SAN FRANCISCO, CA—Statin-naïve patients with non-ST-segment elevation acute coronary syndrome (NSTE-ACS) scheduled for early invasive procedures who receive high-dose rosuvastatin on admission have a significantly lower incidence of contrast-induced acute kidney injury (CI-AKI) and a reduction in 30-day adverse clinical events, according to results of the PRACTO-ACS study presented at ACC.13, the American College of Cardiology’s 62nd Annual Scientific Session.
PRATO-ACS (Protective effect of Rosuvastatin and Antiplatelet Therapy On contrast-induced acute kidney injury and myocardial damage in patients with Acute Coronary Syndrome) “shows that early administration of high-dose statin has a protective effect against kidney damage due to contrast medium in patients with ACS,” said Anna Toso, MD, clinical and interventional cardiologist with the Division of Cardiology, Misericordia e Dolce Hospital, Prato, Italy, and the study’s principal investigator.
“The results help define better the timing of early administration of statins, which should be given as soon as possible after admission and always before the angiographic procedure, to reduce kidney complications and achieve clinical benefits, even before hospital discharge.”
Between July 2010 and August 2012, the study enrolled all consecutive statin-naïve NSTE-ACS patients admitted to the coronary care unit (CCU) scheduled for diagnostic angiographic imaging with intent to perform angioplasty to determine if on-admission statin therapy exerted a protective effect against CI-AKI in addition to standard preventive measures such as hydration and N-acetylcysteine.
Patients were randomly assigned to the control arm (n=242) or to rosuvastatin 40mg (n=241) as soon as they were admitted to the CCU. Those in the rosuvastatin arm continued to receive a single 20mg/day dose until they were discharged, then continued with rosuvastatin 20mg/day or 10mg/day if creatinine clearance <30mL/min. At discharge, all patients received clopidogrel 75mg/day and aspirin 100mg/day; in addition, the control group received atorvastatin 40mg/day.
Development of CI-AKI, defined as increase in serum creatinine ≥25% or ≥0.5 mg/dL above baseline within 72 hours, was the primary end point. The effect of statin treatment was evaluated using multiple CI-AKI definition criteria. A subgroup analysis was performed in prespecified high-risk categories of patients. Adverse clinical events (death, dialysis, myocardial infarction, stroke, persistent renal damage) were evaluated at 30 days.
Incidence of CI-AKI was significantly lower in the statin group (6.7% vs. 15.1%; adjusted OR 0.38 [0.20–0.71]; P=0.001). The 30-day incidence of major adverse clinical events was significantly lower in the statin group than in the control arm (3.6% vs. 7.9%; P=0.036), Dr. Toso reported.
This research is part of the larger PRATO-ACS clinical project to explore rosuvastatin the pleiotropic effects of rosuvastatin on a number of targets, including CI-AKI.
“It would be interesting to compare the effects of lipophilic and hydrophilic statins,” Dr. Toso said. “We are now planning the PRATO-ACS 2 project, a head-to-head comparison between high-dose rosuvastatin and high-dose atorvastatin administered on admission to statin-naïve ACS patients scheduled for early invasive strategy.”
Dr. Toso said N-acetylcysteine is no longer used in her institution based on clinical guidelines that were published after the study was initiated.