DSE vs. FFR in SCAD and BYSTANDER Lesions (DSE-vs-FFR)

Bajcsy-Zsilinszky Hospital

Status: Completed

Conditions: Ischemic Heart Disease

Treatments: Other: Optimal Medical Treatment/OMT; Procedure: Revascularisation

Study type: Observational

Funder types: Other

Identifiers

NCT03383718

1.0

Details and patient eligibility

About

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

Full description

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.

Enrollment: 200 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

200 participants in 2 patient groups

DSE+/FFR+

Description:

Patients with positive Dobutamine Stress Echocardiography and with positive Fractional Flow Reserve Revascularisation

Treatment:

Procedure: Revascularisation

DSE+/FFR- or DSE-/FFR+ or DSE-/FFR-

Description:

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

Treatment:

Other: Optimal Medical Treatment/OMT