PRATO-ACS Trial Finds Rosuvastatin Reduces Contrast Nephropathy

In a study presented March 10 at ACC.13's Late-Breaking Clinical Trials II session, the phase IV PRATO-ACS trial found that rosuvastatin significantly reduced the risk of contrast-induced acute nephropathy in statin-naïve patients with non-ST-elevation acute coronary syndrome (NSTE-ACS) compared with a control group of NSTE-ACS patients.

"In statin-naïve patients with NSTE-ACS scheduled for early invasive strategy on-admission, high-dose rosuvastatin exerts additional preventive effects against contrast-induced acute kidney injury, along with standard hydration and N-acetylcysteine therapy, and is associated with better short-term clinical outcomes," said Anna Toso, MD, a clinical and interventional cardiologist at Misericordia e Dolce Hospital in Prato, Italy.

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For the study, 543 patients were randomized to a rosuvastatin group or a control group. The rosuvastatin group received one 40 mg dose of rosuvastatin on admission to a coronary care unit plus a single 20 mg daily dose of rosuvastatin until discharge. Post-discharge, they received either 20 mg or 10 mg of rosuvastatin daily, depending on their creatinine levels. Patients in the control group received 40 mg of atorvastatin daily after discharge but no statin before that.

The primary endpoint was contrast-induced acute kidney injury, defined as a rise in creatinine of at least 0.5 mg/dl or at least 25 percent from baseline within 72 hours of diagnostic angiographic imaging with the intent to perform angioplasty. In the rosuvastatin group, 6.7 percent of patients were found to have iodixanol contrast-induced acute kidney injury versus 15.1 percent of patients in the control group.

Rosuvastatin showed benefits with other definitions of kidney injury as well, including a creatinine level of at least 0.3 mg/dl from baseline within 48 hours (an incidence of 3.6 percent in the rosuvastatin group versus 8.7 percent in the control group) and within 72 hours (4.4 percent versus 10.7 percent).

The rosuvastatin group also had superior results for 30-day adverse clinical events of death, dialysis, MI, stroke and persistent nephropathy, with a cumulative incidence of 3.9 percent versus 7.9 percent for the control group.

The administration of rosuvastatin before angiography was particularly beneficial in patients with kidney dysfunction evidenced by creatinine clearance of less than 60 ml/min, Toso noted.

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