Author + information
- Received April 13, 2018
- Revision received July 11, 2018
- Accepted July 17, 2018
- Published online November 19, 2018.
- Santiago Garcia, MDa,∗ (, )
- Deepak L. Bhatt, MD, MPHb,
- Martin Gallagher, MD, PhDc,
- Hani Jneid, MDd,
- James Kaufman, MDe,
- Paul M. Palevsky, MDf,
- Hongsheng Wu, PhDe,
- Steven D. Weisbord, MD, MScf,
- for the PRESERVE Trial Group
- aMinneapolis VA Healthcare System, University of Minnesota, Minneapolis Heart Institute, Minneapolis, Minnesota
- bVA Boston Healthcare System and Brigham and Women’s Hospital Heart & Vascular Center, Harvard Medical School, Boston, Massachusetts
- cUniversity of Sydney, Sydney, Australia
- dMichael E. DeBakey VA Medical Center and Baylor College of Medicine, Houston, Texas
- eVA Cooperative Studies Program Coordinating Center, VA Boston Healthcare System, Boston, Massachusetts
- fVA Pittsburgh Healthcare System and University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania
- ↵∗Address for correspondence:
Dr. Santiago Garcia, 920 East 28th Street, Suite 300, Minneapolis Heart Institute, Minneapolis, Minnesota 55407.
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.
The contents of this article do not represent the views of the U.S. Department of Veterans Affairs or U.S. government. This trial was funded by the VA Cooperative Studies Program and the National Health and Medical Research Council of Australia. Dr. Garcia has received grant support from Edwards Lifesciences; and consulting fees from Medtronic, Boston Scientific, Osprey Medical, and Surmodics. Dr. Bhatt has received grant support from Amarin, AstraZeneca, Bristol-Myers Squibb, Eisai, Ethicon, Medtronic, Sanofi, The Medicines Company, Roche, Pfizer, Forest Laboratories/AstraZeneca, Ischemix, Amgen, Lilly, Chiesi, and Ironwood; has participated in an unfunded research collaboration with FlowCo, PLx Pharma, Takeda, and Merck; has received fees for serving on data monitoring committees and the operations committee, publications committee, and steering committee of the Population Health Research Institute; has received fees for serving as editor-in-chief of the Harvard Heart Letter from Belvoir Publications; has received fees for serving as chief medical editor of Cardiology Today’s Intervention from Slack Publications; has received fees for serving on steering committees for continuing medical education from WebMD; has received advisory board fees from Elsevier; has served on advisory boards for Medscape Cardiology, Regado Biosciences, and Cardax; has received fees for serving as editor-in-chief of the Journal of Invasive Cardiology from HMP Communications; has served as deputy editor for Clinical Cardiology; has received fees for serving as guest editor and associate editor for the Journal of the American College of Cardiology; and has served as site coinvestigator for St. Jude Medical, Biotronik, and Boston Scientific. Dr. Gallagher has served on a study steering committee for Baxter Australia. Dr. Palevsky has received consulting fees and advisory committee fees from Durect; consulting fees from HealthSpan Dx; fees for serving as a member of a data and safety monitoring board from Baxter; fees for serving as a member of an endpoint adjudication committee from GE Healthcare; and consulting fees and advisory fees from Novartis. Dr. Weisbord has received consulting fees and advisory fees from Durect. All other authors have reported that they have no relationships relevant to the contents of this article to disclose.
- Received April 13, 2018.
- Revision received July 11, 2018.
- Accepted July 17, 2018.
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