TY - JOUR
T1 - Rationale and design of the DeFACTO (Determination of Fractional Flow Reserve by Anatomic Computed Tomographic AngiOgraphy) study
AU - Min, James K.
AU - Berman, Daniel S.
AU - Budoff, Matthew J.
AU - Jaffer, Farouc A.
AU - Leipsic, Jonathon
AU - Leon, Martin B.
AU - Mancini, G. B.John
AU - Mauri, Laura
AU - Schwartz, Robert S.
AU - Shaw, Leslee J.
PY - 2011/9
Y1 - 2011/9
N2 - Background: Coronary computed tomographic angiography (CTA) allows for noninvasive identification of anatomic coronary artery disease (CAD) severity but does not discriminate whether a stenosis causes ischemia. Computational fluid dynamic techniques applied to CTA images now permit noninvasive computation of fractional flow reserve (FFR), a measure of lesion-specific ischemia, but the diagnostic performance of computed FFR (FFR CT) as compared with measured FFR at the time of invasive coronary angiography remains unexplored. Objective: We determined the diagnostic accuracy of noninvasive FFR CT for the detection and exclusion of ischemia-causing stenoses. Methods: DeFACTO (NCT01233518) is a prospective, international, multicenter study of 238 patients designed to evaluate the diagnostic performance of FFR CT for the detection of hemodynamically significant coronary artery stenoses identified by CTA, compared with invasive FFR as a reference standard. FFR values ≤ 0.80 will be considered hemodynamically significant. Patients enrolled in the DeFACTO study will undergo CTA, invasive coronary angiography, and 3-vessel FFR in the left anterior descending artery, left circumflex artery, and right coronary artery distributions. FFR CT will be computed with acquired CTA images, without modification to CTA image acquisition protocols and without additional image acquisition. Blinded core laboratory interpretation will be performed for CTA, invasive coronary angiography, FFR, and FFR CT. Results: The primary endpoint of the DeFACTO study is the per-patient diagnostic accuracy of FFR CT for noninvasive assessment of the hemodynamic significance of CAD, compared with FFR during invasive coronary angiography as a reference standard. The secondary endpoints include additional per-patient as well as per-vessel diagnostic performance characteristics, including sensitivity, specificity, positive predictive value, and negative predictive value. Conclusion: The DeFACTO study will determine whether the addition of FFR CT to conventional CTA improves the diagnosis of hemodynamically significant CAD.
AB - Background: Coronary computed tomographic angiography (CTA) allows for noninvasive identification of anatomic coronary artery disease (CAD) severity but does not discriminate whether a stenosis causes ischemia. Computational fluid dynamic techniques applied to CTA images now permit noninvasive computation of fractional flow reserve (FFR), a measure of lesion-specific ischemia, but the diagnostic performance of computed FFR (FFR CT) as compared with measured FFR at the time of invasive coronary angiography remains unexplored. Objective: We determined the diagnostic accuracy of noninvasive FFR CT for the detection and exclusion of ischemia-causing stenoses. Methods: DeFACTO (NCT01233518) is a prospective, international, multicenter study of 238 patients designed to evaluate the diagnostic performance of FFR CT for the detection of hemodynamically significant coronary artery stenoses identified by CTA, compared with invasive FFR as a reference standard. FFR values ≤ 0.80 will be considered hemodynamically significant. Patients enrolled in the DeFACTO study will undergo CTA, invasive coronary angiography, and 3-vessel FFR in the left anterior descending artery, left circumflex artery, and right coronary artery distributions. FFR CT will be computed with acquired CTA images, without modification to CTA image acquisition protocols and without additional image acquisition. Blinded core laboratory interpretation will be performed for CTA, invasive coronary angiography, FFR, and FFR CT. Results: The primary endpoint of the DeFACTO study is the per-patient diagnostic accuracy of FFR CT for noninvasive assessment of the hemodynamic significance of CAD, compared with FFR during invasive coronary angiography as a reference standard. The secondary endpoints include additional per-patient as well as per-vessel diagnostic performance characteristics, including sensitivity, specificity, positive predictive value, and negative predictive value. Conclusion: The DeFACTO study will determine whether the addition of FFR CT to conventional CTA improves the diagnosis of hemodynamically significant CAD.
KW - Computed tomography
KW - Coronary artery disease
KW - Fractional flow reserve
UR - http://www.scopus.com/inward/record.url?scp=80052944165&partnerID=8YFLogxK
U2 - 10.1016/j.jcct.2011.08.003
DO - 10.1016/j.jcct.2011.08.003
M3 - Article
C2 - 21930103
AN - SCOPUS:80052944165
SN - 1934-5925
VL - 5
SP - 301
EP - 309
JO - Journal of Cardiovascular Computed Tomography
JF - Journal of Cardiovascular Computed Tomography
IS - 5
ER -