AURORA
A new PET heart-imaging tracer called flurpiridaz was tested against the standard SPECT heart scan in people with suspected coronary artery disease, and found blocked arteries more reliably, especially in women and people with obesity, while using about half the radiation dose.
Overview
AURORA was the second (confirmatory) phase 3, prospective, multicentre trial of 18F-flurpiridaz, a novel PET myocardial perfusion imaging tracer, following an earlier phase 3 study that met its sensitivity endpoint but not its specificity non-inferiority criterion. AURORA enrolled 730 patients with suspected coronary artery disease across 48 sites in the US, Canada, and Europe; 578 were evaluable. Each patient underwent same-day rest/stress flurpiridaz PET and rest-stress 99mTc-labelled SPECT, both read blinded by three experts, before invasive coronary angiography (ICA) as the reference standard for ≥50% stenosis.
Flurpiridaz PET met both co-primary efficacy endpoints: sensitivity was higher than SPECT (80.3% vs 68.7%, p=0.0003) and specificity was non-inferior (63.8% vs 61.7%, p=0.0004). The area under the receiver-operating-characteristic curve favoured PET overall (0.80 vs 0.68) and specifically in women and obese patients, two groups in whom SPECT image quality is often degraded by attenuation artefact. PET also reduced radiation exposure by roughly half compared with SPECT and improved image quality and diagnostic certainty. A prespecified obesity subgroup analysis published in 2026 confirmed the advantage held across BMI categories.
AURORA supported FDA approval of flurpiridaz F-18 for PET myocardial perfusion imaging, giving cardiac PET a second widely available perfusion tracer alongside rubidium-82 and expanding access to PET myocardial perfusion imaging at centres with an on-site or nearby cyclotron rather than a generator.
- 80.3 vs 68.7 out of 100 reached this endpoint with 18F-flurpiridaz PET compared with 99mTc-SPECT; 11.6 more per 100.
- Roughly one extra person helped for every 9 treated. That is a rough figure taken from the two percentages, not a guarantee for any one person.
- The p-value (0.0003) says a difference this large would rarely happen by chance; it does not say how large or how useful the difference is.
- 63.8 vs 61.7 out of 100 reached this endpoint with 18F-flurpiridaz PET compared with 99mTc-SPECT; 2.1 more per 100.
- Roughly one extra person helped for every 48 treated. That is a rough figure taken from the two percentages, not a guarantee for any one person.
- The p-value (0.0004) says a difference this large would rarely happen by chance; it does not say how large or how useful the difference is.
- 18F-flurpiridaz PET: 0.8 AUC; 99mTc-SPECT: 0.7 AUC.
- The p-value (<0.001) says a difference this large would rarely happen by chance; it does not say how large or how useful the difference is.
- This endpoint is not one of the standard survival or response measures; read it alongside the trial's primary result.
- These results apply to the people the trial enrolled: Adults with suspected coronary artery disease undergoing myocardial perfusion imaging before invasive coronary angiography; a diagnostic (cardiac imaging) trial. People in a different situation may not see the same effect.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
730 enrolled.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Sensitivity for coronary artery disease (≥50% stenosis by quantitative coronary angiography)primary | 18F-flurpiridaz PET | 578 | 80.3% | - | 0.0003 | link |
| 99mTc-SPECT | 578 | 68.7% | ||||
| Specificity for coronary artery diseaseprimary | 18F-flurpiridaz PET | 578 | 63.8% | - | 0.0004 | link |
| 99mTc-SPECT | 578 | 61.7% | ||||
| Area under the ROC curve, overall population | 18F-flurpiridaz PET | - | 0.8 AUC | - | <0.001 | - |
| 99mTc-SPECT | - | 0.68 AUC |
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