Manesh R Patel1, Bjarne Linde Nørgaard2, Timothy A Fairbairn3, Koen Nieman4, Takashi Akasaka5, Daniel S Berman6, Gilbert L Raff7, Lynne M Hurwitz Koweek8, Gianluca Pontone9, Tomohiro Kawasaki10, Niels Peter Rønnow Sand11, Jesper M Jensen2, Tetsuya Amano12, Michael Poon13, Kristian A Øvrehus11, Jeroen Sonck14, Mark G Rabbat15, Sarah Mullen16, Bernard De Bruyne17, Campbell Rogers16, Hitoshi Matsuo18, Jeroen J Bax19, Jonathon Leipsic20. 1. Division of Cardiology, Department of Medicine, Duke University Medical Center, Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina. Electronic address: manesh.patel@duke.edu. 2. Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark. 3. Department of Cardiology, University of Liverpool, Liverpool Heart and Chest Hospital, Liverpool, United Kingdom. 4. Departments of Cardiovascular Medicine and Radiology, Stanford University, Stanford, California. 5. Department of Cardiovascular Medicine, Wakayama Medical University, Wakayama, Japan. 6. Division of Nuclear Imaging, Department of Imaging, Cedars-Sinai Heart Institute, Los Angeles, California. 7. Division of Cardiology, Beaumont Academic Heart and Vascular Group, Royal Oak, Michigan. 8. Division of Cardiology, Department of Medicine, Duke University Medical Center, Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina. 9. Centro Cardiologico Monzino, Milan, Italy. 10. Cardiovascular Center, Shin Koga Hospital, Fukuoka, Japan. 11. Cardiac Research Unit, Institute of Regional Health Research, University Hospital of SouthWest DK, University of Southern Denmark, Odense, Denmark. 12. Department of Cardiology, Aichi Medical University, Aichi, Japan. 13. Department of Noninvasive Cardiac Imaging, Northwell Health, New York, New York. 14. Cardiovascular Center Aalst, OLV Clinic, Aalst, Belgium; Department of Advanced Biomedical Sciences, University of Naples Federico II, Naples, Italy. 15. Division of Cardiology, Loyola University Chicago, Chicago, Illinois. 16. HeartFlow Inc., Redwood City, California. 17. Cardiovascular Center, Onze-Lieve-Vrouwziekenhuis, Aalst, Belgium. 18. Department of Cardiovascular Medicine, Gifu Heart Center, Gifu, Japan. 19. Department of Cardiology, Leiden University Medical Center, Leiden, the Netherlands. 20. Department of Radiology, Providence Health Care, St. Paul's Hospital, University of British Columbia, Vancouver, Canada.
Abstract
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).
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).
Authors: Fay M A Nous; Ricardo P J Budde; Marisa M Lubbers; Yuzo Yamasaki; Isabella Kardys; Tobias A Bruning; Jurgen M Akkerhuis; Marcel J M Kofflard; Bas Kietselaer; Tjebbe W Galema; Koen Nieman Journal: Eur Radiol Date: 2020-03-12 Impact factor: 5.315
Authors: Jagat Narula; Y Chandrashekhar; Amir Ahmadi; Suhny Abbara; Daniel S Berman; Ron Blankstein; Jonathon Leipsic; David Newby; Edward D Nicol; Koen Nieman; Leslee Shaw; Todd C Villines; Michelle Williams; Harvey S Hecht Journal: J Cardiovasc Comput Tomogr Date: 2020-11-20
Authors: Michael G Nanna; Sreekanth Vemulapalli; Christopher B Fordyce; Daniel B Mark; Manesh R Patel; Hussein R Al-Khalidi; Michelle Kelsey; Beth Martinez; Eric Yow; Sarah Mullen; Gregg W Stone; Ori Ben-Yehuda; James E Udelson; Campbell Rogers; Pamela S Douglas Journal: Am Heart J Date: 2021-12-23 Impact factor: 4.749