Rationale and design of the DeFACTO (Determination of Fractional Flow Reserve by Anatomic Computed Tomographic AngiOgraphy) study

James K. Min, Daniel S. Berman, Matthew J. Budoff, Farouc A. Jaffer, Jonathon Leipsic, Martin B. Leon, G. B.John Mancini, Laura Mauri, Robert S. Schwartz, Leslee J. Shaw

Research output: Contribution to journalArticlepeer-review

112 Scopus citations

Abstract

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.

Original languageEnglish
Pages (from-to)301-309
Number of pages9
JournalJournal of Cardiovascular Computed Tomography
Volume5
Issue number5
DOIs
StatePublished - Sep 2011
Externally publishedYes

Keywords

  • Computed tomography
  • Coronary artery disease
  • Fractional flow reserve

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