Dr. Xu B. et al., performed a prospective, multicenter clinical trial to examine the diagnostic performance of QFR.
In their publication titled “Diagnostic Accuracy of Angiography-Based Quantitative Flow Ratio Measurements for Online Assessment of Coronary Stenosis”, published in JACC, they outlined the results of this study. The clinical trial aimed to evaluate QFR’s diagnostic performance in identifying hemodynamically significant coronary stenosis defined by FFR ≤ 0.80. Conducted across five centers, the prospective trial included 308 consecutively enrolled patients. QFR, quantitative coronary angiography (QCA), and wire-based FFR were assessed online during coronary angiography and re-evaluated offline at an independent core laboratory. Results demonstrated impressive patient- and vessel-level diagnostic accuracy of QFR at 92.4% and 92.7%, respectively, exceeding the pre-specified target. QFR outperformed QCA, showing higher sensitivity (94.6% vs. 62.5%) and specificity (91.7% vs. 58.1%). Positive and negative predictive values, as well as likelihood ratios, underscored QFR’s reliability. Offline analysis further confirmed high vessel-level diagnostic accuracy at 93.3%.
