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Author: Weisbord, SD, Gallagher M, Jneid H, et al. “Outcomes after angiography with sodium bicarbonate and acetylcysteine.” NEJM 2018; 378(7): 603-614
Reviewed by: Sara Stern-Nezer, MD, MPH, Assistant Clinical Professor, University of California, Irvine
This study was a multi-site, international double-blind, placebo and drug-controlled RCT done between 2013 and 2017. Patients with decreased GFR (15-44.9 for all patients and 45-59.9 among those with DM) were enrolled and randomized in a 2x2 factorial design to receive either IV 1.26% sodium bicarbonate or IV 0.9% sodium chloride and oral acetylcysteine (NAC) or placebo capsules. Patients requiring emergent angiogram were excluded. Patients received IV fluids at 1-3ml/kg before angiography, 1-1.5ml/kg during and 1-3ml/kg after angiography. Fluids were capped at a weight of 125kg to limit excessive fluids to obese patients. Primary end points were death, need for dialysis and persistent increase of 50% or more from baseline in serum creatinine 90-104 days after angiography. Secondary end points included AKI (defined as increase of serum creatinine of at least 25% from baseline 3-5 days post-angiography), dialysis by 90 days, hospitalization for any cause within 90 days or death. Analysis was done using intention-to-treat analysis.
A total of 5177 patients underwent randomization with withdrawal of 184, of which most were excluded as they did not ultimately undergo angiography; 90% of included patients underwent coronary angiography. Median age was around 70 in all groups and there was no significant difference between groups in any demographic or procedural factor. The median volume of IV fluids was 344 ml before [IQR 274-444], 114ml [IQR 74-170] during and 570ml [IQR 472-670] after angiography. Primary end point was reached in 4.4% vs 4.7% in the sodium bicarbonate vs normal saline group and 4.6% vs 4.5% in the NAC vs placebo group. There was similarly no difference in AKI in either group during admission or at 90 days. The study was stopped early as preplanned interim analysis showed no difference in primary endpoint between groups.
The PRESERVE trial shows no benefit of administration of IV sodium bicarbonate nor NAC to prevent contrast-induced acute kidney injury. This study is the largest randomized trial to look at IV sodium bicarbonate and acetylcysteine for prevention of contrast-induced nephropathy; it follows the Acetylcysteine for Contrast-induced Nephropathy Trial (ACT) which enrolled 2308 patients; unlike the ACT trial, this study was limited to patients with lower GFR who are at higher risk for AKI after contrast administration. The one caveat may be that the median volume of contrast material was 85; this volume was relatively small as only 28-29% in each group underwent intervention. It may be that there is some potential benefit in patients undergoing larger volumes of contrast, however, the data to date shows no beneficial effect in this high risk population. #LiteratureWatch #SaraStern-Nezer