A randomised trial testing whether the removal of fasting requirements prior to cath lab procedures requiring conscious sedation has any impact on procedural safety and patient satisfaction has found no difference in complications in patients who fasted or did not fast before cardiac catheterisation procedures.
David Ferreira (John Hunter Hospital, Newcastle, Australia) presented findings of the SCOFF trial during a Hot Line session at the 2024 European Society of Cardiology (ESC) Congress (30 August–2 September, London, UK), where he argued that these results, alongside other existing evidence from studies such as CHOW-NOW, TONIC and Fast-CIED, should open the discussion about changes to guidelines recommending fasting as standard before cardiac catheterisation.
“This is an incredibly important question, because this is bread and butter cardiology,” said Ferreira. “Millions of patients undergo coronary device related procedures every year, and so this is an important clinical question.
“The main take home message from this trial is that, based on the data that we present, removing fasting requirements was safe, and improved patient satisfaction for those undergoing cardiac procedures that require conscious sedation.”
The investigator-initiated, randomised SCOFF trial, with a prospective open-label, blinded endpoint design, assessed the non-inferiority of no fasting prior to cardiac catheterisation laboratory procedures requiring conscious sedation. Patients who had been referred for coronary angiography, coronary intervention or cardiac implantable electronic device-related procedures were recruited.
They were randomised 1:1 to fasting before the procedure (no solid food for six hours and no clear liquids for two hours) or to no fasting where the patient was encouraged to have regular meals as usual, but this was not mandatory.
The primary composite endpoint was hypotension, aspiration pneumonia, hyperglycaemia and hypoglycaemia assessed with a Bayesian approach. Secondary endpoints included contrast-induced nephropathy, new intensive care admissions post-procedure, new ventilation requirements post procedure, new intensive care unit admissions, 30-day readmissions, 30-day mortality, 30-day pneumonia and pre-procedure patient satisfaction.
In total, 716 patients were recruited from six sites in New South Wales, Australia. The mean age was 69 years and 35% were female.
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).
