TY - JOUR
T1 - Diagnostic performance of noninvasive fractional flow reserve derived from coronary computed tomography angiography in suspected coronary artery disease
T2 - The NXT trial (Analysis of Coronary Blood Flow Using CT Angiography: Next Steps)
AU - Nørgaard, Bjarne L.
AU - Leipsic, Jonathon
AU - Gaur, Sara
AU - Seneviratne, Sujith
AU - Ko, Brian S.
AU - Ito, Hiroshi
AU - Jensen, Jesper M.
AU - Mauri, Laura
AU - De Bruyne, Bernard
AU - Bezerra, Hiram
AU - Osawa, Kazuhiro
AU - Marwan, Mohamed
AU - Naber, Christoph
AU - Erglis, Andrejs
AU - Park, Seung Jung
AU - Christiansen, Evald H.
AU - Kaltoft, Anne
AU - Lassen, Jens F.
AU - Bøtker, Hans Erik
AU - Achenbach, Stephan
N1 - Funding Information:
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.
PY - 2014/4/1
Y1 - 2014/4/1
N2 - 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 (FFR CT) 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. FFR CT 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 FFR;bsubesub& 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 FFR;bsubesub& 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 FFR;bsubesub& remained high. Conclusions FFR;bsubesub& 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,FFRled to a marked increase in specificity. (HeartFlowNXT-HeartFlow Analysis of Coronary Blood Flow Using Coronary CT Angiography [HFNXT]; NCT01757678).
AB - 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 (FFR CT) 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. FFR CT 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 FFR;bsubesub& 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 FFR;bsubesub& 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 FFR;bsubesub& remained high. Conclusions FFR;bsubesub& 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,FFRled to a marked increase in specificity. (HeartFlowNXT-HeartFlow Analysis of Coronary Blood Flow Using Coronary CT Angiography [HFNXT]; NCT01757678).
KW - computational fluid dynamics
KW - coronary CT angiography
KW - fractional flow reserve
KW - invasive coronary angiography
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U2 - 10.1016/j.jacc.2013.11.043
DO - 10.1016/j.jacc.2013.11.043
M3 - Article
C2 - 24486266
AN - SCOPUS:84896972430
SN - 0735-1097
VL - 63
SP - 1145
EP - 1155
JO - Journal of the American College of Cardiology
JF - Journal of the American College of Cardiology
IS - 12
ER -