Background

Coronary computed tomography angiography (CCTA)-derived Murray law-based quantitative flow ratio (CT-μFR) is a novel non-invasive method for fast computation of fractional flow reserve (FFR) from CCTA images, yet its diagnostic performance remains to be prospectively validated.

Aims

We aimed to evaluate the diagnostic performance of onsite CT-μFR in patients with coronary artery disease.

Methods

This prospective, single-centre trial enrolled patients with≥ 1 lesion with 30-90% diameter stenosis on CCTA and planned invasive coronary angiography (ICA) within 30 days. CT-μFR, ICA-derived μFR and FFR were evaluated separately in a blinded fashion. The primary endpoint was the diagnostic accuracy of CT-μFR in identifying patients with haemodynamically significant coronary stenosis defined by the invasive standard: FFR≤ 0.80, or μFR≤ 0.80 when FFR was not available.

Results

Between December 2020 and August 2023, 260 patients were consecutively enrolled. Paired comparison between CT-μFR and the invasive standard was obtained in 706 vessels from 260 patients. The patient-level accuracy of CT-μFR was 89.6%(95% confidence interval [CI]: 85.9-93.4%), which was significantly higher than the prespecified target of 72.0%(p< 0.001). Sensitivity, specificity, positive and negative predictive values, and positive and negative likelihood ratios for CT-μFR were 93.1%, 86.1%, 87.1%, 92.5%, 6.7, and 0.1, respectively. Out of the 231 vessels investigated by FFR, the accuracy of CT-μFR in vessels without extensive calcification was non-inferior to that of μFR (90.6% vs 88.9%; difference= 1.8%[95% CI:-2.8 to 5.5%]; p for non-inferiority< 0.001).

Conclusions

The study met its prespecified primary endpoint of the diagnostic accuracy of CT-μFR in identifying patients with haemodynamically significant coronary stenosis. CT-μFR was non-inferior to ICA-derived μFR in vessels without extensive calcification.(ClinicalTrials. gov: NCT04665817).