TY - JOUR
T1 - Clinical impact of coronary computed tomography angiography-derived fractional flow reserve on Japanese population in the ADVANCE registry
AU - Shiono, Yasutsugu
AU - Matsuo, Hitoshi
AU - Kawasaki, Tomohiro
AU - Amano, Tetsuya
AU - Kitabata, Hironori
AU - Kubo, Takashi
AU - Morino, Yoshihiro
AU - Yoda, Shunichi
AU - Sakamoto, Tomohiro
AU - Ito, Hiroshi
AU - Shite, Junya
AU - Otake, Hiromasa
AU - Tanaka, Nobuhiro
AU - Terashima, Mitsuyasu
AU - Kadota, Kazushige
AU - Patel, Manesh R.
AU - Nieman, Koen
AU - Rogers, Campbell
AU - Nørgaard, Bjarne L.
AU - Bax, Jeroen J.
AU - Raff, Gilbert L.
AU - Chinnaiyan, Kavitha M.
AU - Berman, Daniel S.
AU - Fairbairn, Timothy A.
AU - Hurwitz Koweek, Lynne M.
AU - Leipsic, Jonathon
AU - Akasaka, Takashi
N1 - Funding Information:
This study was supported by HeartFlow, Inc., Redwood City, CA, USA, via individual Clinical Study Agreements with each enrolling institution and with the Duke Clinical Research Institute (DCRI) for Core Laboratory activities and Clinical Event Committee adjudication of adverse events.
Funding Information:
B.L.N. has received institutional research grants from Siemens and HeartFlow. C.R. is an employee of and has equity in HeartFlow. G.L.R. has received institutional research grant from HeartFlow. J.L. is an advisor to and holds stock options in HeartFlow and Circle CVI. L.M.H.K. has received grant funding to department from Siemens Healthineers, HeartFlow and Verily and Mallinckrodt. N.T. declares consulting fees from Abbott Vascular Japan Co., Ltd. (St. Jude Medical Japan Co., Ltd.), Boston Scientific Japan and receiving lecture fees from Daiichi-Sankyo Co., Ltd. Y.S has received speaking fees from Philips and Abbott Vascular.
Publisher Copyright:
© 2019, Japanese Circulation Society. All rights reserved.
PY - 2019
Y1 - 2019
N2 - Background: Coronary computed tomography angiography (cCTA)-derived fractional flow reserve (FFRCT) is a promising diagnostic method for the evaluation of coronary artery disease (CAD). However, clinical data regarding FFRCT in Japan are scarce, so we assessed the clinical impact of using FFRCT in a Japanese population. Methods and Results: The ADVANCE registry is an international prospective FFRCT registry of patients suspected of CAD. Of 5,083 patients, 1,829 subjects enrolled from Japan were analyzed. Demographics, symptoms, cCTA, FFRCT, treatment strategy, and 90-day major cardiovascular events (MACE) were assessed. Reclassification of treatment strategy between cCTA alone and cCTA+FFRCT occurred in 55.8% of site investigations and in 56.9% in the core laboratory analysis. Patients with positive FFR (FFRCT ≤0.80) were less likely to have non-obstructive disease on invasive coronary angiography than patients with negative FFR (FFRCT >0.80) (20.5% vs. 46.1%, P=0.0001). After FFRCT, 67.0% of patients with positive results underwent revascularization, whereas 96.1% of patients with negative FFRCT were medically treated. MACE occurred in 5 patients with positive FFRCT, but none occurred in patients with negative FFRCT within 90 days. Conclusions: In this Japanese population, FFRCT modified the treatment strategy in more than half of the patients. FFRCT showed potential for stratifying patients suspected of CAD properly into invasive or non-invasive management pathways.
AB - Background: Coronary computed tomography angiography (cCTA)-derived fractional flow reserve (FFRCT) is a promising diagnostic method for the evaluation of coronary artery disease (CAD). However, clinical data regarding FFRCT in Japan are scarce, so we assessed the clinical impact of using FFRCT in a Japanese population. Methods and Results: The ADVANCE registry is an international prospective FFRCT registry of patients suspected of CAD. Of 5,083 patients, 1,829 subjects enrolled from Japan were analyzed. Demographics, symptoms, cCTA, FFRCT, treatment strategy, and 90-day major cardiovascular events (MACE) were assessed. Reclassification of treatment strategy between cCTA alone and cCTA+FFRCT occurred in 55.8% of site investigations and in 56.9% in the core laboratory analysis. Patients with positive FFR (FFRCT ≤0.80) were less likely to have non-obstructive disease on invasive coronary angiography than patients with negative FFR (FFRCT >0.80) (20.5% vs. 46.1%, P=0.0001). After FFRCT, 67.0% of patients with positive results underwent revascularization, whereas 96.1% of patients with negative FFRCT were medically treated. MACE occurred in 5 patients with positive FFRCT, but none occurred in patients with negative FFRCT within 90 days. Conclusions: In this Japanese population, FFRCT modified the treatment strategy in more than half of the patients. FFRCT showed potential for stratifying patients suspected of CAD properly into invasive or non-invasive management pathways.
KW - Coronary CT angiography
KW - Coronary artery disease
KW - FFR
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U2 - 10.1253/circj.CJ-18-1269
DO - 10.1253/circj.CJ-18-1269
M3 - Article
C2 - 30996150
AN - SCOPUS:85066732133
SN - 1346-9843
VL - 83
SP - 1293
EP - 1301
JO - Circulation Journal
JF - Circulation Journal
IS - 6
ER -