Fenoldopam for prevention of Acute kidNey injury in patients with aCute coronarY syndrome undergoing coronary angiography and/or percutaneous coronary Intervention — The FANCY trial

Abstract

Background: The optimal medical treatment for preventing the occurrence of contrast-induced nephropathy (CIN) in patients with acute coronary syndromes (ACS) undergoing percutaneous coronary intervention (PCI) is still controversial. Current preventive treatments include saline hydration and N-acetylcysteine. It remains unclear, conversely, the benefits associated with sodium bicarbonate, whose benefit among all patients at risk for CIN have not been clearly confirmed, and fenoldopam mesylate, a dopamine A1 receptor agonist augmenting renal plasma flowwhich has reduced the risk of CIN in some studies but not in a randomized trial. Aim of this studywas to investigate the effects of combining high-dose fenoldopamwith sodiumbicarbonate on the occurrence of CIN in patients with ACS. Methods: We studied 102 patients with ACS and estimated glomerular filtration rate b 60 mL/min/1.73 m undergoing PCI. Patients were randomly assigned to i.v. fenoldopam (1 mg/kg/min) and sodium bicarbonate hydration (154 mEq/L at 3 mL/Kg for 1 h followed by 1 mL/Kg for 6 h) (n = 51, Gr. A) or sodium bicarbonate only (n = 51, Gr. B). All patients had low-osmolar contrast dye and oral N-acetylcysteine (1200 mg twice daily). Creatinine levels were assessed prior to PCI, and every 24 h for 96 h thereafter. End-points were post-PCI creatinine levels and occurrence of CIN (as defined by an increase N 25% of the baseline creatinine) in the overall population and in patients stratified by the Mehran risk score for CIN. Results: Baseline creatinine was similar in the 2 groups (1.91 + 0.51 mg/dL vs 1.95 + 0.65 mg/dL, NS). A similar volume of dye was used in the 2 groups (155 + 75 vs 160 + 90 mL, NS). After PCI, creatinine tended to be lower in Gr. A than in Gr. B (1.75 + 0.52 mg/dL vs 1.99 + 0.68 mg/dL, NS), and CIN occurred in no Gr. A patient and in 4/12 Gr. B pts. In patients with Mehran risk score b 10, CIN occurred in Gr. B patients only. On the opposite, in patients with Mehran score N 10, CIN occurred in both groups. Use of fenoldopam was clinically and hemodynamically well tolerated, and no side effects were reported by the 2 groups. Conclusions: The combination of fenoldopam with sodium bicarbonate has additive beneficial effects over N-acetylcysteine for the prevention of CIN in patients with ACS undergoing PCI. These effects are remarkably in patients with low to medium risk of developing CIN.