Background: A recent phase 3 study of the PET perfusion tracer F-18 flurpiridaz (flurpiridaz) met the primary efficacy endpoint for the detection of CAD, demonstrating statistically higher sensitivity, non-inferior specificity compared to Tc-99m-tetrofosmin/sestamibi SPECT (Tc99m-SPECT) in the general population. This study reports a pre-specified subgroup analysis examining the diagnostic accuracy of flurpiridaz in women.
Methods: Patients with suspected CAD underwent rest-stress flurpiridaz PET and Tc99m-SPECT before invasive coronary angiography in the US, Canada and Europe. The primary endpoint was sensitivity and specificity by 2 expert readers (majority rule between 3 blinded readers) for the diagnosis of significant CAD defined as a stenosis ≥50%. Secondary endpoints included comparison of the diagnostic performance of flurpiridaz PET and Tc99m-SPECT.
Results: 188 women were included in the subgroup analysis. Flurpiridaz met the pre-specified primary endpoint of sensitivity [82.9% (95% CI: 71.4, 94.4),p=0.0014] and specificity [72.8% (95%CI: 65.6, 80),p=0.0008]. Flurpiridaz sensitivity was significantly higher than Tc99m-SPECT [82.9% vs.65.9%, difference: 17.1% (-1.5%, 35.6%),p=0.0448] and specificity was non-inferior [72.8% vs. 66%, difference:6.8% (-3.4%, 17.0%) p=0.0004]. Diagnostic certainty was significantly higher for women undergoing flurpiridaz PET compared to Tc99m-SPECT (82.4% v 48.9%). PET perfusion image quality was better than Tc99m-SPECT for rest and pharmacological stress images (p<0.0001). The summed difference score was significantly higher for flurpiridaz (5.3 v 3.5). Radiation exposure was significantly lower for flurpiridaz than same day rest/stress Tc99m-SPECT (6.2 v 11.2 mSv).
Conclusions: This pre-specified secondary analysis of the ARORA study in women, demonstrates high diagnostic accuracy of flurpiridaz PET to detect obstructive CAD. In women, the diagnostic performance of flurpiridaz PET for detection of CAD was significantly higher than with 99mTc-SPECT.
扫码关注我们
求助内容:
应助结果提醒方式:
