The aim of this study is to study whether the use of complex 3-dimensional assessment of the severity of a stenosis improves angina and in general cardiovascular outcomes in patients who have residual intermediate coronary artery stenosis following an acute coronary syndrome (ACS) treated with percutaneous coronary intervention (PCI). Goals of the study are: * To investigate whether decision-making based on quantitative flow reserve (QFR) is associated with a decrease in angina 3 months after an ACS * To investigate whether use of QFR is associated with an improved prognosis.
The study is a single-center, randomized superiority trial to compare two strategies for the assessment of the hemodynamic relevance of coronary lesions. The primary analysis will be on the per-protocol principle (i.e. including all patients who are not protocol violators). A separate analysis will be performed on an intention-to-treat basis (i.e. all randomized patients randomized to a treatment arm). Primary endpoint 1. Angina questionnaire Secondary endpoints: Number and % of patients undergoing PCI Seattle Angina Questionnaire * SAQ Physical limitation scale * SAQ angina stability scale * SAQ angina frequency scale * SAQ quality of life * SAQ Treatment Satisfaction Disease perception scale Follow-up (3 and 12 months) - Patient-oriented composite endpoint (death, myocardial infarction, unplanned revascularization) and its components.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
200
Quantitative flow ratio (QFR) is a computer method that estimates the hemodynamic relevance of a coronary stenosis based on three-dimensional quantitative coronary angiography (3D QCA)
The indication to coronary stent intervention will be based on angiography
Center of Cardiology, Cardiology I, university hospital Mainz
Mainz, Rhineland-Palatinate, Germany
Patient-oriented combined endpoint (clinical endpoint)
composite of patient-oriented events and significant angina (all-cause death, non fatal myocardial infarction including type 1, 2, 4, unplanned hospitalization for angina or heart failure, unplanned revascularization, SAQ\<90)
Time frame: 12 months
Functional endpoint
Proportion of patients assigned to medical treatment in the two groups (QFR vs. Reference)
Time frame: Upon randomization and following QFR assessment
Seattle angina questionaire summary score
Angina severity as assessed by the Seattle Angina Questionnaire (SAQ, score of 0 to 100, where higher scores indicate better function (eg, less physical limitation, less angina, and better quality of life))
Time frame: 12 months
Seattle angina questionaire summary score
Angina severity as assessed by the Seattle Angina Questionnaire (SAQ, score of 0 to 100, where higher scores indicate better function (eg, less physical limitation, less angina, and better quality of life))
Time frame: 3 months
Unplanned admission
Incidence of unplanned hospital admission for angina
Time frame: 12 months
Patient-oriented composite endpoint
Patient-oriented composite endpoint (death, myocardial infarction, unplanned revascularization).
Time frame: 3 months
Patient-oriented composite endpoint
Patient-oriented composite endpoint (death, myocardial infarction, unplanned revascularization).
Time frame: 12 months
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