 天时的死亡或残疾。使用多变量逻辑回归模型进行分析。
在 1000 名随机患者中，974 名患者进行了分析。中位基线 eGFR 为 88（四分位距 68，99）mL/min/1.73m；基线 eGFR 值分别为≥90、60-89 和<60mL/min/1.73m 的患者分别有 451（46.3%）、363（37.3%）和 160（16.4%）例。与正常 eGFR（≥90mL/min/1.73m）相比，eGFR 值<60mL/min/1.73m 的患者死亡或残疾的可能性更高（校正比值比[OR]，2.02；95%置信区间[CI]，1.25-3.26），而 eGFR 值为 60-89mL/min/1.73m 的患者（OR，1.01；95%CI，0.70-1.46）则不然。在 eGFR 降低的患者中，强化组的死亡或残疾风险显著更高；eGFR 值分别为≥90、60-89 和<60mL/min/1.73m 的患者的 OR 分别为 0.89（95%CI，0.55-1.44）、1.13（0.68-1.89）和 3.60（1.47-8.80）（交互检验=0.02）。
eGFR 降低与 ICH 后的不良结局相关。eGFR 组与治疗分组之间存在统计学显著交互作用，这引发了人们对肾功能损害患者强化降压治疗安全性的担忧。
Clinicaltrials.gov 标识符：NCT01176565.
本研究提供了 II 级证据，表明在自发性 ICH 中，eGFR 降低可识别出接受强化 BP 控制后死亡或残疾风险增加的患者。
