Clinical outcomes of fractional flow reserve by computed tomographic angiography-guided diagnostic strategies vs. usual care in patients with suspected coronary artery disease: the prospective longitudinal trial of FFR(CT): outcome and resource impacts study.
OBJECTIVE
In symptomatic patients with suspected coronary artery disease (CAD), computed tomographic angiography (CTA) improves patient selection for invasive coronary angiography (ICA) compared with functional testing. The impact of measuring fractional flow reserve by CTA (FFRCT) is unknown.


RESULTS
At 11 sites, 584 patients with new onset chest pain were prospectively assigned to receive either usual testing (n = 287) or CTA/FFR(CT) (n = 297). Test interpretation and care decisions were made by the clinical care team. The primary endpoint was the percentage of those with planned ICA in whom no significant obstructive CAD (no stenosis ≥50% by core laboratory quantitative analysis or invasive FFR < 0.80) was found at ICA within 90 days. Secondary endpoints including death, myocardial infarction, and unplanned revascularization were independently and blindly adjudicated. Subjects averaged 61 ± 11 years of age, 40% were female, and the mean pre-test probability of obstructive CAD was 49 ± 17%. Among those with intended ICA (FFR(CT)-guided = 193; usual care = 187), no obstructive CAD was found at ICA in 24 (12%) in the CTA/FFR(CT) arm and 137 (73%) in the usual care arm (risk difference 61%, 95% confidence interval 53-69, P< 0.0001), with similar mean cumulative radiation exposure (9.9 vs. 9.4 mSv, P = 0.20). Invasive coronary angiography was cancelled in 61% after receiving CTA/FFR(CT) results. Among those with intended non-invasive testing, the rates of finding no obstructive CAD at ICA were 13% (CTA/FFR(CT)) and 6% (usual care; P = 0.95). Clinical event rates within 90 days were low in usual care and CTA/FFR(CT) arms.


CONCLUSIONS
Computed tomographic angiography/fractional flow reserve by CTA was a feasible and safe alternative to ICA and was associated with a significantly lower rate of invasive angiography showing no obstructive CAD.
Duke Clinical Research Institute, Duke University School of Medicine, 7022 North Pavilion DUMC, PO Box 17969, Durham, NC 27715, USA pamela.douglas@duke.edu.
Pamela S
PS
Douglas
Centro Cardiologico Monzino, IRCCS, University of Milan, Milan, Italy.
Gianluca
G
Pontone
Department of Health Research and Policy, Stanford University School of Medicine, Stanford, CA, USA.
Mark A
MA
Hlatky
Duke Clinical Research Institute, Duke University School of Medicine, 7022 North Pavilion DUMC, PO Box 17969, Durham, NC 27715, USA.
Manesh R
MR
Patel
Department of Cardiology, Aarhus University Hospital, Aarhus Skejby, Denmark.
Bjarne L
BL
Norgaard
Deutsches Herzzentrum München, Technische Universität München, Munich, Germany.
Robert A
RA
Byrne
University Hospital Southampton NHS Trust, Southampton, UK.
Nick
N
Curzen
Freeman Hospital, Newcastle upon Tyne, UK.
Ian
I
Purcell
University of Leipzig Heart Centre, Leipzig, Germany.
Matthias
M
Gutberlet
Hospices Civils de Lyon and CARMEN INSERM 1060, Lyon, France.
Gilles
G
Rioufol
Department of Cardiology, Johannes Gutenberg University Hospital, Mainz, Germany.
Ulrich
U
Hink
LKH Graz West, Graz, Austria.
Herwig Walter
HW
Schuchlenz
Department of Radiology, Innsbruck Medical University, Innsbruck, Austria.
Gudrun
G
Feuchtner
Department of Cardiology, Cavale Blanche Hospital, Brest, France.
Martine
M
Gilard
Centro Cardiologico Monzino, IRCCS, University of Milan, Milan, Italy.
Daniele
D
Andreini
Department of Cardiology, Aarhus University Hospital, Aarhus Skejby, Denmark.
Jesper M
JM
Jensen
Deutsches Herzzentrum München, Technische Universität München, Munich, Germany.
Martin
M
Hadamitzky
Duke Clinical Research Institute, Duke University School of Medicine, 7022 North Pavilion DUMC, PO Box 17969, Durham, NC 27715, USA.
Karen
K
Chiswell
Duke Clinical Research Institute, Duke University School of Medicine, 7022 North Pavilion DUMC, PO Box 17969, Durham, NC 27715, USA.
Derek
D
Cyr
HeartFlow, Redwood City, CA, USA.
Alan
A
Wilk
HeartFlow, Redwood City, CA, USA.
Furong
F
Wang
HeartFlow, Redwood City, CA, USA.
Campbell
C
Rogers
Cardiovascular Centre Aalst, Aalst, Belgium.
Bernard
B
De Bruyne
D060050:Angina, Stable / Q000209:etiology / Q000503:physiopathology; D006328:Cardiac Catheterization; D017023:Coronary Angiography / Q000379:methods; D003324:Coronary Artery Disease / Q000175:diagnosis* / Q000503:physiopathology; D005240:Feasibility Studies; D005260:Female; D053805:Fractional Flow Reserve, Myocardial / Q000502:physiology*; D006760:Hospitalization / Q000706:statistics & numerical data; D006801:Humans; D008137:Longitudinal Studies; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000209:etiology; D009204:Myocardial Revascularization / Q000379:methods; D018579:Patient Selection; D011446:Prospective Studies; D014057:Tomography, X-Ray Computed; D019564:Unnecessary Procedures
Angina; Coronary computed tomographic angiography; Fractional flow reserve; Non-invasive testing