Author + information
- Received October 18, 2013
- Revision received November 21, 2013
- Accepted November 27, 2013
- Published online April 1, 2014.
- Bjarne L. Nørgaard, MD, PhD∗∗ (, )
- Jonathon Leipsic, MD, PhD†,
- Sara Gaur, MD∗,
- Sujith Seneviratne, MBBS‡,
- Brian S. Ko, MBBS, PhD‡,
- Hiroshi Ito, MD, PhD§,
- Jesper M. Jensen, MD, PhD∗,
- Laura Mauri, MD, PhD‖,
- Bernard De Bruyne, MD, PhD¶,
- Hiram Bezerra, MD, PhD#,
- Kazuhiro Osawa, MD§,
- Mohamed Marwan, MD, PhD∗∗,
- Christoph Naber, MD, PhD††,
- Andrejs Erglis, MD, PhD‡‡,
- Seung-Jung Park, MD, PhD§§,
- Evald H. Christiansen, MD, PhD∗,
- Anne Kaltoft, MD, PhD∗,
- Jens F. Lassen, MD, PhD∗,
- Hans Erik Bøtker, MD, DMSci∗,
- Stephan Achenbach, MD, PhD∗∗,
- on behalf of the NXT Trial Study Group
- ∗Department of Cardiology, Aarhus University Hospital Skejby, Aarhus, Denmark
- †Department of Radiology, St. Paul's Hospital, University of British Columbia, Vancouver, British Columbia, Canada
- ‡MonashHeart, Monash Medical Center and Monash University, Victoria, Australia
- §Department of Cardiology, Okayama University Hospital, Okayama, Japan
- ‖Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, Massachusetts
- ¶Cardiovascular Center Aalst, OLV-Clinic, Aalst, Belgium
- #Department of Cardiology, Harrington Heart and Vascular Institute, University Hospitals, Cleveland, Ohio
- ∗∗Department of Cardiology, Erlangen University Hospital, Erlangen, Germany
- ††Department of Cardiology and Angiology, Elisabeth-Krankenhaus Essen, Essen, Germany
- ‡‡Latvian Centre of Cardiology, Pauls Stradins Clinical University Hospital, Riga, Latvia
- §§Heart Institute, University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea
- ↵∗Reprint requests and correspondence:
Dr. Bjarne Linde Nørgaard, Department of Cardiology, Aarhus University Hospital Skejby, Skejby DK-8200 Aarhus N, Denmark.
Objectives The goal of this study was to determine the diagnostic performance of noninvasive fractional flow reserve (FFR) derived from standard acquired coronary computed tomography angiography (CTA) datasets (FFRCT) for the diagnosis of myocardial ischemia in patients with suspected stable coronary artery disease (CAD).
Background FFR measured during invasive coronary angiography (ICA) is the gold standard for lesion-specific coronary revascularization decisions in patients with stable CAD. The potential for FFRCT to noninvasively identify ischemia in patients with suspected CAD has not been sufficiently investigated.
Methods This prospective multicenter trial included 254 patients scheduled to undergo clinically indicated ICA for suspected CAD. Coronary CTA was performed before ICA. Evaluation of stenosis (>50% lumen reduction) in coronary CTA was performed by local investigators and in ICA by an independent core laboratory. FFRCT was calculated and interpreted in a blinded fashion by an independent core laboratory. Results were compared with invasively measured FFR, with ischemia defined as FFRCT or FFR ≤0.80.
Results The area under the receiver-operating characteristic curve for FFRCT was 0.90 (95% confidence interval [CI]: 0.87 to 0.94) versus 0.81 (95% CI: 0.76 to 0.87) for coronary CTA (p = 0.0008). Per-patient sensitivity and specificity (95% CI) to identify myocardial ischemia were 86% (95% CI: 77% to 92%) and 79% (95% CI: 72% to 84%) for FFRCT versus 94% (86 to 97) and 34% (95% CI: 27% to 41%) for coronary CTA, and 64% (95% CI: 53% to 74%) and 83% (95% CI: 77% to 88%) for ICA, respectively. In patients (n = 235) with intermediate stenosis (95% CI: 30% to 70%), the diagnostic accuracy of FFRCT remained high.
Conclusions FFRCT provides high diagnostic accuracy and discrimination for the diagnosis of hemodynamically significant CAD with invasive FFR as the reference standard. When compared with anatomic testing by using coronary CTA, FFRCT led to a marked increase in specificity. (HeartFlowNXT–HeartFlow Analysis of Coronary Blood Flow Using Coronary CT Angiography [HFNXT]; NCT01757678)
- computational fluid dynamics
- coronary CT angiography
- fractional flow reserve
- invasive coronary angiography
Funding for the study was provided by HeartFlow, Inc. Dr. Mauri has received research grants from Abbott Vascular, Boston Scientific, Cordis, Medtronic, HeartFlow, Eli Lilly, Bristol-Myers Squibb, Daiichi Sankyo, and Sanofi-aventis; and serves as a consultant for St. Jude Medical, Biotronik, and Medtronic. Dr. Achenbach has received research grants from Siemens, Guerbet, and Abbott; and is a consultant for Siemens, Biotronik, and HeartFlow. Dr. Christiansen has received research grants from St. Jude Medical, Boston Scientific, Radi, Terumo, and Volcano. Dr. Leipsic has received research grants from GE Healthcare; and serves as a consultant for Edwards Lifesciences and HeartFlow. Dr. Seneviratne has given lectures at meetings organized by Toshiba. Dr. Nørgaard has received research grants from Edwards Lifesciences. All other authors have reported that they have no relationships relevant to the contents of this paper to di disclose.
- Received October 18, 2013.
- Revision received November 21, 2013.
- Accepted November 27, 2013.
- 2014 American College of Cardiology Foundation