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Diagnostic Performance of Noninvasive Fractional Flow Reserve Derived From Coronary Computed Tomography Angiography in Suspected Coronary Artery Disease: The NXT Trial (Analysis of Coronary Blood Flow Using CT Angiography: Next Steps)

https://doi.org/10.1016/j.jacc.2013.11.043Get rights and content
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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)

Key Words

computational fluid dynamics
coronary CT angiography
fractional flow reserve
invasive coronary angiography

Abbreviations and Acronyms

AUC
area under the receiver-operating characteristic curve
CAD
coronary artery disease
CI
confidence interval
CT
computed tomography
CTA
computed tomography angiography
cMR
cardiac magnetic resonance
FFR
fractional flow reserve
FFRCT
fractional flow reserve derived from coronary computed tomography angiography datasets
ICA
invasive coronary angiography
NPV
negative predictive value
PPV
positive predictive value

Cited by (0)

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.