Table 1. Summary of clinical trials evaluating the diagnostic performance of FFRCT.
| Study | Year | Design | No. of patients (n) | No. of vessels (n) | Non-diagnostic (%) | Analysis | Modality | Sensitivity (%) | Specificity (%) | PPV (%) | NPV (%) | AUC |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| DISCOVER-FLOW trial (25) | 2011 | Prospective; 4 sites in 3 countries; powered for per-vessel analysis | 103 | 159 | 0 | Per-vessel | FFRCT ≤0.80 | 87.9 | 82.2 | 73.9 | 92.2 | 0.90 |
| CCTA | 91.4 | 39.6 | 46.5 | 88.9 | 0.75 | |||||||
| Per-patient | FFRCT ≤0.80 | 92.6 | 81.6 | 84.7 | 90.9 | 0.92 | ||||||
| CCTA | 94.4 | 24.5 | 58.0 | 80.0 | 0.70 | |||||||
| DeFACTO trial (26) FFR | 2012 | Prospective; 17 sites in 5 countries; powered for per-patient analysis | 252 | 407 | 11 | Per-vessel | FFRCT ≤0.80 | — | — | — | — | — |
| CCTA | — | — | — | — | — | |||||||
| Per-patient | FFRCT ≤0.80 | 90 | 54 | 67 | 84% | 0.81 | ||||||
| CCTA | 84 | 42 | 61 | 72 | 0.62 | |||||||
| NXT trial (27) | 2014 | Prospective; 10 sites in 9 countries; powered for per-patient analysis | 254 | 484 | 4.5 | Per-vessel | FFRCT ≤0.80 | 84 | 86 | 61 | 95% | 0.93 |
| CCTA | 83 | 60 | 33 | 92 | 0.79 | |||||||
| Per-patient | FFRCT ≤0.80 | 86 | 79 | 65 | 93 | 0.90 | ||||||
| CCTA | 94 | 34 | 40 | 92 | 0.81 |
NPV, negative predictive value; PPV, positive predictive value; FFRCT, fractional flow reserve computed tomography; AUC, area under the receiver operator curve.