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In the phase III REVEAL study, investigational PET tracer 124I-evuzamitide detected cardiac amyloidosis with 93.5% sensitivity and identified early transthyretin disease more often than bone scintigraphy. Bayer plans to submit the tracer for regulatory review, but the study was small, had limited follow-up, and does not yet establish how the test will perform in routine care.
An investigational PET/CT tracer detected cardiac amyloidosis with 93.5% sensitivity in the phase III REVEAL study and identified early transthyretin (ATTR) cases more often than bone scintigraphy, researchers reported at the Heart Failure Society of America annual meeting. Bayer said it plans to submit 124I-evuzamitide for regulatory review, although the results do not yet show how the test will perform in routine practice.
Among 170 people evaluated for suspected cardiac amyloidosis, the tracer had 86.0% specificity, a 94.1% negative predictive value and an 84.7% positive predictive value, according to findings presented by Mathew Maurer, MD, of Columbia University Irving Medical Center. The study reported similar performance in detecting AL and ATTR amyloidosis. These figures describe performance in the study population and may not transfer directly to other clinical settings.
For early ATTR, evuzamitide PET detected disease in 93% of cases, compared with 68% for bone scintigraphy (P=0.016). It also detected more cases in several lower-burden groups: among patients with NT-proBNP below 350 ng/L, the rates were 89% versus 74%; below 600 ng/L, 92% versus 75%. For patients with left ventricular wall thickness under 12 mm, the rates were 100% versus 78%; under 13 mm, they were 95% versus 79%.
Of the participants, 54 were diagnosed with ATTR and 21 with AL. The PET scans detected ATTR across bone-scan grades, including some cases considered equivocal or negative on bone scintigraphy. Researchers reported that no case detected by bone scintigraphy was missed by evuzamitide PET. In a post hoc analysis, 44% of participants whose ATTR was detected by PET met the study’s definition of early disease: NT-proBNP below 350 ng/L or left ventricular wall thickness below 12 mm.
Earlier Detection Beyond Bone Scans
Cardiac amyloidosis involves amyloid protein deposits in the heart and can be caused by different forms of the disease, including ATTR and light-chain (AL) amyloidosis. Identifying the type matters because treatment options differ. The reported ability to detect both forms could offer clinicians another way to investigate suspected disease, particularly when conventional bone scans do not provide a clear result.
The potential value is greatest in patients with early or lower-burden disease, when established imaging may miss cases. Maurer said earlier diagnosis could help patients receive disease-modifying therapies sooner. That is a rationale for further evaluation, not proof from this study that using the tracer improves treatment decisions or patient outcomes.
The study also found that tracer uptake tracked with measures including NT-proBNP, troponin, global longitudinal strain and left ventricular wall thickness. Researchers said this raises the possibility that PET measurements could help quantify amyloid burden over time. Whether repeated scans can reliably show that treatment is working has not been established.
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Limits of Current Diagnostic Testing
Current assessment commonly uses radionuclide imaging with bone-avid tracers to identify ATTR. The report notes that these scans can miss early disease; when clinical suspicion remains despite a negative or equivocal scan, biopsy may be needed to establish a diagnosis. A test that detects both major types without biopsy could address a diagnostic gap, but the REVEAL results alone do not establish that biopsy can be avoided in every patient.
REVEAL was a prospective, single-arm study at 18 U.S. centers. Participants received PET/CT using 1 mCi of 124I-evuzamitide and took oral potassium iodide for three days to block iodine’s effects on the thyroid. Three blinded readers interpreted the scans, while a separate group of amyloidosis experts assessed clinical records without seeing the scans.
The participants had a median age of 72, and 75.3% were men. More than three-quarters were in New York Heart Association functional class I or II. The study also took place as treatment options for ATTR include stabilizers such as tafamidis and acoramidis and the gene silencer vutrisiran. The availability of treatments increases the importance of diagnosis, but does not by itself show that this tracer changes outcomes.
“We’ve made tremendous advances on the therapeutic side.”
— Mathew Maurer, MD, Columbia University Irving Medical Center
Questions Before Routine Clinical Use
The results come with important limits. REVEAL followed participants for 60 days, included relatively few patients with AL amyloidosis, and used a clinical reference standard constrained by the records available to investigators. The report described the safety profile as acceptable based on safety visits on days 5 and 30, but the study size and follow-up do not settle questions about broader or longer-term safety.
The trial was single-arm, and its results do not establish that evuzamitide-guided diagnosis leads to better outcomes than existing testing. It is also unclear how the scan will perform across a wider range of patients and care settings, how its quantitative measurements should be interpreted over time, or whether it will reduce the need for biopsy in practice. Regulatory status, approval timing and any eventual conditions of use remain undetermined.
Regulatory Review and Further Evidence
Bayer said it plans to submit 124I-evuzamitide for regulatory approval. The source report did not specify a submission date or a timeline for a decision. Any regulatory review will assess the evidence available for the tracer; the study results should not be read as an approval announcement.
Further evidence will be needed to clarify performance in routine care, especially among patients with suspected disease but negative or uncertain results from existing scans. Longer follow-up and additional data on AL amyloidosis could also address gaps identified by the investigators. Until then, the findings are evidence of diagnostic promise in a defined study population, rather than confirmation of clinical benefit.
Key Questions
What is 124I-evuzamitide?
It is an investigational PET/CT radiotracer designed to bind to amyloid. In REVEAL, it was evaluated as a way to detect cardiac amyloidosis.
How did it compare with bone scintigraphy for early ATTR?
In the study’s early-ATTR analysis, evuzamitide PET detected disease in 93% of cases, compared with 68% for bone scintigraphy. The result is from REVEAL and does not establish performance in every patient group or setting.
Does this mean patients will no longer need a biopsy?
No. The study suggests the tracer may help identify cases that bone scintigraphy misses, but it does not establish that biopsy can be avoided for all patients. Its role in clinical decisions remains to be determined.
Has the tracer been approved?
The report describes 124I-evuzamitide as investigational. Bayer plans to submit it for regulatory review, but the source does not report an approval or a decision date.
What are the main limitations of the findings?
REVEAL was a single-arm study with 170 participants, a 60-day follow-up, relatively few AL cases and a reference diagnosis based on available clinical records. Its results do not yet show whether the tracer improves patient outcomes or how well it performs in routine practice.
Source: rss
