Fractional Flow Reserve Derived from Computed Tomography Coronary Angiography in the Assessment and Management of Stable Chest Pain: Rationale and Design of the FORECAST Trial.

Background: Fractional flow reserve measurement based on computed tomography (FFR _CT ) is a novel, well validated, non-invasive method for determining the presence and extent of coronary artery disease (CAD) combined with a physiological assessment of vessel-specific ischemia in patients with chest pain. Previous studies indicate that FFR _CT reduces the uptake of invasive angiography that shows no significant CAD, without compromising patient safety. The clinical effectiveness and economic impact of using FFR _CT instead of other tests in the initial evaluation of patients with stable chest pain has not been tested in a randomized trial.
Methods: The FORECAST trial will randomise 1400 patients with stable chest pain to receive either FFR _CT or routine clinical assessment as directed by the National Institute for Health and Care Excellence (NICE) CG95 guideline for Chest Pain of Recent Onset. The primary endpoint will be resource utilisation over the subsequent nine months, including non-invasive cardiac investigations, invasive coronary angiography, coronary revascularization, hospitalization for cardiac events, and the use of cardiac medications. Key pre-specified secondary endpoints will be major adverse cardiac events, angina severity, quality of life, patient satisfaction, time to definitive management plan, time to completion of initial evaluation, number of hospital attendances, and working days lost in patients who are in employment.
Conclusion: The FORECAST randomized trial will assess the clinical and economic outcomes of using FFR _CT as the primary test to evaluate patients presenting with stable chest pain.
Competing Interests: Declaration of competing interest Michael Mahmoudi & Zoe Nicholas have no conflicts of interests. Nick Curzen has received unrestricted research grants from HeartFlow, Haemonetics and Boston Scientific; speaker fees/honoraria from Abbott Vascular, HeartFlow, Haemonetics and Boston Scientific; travel sponsorship from HeartFlow, Haemonetics; Biosensors; Abbott Vascular, Medtronic & Boston Scientific. Mark Hlatky has received research grants from HeartFlow. Colin Berry is employed by the University of Glasgow, which holds consultancy and research agreements with Abbott Vascular, AstraZeneca, Boehringer Ingelheim, Menarini Pharmaceuticals, Philips and Siemens Healthcare. These companies had no involvement in the current research or the manuscript.
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