James Udelson, MD, chief of the division of cardiology, director of nuclear cardiology and professor of medicine at Tufts Medical Center, shared his perspective on the PRECISE trial, which was a late-breaking clinical trial at the American Heart Association Scientific Sessions 2022 meeting. Udelson served as one of the study's investigators.
The analysis showed a 70% reduction in the composite of death, non-fatal myocardial infarction (MI) or the need for diagnostic catheter angiograms in patients without unobstructive coronary artery disease (CAD) who received personalized care, as compared to the traditional approach of testing at one year.
The study looked at which strategy is best to evaluate patients with suspected CAD. PRECISE compared the standard of care (including stress testing or sending patients for a diagnostic angiogram) for evaluating these patients with use of cardiac computed tomography (CT) and fractional flow reserve CT (FFR-CT). It was theorized the CT with FFR-CT arm could offer a more personalized health assessment and care plan compared to what is currently done.
For those at very low risk of CAD, they were deferred from testing. For those who were not low risk, they were given coronary CT with provisional FFR-CT.
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"The study showed in the precision strategy arm, there was a strong signal of favorable effect, with no change in death and no significant difference in non-fatal MI. But, there was a big difference in the number of invasive coronary angiograms in patients without obstructive CAD," Udelson said.
He said the trial supplies additional clinical data to support cardiac CT and FFR-CT in the 2021 AHA/ACC Chest Pain Evaluation Guidelines, which raised coronary CT angiography (CCTA) to a level 1A level of evidence for front-line chest pain evaluation. The guidelines also included recommendations for the use of FFR-CT. Critics of those guidelines, namely the American Society of Nuclear Cardiology (ASNC), called out the inclusion of FFR-CT because of the lack of large randomized trial data.
"Now there is evidence," Udelson said. "We built in the use of FFR-CT as it could be used in everyday life, where if you have an intermediate stenosis on CT and you are not sure of its significance, that is where FFR-CT comes in. We now have randomized controlled trial data showing CT compared to the usual approach."
Another big complaint about CCTA has been that a large number of intermediate lesions seen on CT usually end up going to the cath lab for angiograms, because of the lack of physiological data showing the significance of the lesion on hemodynamic flow. But, Udelson explained, non-invasive FFR-CT now offers that additional data, which prevented a large number of patients from being catheterized unnecessarily in this study.
"In this trial, there were not only fewer catheterizations without obstructive CAD, there were also just fewer catheterizations overall," he explained. "But the number of revacularizations for the patients who did go to the cath lab, which is a measure of efficiency in selection of who goes to the cath lab, was better in the precision strategy group."
Udelson has used FFR-CT at Tufts for several years and said it is not something they use across the board for all patients. He explained that they only use it with patients where it would be helpful to see the physiological data.
"That helps give us a 'yes' or 'no' answer if a lesion is causing ischemia or not. And that helps us better decide who goes to the cath lab and who doesn't," Udelson said.
The study was presented at the AHA late-breaking session by the principle investigator Pamala Douglas, MD, the Ursula Geller Professor for Research in Cardiovascular Disease at Duke University School of Medicine. She said the data was very convincing.
"We conclude the precision strategy is the preferred strategy approach when evaluating patients with stable symptoms and suspected coronary artery disease," Douglas said during her presentation. "PRECISE addresses critical knowledge gaps in the evaluation of symptomatic, low and intermediate risk patients with suspected CAD by defining the testing and specific care pathway concordant with guideline recommendations."
Ron Blankstein, MD, associate director of the cardiovascular imaging program and director of cardiac CT at Brigham and Women's Hospital, and an author of the 2021 chest pain guidelines, discussed the impact on the PRECISE trial at the late-breaking session.
"Coronary CT has revolutionized our ability to visualize the coronary arteries," Blankstein said. "This trial supports the 2021 AHA/ACC chest pain guidelines. I think this will be a trial that will also help inform future guidelines."
He and Udelson noted the trial shows improved quality of life for patients by greatly reducing the need for needless diagnostic angiograms and boosts efficiency in the diagnostic pathway by using CT combined with FFR-CT.
Follow-up data presentations from this trial are expected for the various patient cohorts and with longer-term followups.
Dave Fornell has covered healthcare for more than 17 years, with a focus in cardiology and radiology. Fornell is a 5-time winner of a Jesse H. Neal Award, the most prestigious editorial honors in the field of specialized journalism. The wins included best technical content, best use of social media and best COVID-19 coverage. Fornell was also a three-time Neal finalist for best range of work by a single author. He produces more than 100 editorial videos each year, most of them interviews with key opinion leaders in medicine. He also writes technical articles, covers key trends, conducts video hospital site visits, and is very involved with social media. E-mail: dfornell@innovatehealthcare.com