Author + information
- Received August 5, 2015
- Revision received December 2, 2015
- Accepted December 11, 2015
- Published online October 1, 2016.
- Nicholas P. Curzen, BM, PhDa,∗ (, )
- James Nolan, MDb,
- Azfar G. Zaman, MDc,
- Bjarne L. Nørgaard, PhDd and
- Ronak Rajani, MDe
- aUniversity Hospital Southampton & Faculty of Medicine, University of Southampton, Southampton, United Kingdom
- bUniversity Hospitals of North Staffordshire, Stoke-on-Trent, United Kingdom
- cFreeman Hospital, and Institute of Cellular Medicine Newcastle University, Newcastle upon Tyne, United Kingdom
- dAarhus University Hospital Skejby, Aarhus, Denmark
- eGuy's & St. Thomas’ Hospital, London, United Kingdom
- ↵∗Reprint requests and correspondence:
Prof. Nicholas P. Curzen, Wessex Cardiothoracic Unit, Level North Wing, University Hospital Southampton NHS Foundation Trust, Tremona Road, Southampton SO16 6YD, United Kingdom.
Objectives This study sought to determine the effect of adding computed tomography–derived fractional flow reserve (FFRCT) data to computed tomography angiographic (CTA) data alone for assessment of lesion severity and patient management in 200 patients with chest pain.
Background Invasive and noninvasive tests used in the assessment of patients with angina all have disadvantages. The ideal screening test for patients presenting for the first time with chest pain would describe both coronary anatomy and the presence of ischemia and would be readily accessible, low cost, and noninvasive.
Methods Two hundred patients with stable chest pain underwent CTA for clinical reasons, and FFRCT was calculated. Three experienced interventional cardiologists assessed the CTA result for each patient and by consensus developed a management plan (optimal medical therapy, percutaneous coronary intervention, coronary artery bypass graft surgery, or more information required). FFRCT data for each vessel were then revealed, and the interventional cardiologists made a second plan by consensus, using the same 4 options. The primary endpoint for the study was the difference between the 2 strategies.
Results Overall, after disclosure of FFRCT data there was a change in the allocated management category on the basis of CTA alone in 72 cases (36%). This difference is explained by a discordance between the CTA- and FFRCT-derived assessments of lesion severity. For example, FFRCT was >0.80 in 13 of 44 vessels (29.5%) graded as having a stenosis >90%. In contrast, FFRCT was ≤0.80 in 17 of 366 vessels (4.6%) graded as having stenosis ≤50%.
Conclusions This study demonstrates proof of concept that the availability of FFRCT results has a substantial effect on the labeling of significant coronary artery disease and therefore on the management of patients compared to CTA alone. Further studies are needed to determine whether FFRCT has potential as a noninvasive diagnostic and management screening tool for patients with stable chest pain.
This study was funded by an unrestricted research grant from HeartFlow. Dr. Curzen has received unrestricted research grants from Heart Flow, Boston Scientific, St. Jude Medical, Haemonetics, and Medtronic; honoraria/speaker fees from HeartFlow, St. Jude Medical, and Haemonetics; and travel sponsorships from Biosensors, Lilly/D-S, and Abbott Vascular. Dr. Zaman has received unrestricted research grants from St. Jude Medical. Dr. Norgaard has received unrestricted research grants from Edwards Lifesciences and Siemens. Dr. Rajani has received consultant fees from Edwards Lifesciences. Dr. Nolan has reported that he has no relationships relevant to the contents of this paper to disclose.
- Received August 5, 2015.
- Revision received December 2, 2015.
- Accepted December 11, 2015.
- American College of Cardiology Foundation