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Acetylcysteine for Prevention of Renal Deterioration after Angiography - Acetylcysteine for Prevention of Renal Deterioration after Angiography
Description:
The goal of the trial was to compare the use of acetylcysteine vs placebo for the prevention of renal deterioration after angiography in patients with impaired baseline renal function.
Hypothesis:
To determine whether the antioxidant acetylcysteine prevents acute deterioration in renal function in patients with moderate baseline renal insufficiency who undergo elective coronary angiography.
Study Design
Study Design:
Patients Screened: 219
Patients Enrolled: 200
Mean Patient Age: mean age 68 years
Female: 39%
Patient Populations:
Serum creatinine concentration >1.2 mg/dL or creatinine clearance <60 mL/min, known chronic renal impairment and stable serum creatinine concentrations
Exclusions:
Need for dialysis, acute renal failure, recent change in use of diuretic or antihypertensive agents, use of iodinated contrast media or nephrotoxic agents within the 30 days prior to the study entry, overt congestive heart failure, severe valvular disease, LVEF <35%, acute chronic obstructive lung disease or asthma exacerbation, or allergy to acetylcysteine
Primary Endpoints:
Acute contrast-induced reduction in renal function; change in creatinine clearance and serum creatinine concentration
Secondary Endpoints:
Acute pulmonary edema, major adverse cardiac events (cardiac death, MI or TLR), need for dialysis, and length of hospitalization
Drug/Procedures Used:
Patients were randomized to receive placebo (n=98) or acetylcysteine (600 mg twice daily, n=102) the day preceediing and the day of angiography. All patients received low-osmolality nonionic contrast agent (iopamidol) with or without intervention. Three doses were given before and 1 dose after catheterization. Serum creatinine and urea levels were measured at baseline (admission) and 24 hours, 48 hours, and 7 days following the administration of contrast medium.
Principal Findings:
Acute contrast-induced reduction in renal function (defined as >25% increase from baseline in serum creatinine at 48 hours) occurred less frequently in the acetylcysteine arm vs placebo (12% vs 4%, p=0.03). The average length of hospitalization was shorter in the acetylcysteine arm (3.4 +/-0.9 days vs 3.9 +/-2.0 days, p=0.02). There was no difference in frequency of oliguria (1% vs 3%, p=0.29) or acute increase in serum creatinine levels of >=50% (0% vs 2%, p=0.15), although the overall numbers were low in both arms. Mean serum creatinine concentration decreased significantly at day 2 in the acetylcysteine arm (from 1.35 to 1.22 mg/dL, p<0.001) but did not change significantly in the control arm (1.36 to 1.38 mg/dL p=0.13). The differences in mean creatinine change from baseline between the control and acetylcysteine arms were significant at day 1 (1.32 vs 1.22 mg/dL, p=0.02) and day 2 (1.38 vs 1.22 mg/dL p=0.006), but not at day 7 (1.38 vs 1.31 mg/dL p=0.23). No patients developed acute nephrotoxicity requiring dialysis and 1 patient receiving acetylcysteine developed CHF due to unstable angina. The only major adverse cardiac event occurred in 1 patient in the control arm who had an uncomplicated non ST elevation MI after coronary intervention.
Interpretation:
Among patients with moderate chronic renal insufficiency undergoing coronary angiography with or without interventional procedures, use of acetylcysteine was associated with a reduction in the rate of renal dysfunction at 48 hours. Acetylcysteine has previouisly been shown to prevent acute renal dysfunction in noncardiac patients with chronic renal insufficiency exposed to small doses of contrast agents during computed tomography. Contrast-induced nephropathy is a serious side effect in patients undergoing angiography, especially in patients at higher risk for renal failure such as diabetics and those with impaired baseline renal function. In the recent NEPHRIC study, creatinine levels were also reduced in high-risk patients treated with the iso-osmolar contrast agent iodixanol vs the low-osmoloar agent iohexol. Larger trials will be needed to determine if acetylcysteine or a combination of acetylcysteine and an iso-osmolar agent reduces morbidity and mortality due to nephrotoxicity.
References:
JAMA 2003;289:553-558.
Keywords: Triiodobenzoic Acids, Pyridinolcarbamate, Iopamidol, Kidney Failure, Chronic, Creatinine, Oliguria, Contrast Media, Iohexol, Renal Dialysis, Coronary Angiography, Tomography, Catheterization, Osmolar Concentration, Hospitalization, Diabetes Mellitus, Urea, Renal Insufficiency, Chronic
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