Background:Statins may reduce the risk of contrast-induced nephropathy (CIN) in patients undergoing percutaneous coronary intervention (PCI). However, there is no knowledge that PCI performed at the same time of statin peak concentration in the blood, may cause additional benefit in renal protection.
Methods:This study sought to determine whether PCI realized within the time of rosuvastatin peak concentration was associated with reduced in-hospital CIN compared with standard clinical practice. This single-center prospective, randomized, open-label, non-blinded clinical trial evaluated stable coronary artery disease patients taking chronic statin undergoing PCI. Patients were randomized to receive a loading dose of rosuvastatin (40 mg within 2 to 6 h before angioplasty) or to standard practice (without load dose of rosuvastatin). The pre-specified primary endpoint was the occurrence of CIN defined as an increase in the serum creatinine by {greater than or equal to} 0.3 mg/dl within 24 h after intervention. Contrast-induced nephropathy after coronary angioplasty by creatinine-kinase measure. This trial is registered with (Creatine Leak After Rosuvastatin in Percutaneous Coronary Intervention [CLEAR-PCI]; (ClinicalTrials.gov number: NCT01968577).
Results:Of the 544 patients in the main trial, 528 participated in the CLEAR-CIN-PCI substudy, and 493 patients (244 in the rosuvastatin group and 249 in control) were analyzed. CIN occurred in 6 patients of the 244 patients (2.5%) treated with rosuvastatin compared with 9 of the 249 patients (3.6%) in control group (risk ratio, 0.80; 95% confidence interval [CI], 0.42 to 1.50; P=0.455).
Conclusion:This result does not support the initiation of rosuvastatin before elective PCI to prevent CIN in patients taking chronic statin therapy.
AbStRACtbackground: Contrast-induced nephropathy (CIN) is a potential complication after percutaneous coronary intervention (PCI). The pathogenesis of this complication has been linked to inflammation, endothelial dysfunction and oxidative stress. In this study, statins were investigated as a treatment for CIN because of the pleiotropic effects of these drugs, assessing whether a preload dose of rosuvastatin prior to elective PCI in patients receiving chronic statin treatment reduced the incidence of CIN. Methods: This study was designed as a prospective, randomised, open label, single -centre study. The patients were grouped based on the inclusion (group 1) or exclusion (group 2) of 40 mg rosuvastatin treatment two to six hours prior to PCI. The frequency of CIN in these two groups, as well as the diabetic and renal dysfunction subgroups, was compared. Results: The study comprised 135 patients aged 60.7 ± 9.3 years who were randomised to group 1 (n = 67) or group 2 (n = 68). The overall prevalence of diabetes was 31.1%, and the overall prevalence of a creatinine clearance rate < 60 mL/min was 13.3%. The overall incidence of CIN was 8.1%, with no difference between groups (9% vs. 7.4%; P = 0.89). The incidence of CIN was 15% vs. 13.6% in the diabetic patients (P = 0.75), and 12.5% vs. 0% in those
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