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N-Acetylcysteine and Contrast-Induced Nephropathy in Primary Angioplasty - N-Acetylcysteine and Contrast-Induced Nephropathy in Primary Angioplasty
Description:
The goal of the trial was to evaluate the effect of N-acetylcysteine on the prevention of contrast medium–induced nephropathy among patients undergoing primary angioplasty.
Study Design
Study Design:
Patients Enrolled: 354
Mean Follow Up: Index hospitalization
Mean Patient Age: Mean age 62 years
Female: 20
Mean Ejection Fraction: Baseline ejection fraction 50%
Patient Populations:
All consecutive patients presenting within 12 hours (18 hours for cardiogenic shock) after the onset of symptoms who were admitted to the coronary care unit at Centro Cardiologico Monzino in Milan for ST-segment elevation acute myocardial infarction and underwent primary angioplasty
Exclusions:
Long-term dialysis and known allergy to N-acetylcysteine
Primary Endpoints:
Occurrence of contrast medium–induced nephropathy, defined as ≥25% increase in serum creatinine from baseline within 72 hours after primary angioplasty
Drug/Procedures Used:
Patients were randomized to standard-dose N-acetylcysteine (600 mg IV prior to angioplasty and 600 mg orally BID for 48 hours post-angioplasty; n = 116), high-dose N-acetylcysteine (1200 mg IV prior to angioplasty and 1200 mg orally BID for 48 hours post-angioplasty; n = 119) or placebo (n = 119).
Principal Findings:
Impaired creatinine clearance (≤60 ml/min) was present at baseline in 29% of the standard-dose and placebo groups and 22% of the high-dose group. Mean creatinine clearance at baseline was 79 ml/min in the acetylcysteine groups and 75 ml/min in the placebo group. There was no significant difference in the volume of contrast medium used (274 ml in placebo group, 264 ml in standard-dose, 253 in high-dose group).
Compared with placebo, contrast-induced nephropathy was reduced in both the high-dose and standard-dose acetylcysteine groups (33% vs. 8% and 15%, respectively; p < 0.001). Results were similar in both patients with normal renal function and reduced renal function, with no significant interaction. In-hospital mortality was lower in the acetylcysteine groups compared with placebo (11% for placebo vs. 4% for standard-dose and 3% for high-dose, p = 0.02). The composite of death, acute renal failure requiring temporary renal-replacement therapy, or the need for mechanical ventilation was also lower in the acetylcysteine groups compared with placebo (18% for placebo vs. 7% for standard-dose and 5% for high-dose, p = 0.002).
Interpretation:
Among patients with ST elevation myocardial infarction undergoing primary angioplasty, treatment with N-acetylcysteine was associated with reductions in contrast-induced nephropathy compared with placebo, with a dose-dependent effect seen with standard and high-dose N-acetylcysteine.
Prior studies have suggested N-acetylcysteine reduces contrast-induced nephropathy in patients with renal failure, but the present trial extends these findings to patients with predominantly normal renal function. Despite being a relatively small trial not powered to detect differences in clinical events, mortality was lower in the N-acetylcysteine groups compared with placebo, likely due to the association between increased mortality among patients with contrast-induced nephropathy (26% vs. 1.4%, p < 0.001).
References:
Marenzi G, Assanelli E, Marana I, et al. N-acetylcysteine and contrast-induced nephropathy in primary angioplasty. N Engl J Med 2006;354:2773-82.
Keywords: Contrast Media, Shock, Cardiogenic, Renal Insufficiency, Hospital Mortality, Coronary Care Units, Respiration, Artificial, Acute Kidney Injury, Coronary Disease, Creatinine, Angioplasty, Renal Replacement Therapy
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