SAN FRANCISCO—Giving statins to acute coronary syndrome (ACS) patients before administering contrast agents for imaging prior to coronary procedures significantly lowered the rate of contrast-induced acute kidney injury (CI-AKI), according to late-breaking trial results unveiled March 10 at the American College of Cardiology (ACC) scientific session.
“The development of contrast-induced nephropathy was significantly lower in patients who received the rosuvastatin treatment,” said Anna Toso, MD, of Pavia University in Pavia, Italy. “We need to treat with rosuvastatin 12 patients to prevent one case of contrast-induced nephropathy.”
Toso presented findings from the randomized, controlled clinical trial PRATO-ACS (Early High-Dose Rosuvastatin for Contrast-Induced Nephropathy Prevention in Acute Coronary Syndrome). Previous research has shown that preadministration of statins helps to protect renal function in patients undergoing angioplasty. Statins lower low-density lipoprotein cholesterol, but they also have anti-inflammatory properties.
Noting that ACS patients are at high risk of CI-AKI, Toso et al designed the study to assess whether a high dose of rosuvastatin administered on admission offered any similar renal-protective value in these patients. “But the role of statins in this area is still controversial,” she said. “In particular, our uncertainties include type and dose, timing and target population, meaning what subset of patients will benefit most.”
They enrolled 504 statin-naïve patients with non-ST elevation ACS who were scheduled for diagnostic imaging prior to angioplasty. Patients were randomized to receive either a placebo (252 patients) or 40 mg rosuvastatin (252 patients) on admission in addition to standard care (hydration and N-acetycysteine. Patients in the statin group also took 20 mg rosuvastatin daily until discharge followed by either 20 mg or 10 mg rosuvastatin daily. Patients in the placebo group received 40 mg atorvastatin daily after discharge.
The primary endpoint was the development of CI-AKI, which was defined as either an increase in serum creatinine of 25 percent within 72 hours or a rise in creatinine of 0.5 mg/dl within 72 hours. Researchers also performed subgroup assessments on categories of high-risk patients.
The statin group had a much lower CI-AKI incidence rate, at 6.7 percent vs. 15.1 percent in the placebo group. The statin strategy appeared to be especially beneficial for higher-risk patients such as those with less than 60 mg/min estimated glomerular rate of filtration EGRF check; in that subgroup analysis, the incidence rate was 8.6 percent vs. 20.9 percent in the placebo group.
The rate of 30-day major adverse clinical events (death, dialysis, MI, stroke and persistent kidney damage) also was lower in the statin group, at 3.6 percent vs. 7.9 percent.
Panelist Roxana Mehran, MD, director of interventional cardiovascular research and clinical trials, Mount Sinai School of Medicine in New York City complimented the PRATO-ACS team for “a well-conducted and well-powered” study. She emphasized the need to evaluate permanent renal damage, and that PRATO-ACS showed a trend toward its reduction.
She questioned how patients who already receive statins should be managed. “We don’t know how to manage these patients,” Toso responded. “We suggest that it is important to properly reload these patients to take advantage of all these beneficial effects of statins.”
Ajay J. Kirtane, MD, chief academic officer and director of the interventional cardiology fellowship program at NewYork-Presbyterian Hospital and Columbia University Medical Center in New York City, concluded that PRATO-ACS adds yet another persuasive argument to add statins to ACS patients’ treatment strategies, but identified gaps that still needed to be addressed.
“There is abundant data showing that the treatment of ACS with high-dose statins can work on the ischemic side and now you’ve shown us another reason to do it,” Kirtane said. He noted that many hospital protocols do not call for high-dose statin use and recommended that practice be changed. “The main question is whether this is a class effect or whether this is particular to this particular agent.”
PRATO-ACS is funded by the non-profit Centro Cardiopatici Toscani.