Early high-dose rosuvastatin and cardioprotection in the protective effect of rosuvastatin and antiplatelet therapy on contrast-induced acute kidney injury and myocardial damage in patients with acute coronary syndrome (PRATO-ACS) study

Am Heart J. 2014 Nov;168(5):792-7. doi: 10.1016/j.ahj.2014.08.005. Epub 2014 Aug 10.

Abstract

Background: There is a strong correlation between adverse clinical events and peak values of myocardial necrosis markers in non-ST-elevation acute coronary syndrome patients. In this clinical setting, high-dose statin treatment exerts acute beneficial effects against renal and myocardial damage. The aim of this report was to evaluate if, on admission, high-dose rosuvastatin can exert cardioprotective effects when administered in addition to high-dose clopidogrel.

Methods: In the PRATO-ACS trial, 504 consecutive statin-naïve non-ST-elevation acute coronary syndrome patients scheduled for early invasive strategy and pretreated with high-dose clopidogrel were randomly assigned to rosuvastatin (40 mg on admission followed by 20 mg/d; statin group, n = 252) or no statin treatment (control group, n = 252). Serial myocardial biomarker samples were collected before and after angiography and/or percutaneous coronary intervention. The primary end point was the peak level of cardiac troponin I (cTnI) during the index event.

Results: Statin-treated patients presented median cTnI peak values similar to controls (3.9 [0.6-12.8] vs 3.5 [1.2-11.9] ng/mL, respectively; P = .60]; no differences were found between the 2 groups in cTnI and creatine kinase-MB values at any time point, in either preangiography and postangiography peak values or their cumulative release. In patients submitted to percutaneous coronary intervention, periprocedural myocardial infarction occurred in 8 (4.7%) of 171 statin-treated and 7 (4.3%) of 162 control patients (P = .87).

Conclusion: In the PRATO-ACS trial, early high-dose rosuvastatin did not show cardioprotective effects when administered in addition to high-dose clopidogrel.

Trial registration: ClinicalTrials.gov NCT01185938.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Acute Coronary Syndrome / blood
  • Acute Coronary Syndrome / diagnostic imaging
  • Acute Coronary Syndrome / therapy*
  • Acute Kidney Injury / chemically induced
  • Acute Kidney Injury / prevention & control*
  • Cardiotonic Agents / administration & dosage*
  • Clopidogrel
  • Contrast Media / adverse effects
  • Coronary Angiography
  • Creatine Kinase, MB Form / blood
  • Fluorobenzenes / administration & dosage*
  • Humans
  • Hydroxymethylglutaryl-CoA Reductase Inhibitors / administration & dosage*
  • Hydroxymethylglutaryl-CoA Reductase Inhibitors / therapeutic use*
  • Myocardium / metabolism*
  • Myocardium / pathology
  • Necrosis / blood
  • Percutaneous Coronary Intervention
  • Platelet Aggregation Inhibitors / administration & dosage*
  • Pyrimidines / administration & dosage*
  • Rosuvastatin Calcium
  • Sulfonamides / administration & dosage*
  • Ticlopidine / administration & dosage
  • Ticlopidine / analogs & derivatives*
  • Treatment Outcome
  • Troponin I / blood

Substances

  • Cardiotonic Agents
  • Contrast Media
  • Fluorobenzenes
  • Hydroxymethylglutaryl-CoA Reductase Inhibitors
  • Platelet Aggregation Inhibitors
  • Pyrimidines
  • Sulfonamides
  • Troponin I
  • Rosuvastatin Calcium
  • Clopidogrel
  • Creatine Kinase, MB Form
  • Ticlopidine

Associated data

  • ClinicalTrials.gov/NCT01185938