Early high-dose rosuvastatin for contrast-induced nephropathy prevention in acute coronary syndrome: Results from the PRATO-ACS Study (Protective Effect of Rosuvastatin and Antiplatelet Therapy On contrast-induced acute kidney injury and myocardial damage in patients with Acute Coronary Syndrome)

J Am Coll Cardiol. 2014 Jan;63(1):71-9. doi: 10.1016/j.jacc.2013.04.105. Epub 2013 Sep 26.


Objectives: This study sought to determine if in addition to standard preventive measures on-admission, high-dose rosuvastatin exerts a protective effect against contrast-induced acute kidney injury (CI-AKI).

Background: Patients with acute coronary syndrome (ACS) are at high risk for CI-AKI, and the role of statin pre-treatment in preventing renal damage remains uncertain.

Methods: Consecutive statin-naïve non-ST elevation ACS patients scheduled to undergo early invasive strategy were randomly assigned to receive rosuvastatin (40 mg on admission, followed by 20 mg/day; statin group n = 252) or no statin treatment (control group n = 252). CI-AKI was defined as an increase in creatinine concentration of ≥0.5 mg/dl or ≥25% above baseline within 72 h after contrast administration.

Results: The incidence of CI-AKI was significantly lower in the statin group than in controls (6.7% vs. 15.1%; adjusted odds ratio: 0.38; 95% confidence interval [CI]: 0.20 to 0.71; p = 0.003). The benefits against CI-AKI were consistent, even applying different CI-AKI definition criteria and in all the pre-specified risk categories. The 30-day incidence of adverse cardiovascular and renal events (death, dialysis, myocardial infarction, stroke, or persistent renal damage) was significantly lower in the statin group (3.6% vs. 7.9%, respectively; p = 0.036). Moreover, statin treatment given on admission was associated with a lower rate of death or nonfatal myocardial infarction at 6 month follow-up (3.6% vs. 7.2%, respectively; p = 0.07).

Conclusions: High-dose rosuvastatin given on admission to statin-naïve patients with ACS who are scheduled for an early invasive procedure can prevent CI-AKI and improve short-term clinical outcome. (Statin Contrast Induced Nephropathy Prevention [PRATO-ACS]; NCT01185938).

Keywords: 3-hydroxyl-3-methylglutaryl coenzyme A; ACS; CI-AKI; HMG-CoA; LVEF; N-acetylcysteine; NAC; NSTE; PCI; acute coronary syndrome(s); contrast-induced acute kidney injury; contrast-induced nephropathy; eCrCl; eGFR; estimated creatinine clearance; estimated glomerular filtration rate; left ventricular ejection fraction; percutaneous coronary intervention; statins; without ST-segment elevation.

Publication types

  • Comparative Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Acute Coronary Syndrome / diagnostic imaging*
  • Acute Coronary Syndrome / drug therapy
  • Acute Kidney Injury / chemically induced
  • Acute Kidney Injury / prevention & control*
  • Aged
  • Contrast Media / adverse effects*
  • Coronary Angiography / adverse effects*
  • Coronary Angiography / methods
  • Dose-Response Relationship, Drug
  • Drug Therapy, Combination
  • Female
  • Fluorobenzenes / administration & dosage*
  • Follow-Up Studies
  • Humans
  • Hydroxymethylglutaryl-CoA Reductase Inhibitors / administration & dosage
  • Male
  • Platelet Aggregation Inhibitors / therapeutic use*
  • Prospective Studies
  • Pyrimidines / administration & dosage*
  • Rosuvastatin Calcium
  • Sulfonamides / administration & dosage*
  • Time Factors
  • Treatment Outcome


  • Contrast Media
  • Fluorobenzenes
  • Hydroxymethylglutaryl-CoA Reductase Inhibitors
  • Platelet Aggregation Inhibitors
  • Pyrimidines
  • Sulfonamides
  • Rosuvastatin Calcium

Associated data

  • ClinicalTrials.gov/NCT01185938