Coronary Artery Disease
Conditions
Brief summary
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
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.
Interventions
DEVICEQuantitative flow ratio
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)
DIAGNOSTIC_TESTAssessment of angiographic severity of the stenosis
The indication to coronary stent intervention will be based on angiography
Sponsors
Johannes Gutenberg University Mainz
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Patients and outcome assessors will be blinded to the randomization group.
Intervention 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).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient-oriented combined endpoint (clinical endpoint) | 12 months | 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) |
| Functional endpoint | Upon randomization and following QFR assessment | Proportion of patients assigned to medical treatment in the two groups (QFR vs. Reference) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Seattle angina questionaire summary score | 12 months | 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)) |
| Unplanned admission | 12 months | Incidence of unplanned hospital admission for angina |
| Patient-oriented composite endpoint | 3 months | Patient-oriented composite endpoint (death, myocardial infarction, unplanned revascularization). |
Countries
Germany
Outcome results
None listed