DSE vs. FFR in SCAD and BYSTANDER Lesions

Study Overview
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Brief Summary
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Enrollment: Patients with stable coronary artery disease (SCAD) and moderate coronary artery stenoses (30-70 %) Patients with acute myocardial infarction and moderate stenosis of non-culprit arteries (NCL; BYSTANDER LESION) Aims: To assess the diagnostic accuracy of dobutamine stress echocardiography (DSE) and invasive fractional flow reserve (FFR) measurement To assess the prognostic impact of reclassification by a mismatching negative test Hypothesis: DSE and FFR have similar prognostic value in both clinical settings (SCAD and NCL) Considering the strong negative predictive value of both DSE and FFR, one negative test is sufficiently enough to defer revascularisation, even in the case of mismatch

Detailed Description
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Easy accessibility made fractional flow reserve (FFR) a widely accepted method to evaluate myocardial ischaemia in patients with moderate coronary artery stenosis, although the prognostic value for hard endpoints such as myocardial infarction and cardiovascular death is equivocal. Dobutamine stress echocardiography (DSE) is a useful and safe non-invasive functional test for myocardial ichaemia evaluation. There are robust data confirming the prognostic value of DSE regarding the same hard endpoints. In patients with SCAD there are clear recommendations in the recent guidelines both for DSE guided or FFR guided revascularization but the data about prognosis is limited, especially in the case of FFR guidance. The outcome is also equivocal if there is a difference between the invasive and non-invasive test result. In patients with acute myocardial infarction, more than 50% of patients have multivessel disease. There are clear recommendations for the management of infarct related artery, however controversy still exists for the management of angiographically moderate NCLs. In DSE vs. FFR prospective trial, the Investigators plan to perform both the DSE and FFR tests in the above mentioned clinical settings, to investigate the correlation between them. The causes of differences between them would be investigated as well as the prognostic impact of reclassification by a second test (either DSE or FFR). If both tests are positive, revascularisation is planned to be performed (PCI Group). In cases of either double negative or mismatching tests, optimal medical therapy will be chosen (OMT Group) with clinical follow up of at least 2 years.

Official Title
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Comparison of Dobutamine Stress Echocardiography and Fractional Flow Reserve in Patients With Moderate Coronary Artery Disease: Stable and Non-culprit Lesions Investigation

Conditions
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Ischemic Heart Disease

Intervention / Treatment
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* Procedure: Revascularisation
* Other: Optimal Medical Treatment/OMT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age>18 years Moderate Coronary Stenosis (30-70 %) Stable coronary artery disease or patients with acute myocardial infarction and at least one moderate non-culprit vessel stenosis Exclusion Criteria: Left Main Coronary artery stenosis Age>80 years Known non-cardiovascular disease with poor prognosis Patients for whom coronary angiography or stress echocardiography is contraindicated per institutional standard of care (e.g. History of severe and/or anaphylactic contrast reaction) Inability to provide informed consent; Inability to cooperate with the investigation Pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| DSE+/FFR+<br>Patients with positive Dobutamine Stress Echocardiography and with positive Fractional Flow Reserve Revascularisation | Procedure: Revascularisation<br>* Percutaneous coronary intervention or coronary artery bypass surgery<br>* Other names: PCI or CABG;|
| DSE+/FFR- or DSE-/FFR+ or DSE-/FFR-<br>Patients with positive Dobutamine Stress Echocardiography and with negative Fractional Flow Reserve Patients with negative Dobutamine Stress Echocardiography and with positive Fractional Flow Reserve Patients with negative Dobutamine Stress Echocardiography and with negative Fractional Flow Reserve Optimal Medical Treatment/OMT | Other: Optimal Medical Treatment/OMT<br>* Standard of care in stable coronary artery disease or after acute myocardial infarction.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute Myocardial Infarction | Detection of a rise and/or fall of cardiac biomarker values [preferably cardiac troponin (cTn)] with at least one value above the 99th percentile upper reference limit (URL) and with at least one of the following: Symptoms of ischaemia. New or presumed new significant ST-segment-T wave (ST-T) changes or new left bundle branch block (LBBB). Development of pathological Q waves in the ECG. Imaging evidence of new loss of viable myocardium or new regional wall motion abnormality. Identification of an intracoronary thrombus by angiography or autopsy | From baseline to at least 2 years | 
| Target Vessel Revascularisation | The Investigated Vessel need Revascularisation because of at least Canadian Cardiology Society Angina Class III | From baseline to at least 2 years | 
| Cardiovascular Death | Death occurs due to Cardiovascular cause | From baseline to at least 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Angina | Rehospitalisation due to Angina | From baseline to at least 2 years | 
| Heart failure | Rehospitalisation due to Heart Failure | From baseline to at least 2 years | 
| Non-Cardiac Death | Death occurs due to Non-Cardiovascular cause | From baseline to at least 2 years | 
| Non-Target Vessel Revascularisation | The Non-Investigated Vessel need Revascularisation | From baseline to at least 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coronary Artery Disease, Fractional Flow Reserve, Dobutamine Stress Echocardiography, Stable Coronary Artery Disease, Bystander Coronary Artery Disease, Non-Culprit Lesions, Acute Myocardial Infarction