Removal of fasting requirements before cardiac procedures is not only safe, but also results in more satisfied patients, say the SCOFF trial investigators. This information was presented by Principal Investigator David Ferreira, of the John Hunter Hospital, Newcastle, Australia, during a late-breaking trials session on Sunday at the European Society of Cardiology (ESC) Congress 2024. “Fasting before a cardiac catheterization procedure has been recommended to reduce the risk of inhaling the stomach contents and developing aspiration pneumonia. However, for procedures in the catheterization 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,” said Dr. Ferreira in a press release on Sunday. Use of sedation occurs in millions of cardiac procedures worldwide. Under current guidelines, patients are required to fast prior to undergoing these procedures. The investigators in this study questioned whether these fasting requirements were necessary. The SCOFF trial was an investigator-initiated, randomized, open-label trial. The study was designed to examine the safety of fasting versus no fasting prior to cardiac procedures that required sedation. Investigators also sought to determine if removing the fasting requirements improved patient satisfaction. Aspiration pneumonia, low blood pressure, high blood sugar and low blood sugar made up the composite primary endpoint of this study. A key component of the secondary outcomes was pre-procedure patient satisfaction. A total of 716 patients (mean age=69 years, 35% female) from 6 sites across New South Wales, Australia, were included in this study. The primary outcome occurred in 19.1% of the fasting group, compared with 12.0% in the no-fasting group. An intention to treat analysis demonstrated the favorability of no fasting (mean posterior difference estimate: -5.2%; 95% confidence interval [CI]: -9.6 to –0.9) based on a noninferiority margin of 3% (likelihood >99.5%). For the primary outcome, the potential superiority of no fasting had a likelihood of 99.1%. The between-group absolute risk difference was 7.1%, favoring no fasting (14.1 needed-to-treat to prevent one primary outcome event). Pre-procedure patient satisfaction was significantly better in patients who did not fast, compared with the fasting group patients, when assessed with a questionnaire (11 versus 15 points; lower score=greater satisfaction; posterior mean difference=4.02 points; 95% CI=3.36-4.67; Bayes factor ≥100). In summary, the removal of fasting requirements before cardiac procedures involving sedation was safe and better than fasting in the tested outcomes in the SCOFF trial. Patient satisfaction was also significantly better in patients who were not required to fast. “With this new evidence, I think it is now time to reconsider fasting requirements in clinical guidelines,” said Dr. Ferreira. Photo Credit: Screenshot by Bailey G. Salimes/CRTonline.org Photo Caption: David Ferreira presents results from the SCOFF trial on Sunday at ESC 2024.