Effectiveness and Cost-effectiveness of Noninvasive Fractional Flow Reserve for Physiological Assessment in Suspected Coronary Artery Disease (ECONOMY)

Chest pain due to coronary artery disease (CAD) is a main driver of healthcare costs. Fractional flow reserve (FFR) measurement during invasive coronary angiography (ICA) is the gold standard to discriminate ischemia. A rapid simplified method had been developed to determine non-invasive FFR (FFRB) by applying computational fluid dynamics (CFD) simulation on anatomic models derived from computed tomographic coronary angiography (CTCA), which compares favorably with invasive FFR and significantly improves diagnostic accuracy than CTCA alone in a previous preliminary study.

In this study, the aim is to compare the diagnostic accuracy, clinical effectiveness, safety outcomes, and quality of life of using FFRB on top of CTCA for CAD diagnosis and treatment planning, versus standard of care in Singapore; and measure health care resource utilization and assess cost-effectiveness of adopting FFRB on top of CTCA to support decision making in managing patients with suspected CAD.

The study protocol for CTCA scan is as follows.

1. CTCA will be performed with Single- or dual-source CT scanners (Toshiba AquilionOne, Cannon Aquilion One, Philips 256-dector, GE Revolution, Siemens Somatom Force Dual Source 384-detector, Siemens Somatom Drive Dual Source 256-detector) scanners.
2. CTCA scan will follow local CTCA scanning protocols that meet the quality standards defined by the Society of Cardiac Computed Tomography.
3. The CTCA image analysis will be performed according to accepted guidelines for reporting.

A total of 400 patients with chest pain will be recruited and randomly assigned into two groups. Both groups of patients will receive CTCA. But only one group of patients will be given the FFRB results. Based on the available medical information, the patients may be referred for additional non-invasive tests or ICA. For the recruited patients, who are referred for ICA subsequently, at least one FFR measurement will be conducted. All recruited patients will receive follow up at the time of 90days, 180 days and 365 days post-CTCA, as well as at the end-of-study, to record the quality of life, medical expenses and MACE events. The recruited patients will also receive follow up (phone or office visit) at the time of 90days (+30/-15 days), 180 days (+/-30 days) and 365 days (+/- 30 days) after enrolment, as well as at the end-of-study when the last recruited patient has completed one-year follow-up. Patient's response to the two questionnaires (SAQ 7 and EQ-5D-5L), their use of medication and the following clinical events will be recorded during the baseline visit and follow ups.