High-Dose Atorvastatin Raises Threshold of Contrast-Induced Nephropathy in Diabetic Patients Undergoing Elective Coronary Intervention: A Randomized Controlled Study

Abstract

Background. Contrast-induced nephropathy (CIN) is a significant complication of angiographic procedures resulting from injection of iodinated contrast media (CM). Patients with diabetes mellitus (DM) are at the highest risk of CIN. Statins have recently been proposed for protection against CIN due to their antioxidant and anti-inflammatory properties. Aim of Work. To investigate the potential benefit of acute pretreatment with high-dose atorvastatin (80 mg) in reduction of the incidence of CIN in diabetic patients indicated for elective coronary intervention. Patients and Methods. 200 diabetic patients with indication for coronary intervention were enrolled in the study. 100 patients will be randomly assigned to receive atorvastatin (80 mg) just before coronary intervention (statin group) and 100 patients received placebo (control group). CIN was defined as a rise of serum creatinine of more than 25% or ≥0.5 mg/dl (44 μmol/l) from baseline within 48 hours of the angiography. After the procedure, Thrombolysis in Myocardial Infarction (TIMI) flow of the culprit vessel was reported, as well as the volume of used contrast media and time of X-ray exposure. Results. Our study reported a CIN incidence of 12, 18, and 6% among the whole study, placebo, and statin groups, respectively, $P$ value of 0.001. Among the placebo group, CIN is likely to develop after a 13.5-minute X-ray exposure time with a specificity of 73.2% and sensitivity of 77.8%, area under the curve (AUC) of 0.879 (CI: 0.798–0.960), and $P$ value of 0.001, while in the statin group, CIN is likely to develop after 14.5-minute X-ray exposure time with a specificity of 74.5% and sensitivity of 83.3%, AUC of 0.818 (CI: 0.727–0.910), and P value of 0.009. In the placebo group, CIN is likely to develop after injection of 145 ml of contrast media with a specificity of 75.6% and sensitivity of 77.8%, AUC of 0.855 (CI: 0.757–0.952), and $P$ value of 0.001, while in the statin group, CIN is likely to develop after injection of 165 ml of contrast media with a specificity of 84% and sensitivity of 83.3%, AUC of 0.878 (CI: 0.811–0.944), and $P$ value of 0.002. Conclusions. Acute pretreatment with high-dose atorvastatin can effectively protect against CIN and was associated with a marked decrease in the prevalence of CIN in diabetic patients undergoing coronary interventions. Moreover, pretreatment with high-dose atorvastatin raises the threshold of X-ray exposure time and the amount of contrast media beyond which CIN is likely to develop. The trial is registered with NCT04375787.