Addition of FFRct in the Diagnostic Pathway of Patients With Stable Chest Pain

In the Netherlands, annually 180.000 new patients present with stable chest pain - the most common symptom of coronary artery disease (CAD) \[1\]. Stable chest pain has a 1.5% 1-year mortality and 0.7% incidence of myocardial infarction \[2\]. The "Kennisagenda" of the Dutch Societies of Radiology and Cardiology include CAD diagnosis as a top 10 priority.

Patients with stable chest pain enter a diagnostic pathway to detect or exclude significant coronary stenosis which is defined as \> 50% luminal narrowing.

The "Verbetersignalement pijn op de borst" published by the Zorginstituut, advocates that the diagnosis should be based on a single non-invasive first line test.

Based on the National Institute for Health and Excellence (NICE) and European Society of Cardiology (ESC) guidelines, the Coronary Computed Tomography Angiography (CCTA) is a good option as the first line test in low to intermediate risk patients.

CCTA is the most sensitive non-invasive technique available, but only provides anatomical information. CCTA has an excellent negative predictive value (99%), therefore CCTA can accurately rule out CAD. However the positive predictive value is moderate (64%). Hence, anatomically significant stenoses on CCTA often turn out not to be hemodynamically significant on ICA .

Patients with significant anatomical stenosis on CCTA are often referred for invasive coronary angiography (ICA) to confirm the presence of a stenosis and subsequent revascularization of hemodynamically significant stenoses. To determine the latter, invasive fractional flow reserve (FFR) measurements can be performed during ICA. In FFR, the pressure drop across an anatomical stenosis is measured, yielding a numerical value between 0 and 1, with 1 being normal and 0.80 considered a significant stenosis.

As with all invasive procedures, ICA is associated with morbidity, mortality, patient discomfort, time and costs. Due to the moderate specificity of CCTA, many patients referred for ICA turn out to not have hemodynamically significant coronary stenosis (28-41%) in Dutch populations.

To reduce the percentage of patients referred for ICA without significant CAD, the FFRct can be useful. FFRct is a non-invasive method that uses the already acquired CCTA images to calculate coronary FFR values as they would be expected if measured invasively.

Based on data of two randomised trials conducted in the Netherlands, around 20% of patients with chest pain referred for CCTA have at least 50% anatomical coronary stenosis on CCTA . Prior FFRct studies involved populations of different countries, with different risk and work-up There are no prospective data on the real-world use of FFRct in the Dutch population of stable chest pain patients with stenosis on CCTA. The effect of FFRct in reducing unnecessary ICA or other non-invasive tests compared to CCTA alone in the Dutch health care situation is unknown. Evidence in the specific Dutch situation and population is needed to evaluate the impact and cost-effectiveness in the Dutch healthcare system.

The FUSION study is a randomized controlled trial which will investigate the impact of adding the FFRct analysis in the diagnostic pathway of stable chest pain on the rate of unnecessary ICA's.

• Rate of unnecessary ICA [Срок оценки: 1 year]
• Rate of major adverse cardiac events (MACE) [Срок оценки: 90 days; 1 year]
• Number of additional non-invasive tests for coronary artery disease (CAD) assessment [Срок оценки: 90 days; 1 year]
• Number of coronary revascularisations (planned/unplanned) [Срок оценки: 90 days; 1 year]
• Rate of cardiovascular death [Срок оценки: 90 days; 1 year]
• Rate of complications during and after ICA [Срок оценки: 90 days; 1 year]
• Rate of non-fatal stroke [Срок оценки: 90 days; 1 year]
• EuroQoL 5-Dimension 5-Level (EQ5D5L) to measure quality of life [Срок оценки: 90 days; 1 year]
• Seattle Angina Questionnaire (SAQ) to quantify patients' symptoms of angina and the extent to which their angina affects their quality of life [Срок оценки: 90 days; 1 year]
• 36-Item Short Form Survey (SF-36) to measure quality of life [Срок оценки: 90 days; 1 year]
• Cost-effectiveness [Срок оценки: 1 year]