QUantitative Flow Ratio Or Angiography for the assessMent of nOn-culprit Lesions

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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QUantitative Flow Ratio Or Angiography for the assessMent of nOn-culprit Lesions

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Device: Quantitative flow ratio
* Diagnostic Test: Assessment of angiographic severity of the stenosis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Successfully treated acute coronary syndrome At least one additional intermediate stenosis (>30% and <90%). Patient ≥18 years old Exclusion Criteria: Stenoses or patients a priori not amenable to treatment with PCI (at the discretion of two interventional cardiologists - e.g. patients with limited life expectancy, stenosis in very small vessels, very diffuse disease with complex/very calcified stenosis requiring surgery etc). Persistent symptoms or evidence of ischemia requiring intervention of the non-culprit lesion. Any contraindication to PCI according to guidelines An ACS in the period following the index ACS and randomization TIMI (Thrombolysis in Myocardial Infarction) flow grade < 3 in the culprit vessel Presence of thrombus in the non-culprit lesion Participation in another randomized interventional study interfering with the present protocol Patient unable to give informed consent Women of child-bearing potential or lactating Previous coronary artery bypass surgery CABG Recent (within 30 days) unsuccessful PCI Decompensated congestive heart failure (CHF) or hospitalization due to CHF during the last 3 months Left ventricular ejection fraction <30% Severe chronic obstructive pulmonary disease (COPD) Severe valvular heart disease FFR (or RFR, iFR etc) assessment of non-culprit lesions at the time of the index procedure

Ages Eligible for Study
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Minimum Age: 18 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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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients will be randomized 1:1 to one of the two study arms. Randomization will be done by using a computer-generated random sequence (Medcalc, Mariakerke, BE).
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Angiography<br>The indication to further coronary intervention will be based on angiographic diameter stenosis. | Diagnostic Test: Assessment of angiographic severity of the stenosis<br>* The indication to coronary stent intervention will be based on angiography<br>|
| Experimental: Quantitative flow ratio (QFR)<br>The indication to further coronary intervention will be based on QFR. | Device: Quantitative flow ratio<br>* 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)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 12 months | 
| Functional endpoint | Proportion of patients assigned to medical treatment in the two groups (QFR vs. Reference) | Upon randomization and following QFR assessment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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)) | 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)) | 3 months | 
| Unplanned admission | Incidence of unplanned hospital admission for angina | 12 months | 
| Patient-oriented composite endpoint | Patient-oriented composite endpoint (death, myocardial infarction, unplanned revascularization). | 3 months | 
| Patient-oriented composite endpoint | Patient-oriented composite endpoint (death, myocardial infarction, unplanned revascularization). | 12 months |