NCT03383718

DSE vs. FFR in SCAD and BYSTANDER Lesions

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 200 (actual)
• Sponsor: Bajcsy-Zsilinszky Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Ischemic Heart Disease

Interventions

Type	Name	Description
PROCEDURE	Revascularisation	Percutaneous coronary intervention or coronary artery bypass surgery
OTHER	Optimal Medical Treatment/OMT	Standard of care in stable coronary artery disease or after acute myocardial infarction.

Timeline

• Start date: 2014-12-01
• Primary completion: 2017-12-01
• Completion: 2019-12-01
• First posted: 2017-12-26
• Last updated: 2020-01-02