Screening Of CoRonary ArTEry diSease

Study Overview
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Brief Summary
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This study is a randomized trial with the objective of comparing the cost-effectiveness of the 2 recommended strategies: CCTA vs functional tests, allowing the evaluation of the quality of life of these patients in relation to the health resources used. In symptomatic patients with an intermediate probability of having stable CAD, i.e., whose pretest or clinical probability does not allow the elimination of the disease, and in patients without anginal symptoms for low levels of exercise who do not respond to medical therapy, in France, the diagnostic care pathways have become mature enough to set up a pragmatic prospective randomized trial with the objective of comparing the cost-effectiveness of the 2 recommended strategies: CCTA vs. Probabilistic medico-economic reasoning makes it possible to establish this two-way hypothesis more easily than in clinical research without the need to impose the superiority of one of the strategies.

Detailed Description
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In Europe, cardiovascular disease remains the leading cause of death with 4 million deaths per year, of which 1.8 million are due to coronary heart disease (CHD). CAD also has a cost with 46 billion / year spent for its management. In France, 4 billion are spent on it, which shows that it remains a public health problem and that most of the premature events are avoidable, in particular by screening patients with symptoms that make them suspect it. In these symptomatic patients suspected of having CAD, screening is carried out in particular through the use of imaging with technological innovations and performances that are constantly being improved and validated in large randomized trials. The PROMISE trial randomized an impressive number of 10003 patients comparing coronary computed tomography angiography (CCTA) and functional testing to assess suspected CAD, which showed similar efficacy of the 2 strategies in terms of major adverse cardiovascular events (MACE) at 2 years: 3.3% for CCTA and 3% for functional testing. Thus, the 2019 European guidelines allow CCTA or functional testing as the initial test to diagnose CAD in symptomatic patients. Thus, clinicians now have 2 first-line strategies: CCTA or functional tests (myocardial scintigraphy, echocardiography, MRI). The clinician can choose to initiate management with an anatomic evaluation of the coronary arteries (CCTA) or a search for ischemia (functional test). These two ways of assessing CAD are very different and are the subject of debate in Europe. For example, the National Institute of Health and Care Excellence (NICE) in the United Kingdom now recommends CCTA as the first test, unlike in Europe. In view of all these arguments, it is relevant to propose a randomized trial with the objective of comparing the cost-effectiveness of the 2 recommended strategies: CCTA vs. functional tests, making it possible to evaluate the quality of life of these patients in relation to the health resources used. In symptomatic patients with an intermediate probability of having stable CAD, i.e., whose pretest or clinical probability does not allow the elimination of the disease, and in patients without anginal symptoms for low levels of exercise who do not respond to medical therapy, in France, the diagnostic care pathways have become mature enough to set up a pragmatic prospective randomized trial with the objective of comparing the cost-effectiveness of the 2 recommended strategies: CCTA vs. Probabilistic medico-economic reasoning makes it possible to establish this two-way hypothesis more easily than in clinical research without the need to impose the superiority of one of the strategies.

Official Title
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Medico-economic Evaluation of a Strategy With Coronary CT as First Line (CCTA) Compared With the Strategy With Functional Test as First Line, in Patients at Intermediate Risk of Developing Stable Coronary Disease.

Conditions
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Cardiology, Coronary Artery Disease

Intervention / Treatment
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* Other: Coronary CT in 1st line compared to the strategy with functional test in 1st line in patient at Intermediate Risk of Developing Stable Coronary Disease:


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged 18 to 75 years Symptomatic patient in whom CAD cannot be excluded by clinical evaluation alone : patient with a pre-test or intermediate clinical probability indicating imaging test according to European recommendations Patient affiliated to the social security system or beneficiary of such a system Written informed consent Exclusion Criteria: Pre-test probability low < 5% or 5-15% without additive pejorative factors Clinical probability of high CAD, defined by symptoms typical of low exercise levels not responding to medical therapies Known history of CAD Severe impairment of left ventricular ejection fraction < 40%. Known chronic renal failure not on dialysis (GFR <30 ml / min /1.73 m²) Patient considered unfit for the study according to the investigator's judgement and in particular the impossibility of performing an anatomical and/or functional test of ischemia of the coronary disease Patient in a period of exclusion for another study Persons referred to in articles L1121-5 to L1121-8 of the public health code Patient participating in another interventional research

