In collaboration with the Catharina hospital in Eindhoven the angio-based data that has been gathered in the FAME 1 and FAME 3 clinical trials to validate FFR guided versus angio-based PCI and FFR guided PCI versus CABG respectively. The data collections consist of 1000 and 1500 X-ray angio’s partly mono-plane and partly biplane combined with measured local and pull-back FFR at specific annotated branches of the coronary tree.
Automated segmentation will be developed and carried out to represent these data in terms of centrelines and local diameter. Patient phenotype and all available and relevant patent record data will be collected in a predefined database structure. Data uncertainty will be defined based on known or estimated accuracy measures. The resulting data collection will be suitable for validation of angio-based computed (virtual) FFR procedures that can be used in ISTs for medical devices such as stents, hypothermia procedures, and decision support systems for PCI planning.
The data collection will also be used to develop procedures for data assimilation, generation of virtual patient cohorts, sensitivity analysis and uncertainty quantification, hybrid modelling combining data-driven models with mechanistic models and meta-modelling. The FAME studies are hallmark clinical trials with real impact on guidelines see also e.g. conclusion in Interventional Cardiological Review 2016, 11(2), 116-9 “The FAME trials have lifted the last roadblocks towards the general acceptance by the cardiology community of this novel paradigm in which the diagnostic focus of coronary lesions is shifted from anatomical characteristics to a functional impact on myocardial perfusion.
This unique vision on how to evaluate the severity and prognosis of coronary lesions should force us to rethink our current algorithm for the treatment of patients with chest pain where FFR measurements may supplant non-invasive stress tests, which are only being performed in <50 % of patients prior to elective PCI. However, it will take some time to alter the current course of patient care.