It has been generally established that coronary procedures with local anesthesia and moderate sedation minimally require a 6 hour fast for solids and 2 hours for liquids (according to SCAI guidelines 2021). However, complications requiring emergency orotracheal intubation are extremely rare.
Prolonged fasting can have adverse effects such as hypoglycemia, insulin resistance, acute renal failure because of dehydration and patient discomfort. It has also been associated with higher incidence of vagal responses.
The aim of the TONIC trial (Comparison Between Fasting and No Fasting Before Interventional Coronary Intervention on the Occurrence of Adverse Events) was to show the non-inferiority of a no fast strategy in patients undergoing percutaneous coronary intervention (PCI) in relation to safety events. This was a prospective non-inferiority study, randomized 1:1, carried out at the Henri Mondor Hospital in Creteil, France.
It included patients programed for elective or semi-urgent coronary procedures, and excluded patients with hemodynamic instability, emergency, pregnancy, breastfeeding, and those undergoing any other simultaneous intervention (such as TAVR, for instance). The transracial approach was carried out with local anesthesia (lidocaine 1%), intra-arterial vasodilators and heparin NF, using iso-osmolar contrast.
Fasting patients had to abstain from solids and liquids for at least 6 hours, while no fasting patients could eat and drink following hospital standards.
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Primary end point was a combination of post procedural vasovagal reaction, hypoglycemia and nausea/vomiting. Secondary end points included acute renal injury, aspirating pneumonia, and patient satisfaction.
It included 755 patients, randomized to fasting (n=379) and no fasting (n=376). Mean age was 68 and 75% were men, 50% were active or former smokers and 29% diabetic. Most procedures were elective (94%), mainly for chronic coronary syndrome. 30% of cases received PCI and 8% required femoral access. During the procedure, conscious sedation was given to 21% of patients, mainly with midazolam. Fasting mean time was 15 hours in the fasting group and 3 hours in the no fasting group.
Primary end point happened in 8.2% of no fasting patients and in 9.9% of fasting patients (absolute difference -1.7%, without reaching pre-established non-inferiority). These results were consistent at protocol analysis (absolute difference -2.1%). Also, there were no significant differences in individual components. Vasovagal reaction was more frequent among fasting patients. (5.4% vs 2.7%).
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There were no differences in kidney injury, aspirating pneumonia or events related to food intake. As regards patient satisfaction, those in the no fasting group showed higher satisfaction rate and those undergoing repeat procedures preferred not to fast.
Conclusions
The TONIC randomized prospective study showed that a no fast strategy is safe and is associated to a feeling of wellbeing in patients undergoing elective or semi urgent coronary procedures.
Dr. Omar Tupayachi.
Member of the Editorial Board of SOLACI.org.
Original Title: A Randomized Controlled Trial of Nonfasting vs Fasting Before Interventional Coronary Procedures: The TONIC Trial.
Reference: Boukantar, M, Chiaroni, P, Gallet, R. et al. A Randomized Controlled Trial of Nonfasting vs Fasting Before Interventional Coronary Procedures: The TONIC Trial. J Am Coll Cardiol Intv. 2024 May, 17 (10) 1200–1210. https://doi.org/10.1016/j.jcin.2024.03.033.
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