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Rosuvastatin and contrast-induced nephropathy in elective percutaneous coronary intervention: The randomized CLEAR-CIN-PCI sub study

Kleber Bomfim A Martins, Mauricio S de Oliveira and Luiz Alberto Mattos

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 (40mg within 2 to 6 hours 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 hours 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). (J. Interven Cardiol 2015;28:339-347)@2015, Wiley Periodicals, Inc. 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.