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: First line coronary scanner group<br>The patient will benefit from a coronary CT scan in 1st line (evaluation of the coronary anatomy), then according to the result it will be managed according to the CAD-RADS decision algorithm. | Other: Coronary CT in 1st line compared to the strategy with functional test in 1st line in patient at Intermediate Risk of Developing Stable Coronary Disease:<br>* Coronary CT in 1st line compared to the strategy with functional test in 1st line in Patients at Intermediate Risk of Developing Stable Coronary Disease:<br>|
| Other: First line functional test strategy group<br>The patient benefits from a functional test in 1st line (search for myocardial ischemia by myocardial scintigraphy: SPECT, stress echography, or MRI), then according to the result he will be managed in accordance with the European recommendations. | Other: Coronary CT in 1st line compared to the strategy with functional test in 1st line in patient at Intermediate Risk of Developing Stable Coronary Disease:<br>* Coronary CT in 1st line compared to the strategy with functional test in 1st line in Patients at Intermediate Risk of Developing Stable Coronary Disease:<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Conduct a cost-utility analysis (CUA) comparing the strategy CCTA in 1st line to the strategy functional test in 1st line in patients with suspected stable CAD in a collective perspective, at 1 year. | The incremental cost-utility ratio (ICER) will be calculated by relating the difference in costs to the difference in the average number of QALYs. The ratio will therefore be expressed as cost per QALY gained, which represents the additional cost of gaining one year of healthy life with the CCTA strategy vs. the functional test strategy. Since CCTA is a special case of CEA, the incremental cost-effectiveness ratio (ICER) expressed as the incremental cost per life-year gained will also be calculated. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To model in the long term (10 years) the impact of the 2 diagnostic strategies in terms of cost and consequences as defined in the main objective. | Incremental cost-effectiveness ratio (ICER and ICER) at 10 years as defined in Primary Objective 1. | 10 years | 
| Conduct a budget impact analysis (BIA) from the National Health System's perspective at 3 and 5 years. | Measure the financial impact on the National Health System of the deployment of the CCTA strategy in 3 and 5 years | 3 and 5 years | 
| To compare angina symptoms (limitation, stability, frequency) at 1 year. | SAQ (Seattle Angina Questionnaire): physical limitation is assessed by question 1; angina stability by question 2 and angina frequency by questions 3 and 4 | 1 year | 
| Compare treatment satisfaction at 1 year | SAQ: patients' satisfaction with their current treatment is assessed in questions 5 to 8 | 1 year | 
| Compare quality of life at 1 year | SAQ: quality of life is assessed in questions 9 to 11 of the questionnaire | 1 year | 
| Compare dyspnea at 1 year | ROSE dyspnea scale : grade 1 to 4 (worst condition) | 1 year | 
| Compare severity of angina at 1, 2 and 3 years | CCS score (Canadian Cardiovascular Society) : grade asymptomatic to 4 (worst condition) | 1, 2 and 3 years | 
| Compare quality of life at 1, 2 and 3 years | Quality of life: EuroQol 5D-5 : cotation from 0 (worst condition) to 1. | 1, 2 and 3 years | 
| Compare the care pathways of the CCTA strategy to the Functional Test strategy at 1 year. | Number of CAD imaging tests | 1 year | 
| Compare the care pathways of the CCTA strategy to the Functional Test strategy at 1 year. | Time to obtain CAD imaging tests | 1 year | 
| Compare the care pathways of the CCTA strategy to the Functional Test strategy at 1 year. | Type of CAD imaging tests | 1 year | 
| Compare the care pathways of the CCTA strategy to the Functional Test strategy at 1 year. | Treatments used after the first line examination to manage chest pain symptomatology | 1 year | 
| Observe deviations in management from current recommendations at 1 year. | Number and percentage of deviations from current recommendations | 1 year | 
| Compare the diagnostic benefit of the CCTA strategy to the Functional Test strategy at 1 year. | Number and rate of coronary angiography with or without FFR/iwFR | 1 year | 
| Compare the diagnostic benefit of the CCTA strategy to the Functional Test strategy at 1 year. | Number and rate of revascularization | 1 year | 
| Compare major clinical events at 1, 2 and 3 years. | Deaths from cardiovascular causes, myocardial infarction, or ischemia-guided revascularization, heart failure, or recovered cardiac arrest. | 1, 2 and 3 years. | 
| Compare the radiation exposure of patients for each strategy at 1 year. | Measurement of radiation exposure related to cardiovascular tests and procedures in millisieverts | 1 year | 
| To study the influence of new indexes from post image processing on the consumption of care and on the symptoms of angina. | New indexes from post image processing | 1 year | 
| To study the influence of new indexes from post image processing on the consumption of care and on the symptoms of angina. | QUALY | 1 year | 
| To study the influence of new indexes from post image processing on the consumption of care and on the symptoms of angina. | SAQ (Seattle Angina questionnaire) question 1 to 19 | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Medico-economic study, Coronary CT scanner, Cardiac functionel test