Safety and care of no fasting prior to catheterization laboratory procedures: a non-inferiority randomized control trial protocol (SCOFF trial)

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By John Vitarello on

KEY POINTS:

  • Fasting before cardiac catheterization is a common practice, however, the evidence supporting its benefit is limited
  • The SCOFF trial demonstrated that during routine cardiac catheterization with conscious sedation, safety events, including aspiration, did not occur more frequently in the non-fasting group 

Cardiac catheterization is a commonly performed procedure in which patients are instructed to fast beforehand. This recommendation is based on the premise that fasting reduces the risk of aspirating stomach contents, improving procedural safety. However, there is a lack of evidence to support this practice with cardiac procedures, and recent trials suggest that it may be safe to forgo fasting in cardiac catheterization utilizing conscious sedation. For example, the CHOW NOW trial published in 2024, randomized 197 patients to fast or a follow a low-acid diet, in which there were zero incidents of aspiration and higher levels of patient satisfaction in the non-fasting group.

The SCOFF trial is a multi-center, randomized, open-label trial that assessed the safety and patient satisfaction of no fasting prior to cardiac catheterization with conscious sedation. A total of 716 patients in New South Wales Australia were randomized in 1:1 fashion to either fasting, which consisted of 6 hours of avoiding solid foods and 2 hours of liquids- or no fasting. Patients requiring general anesthesia, emergent intervention, or complex catheterization (including valve interventions, rotational atherectomy, or mechanical support) were excluded.

The primary endpoint was a composite outcome of aspiration pneumonia, hyperglycemia, hypoglycemia, or hypotension. The secondary outcome evaluated patient satisfaction assessed via pre- procedure and post-procedure survey. The mean age was 69 years and 35% were female. As expected, fasting times were longer with fasting compared with no fasting (solid fasting 13.2 hours vs. 3.0 hours, clear liquid fasting 7.0 hours vs. 2.4 hours)

The primary endpoint occurred in 19.1% of the fasting group, compared to 12.0% in the no fasting group. Patients in the non-fasting group reported improved satisfaction (15 ± 4.3) compared to the fasting group (11±4.0), with lower scores indicating better patient satisfaction (Difference -4.02, [95% CI 4.67- 3.34]).

Dr. David Ferreira from John Hunter Hospital in Newcastle Australia presented the results at the European Society of Cardiology Conference, suggesting that “removing fasting requirements was safe and improved satisfaction for patients undergoing cardiac procedures with conscious sedation.” Furthermore, in his protocol paper, he noted the “potential benefits to removing fasting requirements including improved patient satisfaction, superior hydration status, and prevention of procedure delays and cancellations.”