Introduction: The PRATO-ACS trial showed that early on-admission high-dose rosuvastatin reduced contrast induced-acute kidney injury (CI-AKI) occurrence and improved clinical outcome in statin-naïve patients with non-ST elevation acute coronary syndrome (ACS) scheduled for early invasive strategy. In this noninferiority study we compared the efficacy of high-dose atorvastatin and rosuvastatin in preventing renal damage.
Methods: We randomly assigned 700 consecutive statin-naïve ACS patients to receive atorvastatin (80 mg on-admission followed by 40 mg/day) or rosuvastatin (40 mg on-admission followed by 20 mg/day). At discharge patients continued the same statin treatment. The primary end-point was CI-AKI (increase in serum creatinine of ≥ 0.5 mg/dl or ≥ 25% above baseline within 72 hours). Persistent renal damage (PRD) (decrease of ≥ 25% in glomerular filtration rate from baseline to 30 days) and adverse clinical events at 12 months were evaluated
Results: The study population (67±13 years, 66% men) included 27% patients with diabetes, 84% with low density lipoprotein cholesterol (LDLc) > 100 mg/dl and 41% with creatinine clearance ≤ 60 ml/min. Percutaneous coronary angioplasty was performed in 63% of cases. The incidence of CI-AKI was similar in the two groups (7.4% with atorvastatin and 8.6% with rosuvastatin; 90% CI -4.4 to 2.4%), satisfying the noninferiority criteria. PRD occurred in 7.6% of patients (8.6% with atorvastatin and 6.6% with rosuvastatin, p=0.45), 41% of whom had developed CI-AKI. At 30 days the persistence of LDLc > 100 mg/dl was 29% with rosuvastatin and 30% with atorvastatin, p=0.75. CI-AKI occurrence (adjusted OR 13; 95% CI 4.5-37.3; p= 0.0001) and 30-day high sensitivity C-reactive protein (adjusted OR 1.32; 95% CI 1.07-1.63; p= 0.01) resulted independent predictors of PRD.
Conclusions: In statin-naive ACS patients, scheduled for early invasive strategy, high-dose atorvastatin resulted not inferior to high-dose rosuvastatin against the development of CI-AKI. Since CI-AKI is an important predictor of PRD in these patients, all efforts must be made to prevent development of this condition. (Atorvastatin Versus Rosuvastatin on Contrast Induced Acute Kidney Injury [PRATO-ACS 2]; NCT01870804)