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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
800
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:
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.
Time frame: 1 year
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.
Time frame: 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
Time frame: 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
Time frame: 1 year
Compare treatment satisfaction at 1 year
SAQ: patients' satisfaction with their current treatment is assessed in questions 5 to 8
Time frame: 1 year
Compare quality of life at 1 year
SAQ: quality of life is assessed in questions 9 to 11 of the questionnaire
Time frame: 1 year
Compare dyspnea at 1 year
ROSE dyspnea scale : grade 1 to 4 (worst condition)
Time frame: 1 year
Compare severity of angina at 1, 2 and 3 years
CCS score (Canadian Cardiovascular Society) : grade asymptomatic to 4 (worst condition)
Time frame: 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.
Time frame: 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
Time frame: 1 year
Compare the care pathways of the "CCTA" strategy to the "Functional Test" strategy at 1 year.
Time to obtain CAD imaging tests
Time frame: 1 year
Compare the care pathways of the "CCTA" strategy to the "Functional Test" strategy at 1 year.
Type of CAD imaging tests
Time frame: 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
Time frame: 1 year
Observe deviations in management from current recommendations at 1 year.
Number and percentage of deviations from current recommendations
Time frame: 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
Time frame: 1 year
Compare the diagnostic benefit of the CCTA strategy to the Functional Test strategy at 1 year.
Number and rate of revascularization
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 1 year
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