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

Garcia S 1 , Bhatt DL 2 , Gallagher M 3 , Jneid H 4 , Kaufman J 5 , Palevsky PM 6 Show all authors , Wu H 5 , Weisbord SD 6 , PRESERVE Trial Group

Affiliations 

  • 1 Minneapolis VA Healthcare System, University of Minnesota, Minneapolis Heart Institute, Minneapolis, Minnesota. Electronic address: garci205@umn.edu
  • 2 VA Boston Healthcare System and Brigham and Women's Hospital Heart & Vascular Center, Harvard Medical School, Boston, Massachusetts
  • 3 University of Sydney, Sydney, Australia
  • 4 Michael E. DeBakey VA Medical Center and Baylor College of Medicine, Houston, Texas
  • 5 VA Cooperative Studies Program Coordinating Center, VA Boston Healthcare System, Boston, Massachusetts
  • 6 VA Pittsburgh Healthcare System and University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania
JACC Cardiovasc Interv, 2018 11 26;11(22):2254-2261.
PMID: 30466822 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.

* Title and MeSH Headings from MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine.

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