Author + information
- Received September 15, 2017
- Revision received October 13, 2017
- Accepted October 16, 2017
- Published online October 31, 2017.
- Bo Xu, MBBSa,
- Shengxian Tu, PhDb,∗∗ (, )
- Shubin Qiao, MDa,
- Xinkai Qu, MDc,
- Yundai Chen, MDd,
- Junqing Yang, MDe,
- Lijun Guo, MDf,
- Zhongwei Sun, MSca,
- Zehang Li, BScb,
- Feng Tian, MDd,
- Weiyi Fang, MDc,
- Jiyan Chen, MDf,
- Wei Li, PhDg,
- Changdong Guan, MSca,
- Niels R. Holm, MDh,
- William Wijns, MD, PhDi and
- Shengshou Hu, MDa,∗ ()
- aFu Wai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences, Beijing, China
- bBiomedical Instrument Institute, School of Biomedical Engineering, Shanghai Jiao Tong University, Shanghai, China
- cShanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai, China
- dChinese PLA General Hospital, Beijing, China
- eGuangdong General Hospital, Guangzhou, China
- fPeking University Third Hospital, Beijing, China
- gMedical Research and Biometrics Center, National Center for Cardiovascular Diseases, Beijing, China
- hAarhus University Hospital, Skejby, Denmark
- iThe Lambe Institute for Translational Medicine and Curam, National University of Ireland, Galway, and Saolta University Healthcare Group, Galway, Ireland
- ↵∗Address for Correspondence: Shengshou Hu, MD, National Clinical Research Center of Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Fu Wai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, A 167, Beilishi Road, Xicheng District, Beijing, 100037, China, Telephone: +86-10-8839-8359, Fax: +86-10-6839-6356.
- ↵∗∗Address for Correspondence: Shengxian Tu, PhD, Biomedical Instrument Institute, School of Biomedical Engineering, Shanghai Jiao Tong University, No. 1954, Huashan Road, Xuhui District, Shanghai, 200030, China, Telephone: +86-21-6293-2631, Fax: +86-21-6293-2156.
Objectives To assess the diagnostic performance of quantitative flow ratio (QFR) for diagnosis of hemodynamically-significant coronary stenosis defined by fractional flow reserve (FFR) ≤0.80.
Background QFR is a novel angiography-based method for deriving FFR without pressure wire or induction of hyperemia. The accuracy of QFR when assessed online in the catheterization laboratory has not been adequately examined to date.
Methods This prospective, multicenter trial enrolled patients who had at least one lesion with diameter stenosis of 30-90% and reference diameter ≥ 2mm by visual estimation. QFR, quantitative coronary angiography (QCA), and wire-based FFR were assessed online in blinded fashion during coronary angiography and re-analyzed offline at an independent core laboratory. The primary endpoint was that QFR would improve the diagnostic accuracy of coronary angiography such that the lower boundary of the 2-sided 95% confidence interval (CI) of this estimate exceeded 75%.
Results Between June and July 2017, 308 patients were consecutively enrolled at 5 centers. Online QFR and FFR results were both obtained in 328 of 332 interrogated vessels. Patient-level and vessel-level diagnostic accuracy of QFR were 92.4% (95% CI: 88.9%-95.1%) and 92.7% (95% CI: 89.3%-95.3%), that were both significantly higher than the prespecified target value (p <0.001). Sensitivity and specificity in identifying hemodynamically-significant stenosis were significantly higher for QFR than QCA (sensitivity: 94.6% versus 62.5%, difference: 32.0%, p <0.001; specificity: 91.7% versus 58.1%, difference: 36.1%, p <0.001). Positive predictive value, negative predictive value, positive likelihood ratio, and negative likelihood ratio for QFR was 85.5%, 97.1%, 11.4, and 0.06, respectively. Offline analysis also showed vessel-level QFR had a high diagnostic accuracy of 93.3% (95% CI: 90.0%, 95.7%).
Conclusions The study met its prespecified primary performance goal for the level of diagnostic accuracy of QFR in identifying hemodynamically-significant coronary stenosis.
The first two authors (BX and ST) contributed equally to this work.
Funding: Provided by Pulse medical imaging technology (Shanghai) Co., Ltd, the National Key Research and Development Program of China (Grant No. 2016YFC0100500), and the Natural Science Foundation of China (Grant No. 31500797 and 81570456).
Disclosures: S Tu received research support from Medis medical imaging and Pulse medical imaging. NR Holm has received institutional research grants from Abbott, Medis medical imaging, and Boston Scientific, and speaker fees from Boston Scientific and Abbott. W Wijns has received research grants from Abbott, MiCell, MicroPort, and Terumo. Other authors report no conflicts of interest regarding this manuscript.
- Received September 15, 2017.
- Revision received October 13, 2017.
- Accepted October 16, 2017.