A Randomized Controlled Trial of Nonfasting vs Fasting Before Interventional Coronary Procedures: The TONIC Trial.
Humans
Fasting
/ blood
Male
Female
Prospective Studies
Single-Blind Method
Middle Aged
Treatment Outcome
Aged
Time Factors
Risk Factors
Patient Satisfaction
Percutaneous Coronary Intervention
/ adverse effects
Coronary Angiography
/ adverse effects
Hypoglycemia
/ chemically induced
Syncope, Vasovagal
/ etiology
Blood Glucose
/ metabolism
Coronary Artery Disease
/ therapy
Risk Assessment
angiography
angioplasty
cardiac
catheterization
fasting
nil per os
Journal
JACC. Cardiovascular interventions
ISSN: 1876-7605
Titre abrégé: JACC Cardiovasc Interv
Pays: United States
ID NLM: 101467004
Informations de publication
Date de publication:
27 May 2024
27 May 2024
Historique:
received:
24
01
2024
revised:
11
03
2024
accepted:
26
03
2024
medline:
30
5
2024
pubmed:
30
5
2024
entrez:
29
5
2024
Statut:
ppublish
Résumé
Fasting before coronary procedures is currently recommended to reduce complications despite the lack of scientific evidence. The TONIC (Comparison Between Fasting and No Fasting Before Interventional Coronary Intervention on the Occurrence of Adverse Events) noninferiority trial investigated the safety and comfort of a nonfasting strategy (ad libitum food and drinks) vs traditional fasting (>6 hours for solid food and liquids) before coronary procedures. In this monocentric, prospective, single-blind randomized controlled trial, 739 patients undergoing coronary procedures were included and randomized to a fasting or a nonfasting strategy. Emergency procedures were excluded. The primary endpoint was a composite of vasovagal reaction, hypoglycemia (defined by blood sugar ≤0.7 g/L), and isolated nausea and/or vomiting. Noninferiority margin was 4%. Secondary endpoints were contrast-induced nephropathy and patients' satisfaction. Among the 739 procedures (697 elective and 42 semiurgent), 517 angiographies, and 222 angioplasties (including complex and high-risk procedures) were performed. The primary endpoint occurred in 30 of 365 nonfasting patients (8.2%) vs 37 of 374 fasting patients (9.9%), demonstrating noninferiority (absolute between-group difference, -1.7%; 1-sided 95% CI upper limit: 1.8%). No food-related adverse event occurred, and contrast-related acute kidney injuries were similar between groups. Overall, procedure satisfaction and perceived pain were similar in both groups, but nonfasting patients reported less hunger and thirst (P < 0.01). In case of redo coronary procedures, most patients (79%) would choose a nonfasting strategy. The TONIC randomized trial demonstrates the noninferiority of a nonfasting strategy to the usual fasting strategy for coronary procedures regarding safety, while improving patients' comfort.
Sections du résumé
BACKGROUND
BACKGROUND
Fasting before coronary procedures is currently recommended to reduce complications despite the lack of scientific evidence.
OBJECTIVES
OBJECTIVE
The TONIC (Comparison Between Fasting and No Fasting Before Interventional Coronary Intervention on the Occurrence of Adverse Events) noninferiority trial investigated the safety and comfort of a nonfasting strategy (ad libitum food and drinks) vs traditional fasting (>6 hours for solid food and liquids) before coronary procedures.
METHODS
METHODS
In this monocentric, prospective, single-blind randomized controlled trial, 739 patients undergoing coronary procedures were included and randomized to a fasting or a nonfasting strategy. Emergency procedures were excluded. The primary endpoint was a composite of vasovagal reaction, hypoglycemia (defined by blood sugar ≤0.7 g/L), and isolated nausea and/or vomiting. Noninferiority margin was 4%. Secondary endpoints were contrast-induced nephropathy and patients' satisfaction.
RESULTS
RESULTS
Among the 739 procedures (697 elective and 42 semiurgent), 517 angiographies, and 222 angioplasties (including complex and high-risk procedures) were performed. The primary endpoint occurred in 30 of 365 nonfasting patients (8.2%) vs 37 of 374 fasting patients (9.9%), demonstrating noninferiority (absolute between-group difference, -1.7%; 1-sided 95% CI upper limit: 1.8%). No food-related adverse event occurred, and contrast-related acute kidney injuries were similar between groups. Overall, procedure satisfaction and perceived pain were similar in both groups, but nonfasting patients reported less hunger and thirst (P < 0.01). In case of redo coronary procedures, most patients (79%) would choose a nonfasting strategy.
CONCLUSIONS
CONCLUSIONS
The TONIC randomized trial demonstrates the noninferiority of a nonfasting strategy to the usual fasting strategy for coronary procedures regarding safety, while improving patients' comfort.
Identifiants
pubmed: 38811102
pii: S1936-8798(24)00649-6
doi: 10.1016/j.jcin.2024.03.033
pii:
doi:
Substances chimiques
Blood Glucose
0
Types de publication
Journal Article
Comparative Study
Equivalence Trial
Randomized Controlled Trial
Langues
eng
Sous-ensembles de citation
IM
Pagination
1200-1210Informations de copyright
Copyright © 2024 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
Déclaration de conflit d'intérêts
Funding Support and Author Disclosures The study’s sponsor was Assistance Publique–Hôpitaux de Paris (Délégation à la Recherche Clinique et à l'Innovation). The authors have reported that they have no relationships relevant to the contents of this paper to disclose.