Pamela S Douglas1, Bernard De Bruyne2, Gianluca Pontone3, Manesh R Patel4, Bjarne L Norgaard5, Robert A Byrne6, Nick Curzen7, Ian Purcell8, Matthias Gutberlet9, Gilles Rioufol10, Ulrich Hink11, Herwig Walter Schuchlenz12, Gudrun Feuchtner13, Martine Gilard14, Daniele Andreini3, Jesper M Jensen5, Martin Hadamitzky6, Karen Chiswell4, Derek Cyr4, Alan Wilk15, Furong Wang15, Campbell Rogers15, Mark A Hlatky16. 1. Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina. Electronic address: pamela.douglas@duke.edu. 2. Cardiovascular Centre Aalst, Aalst, Belgium. 3. Cardiovascular CT Unit, Centro Cardiologico Monzino, IRCCS, University of Milan, Milan, Italy. 4. Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina. 5. Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark. 6. Deutsches Herzzentrum München, Technische Universität München, Munich, Germany. 7. University Hospital Southampton NHS Trust, Southampton, United Kingdom. 8. Freeman Hospital, Newcastle upon Tyne, United Kingdom. 9. University of Leipzig Heart Centre, Leipzig, Germany. 10. Hospices Civils de Lyon and CARMEN INSERM 1060, Lyon, France. 11. Department of Cardiology, Johannes Gutenberg University Hospital, Mainz, Germany. 12. LKH Graz West, Graz, Austria. 13. Department of Radiology, Innsbruck Medical University, Innsbruck, Austria. 14. Department of Cardiology, Cavale Blanche Hospital, Brest, France. 15. HeartFlow, Redwood City, California. 16. Department of Health Research and Policy and Department of Medicine, Stanford University School of Medicine, Stanford, California.
Abstract
BACKGROUND:Coronary computed tomographic angiography (CTA) plus estimation of fractional flow reserve using CTA (FFRCT) safely and effectively guides initial care over 90 days in patients with stable chest pain. Longer-term outcomes are unknown. OBJECTIVES: The study sought to determine the 1-year clinical, economic, and quality-of-life (QOL) outcomes of using FFRCT instead of usual care. METHODS:Consecutive patients with stable, new onset chest pain were managed by either usual testing (n = 287) or CTA (n = 297) with selective FFRCT (submitted in 201, analyzed in 177); 581 of 584 (99.5%) completed 1-year follow-up. Endpoints were adjudicated major adverse cardiac events (MACE) (death, myocardial infarction, unplanned revascularization), total medical costs, and QOL. RESULTS:Patients averaged 61 years of age with a mean 49% pre-test probability of coronary artery disease. At 1 year, MACE events were infrequent, with 2 in each arm of the planned invasive group and 1 in the planned noninvasive cohort (usual care strategy). In the planned invasive stratum, mean costs were 33% lower with CTA and selective FFRCT ($8,127 vs. $12,145 usual care; p < 0.0001); in the planned noninvasive stratum, mean costs did not differ when using an FFRCT cost weight of zero ($3,049 FFRCT vs. $2,579; p = 0.82), but were higher when using an FFRCT cost weight equal to CTA. QOL scores improved overall at 1 year (p < 0.001), with similar improvements in both groups, apart from the 5-item EuroQOL scale scores in the noninvasive stratum (mean change of 0.12 for FFRCT vs. 0.07 for usual care; p = 0.02). CONCLUSIONS: In patients with stable chest pain andplanned invasive coronary angiography, care guided by CTA and selective FFRCT was associated with equivalent clinical outcomes and QOL, and lower costs, compared with usual care over 1-year follow-up. (The PLATFORM Study: Prospective LongitudinAl Trial of FFRct: Outcome and Resource IMpacts [PLATFORM]; NCT01943903).
RCT Entities:
BACKGROUND: Coronary computed tomographic angiography (CTA) plus estimation of fractional flow reserve using CTA (FFRCT) safely and effectively guides initial care over 90 days in patients with stable chest pain. Longer-term outcomes are unknown. OBJECTIVES: The study sought to determine the 1-year clinical, economic, and quality-of-life (QOL) outcomes of using FFRCT instead of usual care. METHODS: Consecutive patients with stable, new onset chest pain were managed by either usual testing (n = 287) or CTA (n = 297) with selective FFRCT (submitted in 201, analyzed in 177); 581 of 584 (99.5%) completed 1-year follow-up. Endpoints were adjudicated major adverse cardiac events (MACE) (death, myocardial infarction, unplanned revascularization), total medical costs, and QOL. RESULTS:Patients averaged 61 years of age with a mean 49% pre-test probability of coronary artery disease. At 1 year, MACE events were infrequent, with 2 in each arm of the planned invasive group and 1 in the planned noninvasive cohort (usual care strategy). In the planned invasive stratum, mean costs were 33% lower with CTA and selective FFRCT ($8,127 vs. $12,145 usual care; p < 0.0001); in the planned noninvasive stratum, mean costs did not differ when using an FFRCT cost weight of zero ($3,049 FFRCT vs. $2,579; p = 0.82), but were higher when using an FFRCT cost weight equal to CTA. QOL scores improved overall at 1 year (p < 0.001), with similar improvements in both groups, apart from the 5-item EuroQOL scale scores in the noninvasive stratum (mean change of 0.12 for FFRCT vs. 0.07 for usual care; p = 0.02). CONCLUSIONS: In patients with stable chest pain and planned invasive coronary angiography, care guided by CTA and selective FFRCT was associated with equivalent clinical outcomes and QOL, and lower costs, compared with usual care over 1-year follow-up. (The PLATFORM Study: Prospective LongitudinAl Trial of FFRct: Outcome and Resource IMpacts [PLATFORM]; NCT01943903).
Authors: Maros Ferencik; Michael T Lu; Thomas Mayrhofer; Stefan B Puchner; Ting Liu; Pal Maurovich-Horvat; Khristine Ghemigian; Alexander Ivanov; Elizabeth Adami; John T Nagurney; Pamela K Woodard; Quynh A Truong; James E Udelson; Udo Hoffmann Journal: J Cardiovasc Comput Tomogr Date: 2019-05-15
Authors: Ahmet Erdemir; Peter J Hunter; Gerhard A Holzapfel; Leslie M Loew; John Middleton; Christopher R Jacobs; Perumal Nithiarasu; Rainlad Löhner; Guowei Wei; Beth A Winkelstein; Victor H Barocas; Farshid Guilak; Joy P Ku; Jennifer L Hicks; Scott L Delp; Michael Sacks; Jeffrey A Weiss; Gerard A Ateshian; Steve A Maas; Andrew D McCulloch; Grace C Y Peng Journal: J Biomech Eng Date: 2018-02-01 Impact factor: 2.097
Authors: Andrea Acuna; Alycia G Berman; Frederick W Damen; Brett A Meyers; Amelia R Adelsperger; Kelsey C Bayer; Melissa C Brindise; Brittani Bungart; Alexander M Kiel; Rachel A Morrison; Joseph C Muskat; Kelsey M Wasilczuk; Yi Wen; Jiacheng Zhang; Patrick Zito; Craig J Goergen Journal: J Biomech Eng Date: 2018-08-01 Impact factor: 2.097