Last January 23, 2009, the final Grant Agreement has been signed with the European Commission (EC) for a proposed three‐year, multicentre project, with cardiac multimodality imaging as the major focus.
With an EC financial contribution of 2 695 402. 00 euros (two million six hundred and ninety five thousands four hundred and two Euros), the EVINCI (EValuation of INtegrated Cardiac Imaging) study will be one of the two projects dealing with cardiac imaging among the almost 200 projects approved in the FPVII Health of the EC.
The Study was initially designed within the ESC Working Group on Nuclear Cardiology and Cardiac CT and includes 17 partners in nine European countries. Specifically 14 clinical centres (three in Spain, four in Italy, and one each in Paris, Zurich, Munich, London, Leiden, Turku and Warsaw) will be involved.
The European Society for Cardiology (ESC) will disseminate results; CFC Consulting in Milan will provide project management, and InforSense, in London, will provide the informatic background for integrated analysis of multiparametric data and for development of advanced softwares dedicated to innovative multi‐modality imaging clinical reporting systems.
Dr. Danilo Neglia, Head of the PET and PET‐CT Unit at the Institute of Clinical
Physiology, National Research Council, in Pisa, Italy, with the help of Dr. Juhani Knuuti and the support of the Working Group on Nuclear Cardiology and Cardiac CT, will coordinate the project.
EVINCI promises to be a relevant study, because its major goal is to provide objective evidence of the clinical role of multimodality imaging for the early diagnosis, complete characterization and targeting of treatment in patients with suspected Coronary Artery Disease (CAD). CAD is the major cause of morbidity and mortality in developed countries and one of the major sources of sanitary costs.
A wide population of patients will be selected with an intermediate probability of CAD based on individual risk factors, clinical observation, biohumoral profile and a preliminary stress ECG test. In this subset of patients non‐invasive imaging is expected to be most cost‐effective. Every patient, fulfilling inclusion and exclusion criteria and providing an informed consent, will be submitted to a complete non‐invasive imaging evaluation.
Multi‐slice CT will be used to define coronary anatomy. Radionuclide imaging (either SPECT or PET) will be performed to measure myocardial perfusion at rest and during stress. In each patient the possible effects of myocardial ischemia on ventricular function will also be assessed by either Magnetic Resonance (MR) or Echocardiography (Echo) during stress.
Patients will then undergo heart catheterization as a reference method to define the presence and the extent of coronary disease and its effects in limiting coronary flow reserve. Finally, the patients will be followed up for a maximum of three years and events will be recorded.
Patients participating to the EVINCI Study will be followed and treated by their referring clinicians according to current good clinical practice and European guidelines. The clinicians will be advantaged in their decision making by the additional information that will be available in each patient.
Procedural risks, radiation exposure and costs will be strictly monitored during the protocol and a cost‐benefit analysis will be one of the expected outputs of the study.
The major end point of EVINCI will be to assess the ability of non‐invasive multimodality imaging to recognize in the single patient not only if coronary disease is present but if it mainly involves the major coronary arteries or the microvessels and most importantly if it causes ischemia and hence should be aggressively treated.
Other relevant outputs would be the standardization of non‐invasive imaging procedures throughout Europe and the development of new informatic tools for advanced reporting of multimodal cardiac imaging.
- Benefits and Expectations
The expected benefits from the EVINCI results include early diagnosis and accurate characterization of coronary disease by multimodality imaging in anginal patients avoiding unuseful invasive procedures. If this approach will demonstrate to be accurate, we could expect in the future that heart catheterization could be mainly reserved to interventions, i.e. to revascularize coronary stenosis known to cause myocardial ischemia.
Multimodality imaging approach could be apparently more costly in the beginning but could prove to be cheaper at the end. In the cost/risk‐benefit workpackage of the study, this hypothesis will be evaluated. Moreover, it should also be possible to define the most cost‐effective diagnostic work‐up for the recognition of “significant” CAD among the different imaging modalities or combination of modalities. Interestingly, it could also be possible to recognize patients who don’t have full blown CAD (a stenosis to be revascularized) but are at high risk of future events due to early and/or functional abnormalities of the coronary system.
We know that these patients, if unrecognized and left untreated, are at increased risk of developing myocardial infarction or heart failure. Again, resources used to recognize this population will save lifes and will spare future sanitary costs.
Finally, results coming from the EVINCI Study could help in the future to tailor specific imaging modalities or combination of techniques to specific patients. Chosing the most cost‐effective approach for the specific clinical question will avoid redundancy in using technology in medicine. A particular advantage of the experimental design of the EVINCI Study consists in the presence of independent core‐labs for each different imaging modality. This approach could ensure a fair comparison of different modalities even if this is not the major goal of the study.
The ESC Working Group on Nuclear Cardiology and Cardiac CT made an incredible effort to help in the design and to support the EVINCI project since its beginning. It was a shared opinion that this could be a landmark study in cardiology, potentially able to change the approach to coronary artery disease in the near future. The process began almost two years ago and now investigators are crossing fingers waiting for the final signature of the contract with the EC.
One of the problems is that the budgeting from the EC is underestimated for the actual costs of this study. Apart from enrolling 700 patients, our study will probably involve about 100 operators, because every centre should provide specialists for different modalities. It’s a very big study. However, since many relevant clinical centers and universities are involved throughout Europe a substantial local economical support and possible external support from the Industry are expected.