Minneapolis VA Healthcare System, University of Minnesota, Minneapolis Heart Institute, Minneapolis, Minnesota.
VA Boston Healthcare System and Brigham and Women's Hospital Heart & Vascular Center, Harvard Medical School, Boston, Massachusetts.
JACC Cardiovasc Interv. 2018 Nov 26;11(22):2254-2261. doi: 10.1016/j.jcin.2018.07.044.
The aim of this study was to compare intravenous (IV) sodium bicarbonate with IV sodium chloride and oral acetylcysteine with placebo for the prevention of contrast-associated acute kidney injury (CAAKI) and intermediate-term adverse outcomes.
Data are conflicting on the optimal strategy to reduce CAAKI and related complications after percutaneous coronary intervention (PCI).
The PRESERVE (Prevention of Serious Adverse Events Following Angiography) trial used a 2 × 2 factorial design to randomize 5,177 patients with stage III or IV chronic kidney disease undergoing angiography to IV 1.26% sodium bicarbonate or IV 0.9% sodium chloride and 5 days of oral acetylcysteine or placebo. A subgroup analysis was conducted of the efficacy of these interventions in patients who underwent PCI during the study angiographic examination. The primary endpoint was a composite of death, need for dialysis, or persistent kidney impairment at 90 days; CAAKI was a secondary endpoint.
A total of 1,161 PRESERVE patients (mean age 69 ± 8 years) underwent PCI. The median estimated glomerular filtration rate was 50.7 ml/min/1.73 m (interquartile range: 41.7 to 60.1 ml/min/1.73 m), and 952 patients (82%) had diabetes mellitus. The primary endpoint occurred in 15 of 568 patients (2.6%) in the IV sodium bicarbonate group and 24 of 593 patients (4.0%) in the IV sodium chloride group (odds ratio: 0.64; 95% confidence interval: 0.33 to 1.24; p for interaction = 0.41) and in 23 of 598 patients (3.8%) in the acetylcysteine group and 16 of 563 patients (2.8%) in the placebo group (odds ratio: 1.37; 95% confidence interval: 0.71 to 2.62; p for interaction = 0.29). There were no significant between-group differences in the rates of CAAKI.
Among patients with CKD undergoing PCI, there was no benefit of IV sodium bicarbonate over IV sodium chloride or of acetylcysteine over placebo for the prevention of CAAKI or intermediate-term adverse outcomes.
本研究旨在比较静脉内（IV）碳酸氢钠与 IV 氯化钠以及口服乙酰半胱氨酸与安慰剂在预防对比剂相关急性肾损伤（CAAKI）和中期不良结局方面的作用。
关于经皮冠状动脉介入治疗（PCI）后降低 CAAKI 和相关并发症的最佳策略，数据存在争议。
PRESERVE（血管造影后严重不良事件预防）试验采用 2×2 析因设计，将 5177 例 III 期或 IV 期慢性肾脏病患者随机分为 IV 组 1.26%碳酸氢钠或 IV 组 0.9%氯化钠，以及口服组 5 天乙酰半胱氨酸或安慰剂。对研究血管造影检查期间行 PCI 的患者进行了这些干预措施疗效的亚组分析。主要终点为 90 天时死亡、需要透析或持续性肾功能损害的复合终点；CAAKI 为次要终点。
共有 1161 例 PRESERVE 患者（平均年龄 69±8 岁）接受了 PCI。估计肾小球滤过率中位数为 50.7ml/min/1.73m（四分位间距：41.7 至 60.1ml/min/1.73m），952 例患者（82%）患有糖尿病。IV 碳酸氢钠组 568 例患者中有 15 例（2.6%）和 IV 氯化钠组 593 例患者中有 24 例（4.0%）发生主要终点（比值比：0.64；95%置信区间：0.33 至 1.24；p 交互=0.41），乙酰半胱氨酸组 598 例患者中有 23 例（3.8%）和安慰剂组 563 例患者中有 16 例（2.8%）发生主要终点（比值比：1.37；95%置信区间：0.71 至 2.62；p 交互=0.29）。两组间 CAAKI 发生率无显著差异。
在接受 PCI 的 CKD 患者中，与 IV 氯化钠相比，IV 碳酸氢钠或与安慰剂相比，乙酰半胱氨酸对预防 CAAKI 或中期不良结局均无益处。
