Author + information
- Received March 11, 2019
- Accepted March 11, 2019
- Published online May 15, 2019.
- Manesh R. Patel, MDa,∗ (, )
- Bjarne Linde Nørgaard, MD, PhDb,
- Timothy A. Fairbairn, MB ChB, PhDc,
- Koen Nieman, MD, PhDd,
- Takashi Akasaka, MDe,
- Daniel S. Berman, MDf,
- Gilbert L. Raff, MDg,
- Lynne M. Hurwitz Koweek, MDa,
- Gianluca Pontone, MD, PhDh,
- Tomohiro Kawasaki, MDi,
- Niels Peter Rønnow Sand, MD, PhDj,
- Jesper M. Jensen, MD, PhDb,
- Tetsuya Amano, MDk,
- Michael Poon, MDl,
- Kristian A. Øvrehus, MD, PhDj,
- Jeroen Sonck, MDm,n,
- Mark G. Rabbat, MDo,
- Sarah Mullen, MBTp,
- Bernard De Bruyne, MD, PhDq,
- Campbell Rogers, MDp,
- Hitoshi Matsuo, MD, PhDr,
- Jeroen J. Bax, MD, PhDs and
- Jonathon Leipsic, MDt
- aDivision of Cardiology, Department of Medicine, Duke University Medical Center, Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina
- bDepartment of Cardiology, Aarhus University Hospital, Aarhus, Denmark
- cDepartment of Cardiology, University of Liverpool, Liverpool Heart and Chest Hospital, Liverpool, United Kingdom
- dDepartments of Cardiovascular Medicine and Radiology, Stanford University, Stanford, California
- eDepartment of Cardiovascular Medicine, Wakayama Medical University, Wakayama, Japan
- fDivision of Nuclear Imaging, Department of Imaging, Cedars-Sinai Heart Institute, Los Angeles, California
- gDivision of Cardiology, Beaumont Academic Heart and Vascular Group, Royal Oak, Michigan
- hCentro Cardiologico Monzino, Milan, Italy
- iCardiovascular Center, Shin Koga Hospital, Fukuoka, Japan
- jCardiac Research Unit, Institute of Regional Health Research, University Hospital of SouthWest DK, University of Southern Denmark, Odense, Denmark
- kDepartment of Cardiology, Aichi Medical University, Aichi, Japan
- lDepartment of Noninvasive Cardiac Imaging, Northwell Health, New York, New York
- mCardiovascular Center Aalst, OLV Clinic, Aalst, Belgium
- nDepartment of Advanced Biomedical Sciences, University of Naples Federico II, Naples, Italy
- oDivision of Cardiology, Loyola University Chicago, Chicago, Illinois
- pHeartFlow Inc., Redwood City, California
- qCardiovascular Center, Onze-Lieve-Vrouwziekenhuis, Aalst, Belgium
- rDepartment of Cardiovascular Medicine, Gifu Heart Center, Gifu, Japan
- sDepartment of Cardiology, Leiden University Medical Center, Leiden, the Netherlands
- tDepartment of Radiology, Providence Health Care, St. Paul’s Hospital, University of British Columbia, Vancouver, Canada
- ↵∗Address for correspondence:
Dr. Manesh R. Patel, Duke Heart Center, Duke Clinical Research Institute, Duke University, 2400 Pratt Street, Durham, North Carolina 27710.
Objectives The 1-year data from the international ADVANCE (Assessing Diagnostic Value of Non-invasive FFRCT in Coronary Care) Registry of patients undergoing coronary computed tomography angiography (CTA) was used to evaluate the relationship of fractional flow reserve derived from coronary CTA (FFRCT) with downstream care and clinical outcomes.
Background Guidelines for management of chest pain using noninvasive imaging pathways are based on short- to intermediate-term outcomes.
Methods Patients (N = 5,083) evaluated for clinically suspected coronary artery disease and in whom atherosclerosis was identified by coronary CTA were prospectively enrolled at 38 international sites from July 15, 2015, to October 20, 2017. Demographics, symptom status, coronary CTA and FFRCT findings and resultant site-based treatment plans, and clinical outcomes through 1 year were recorded and adjudicated by a blinded core laboratory. Major adverse cardiac events (MACE), death, myocardial infarction (MI), and acute coronary syndrome leading to urgent revascularization were captured.
Results At 1 year, 449 patients did not have follow-up data. Revascularization occurred in 1,208 (38.40%) patients with an FFRCT ≤0.80 and in 89 (5.60%) with an FFRCT >0.80 (relative risk [RR]: 6.87; 95% confidence interval [CI]: 5.59 to 8.45; p < 0.001). MACE occurred in 55 patients, 43 events occurred in patients with an FFRCT ≤0.80 and 12 occurred in those with an FFRCT >0.80 (RR: 1.81; 95% CI: 0.96 to 3.43; p = 0.06). Time to first event (all-cause death or MI) occurred in 38 (1.20%) patients with an FFRCT ≤0.80 compared with 10 (0.60%) patients with an FFRCT >0.80 (RR: 1.92; 95% CI: 0.96 to 3.85; p = 0.06). Time to first event (cardiovascular death or MI) occurred cardiovascular death or MI occurred more in patients with an FFRCT ≤0.80 compared with patients with an FFRCT >0.80 (25 [0.80%] vs. 3 [0.20%]; RR: 4.22; 95% CI: 1.28 to 13.95; p = 0.01).
Conclusions The 1-year outcomes from the ADVANCE FFRCT Registry show low rates of events in all patients, with less revascularization and a trend toward lower MACE and significantly lower cardiovascular death or MI in patients with a negative FFRCT compared with patients with abnormal FFRCT values. (Assessing Diagnostic Value of Non-invasive FFRCT in Coronary Wave [ADVANCE]; NCT02499679)
- clinical outcomes
- clinical practice
- coronary computed tomography angiography
- fractional flow reserve
- major adverse cardiac events
The ADVANCE Registry was funded by HeartFlow, Inc. Dr. Patel has received research grants from HeartFlow, Bayer, Janssen, and the National Heart, Lung, and Blood Institute; and has served on the advisory board for HeartFlow, Bayer, and Janssen. Dr. Nørgaard has received unrestricted institutional research grants from Siemens and HeartFlow. Dr. Fairbairn has served on the Speakers Bureau for HeartFlow. Dr. Nieman has received institutional research support from Siemens Healthineers, HeartFlow, GE Healthcare, and Bayer Healthcare. Dr. Berman has received unrestricted research support from HeartFlow. Dr. Hurwitz Koweek has received research support and speaking fees from HeartFlow and Siemens. Dr. Pontone has received institutional research grant and/or honorarium as consultant/speaker from GE Healthcare, Bracco, Medtronic, Bayer, and HeartFlow. Dr. Sonck has received research grant support from the Cardiopath PhD program. Dr. Rabbat has served as a consultant for HeartFlow. Dr. Mullen is an employee of and owns equity in HeartFlow. Dr. De Bruyne has received consulting fees from Abbott, Opsens, and Boston Scientific; and is a shareholder for Siemens, GE Healthcare, Bayer, Philips, HeartFlow, Edwards Lifesciences, and Sanofi. Dr. Rogers is employee of and owns equity in HeartFlow. Dr. Leipsic has served as a consultant for and owns stock options in Circle CVI and HeartFlow. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received March 11, 2019.
- Accepted March 11, 2019.
- 2019 The Authors