A non-fasting strategy before coronary procedures was non-inferior to the routine fasting strategy, with similar incidence of vasovagal reaction, hypoglycemia and nausea, according to new trial data. The study, published online Monday and in the May 27 issue of JACC: Cardiovascular Interventions, noted that fasting before coronary angiographies has been routine practice since the first procedures in the 1960s, with severe complications requiring intubation frequently occurring. “Such complications are now exceptional, but fasting is still recommended in the guidelines despite the absence of scientific evidence,” said the research team, led by Madjid Boukantar, MD, and Paul-Matthieu Chiaroni, MD, from the Henri Mondor Hospital in Créteil, France. Boukantar, Chiaroni and colleagues noted that in current practice, the precaution of fasting often also applies to exams performed under local anesthesia – adding that for coronary procedures under local anesthesia with moderate sedation, patients are usually kept fasting for a minimum of 6 hours for solid food and 2 hours for clear liquids, as this is thought to reduce those risks. However, they said that major complications of percutaneous coronary interventions (PCI) requiring intubation are now very rare, with an incidence of emergency cardiac surgery between 0.15% and 0.4%, and under 1% for cardiac arrest. “On the other side, fasting could be associated with adverse outcomes such as hypoglycemia, insulin resistance, acute renal injury caused by dehydration, and patient discomfort, while increasing periprocedural pain,” they said – noting that recent retrospective studies have reported no difference in adverse outcomes between fasting ad non-fasted patients. Furthermore, the authors suggested that by improving patients’ comfort and satisfaction by removing the need to fast, “such changes in practice would also prevent procedures cancelation caused by nonfasting patients, and thus improve catheterization laboratories efficiency.” “However, the lack of a well-designed published randomized study regarding coronary procedures safety is still hindering changes in daily practice,” they added. Study details Boukantar, Chiaroni and colleagues noted that the TONIC (Comparison Between Fasting and No Fasting Before Interventional Coronary Intervention on the Occurrence of Adverse Events) randomized trial aimed to demonstrate the noninferiority of a non-fasting strategy to the current fasting strategy for patients undergoing coronary procedures regarding safety outcomes. The single-center, prospective, single-blind randomized controlled trial recruited 739 patients undergoing coronary procedures, who were randomized (1:1 ratio) to a fasting or non-fasting strategy. Emergency procedures were excluded, and the primary endpoint was a composite of vasovagal reaction, hypoglycemia (defined by blood sugar ≤0.7 g/L), and isolated nausea and/or vomiting, they said – adding that the non-inferiority margin was 4%. Secondary endpoints were contrast-induced nephropathy and patients’ satisfaction. The team reported that a primary outcome event occurred in 30 of 365 (8.2%) patients in the non-fasting group and in 37 of 374 (9.9%) patients in the fasting group (absolute difference: 1.7%, upper limit of the 1-sided 95% confidence interval [CI]: 1.8%). No food-related adverse event occurred, and contrast-related acute kidney injuries were similar between the groups, they added. “Overall, procedure satisfaction and perceived pain were similar in both groups, but non-fasting patients reported less hunger and thirst (P < 0.01),” said Boukantar, Chiaroni and colleagues, adding that in case of redo coronary procedures, most patients (79%) would choose a non-fasting strategy. “The TONIC trial demonstrates non-inferiority in regard to safety of a non-fasting strategy to the routine fasting strategy for all patients undergoing elective or semi-urgent coronary procedures, with no food-related adverse event,” they added, noting that a non-fasting strategy could improve patients’ comfort as well as catheterization laboratories efficiency. Source: Boukantar M, Chiaroni P-M, Gallet R, et al. A Randomized Controlled Trial of Nonfasting vs Fasting Before Interventional Coronary Procedures: The TONIC Trial. JACC Cardiovasc Interv 2024;17:1200-1210. Image Credit: SewcreamStudio – stock.adobe.com