Strategies to Reduce Acute Kidney Injury and Improve Clinical Outcomes Following Percutaneous Coronary Intervention: A Subgroup Analysis of the PRESERVE Trial

JACC Cardiovasc Interv. 2018 Nov 26;11(22):2254-2261. doi: 10.1016/j.jcin.2018.07.044.

Abstract

Objectives: The aim of this study was to compare intravenous (IV) sodium bicarbonate with IV sodium chloride and oral acetylcysteine with placebo for the prevention of contrast-associated acute kidney injury (CAAKI) and intermediate-term adverse outcomes.

Background: Data are conflicting on the optimal strategy to reduce CAAKI and related complications after percutaneous coronary intervention (PCI).

Methods: The PRESERVE (Prevention of Serious Adverse Events Following Angiography) trial used a 2 × 2 factorial design to randomize 5,177 patients with stage III or IV chronic kidney disease undergoing angiography to IV 1.26% sodium bicarbonate or IV 0.9% sodium chloride and 5 days of oral acetylcysteine or placebo. A subgroup analysis was conducted of the efficacy of these interventions in patients who underwent PCI during the study angiographic examination. The primary endpoint was a composite of death, need for dialysis, or persistent kidney impairment at 90 days; CAAKI was a secondary endpoint.

Results: A total of 1,161 PRESERVE patients (mean age 69 ± 8 years) underwent PCI. The median estimated glomerular filtration rate was 50.7 ml/min/1.73 m2 (interquartile range: 41.7 to 60.1 ml/min/1.73 m2), and 952 patients (82%) had diabetes mellitus. The primary endpoint occurred in 15 of 568 patients (2.6%) in the IV sodium bicarbonate group and 24 of 593 patients (4.0%) in the IV sodium chloride group (odds ratio: 0.64; 95% confidence interval: 0.33 to 1.24; p for interaction = 0.41) and in 23 of 598 patients (3.8%) in the acetylcysteine group and 16 of 563 patients (2.8%) in the placebo group (odds ratio: 1.37; 95% confidence interval: 0.71 to 2.62; p for interaction = 0.29). There were no significant between-group differences in the rates of CAAKI.

Conclusions: Among patients with CKD undergoing PCI, there was no benefit of IV sodium bicarbonate over IV sodium chloride or of acetylcysteine over placebo for the prevention of CAAKI or intermediate-term adverse outcomes.

Keywords: acute kidney injury; percutaneous coronary intervention; prevention.

Publication types

  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, U.S. Gov't, Non-P.H.S.

MeSH terms

  • Acetylcysteine / administration & dosage*
  • Acetylcysteine / adverse effects
  • Acute Kidney Injury / chemically induced
  • Acute Kidney Injury / diagnosis
  • Acute Kidney Injury / physiopathology
  • Acute Kidney Injury / prevention & control*
  • Administration, Intravenous
  • Administration, Oral
  • Aged
  • Australia
  • Contrast Media / administration & dosage
  • Contrast Media / adverse effects*
  • Double-Blind Method
  • Female
  • Glomerular Filtration Rate / drug effects
  • Humans
  • Kidney / drug effects*
  • Kidney / physiopathology
  • Malaysia
  • Male
  • Middle Aged
  • New Zealand
  • Percutaneous Coronary Intervention / adverse effects*
  • Renal Insufficiency, Chronic / complications*
  • Renal Insufficiency, Chronic / diagnosis
  • Renal Insufficiency, Chronic / physiopathology
  • Risk Factors
  • Sodium Bicarbonate / administration & dosage*
  • Sodium Bicarbonate / adverse effects
  • Sodium Chloride / administration & dosage*
  • Sodium Chloride / adverse effects
  • Time Factors
  • Treatment Outcome
  • United States

Substances

  • Contrast Media
  • Sodium Chloride
  • Sodium Bicarbonate
  • Acetylcysteine