The SCOFF (Should We Continue to Offer Fasting?) trial, presented at ESC Congress 2024, reveals that fasting before cardiac catheterization procedures requiring conscious sedation is unnecessary and may even be detrimental. The randomized, open-label study found no increased risk of complications in patients who ate normally compared to those who fasted, challenging established guidelines and potentially improving patient comfort and healthcare efficiency.
SCOFF Trial Details
The investigator-initiated SCOFF trial enrolled 716 patients across six sites in New South Wales, Australia, who were referred for coronary angiography, coronary intervention, or cardiac implantable electronic device-related procedures. Participants were randomized 1:1 to either a fasting group (no solid food for 6 hours and no clear liquids for 2 hours) or a no-fasting group, where they were encouraged to eat regular meals. The primary composite endpoint included hypotension, aspiration pneumonia, hyperglycemia, and hypoglycemia, assessed using a Bayesian approach. Secondary endpoints encompassed contrast-induced nephropathy, new intensive care admissions, ventilation requirements, 30-day readmissions, mortality, pneumonia, and pre-procedure patient satisfaction.
Key Findings
The primary composite outcome occurred in 19.1% of the fasting group and 12.0% of the no-fasting group. Intention-to-treat analysis estimated a mean posterior difference of -5.2% (95% CI -9.6 to -0.9) favoring no fasting, confirming non-inferiority with a >99.5% likelihood based on a 3% non-inferiority margin. No fasting also showed potential superiority (99.1% likelihood). The absolute risk difference was 7.1% in favor of no fasting, with a number needed to treat of 14.1 to prevent one primary outcome event.
Patient satisfaction was significantly higher in the no-fasting group, with scores of 11 vs. 15 (lower score indicates greater satisfaction; posterior mean difference, 4.02 points; 95% CI 3.36 to 4.67; Bayes factor ≥100).
Implications for Clinical Practice
Principal Investigator Dr. David Ferreira from John Hunter Hospital, Newcastle, Australia, stated, "Fasting before a cardiac catheterisation procedure has been recommended to reduce the risk of inhaling the stomach contents and developing aspiration pneumonia. However, for procedures in the catheterisation lab, fasting may not reduce aspiration risk and there are downsides, such as patient discomfort, water depletion, poor blood sugar control and unnecessary fasting for delayed/cancelled procedures. In the SCOFF trial, we were able to show no increased risk of complications with normal eating and that is good news for patients and for healthcare professionals."
Dr. Ferreira also noted that these findings, combined with data from the CHOW-NOW, TONIC, and Fast-CIED trials, provide a strong case for reconsidering fasting requirements in clinical guidelines. Removing fasting has consistently proven safe, is preferred by patients, and offers logistical benefits to healthcare systems.
Moving Forward
The SCOFF trial provides compelling evidence to support a change in pre-procedural guidelines for cardiac catheterization. By eliminating the need for fasting, healthcare providers can enhance patient comfort, reduce unnecessary delays, and streamline workflows without compromising patient safety.
