Author + information
- Received March 25, 2016
- Revision received April 27, 2016
- Accepted May 3, 2016
- Published online August 2, 2016.
- Pamela S. Douglas, MDa,∗ (, )
- Bernard De Bruyne, MDb,
- Gianluca Pontone, MDc,
- Manesh R. Patel, MDa,
- Bjarne L. Norgaard, MDd,
- Robert A. Byrne, MB BChe,
- Nick Curzen, BMf,
- Ian Purcell, MDg,
- Matthias Gutberlet, MDh,
- Gilles Rioufol, MDi,
- Ulrich Hink, MDj,
- Herwig Walter Schuchlenz, MDk,
- Gudrun Feuchtner, MDl,
- Martine Gilard, MDm,
- Daniele Andreini, MDc,
- Jesper M. Jensen, MDd,
- Martin Hadamitzky, MDe,
- Karen Chiswell, PhDa,
- Derek Cyr, PhDa,
- Alan Wilk, BSn,
- Furong Wang, MDn,
- Campbell Rogers, MDn,
- Mark A. Hlatky, MDo,
- on behalf of the PLATFORM Investigators
- aDuke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina
- bCardiovascular Centre Aalst, Aalst, Belgium
- cCardiovascular CT Unit, Centro Cardiologico Monzino, IRCCS, University of Milan, Milan, Italy
- dDepartment of Cardiology, Aarhus University Hospital, Aarhus, Denmark
- eDeutsches Herzzentrum München, Technische Universität München, Munich, Germany
- fUniversity Hospital Southampton NHS Trust, Southampton, United Kingdom
- gFreeman Hospital, Newcastle upon Tyne, United Kingdom
- hUniversity of Leipzig Heart Centre, Leipzig, Germany
- iHospices Civils de Lyon and CARMEN INSERM 1060, Lyon, France
- jDepartment of Cardiology, Johannes Gutenberg University Hospital, Mainz, Germany
- kLKH Graz West, Graz, Austria
- lDepartment of Radiology, Innsbruck Medical University, Innsbruck, Austria
- mDepartment of Cardiology, Cavale Blanche Hospital, Brest, France
- nHeartFlow, Redwood City, California
- oDepartment of Health Research and Policy and Department of Medicine, Stanford University School of Medicine, Stanford, California
- ↵∗Reprint requests and correspondence:
Dr. Pamela S. Douglas, Duke Clinical Research Institute, 7022 North Pavilion, Duke University Medical Center, PO Box 17969, Durham, North Carolina 27715.
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)
- economic outcomes
- fractional flow reserve using computed tomography
- major adverse cardiac events
- quality of life
The PLATFORM study was funded by HeartFlow (Redwood City, California). DCRI independently performed quantitative coronary angiography, adjudicated clinical events, and performed the analysis of the primary and secondary endpoint determinations. There were no data confidentiality agreements. An Executive Committee oversaw trial design and study conduct, final data review, and presentation and publication of results, independently making the decision to publish. The investigators independently drafted the manuscript and take full responsibility for the accuracy and completeness of data analyses. Dr. Douglas received grants from HeartFlow during the conduct of the study; and has previously received other support from GE Medical Systems outside the submitted work. Dr. De Bruyne has received grants from Abbott, St. Jude Medical, and Medtronic; and other support from St. Jude Medical, Boston Scientific, Opsens, Omega Pharma, Siemens, Edwards, GE, Sanofi, HeartFlow, and Bayer outside the submitted work. Dr. Patel received grants from HeartFlow during the conduct of the study; has previously received grants from Janssen, Johnson & Johnson, AstraZeneca, Genzyme, NHLBI, and AHRQ; and personal fees from AstraZeneca, Bayer, and Otsuka outside the submitted work. Dr. Norgaard has received unrestricted institutional research grants from Siemens, Edwards Lifesciences, and HeartFlow. Dr. Byrne received grants from HeartFlow during the conduct of the study; has previously received grants from Boston Scientific; and lecture fees from B. Braun, Biotronik, and Boston Scientific outside the submitted work. Dr. Curzen has received grants from Boston Scientific and Medtronic; and grants and personal fees from HeartFlow, Haemonectics, and St. Jude Medical outside the submitted work. Dr. Gutberlet has received speaker honoraria from Siemens, Philips, Bracco, and Bayer. Dr. Feuchtner received grants from HeartFlow during the conduct of the study; and has previously received personal fees from St. Jude Medical and Boston Scientific outside the submitted work. Dr. Andreini has received grants and personal fees from GE Healthcare outside the submitted work. Dr. Jensen has received speaker honoraria from Bracco Imaging. Dr. Hadamitzky has received an unrestricted institutional research grant from Siemens Healthcare outside the submitted work. Dr. Chiswell received support from HeartFlow during the conduct of the study. Mr. Wilk is an employee of HeartFlow. Dr. Wang received personal fees and other support from HeartFlow during the conduct of the study. Dr. Rogers is an employee of and owns equity in HeartFlow; and received personal fees and other support from HeartFlow during the conduct of the study and previously outside the submitted work. Dr. Hlatky received grants from HeartFlow during the conduct of the study. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose. Ronald Karlsberg, MD, served as Guest Editor for this paper.
- Received March 25, 2016.
- Revision received April 27, 2016.
- Accepted May 3, 2016.
- 2016 American College of Cardiology Foundation