SPRINT 研究（收缩压干预试验）中估算肾小球滤过率变异性与心血管事件和死亡风险。
Estimated GFR Variability and Risk of Cardiovascular Events and Mortality in SPRINT (Systolic Blood Pressure Intervention Trial).
机构信息
Division of Nephrology and Hypertension, Department of Medicine, University of California San Diego, San Diego, CA.
Kidney Research Institute, University of Washington, Seattle, WA.
出版信息
Am J Kidney Dis. 2021 Jul;78(1):48-56. doi: 10.1053/j.ajkd.2020.10.016. Epub 2020 Dec 14.
RATIONALE AND OBJECTIVE
Although low estimated glomerular filtration rate (eGFR) is associated with cardiovascular disease (CVD) events and mortality, the clinical significance of variability in eGFR over time is uncertain. This study aimed to evaluate the associations between variability in eGFR and the risk of CVD events and all-cause mortality.
STUDY DESIGN
Longitudinal analysis of clinical trial participants.
SETTINGS AND PARTICIPANTS
7,520 Systolic Blood Pressure Intervention Trial (SPRINT) participants ≥50 year of age with 1 or more CVD risk factors.
PREDICTORS
eGFR variability, estimated by the coefficient of variation of eGFR assessments at the 6th, 12th, and 18-month study visits.
OUTCOMES
The SPRINT primary CVD composite outcome (myocardial infarction, acute coronary syndrome, stroke, heart failure, or CVD death) and all-cause mortality from month 18 to the end of follow-up.
ANALYTICAL APPROACH
Cox models were used to evaluate associations between eGFR variability and CVD outcomes and all-cause mortality. Models were adjusted for demographics, randomization arm, CVD risk factors, albuminuria, and eGFR at month 18.
RESULTS
Mean age was 68 ± 9 years; 65% were men; and 58% were White. The mean eGFR was 73 ± 21 (SD) mL/min/1.73 m at 6 months. There were 370 CVD events and 154 deaths during a median follow-up of 2.4 years. Greater eGFR variability was associated with higher risk for all-cause mortality (hazard ratio [HR] per 1 SD greater variability, 1.29; 95% CI, 1.14-1.45) but not CVD events (HR, 1.05; 95% CI, 0.95-1.16) after adjusting for albuminuria, eGFR, and other CVD risk factors. Associations were similar when stratified by treatment arm and by baseline CKD status, when accounting for concurrent systolic blood pressure changes, use of angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, and diuretic medications during follow up.
LIMITATIONS
Persons with diabetes and proteinuria > 1 g/d were excluded.
CONCLUSIONS
In trial participants at high risk for CVD, greater eGFR variability was independently associated with all-cause mortality but not CVD events.
背景和目的
尽管估算肾小球滤过率（eGFR）较低与心血管疾病（CVD）事件和死亡率相关，但 eGFR 随时间变化的可变性的临床意义尚不确定。本研究旨在评估 eGFR 变异性与 CVD 事件和全因死亡率风险之间的关联。
研究设计
临床试验参与者的纵向分析。
研究场所和参与者
≥50 岁且有 1 种或多种 CVD 危险因素的 7520 例收缩压干预试验（SPRINT）参与者。
预测指标
通过第 6、12 和 18 个月研究访视时 eGFR 评估的变异系数来估计 eGFR 变异性。
结局
SPRINT 主要 CVD 复合结局（心肌梗死、急性冠脉综合征、卒中和心力衰竭或 CVD 死亡）和从第 18 个月到随访结束时的全因死亡率。
分析方法
使用 Cox 模型评估 eGFR 变异性与 CVD 结局和全因死亡率之间的关联。模型根据人口统计学、随机分组、CVD 危险因素、白蛋白尿和第 18 个月的 eGFR 进行了调整。
结果
平均年龄为 68±9 岁；65%为男性；58%为白人。6 个月时 eGFR 平均为 73±21（SD）mL/min/1.73m。中位随访 2.4 年后，发生 370 例 CVD 事件和 154 例死亡。在调整白蛋白尿、eGFR 和其他 CVD 危险因素后，eGFR 变异性每增加 1 个标准差，全因死亡率的风险就会更高（每增加 1 个标准差的危险比[HR]，1.29；95%CI，1.14-1.45），但与 CVD 事件无关（HR，1.05；95%CI，0.95-1.16）。在按治疗组和基线 CKD 状态分层、在考虑到同期收缩压变化、使用血管紧张素转换酶抑制剂或血管紧张素受体阻滞剂以及在随访期间使用利尿剂药物的情况下，结果相似。
局限性
排除了患有糖尿病和蛋白尿>1g/d 的患者。
结论
在 CVD 风险较高的试验参与者中，更大的 eGFR 变异性与全因死亡率独立相关，但与 CVD 事件无关。
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