A Randomized Controlled Trial of Nonfasting vs Fasting Before Interventional Coronary Procedures: The TONIC Trial.

Autor:	Boukantar M; Interventional Cardiology, Henri Mondor Hospital, Créteil, France. Electronic address: madjid.boukantar@aphp.fr., Chiaroni PM; Interventional Cardiology, Henri Mondor Hospital, Créteil, France., Gallet R; Interventional Cardiology, Henri Mondor Hospital, Créteil, France., Zamora P; Interventional Cardiology, Henri Mondor Hospital, Créteil, France., Truong T; Interventional Cardiology, Henri Mondor Hospital, Créteil, France., Mangiameli A; Interventional Cardiology, Henri Mondor Hospital, Créteil, France., Rostain L; Interventional Cardiology, Henri Mondor Hospital, Créteil, France., Tuffreau-Martin AS; Interventional Cardiology, Henri Mondor Hospital, Créteil, France., Natella PA; Clinical Research Unit, Henri Mondor Hospital, Créteil, France., Oubaya N; University Paris Est Créteil, INSERM, IMRB, Créteil, France; AP-HP, Hôpitaux Henri-Mondor, Department of Public Health, Creteil, France., Teiger E; Interventional Cardiology, Henri Mondor Hospital, Créteil, France.
Jazyk:	angličtina
Zdroj:	JACC. Cardiovascular interventions [JACC Cardiovasc Interv] 2024 May 27; Vol. 17 (10), pp. 1200-1210.
DOI:	10.1016/j.jcin.2024.03.033
Abstrakt:	Background: Fasting before coronary procedures is currently recommended to reduce complications despite the lack of scientific evidence. Objectives: 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: 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: 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: 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. Competing Interests: 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. (Copyright © 2024 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)
Databáze:	MEDLINE
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