PRESERVE (acetylcysteine)
Trial question
What is the role of acetylcysteine in patients at high risk for renal complications who were undergoing angiography?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
6.0% female
94.0% male
N = 4993
4993 patients (322 female, 4671 male)
Inclusion criteria: patients at high risk for renal complications who were scheduled to undergo angiography
Key exclusion criteria: patients undergoing emergency angiography; unstable baseline levels of blood creatinine
Interventions
N=2495 acetylcysteine (an oral dose of 1,200 mg BID for 5 days)
N=2498 placebo (matching placebo BID for 5 days)
Primary outcome
Death, need for dialysis, or a persistent elevation of serum creatinine level by at least 50% from baseline at day 90
4.6
4.5
4.6 %
3.4 %
2.3 %
1.1 %
0.0 %
Acetylcysteine
Placebo
No significant
difference ↔
No significant difference in death, need for dialysis, or a persistent elevation of serum creatinine level by at least 50% from baseline at day 90 (4.6% vs. 4.5%; OR 1.02, 95% CI 0.78 to 1.33)
Secondary outcomes
No significant difference in contrast-associated AKI (9.1% vs. 8.7%; OR 1.06, 95% CI 0.87 to 1.28)
No significant difference in the rate of death by day 90 (2.7% vs. 2.4%; OR 1.1, 95% CI 0.78 to 1.57)
No significant difference in the rate of need for dialysis by day 90 (1.2% vs. 1.2%; OR 0.97, 95% CI 0.58 to 1.6)
Conclusion
In patients at high risk for renal complications who were scheduled to undergo angiography, acetylcysteine was not superior to placebo with respect to death, need for dialysis, or a persistent elevation of serum creatinine level by at least 50% from baseline at day 90.
Reference
Steven D Weisbord, Martin Gallagher, Hani Jneid et al. Outcomes after Angiography with Sodium Bicarbonate and Acetylcysteine. N Engl J Med. 2018 Feb 15;378(7):603-614.
Open reference URL