Dataset Information

Preventive Effect of Pretreatment with Pitavastatin on Contrast-Induced Nephropathy in Patients with Renal Dysfunction Undergoing Coronary Procedure: PRINCIPLE-II Randomized Clinical Trial.

ABSTRACT: This study aimed to evaluate the efficacy of pitavastatin pretreatment on contrast-induced nephropathy (CIN) in patients with chronic kidney disease (CKD) after a coronary procedure. This was a prospective, randomized, double-blinded, placebo-controlled, multicenter clinical trial. All consecutive 70 patients with CKD (eGFR < 60 mL/min/1.73 m²) were enrolled and randomized into two groups. Group I consisted of patients who were treated with statins (pitavastatin 4 mg/day) for seven days before and three days after the procedure (n = 37, 52.9%), and group II consisted of patients who were treated with a placebo (n = 33, 47.1%). The primary endpoint was the incidence of CIN, and the secondary endpoints were the change in serum creatinine (?sCr) level and estimated glomerular filtration rate (?eGFR) after the procedure. The mean age of the patients (males, 74%) was 70.4 ± 9.0 years. After the coronary procedure, the incidence of CIN was lower in group I than in group II, but the difference was not significant (5.4% vs. 9.1%, p = 0.661). The maximal ?sCr was lower and the maximal ?eGFR was higher in group I than in group II, but the difference was not significant (-0.11 ± 0.53 mg/dL and -0.04 ± 0.33 mg/dL, p = 0.678; 4.3 ± 11.2 mL/min/1.73 m² and -2.9 ± 20.4 mL/min/1.73 m², p = 0.161, respectively). This study showed the possibility of a clinical benefit of pretreatment with a high dose of pitavastatin for the prevention of CIN in patients with CKD after coronary procedure (ClinicalTrials.gov Identifier: NCT01871792).

SUBMITTER: Kang WC

PROVIDER: S-EPMC7698581 | biostudies-literature | 2020 Nov

REPOSITORIES: biostudies-literature

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Preventive Effect of Pretreatment with Pitavastatin on Contrast-Induced Nephropathy in Patients with Renal Dysfunction Undergoing Coronary Procedure: PRINCIPLE-II Randomized Clinical Trial.

Kang Woong Chol WC Kim Minsu M Park Sang Min SM Kim Byeong-Keuk BK Lee Byoung-Kwon BK Kwon Hyuck Moon HM

Journal of clinical medicine 20201117 11

This study aimed to evaluate the efficacy of pitavastatin pretreatment on contrast-induced nephropathy (CIN) in patients with chronic kidney disease (CKD) after a coronary procedure. This was a prospective, randomized, double-blinded, placebo-controlled, multicenter clinical trial. All consecutive 70 patients with CKD (eGFR < 60 mL/min/1.73 m<sup>2</sup>) were enrolled and randomized into two groups. Group I consisted of patients who were treated with statins (pitavastatin 4 mg/day) for seven da ...[more]

PMID: 33213012

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Project description:Background: Hyperhomocysteinemia is a risk factor for contrast-induced nephropathy. Folic acid can attenuate such nephropathies in rats. The protective effect of folic acid against contrast-induced nephropathy has not been studied in humans. We aimed to investigate the effect of folic acid on the incidence of contrast-induced nephropathy (CIN) after coronary catheterization in patients with hyperhomocysteinemia. Methods: This was a single-center, prospective, double-blind, randomized controlled trial (ClinicalTrials.gov, NCT02444013). In total, 412 patients (mean age: 65 ± 12 years, 268 male) with plasma homocysteine ≥15 μM, who underwent coronary arteriography (CAG) or percutaneous coronary intervention (PCI) from May 2015 to August 2018, were enrolled. Patients were randomly assigned to two groups: a treatment group (n = 203), taking 5 mg of folic acid (orally, three times/day) immediately after enrollment and for 72 h after operation, and a control group (n = 209), taking placebo. Contrast-induced nephropathy was defined as an increase in serum creatinine of >25% or 44 μM within 48 or 72 h after contrast medium administration. Results: In total, 50 (12%) patients developed CIN after 48 h after catheterization, including 16 (8%) in the treatment group and 34 (16%) in the control group (P = 0.009). Meanwhile, 53 (13%) patients developed CIN after 72 h of CAG/PCI, including 18 (9%) in the treatment group and 35 (17%) in the control group (P = 0.017). The incidence of contrast-induced nephropathy in the treatment group was lower than that in the control group (P = 0.017). Logistic regression analysis confirmed that administration of folic acid was a protective factor against contrast-induced nephropathy (RD = 0.0788, 95%CI: 0.0105-0.1469, P = 0.019). We found no serious adverse events associated with folic acid. No death or hemodialysis occurred in either group. Conclusions: Perioperative administration of folic acid attenuates the incidence of contrast-induced nephropathy after coronary catheterization in patients with hyperhomocysteinemia. Clinical Trial Registration: ClinicalTrials.gov, identifier [NCT02444013].

