'This could be a paradigm shift': How PET with newly approved flurpiridaz compares to SPECT
For the first time in three decades, the U.S. Food and Drug Administration (FDA) has approved a new PET nuclear myocardial perfusion imaging agent, flurpiridaz F-18, branded Flyrcado by GE HealthCare. The FDA’s clearance follows the pivotal AURORA Phase III clinical trial,[1] which demonstrated that this novel radiotracer outperforms SPECT, the current standard for cardiac nuclear perfusion imaging. The results of the trial and FDA clearance could mark a major shift toward more widespread adoption of PET in nuclear cardiology.
The AURORA trial was led by Jamshid Maddahi, MD, a professor of molecular and medical pharmacology at UCLA and director of the Biomedical Imaging Institute at UCLA. In an interview with Cardiovascular Business, Maddahi reviewed key highlights from the trial, which he believes will spur wider adoption of cardiac PET.
"The trial focused on comparing the diagnostic performance of flurpiridaz against both invasive coronary angiography and the currently widely used SPECT imaging with technetium-99m (99mTc)," Maddahi said. "The results were striking. Flurpiridaz demonstrated a significantly higher diagnostic accuracy, especially in subgroups where SPECT has traditionally been less effective, such as female and obese patients."
One of the key advantages of flurpiridaz F-18, according to Maddahi, is its superior sensitivity and specificity in detecting coronary artery disease (CAD). "SPECT imaging has limitations due to attenuation issues, particularly in women and obese individuals, but flurpiridaz overcomes these barriers," he explained.
The new radiotracer's improved accuracy means fewer ambiguous results, reducing the number of cases where clinicians must interpret studies as "probably normal" or "probably abnormal." Instead, he said studies using flurpiridaz were more often categorized with greater certainty as either "definitely normal" or "definitely abnormal."
In addition to diagnostic accuracy, the AURORA trial found that image quality with flurpiridaz was notably superior to SPECT, better enhancing perfusion defects.
"The percentage of studies rated as having excellent image quality was significantly higher with flurpiridaz," explained Maddahi. "This gives clinicians more confidence in their diagnoses and reduces the need for follow-up testing."
The trial also revealed that flurpiridaz provides clearer and more detailed images of ischemic defects in the heart.
"The size of ischemic defects was larger and better defined with flurpiridaz than with SPECT," Maddahi noted. "This is due to flurpiridaz’s higher extraction fraction, meaning it has a better ability to detect milder cases of CAD."
These findings indicate that flurpiridaz F-18 may offer a much-needed improvement in noninvasive cardiac imaging, especially for patients who may not benefit as much from SPECT. He said the trial also showed improved detection of coronary disease in women and obese patients, both of which have had issues with accuracy with SPECT imaging.
Flurpiridaz will change the economics of PET imaging
The introduction of flurpiridaz comes at a time when there is growing interest in the benefits of PET imaging over traditional SPECT. While SPECT has been the workhorse of myocardial perfusion imaging for decades, PET offers superior image quality, lower radiation doses, and faster imaging times. Despite these advantages, the higher costs of PET imaging systems and dominant Rb-82 generators have limited availability and hindered widespread use of PET. Due to the expense of the Rubidium generators, many lower volume centers have opted to stay with SPECT, where tracers can be purchased in unit doses as needed for regional commercial radiopharmacies. Now, however, Flurpiridaz is available in unit doses from radiopharmacies and can be ordered as needed at a lower cost than Rb-82 generators, making the economic side much more attractive.
"This could be a paradigm shift," said Maddahi. "With flurpiridaz, we have a radiotracer that not only surpasses SPECT in terms of diagnostic performance but also offers enhanced confidence for clinicians. This is a long-awaited development in nuclear cardiology, and I believe it will lead to much greater use of PET in the diagnosis and management of heart disease."
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