Prevention of radiocontrast medium-induced nephropathy using short-term high-dose simvastatin in patients with renal insufficiency undergoing coronary angiography (PROMISS) trial - a randomized controlled study
Prevention of radiocontrast medium-induced nephropathy using short-term high-dose simvastatin in patients with renal insufficiency undergoing coronary angiography (PROMISS) trial - a randomized controlled study
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DOI：
10.1016/j.ahj.2007.11.042
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发表时间：
2008-03-01
影响因子：
4.8
通讯作者：
Kim, Hyo-Soo
中科院分区：
文献类型：
--
作者：
Jo, Sang-Ho;Koo, Bon-Kwon;Kim, Hyo-Soo
背景造影剂引起氧化应激，这被认为是造影剂肾病的一种可能机制。他汀类药物似乎具有多效性，包括抗氧化特性。我们进行了一项前瞻性、随机、双盲、安慰剂对照、2中心试验，包括247例连续接受冠状动脉造影的慢性肾功能不全患者（计算肌酐清除率= 1.1 mg/dL）。患者被随机分配至辛伐他汀组（n = 124;共160 mg，40 mg口服，每12小时一次，从手术前一天晚上开始，在手术后第二天早上结束）或安慰剂组（n = 123）。所有患者均接受术前和术后水化。结果辛伐他汀组和安慰剂组在冠状动脉造影后48小时内血清肌酐的平均峰值增加（主要研究终点）无差异（分别为0.002 +/- 0.164 vs 0.017 +/- 0.230 mg/mL，P = 0.559）。造影剂肾病的发生率（次要终点定义为血清肌酐升高>= 25%或>= 0.5 mg/dL）在辛伐他汀治疗的患者中为2.5%（3/118），在安慰剂治疗的患者中为3.4%（4/118），差异无统计学意义（P = 1.00）。两组间住院时间或1个月和6个月的临床outcomes.Conclusions辛伐他汀预处理短期在高剂量不防止肾功能恶化后，基线肾功能不全的患者进行冠状动脉造影剂管理。
Background Contrast media cause oxidative stress, which has been suggested as one possible mechanism responsible for contrast-induced nephropathy. Statins appear to have pleiotropic effects, including antioxidant properties. We investigated to determine whether simvastatin pretreatment reduces the risk of contrast-induced nephropathy in a high-risk population of patients with renal insufficiency undergoing coronary angiography.Methods We conducted a prospective, randomized, double-blind, placebo-controlled, 2-center trial, involving 247 consecutive patients with chronic renal insufficiency (calculated creatinine clearance = 1.1 mg/dL) undergoing coronary angiography. Patients were randomized to simvastatin (n = 124; 160 mg total, 40 mg orally every 12 hours starting the evening before and ending the morning after the procedure) or placebo (n = 123). All patients received pre - and postprocedure hydration. The iso-osmolar contrast agent iodixanol was used for coronary angiography in all patients.Results There was no difference between simvastatin and placebo in mean peak increase in serum creatinine measured within 48 hours after coronary angiography, the primary study end point (0.002 +/- 0.164 vs 0.017 +/- 0.230 mg/mL respectively, P = .559). The incidence of contrast-induced nephropathy, a secondary end point defined as increase of either >= 25% or >= 0.5 mg/dL in serum creatinine, was 2.5% in simvastatin-treated patients (3/118) and 3.4% in placebo-treated patients (4/118), a nonsignificant difference (P = 1.00). There were also no differences between the 2 groups in length of hospital stay or 1- and 6-month clinical outcomes.Conclusions Simvastatin pretreatment for short-term at high dose do not prevent renal function deterioration after administration of contrast medium in patients with baseline renal insufficiency undergoing coronary angiography.