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.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cardiology
- Sponsor
- University Hospital, Grenoble
- Enrollment
- 800
- Primary Endpoint
- 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.
- Status
- Not yet recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
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
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
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.
Time Frame: 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.
Secondary Outcomes
- Compare treatment satisfaction at 1 year(1 year)
- Compare dyspnea at 1 year(1 year)
- Conduct a budget impact analysis (BIA) from the National Health System's perspective at 3 and 5 years.(3 and 5 years)
- Compare severity of angina at 1, 2 and 3 years(1, 2 and 3 years)
- Compare the diagnostic benefit of the CCTA strategy to the Functional Test strategy at 1 year.(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.(10 years)
- To compare angina symptoms (limitation, stability, frequency) at 1 year.(1 year)
- Compare quality of life at 1 year(1 year)
- Compare major clinical events at 1, 2 and 3 years.(1, 2 and 3 years.)
- Compare the radiation exposure of patients for each strategy at 1 year.(1 year)
- Compare quality of life at 1, 2 and 3 years(1, 2 and 3 years)
- Compare the care pathways of the "CCTA" strategy to the "Functional Test" strategy at 1 year.(1 year)
- To study the influence of new indexes from post image processing on the consumption of care and on the symptoms of angina.(1 year)
- Observe deviations in management from current recommendations at 1 year.(1 year)