Project description:To investigate the association between growth differentiation factor-15 (GDF-15) and contrast-induced nephropathy (CIN) in patients with acute myocardial infarction (AMI) undergoing percutaneous coronary intervention (PCI).A total of 311 patients with AMI were studied retrospectively. All patients were divided into two groups according to the occurrence of CIN after PCI. Baseline clinical data were compared between two groups. Multivariate logistic regression analysis was used to identify the risk factors for CIN. Cox regression analysis was used to identify the association between GDF-15, CIN and short-term outcome.There were 80 patients in CIN group (average age was 71.60 ± 13.00 years; 67.5% male) and 231 patients in non-CIN group (average age was 63.80 ± 11.70 years; 71.9%male). The concentration of GDF-15 in CIN group was higher than that of non-CIN group (1232 ± 366.6 ng/L vs. 939.20 ± 309.6 ng/L, P <0.001). According to GDF-15 quartiles, patients were divided into four groups. Multivariate logistic model indicated that the highest quartile(Q4) was significantly associated with an increased risk of CIN compared with lower level of GDF-15 (Q1, Q2 and Q3) (OR : 3.572, 1.803-7.078, P < 0.001). Of 243 patients who could calculate the ACEF risk score, area under the curve (AUC) of GDF-15 was 0.793, 95%CI: 0.729-0.856, P < 0.001, while AUC of ACEF was 0.708, 95%CI: 0.630-0.786, P < 0.001. Using 10% and 30% as arbitrary thresholds to define patients at low, intermediate, and high risk, GDF-15 achieved a net reclassification improvement (NRI) of 0.32 (95%CI: 0.123-0.518, P = 0.001) compared with the ACEF risk score. Cox regression model showed that high concentration of GDF-15 (Q4) was significantly associated with an increased risk of all-cause mortality and major adverse clinical events (MACE) (HR: 8.434, 95%CI: 2.650-26.837, P <0.001; HR: 3.562, 95%CI: 1.658-7.652, P = 0.001) compared with low level of GDF-15 (Q1, Q2 and Q3). CIN was an independent predictor of all-cause mortality and MACE in AMI patients (HR: 3.535, 95%CI: 1.135-11.005, P = 0.029; HR: 5.154, 95%CI: 2.228-11.925, P <0.001).GDF-15 levels increased in CIN group in AMI patients underwent PCI. GDF-15 was an independent risk factor for CIN in AMI patients underwent PCI. GDF-15 level and CIN are independent risk factors for all-cause mortality and MACE in short-term follow-ups.

Dataset Information

Preventive Effect of Pretreatment with Pitavastatin on Contrast-Induced Nephropathy in Patients with Renal Dysfunction Undergoing Coronary Procedure: PRINCIPLE-II Randomized Clinical Trial.

Publications

Preventive Effect of Pretreatment with Pitavastatin on Contrast-Induced Nephropathy in Patients with Renal Dysfunction Undergoing Coronary Procedure: PRINCIPLE-II Randomized Clinical Trial.

Similar Datasets

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