Trial Summary ACT
Title: Acetylcysteine for the prevention of Contrast-induced nephropaThy
Trial Sponsor: Ministry of Health Brazil
Year Presented: 2010
Topic(s): General Cardiology, Interventional Cardiology, Prevention/Vascular
Summary Posted: 11/16/2010
Writer: Anthony A. Bavry, M.D., M.P.H., F.A.C.C.
Author Disclosure: NOTHING TO DISCLOSE
Reviewer: Deepak L. Bhatt, M.D., M.P.H., F.A.C.C.
Reviewer Disclosure: RESEARCH/RESEARCH GRANTS: Astra Zeneca(SIGNIFICANT), Eisai(SIGNIFICANT), Sanofi Aventis(SIGNIFICANT), The Medicines Company(SIGNIFICANT), Ethicon(SIGNIFICANT), Bristol Myers Squibb(SIGNIFICANT), Heartscape(SIGNIFICANT), Cogentus(NONE), PLx Pharma(NONE), Takeda(NONE)
Description:
The goal of the trial was to evaluate treatment with acetylcysteine compared with placebo among patients at risk for contrast-induced nephropathy (CIN) undergoing an angiographic procedure.
Hypothesis:
Acetylcysteine will be superior at preventing CIN.
Drugs/Procedures Used:
Patients at risk for CIN were randomized to acetylcysteine 1200 mg twice daily for 2 days (n = 1,172) versus placebo (n = 1,136). Patients in both groups underwent prehydration with normal saline or bicarbonate.
Principal Findings:
Overall, 2,308 patients were randomized. In the acetylcysteine group, the mean age was 68 years, 38% were women, 15% had chronic renal failure, 61% had diabetes, 67% underwent diagnostic coronary angiography, and the mean volume of contrast delivered was 100 cc.
The primary outcome, CIN, occurred in 12.7% of the acetylcysteine group versus 12.7% of the placebo group (p = 0.97). Doubling of serum creatinine occurred in 1.1% versus 1.5% (p = 0.41), total mortality occurred in 2.0% versus 2.1% (p = 0.80), cardiovascular mortality occurred in 1.5% versus 1.6% (p = 0.93), need for dialysis occurred in 0.3% versus 0.3% (p = 0.97), and serious adverse events occurred in 1.3% versus 2.2% (p = 0.09), respectively, for acetylcysteine versus placebo.
Interpretation:
Among patients at risk for CIN undergoing an angiographic procedure, the use of acetylcysteine was not effective at preventing CIN or important clinical outcomes. This represents the largest and most definitive trial on the topic. Adequate prehydration remains the principal measure to prevent CIN.
Study Design:
Blinded. Placebo Controlled. Randomized.
Primary Endpoints:
CIN defined as 25% increase in creatinine from baseline
Secondary Endpoints:
Total mortality
Cardiovascular mortality
Dialysis
Doubling of serum creatinine
Side effects
Patient Population:
Patients at risk of CIN undergoing an angiographic procedure
Risk factors for CIN defined as age >70 years, chronic renal failure, diabetes, heart failure, left ventricular ejection fraction <45%, or shock
Number of enrollees: 2,308
Duration of follow-up: 30 days
Mean patient age: 68 years
Percentage female: 38%
References:
Presented by Dr. Otavio Berwanger at the American Heart Association Scientific Sessions, Chicago, IL, November 16, 2010.