ACT
Trial question
What is the role of acetylcysteine for the prevention of contrast-induced AKI in patients undergoing coronary and peripheral vascular angiography?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
39.0% female
61.0% male
N = 2308
2308 patients (892 female, 1416 male)
Inclusion criteria: patients undergoing an intravascular angiographic procedure with at least 1 risk factor for contrast-induced AKI (age > 70 years, renal failure, diabetes mellitus, HF, or hypotension)
Key exclusion criteria: patients on dialysis, ST-segment elevation myocardial infarction undergoing primary angioplasty, pregnant, breastfeeding, or women aged < 45 years and did not use contraceptive methods
Interventions
N=1172 acetylcysteine (1200 mg BID PO, for 2 doses before and 2 doses after the procedure)
N=1136 placebo (matching placebo BID PO, for 2 doses before and 2 doses after the procedure)
Primary outcome
Contrast-induced acute kidney injury
12.7
12.7
12.7 %
9.5 %
6.3 %
3.2 %
0.0 %
Acetylcysteine
Placebo
No significant difference ↔
No significant difference in contrast-induced AKI (12.7% vs. 12.7%; RR 1, 95% CI 0.81 to 1.25)
Secondary outcomes
No significant difference in death or need for dialysis at 30 days (2.2% vs. 2.3%; HR 0.97, 95% CI 0.56 to 1.69)
No significant difference in death, need for dialysis, or doubling in serum creatinine at 30 days (3.2% vs. 3.6%; RR 0.9, 95% CI 0.58 to 1.39)
No significant difference in death at 30 days (2% vs. 2.1%; HR 0.97, 95% CI 0.54 to 1.73)
Safety outcomes
No significant differences in any other adverse events, except for vomiting (0.3% vs. 1.2%, p=0.02).
Significant differences in other serious adverse events (1.3% vs. 2.2%, p = 0.09).
Conclusion
In patients undergoing an intravascular angiographic procedure with at least 1 risk factor for contrast-induced AKI (age > 70 years, renal failure, diabetes mellitus, HF, or hypotension), acetylcysteine was not superior to placebo with respect to a contrast-induced AKI.
Reference
ACT Investigators. Acetylcysteine for prevention of renal outcomes in patients undergoing coronary and peripheral vascular angiography: main results from the randomized Acetylcysteine for Contrast-induced nephropathy Trial (ACT). Circulation. 2011 Sep 13;124(11):1250-9.
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