Evolving Routine Standards in Intracoronary Physiology

Study Overview
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Brief Summary
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Italy is the European country with the minor penetration of FFR as compared to the number of percutaneous coronary intervention. Accordingly, the Società Italiana di Cardiologia Invasiva (SICI-GISE) conceived and promoted a prospective nationwide study to describe the patterns of the use of FFR in an unselected real-world population and to to assess the reasons, on clinical decision making, driving operators in the use or not of the FFR.

Detailed Description
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Fractional flow reserve (FFR) has been validated as a reliable surrogate for inducible ischemia, supporting its use during invasive procedures for functional assessment of coronary lesions. Landmark randomized trials have demonstrated that deferral of nonsignificant lesions based on FFR is not only safe, but also that FFR-guided revascularization is associated with a better clinical outcome up to 2 years, when compared with standard angiography. In spite of the overwhelming evidence of its potential clinical and economic benefits and strong guideline recommendation, the adoption of FFR in the real-world is perceived to vary significantly. Reasons for this disparity are several, but most operators still do rely the most on angiographic eye-balling to decide on the functional significance of coronary lesions and the need for revascularization. Italy is the European country with the minor penetration of FFR as compared to the number of percutaneous coronary intervention. Accordingly, the Società Italiana di Cardiologia Invasiva (SICI-GISE) conceived and promoted a prospective nationwide study to describe the patterns of the use of FFR in an unselected real-world population and to to assess the reasons, on clinical decision making, driving operators in the use or not of the FFR.

Official Title
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Prospective Study Evaluating the Routine Standard Use of Fractional Flow Reserve and Disagreement With Guideline Recommendations: a Nationwide Study

Conditions
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Myocardial Ischemia

Intervention / Treatment
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* Device: fractional flow reserve performed
* Other: fractional flow reserve not performed


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: FRACTIONAL FLOW RESERVE PERFORMED GROUP age >18 years written consent assessment with FFR of at least one coronary lesion FRACTIONAL FLOW RESERVE NOT PERFORMED GROUP age >18 years written consent absence of assessment with FFR of at least one coronary lesion + at least one of the following criteria stable coronary artery disease, absence of non-invasive stress test, evidence of coronary lesions between 50%-90% (visual estimation or quantitative coronary analysis) stable coronary artery disease, presence of non-invasive stress test, evidence of coronary lesions between 50%-70% (visual estimation or quantitative coronary analysis) acute coronary syndrome, culprit lesion not identifiable or coronary lesions different from the culprit between 50%-70% (visual estimation or quantitative coronary analysis) Exclusion Criteria: written consent denied

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| fractional flow reserve performed<br>consecutive patients with ischemic heart disease and clinical indication to coronary artery angiography where the operator decided to use fractional flow reserve to drive the revascularization | Device: fractional flow reserve performed<br>* assessing fractional flow reserve to drive revascularization<br>|
| fractional flow reserve not performed<br>consecutive patients with ischemic heart disease and clinical indication to coronary artery angiography and satisfying prespecified criteria where the operator decided to not use fractional flow reserve to drive the revascularization | Other: fractional flow reserve not performed<br>* description of the main reasons leading the operator to not use fractional flow reserve to drive the coronary revascularization<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| agreement with current guidelines | percentage of patients receiving a FFR assessment in agreement with current guidelines | intra-procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| reasons leading to FFR disuse | description of the main reasons leading operator to prefer not assessment of coronary | intra-procedure |