Author + information
- Received March 11, 2019
- Accepted March 11, 2019
- Published online March 17, 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,
- Mark G. Rabbat, MDn,
- Sarah Mullen, MBTo,
- Bernard De Bruyne, MD, PhDp,
- Campbell Rogers, MDo,
- Hitoshi Matsuo, MD, PhDq,
- Jeroen J. Bax, MD, PhDr and
- Jonathon Leipsic, MDs
- aDuke University Medical Center, Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC
- bAarhus University Hospital, Aarhus, Denmark
- cUniversity of Liverpool, Liverpool Heart and Chest Hospital, Liverpool, UK
- dStanford University, Stanford, CA
- eWakayama Medical University, Wakayama, Japan
- fCedars-Sinai Heart Institute, Los Angeles, CA
- gBeaumont Academic Heart and Vascular Group, Royal Oak, MI
- hCentro Cardiologico Monzino, IRCCS, University of Milan, Italy
- iShin Koga Hospital, Fukuoka, Japan
- jUniversity Hospital of SouthWest DK, Institute of Regional Health Research, University of Southern Denmark, Odense, Denmark
- kAichi Medical University, Aichi, Japan
- lNorthwell Health, New York, NY
- mCardiovascular Center Aalst, OLV Clinic, Belgium, and Department of Advanced Biomedical Sciences, University of Naples Federico II, Aalst, Italy
- nDivision of Cardiology, Loyola University Chicago, Chicago, IL
- oHeartFlow Inc., Redwood City, CA
- pOnze-Lieve-Vrouwziekenhuis, Aalst, Belgium
- qGifu Heart Center, Gifu, Japan
- rLeiden University Medical Center, Leiden, Netherlands
- sProvidence Health Care, St. Paul’s Hospital, University of British Columbia, Vancouver, BC, Canada
- ↵∗Address for correspondence: Manesh R. Patel, MD, Duke Heart Center, Duke Clinical Research Institute, Duke University, 2400 Pratt St. Durham, NC 27710, USA, Phone +1 919-668-8917, Fax +1 919-668-7057.
Background Guidelines for management of chest pain using non-invasive imaging pathways are based on short-to-intermediate term outcomes.
Objectives One-year data from the international ADVANCE Registry of patients undergoing coronary computed tomography angiography (CCTA) was used to evaluate the relationship of fractional flow reserve derived from CTA (FFRCT) with downstream care and clinical outcomes.
Methods Patients (n=5083) evaluated for clinically suspected coronary artery disease (CAD) and in whom atherosclerosis was identified by CCTA were prospectively enrolled at 38 international sites from July 15, 2015–October 20, 2017. Demographics, symptom status, CCTA 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 1208 (38.4%) with FFRCT ≤0.80 and in 89 (5.6%) with an FFRCT >0.80 (RR 6.87, CI 5.59–8.45; p<0.001). MACE occurred in 55 patients, 43 events occurred in patients with an FFRCT ≤0.80 and 12 in those with an FFRCT >0.80 (RR 1.81, CI 0.96–3.43; P=0.06). Time to first all-cause death or MI occurred in 38 (1.2%) patients with FFRCT ≤0.80 compared with 10 (0.6%) patients with FFRCT >0.80 (RR 1.92, CI 0.96-3.85; P=0.06). Time to first cardiovascular death or MI occurred more in patients with FFRCT ≤0.80 compared with FFRCT >0.80 (25 [0.8%] vs. 3 [0.2%]; RR 4.22, CI 1.28-13.95; 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 towards lower MACE and significantly lower cardiovascular death or MI in patients with a negative FFRCT compared with patients with abnormal FFRCT values.
- coronary computed tomography angiography
- clinical outcomes
- major adverse cardiac events
- clinical practice
- fractional flow reserve
Funding source: The ADVANCE Registry was funded by HeartFlow, Inc.
Disclosures: Patel: Research grants from HeartFlow, Bayer, Janssen, NHLBI; Advisory board: HeartFlow, Bayer, Janssen. Nørgaard: Unrestricted institutional research grants from Siemens and HeartFlow. Fairbairn: Speaker’s bureau for HeartFlow. Nieman: Institutional research support from Siemens Healthineers, Heartflow Inc, GE Healthcare and Bayer Healthcare. Akasaka: Nothing to report.
Berman: Unrestricted research support from HeartFlow. Raff: Nothing to report. Hurwitz Koweek: Research support and speaking fees from HeartFlow and Siemens. Pontone: Institutional research grant and/or honorarium as consultant/speaker from GE Healthcare, Bracco, Medtronic, Bayer, HeartFlow.
Kawasaki: Nothing to report. Sand: Nothing to report. Jensen: Nothing to report. Amano: Nothing to report. Poon: Nothing to report. Øvrehus: Nothing to report. Sonck: Research grant support provided by the Cardiopath PhD program. Rabbat: Consultant for HeartFlow Inc. Mullen: Employee of and has equity in HeartFlow. De Bruyne: Consulting fees from Abbott, Opsens, and Boston Scientific and is a shareholder for Siemens, GE, Bayer, Philips, HeartFlow, Edwards Life Sciences, and Sanofi. Rogers: Employee of and has equity in HeartFlow. Matsuo: Nothing to report. Bax: Nothing to report. Leipsic: Consultant and stock options Circle CVI and HeartFlow.
- Received March 11, 2019.
- Accepted March 11, 2019.