Dr. Serkan Bulgurluoğlu

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

Published in Congress: ESC 2024

Link: https://doi.org/10.1093/ehjopen/oead111

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Background:

Cardiac catheterization procedures are usually conducted with local anesthesia and proceduralist-guided sedation. Various fasting protocols are routinely implemented before these procedures to mitigate the risk of aspiration, despite the lack of prospective evidence supporting their effectiveness. However, fasting also introduces additional risks, including patient discomfort, intravascular volume depletion, neuro-cardiogenic syncope, glycemic disturbances, and unnecessary fasting in the event of delayed or canceled procedures.

Objective:

SCOFF study compared procedural practices in the catheter laboratory regarding fasting versus non-fasting before the procedure.

Methods:

This is an investigator-initiated, multicentre, randomized trial with a prospective, open-label, blinded endpoint (PROBE) assessment based in New South Wales, Australia. Patients will be randomized 1:1 to fasting (6 h solid food and 2 h clear liquids) or to no fasting requirements. The primary outcome will be a composite of hypotension, hyperglycaemia, hypoglycaemia, and aspiration pneumonia. Secondary outcomes will include patient satisfaction, contrast-induced nephropathy, new intensive care admission, new non-invasive or invasive ventilation requirement post procedure, and 30-day mortality and readmission.

Results:

In total, 716 patients were recruited from six sites in New South Wales, Australia. 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 composite outcome occurred in 19.1% in the fasting group and 12.0% in the no-fasting group. In an intention to treat analysis, the estimate of the mean posterior difference was -5.2% (95% confidence interval [CI] -9.6 to -0.9) favouring no fasting. This result confirmed the non-inferiority of no fasting, based on a non-inferiority margin of 3% with a likelihood of greater than 99.5%. No fasting was also potentially superior to fasting for the primary outcome with a likelihood of 99.1%. There was an absolute risk difference between the groups of 7.1% in favour of no fasting, with a number needed to treat of 14.1 to prevent one primary outcome event.  
In analyses of secondary outcome events, no apparent differences were observed without and with fasting. Patient satisfaction was significantly better without fasting vs. with fasting when assessed via a questionnaire: 11 vs. 15 points where a lower score indicates greater satisfaction (posterior mean difference, 4.02 points; 95% CI 3.36 to 4.67; Bayes factor ?100). 

Conclusion:

After completion, this will be the largest randomized trial in the pre-procedural fasting space. Routine fasting prior to cardiac laboratory procedures may not reduce the risk of periprocedural outcomes. We are performing a clinically relevant, pragmatic, randomized multicentre trial to assess this question in a prospective fashion. The authors argue that if the non-inferiority of no-fasting is confirmed, it would be a practice-changing finding. This may also have implications for fasting requirements for other non-cardiac procedures that utilize conscious sedation.