Background/Aims: Both high-dose atorvastatin and rosuvastatin have been shown to reduce contrast-induced acute kidney injury (AKI) occurrence and improve clinical outcomes in high-risk coronary patients undergoing angiographic procedures. However, there is a lack of head-to-head comparative studies on the effects of atorvastatin or rosuvastatin administered upon hospital admission in statin-naive patients with non-ST segment elevation acute coronary syndrome (NSTE-ACS). Methods: In this open-label, noninferiority study, we compared changes in renal function in 709 NSTE-ACS patients randomized to atorvastatin (80 mg upon admission followed by 40 mg/day) or rosuvastatin (40 mg upon admission followed by 20 mg/day). The primary end point was AKI (increase in serum creatinine ≥0.5 mg/dL or ≥25% above baseline within 72 h). Worsening renal function (WRF) (decrease of ≥25% in the glomerular filtration rate from baseline to 30 days), 30-day major adverse cardiovascular events, and 12-month myocardial infarction (MI) or death were also evaluated. Results: The AKI incidence was similar in the 2 groups (i.e., 8.2% with rosuvastatin and 7.6% with atorvastatin; absolute risk difference = 0.54; 90% CI –3.9 to 2.8), satisfying the noninferiority criteria. WRF occurred in 53 (7.5%) patients, 19 (34%) of whom had developed AKI. The rates of WRF and adverse events at 30 days and at 12 months did not differ significantly between the 2 groups. Both AKI and WRF were found to be closely associated with the 12-month cardiovascular outcome irrespectively of statin choice. Conclusions: High-dose rosuvastatin or atorvastatin started upon hospital admission led to similar rates of AKI, 30-day renal function changes, and 12-month death or MI in NSTE-ACS patients who underwent an early invasive strategy (clinical trial registration: https://www.clinicaltrials.gov; unique identifier: NCT01870804).
Cardiorenal Med

中文翻译：

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阿托伐他汀与瑞舒伐他汀预防造影剂所致急性肾损伤、30 天肾功能恶化和急性冠状动脉造影后临床事件的前瞻性、随机、开放标签试验：PRATO-ACS-2 研究。

背景/目的：大剂量阿托伐他汀和瑞舒伐他汀均已被证明可减少造影剂诱发的急性肾损伤 (AKI) 的发生并改善接受血管造影术的高危冠状动脉患者的临床结果。然而，目前还缺乏关于阿托伐他汀或瑞舒伐他汀对非 ST 段抬高急性冠脉综合征 (NSTE-ACS) 未接受他汀类药物患者入院时的影响的头对头比较研究。方法：在这项开放标签、非劣效性研究中，我们比较了 709 名随机接受阿托伐他汀（入院时 80 毫克，然后 40 毫克/天）或瑞舒伐他汀（入院时 40 毫克，然后是 20 毫克/天）的 NSTE-ACS 患者的肾功能变化. 主要终点是 AKI（72 小时内血清肌酐增加 ≥ 0.5 mg/dL 或高于基线 ≥ 25%）。还评估了肾功能恶化 (WRF)（肾小球滤过率从基线到 30 天下降≥25%）、30 天主要不良心血管事件和 12 个月心肌梗死 (MI) 或死亡。结果：两组的 AKI 发生率相似（即，瑞舒伐他汀组为 8.2%，阿托伐他汀组为 7.6%；绝对风险差 = 0.54；90% CI –3.9 至 2.8），满足非劣效性标准。53 名 (7.5%) 患者发生 WRF，其中 19 名 (34%) 患有 AKI。2 组在 30 天和 12 个月时的 WRF 和不良事件发生率没有显着差异。无论选择何种他汀类药物，AKI 和 WRF 均与 12 个月的心血管结局密切相关。结论：在接受早期侵入性策略的 NSTE-ACS 患者中，入院后开始使用大剂量瑞舒伐他汀或阿托伐他汀导致相似的 AKI、30 天肾功能变化和 12 个月死亡或 MI 发生率（临床试验注册：https：/ /www.clinicaltrials.gov；唯一标识符：NCT01870804）。
心肾医学