Post-Revascularization Optimization and PHysiological Evaluation of intermediaTe Lesions

Study Overview
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Brief Summary
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PROPHET-FFR is a single center ambispective registry aiming to explore the impact of post-revascularization functional assessment on later outcomes.

Detailed Description
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PROPHET-FFR is a ambispective observational study enrolling patients that need invasive functional evaluation in the diagnostic workup of coronary artery disease. Clinical outcomes of patients that undergo functional assessment after PCI will be compared both to patients undergoing PCI without further evaluations and both to patients that will be deferred due to to negative functional evaluation. Since the observational nature of the study the decision to perform post-PCI physiological assessment will be left to operator's discretion. In case of post-PCI functional evaluation results that will be deemed as unsatisfactory by the operator further actions can be taken in order to optimize procedural result. The decision on this opportunity as well as the choice of the strategy to adopt are left to operator's discretion. The primary endpoint of the study is the rate of MACE defined as the composite of spontaneous MI, target vessel failure, cardiac deaths at 24 months. Follow up will be performed by telephone contact and medical records screening at 12, 24 and 36 months. Moreover data about in-hospital events will be collected including the release of myocardial damage markers, change in Creatinine, and lenght of hospital stay.

Official Title
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Post-Revascularization Optimization and PHysiological Evaluation of intermediaTe Lesions: an FFR-based Single Center Registry

Conditions
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Ischemic Heart Disease, Angina, Stable, Non ST Elevation Myocardial Infarction, ST Elevation Myocardial Infarction, Unstable Angina, Coronary Disease

Intervention / Treatment
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* Diagnostic Test: Invasive functional evaluation with either Pd/Pa, FFR, iFR or contrast FFR


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: requiring coronary angiography to assess coronary artery disease; having at least one angiographically intermediate coronary stenosis (eg. 40%-80%) on any vessel requiring invasive functional assessment using FFR (and/or any other surrogate index) being able and legally entitled to give informed consent Exclusion Criteria: history of severe poorly uncontrolled pulmonary disease hemodynamic instability during the diagnostic or therapeutic procedures; known adenosine intolerance need of mechanical circulatory or ventilatory support; stage IV chronic kidney disease. life expectancy <1 year patients gaining indication to surgical revascularization; major procedural complications during percutaneous revascularization (cardiac arrest needing cardiopulmonary resuscitation, major bleeding , large iatrogenic coronary dissection, coronary embolization in a main vessel, suspected stroke) making post-PCI functional evaluation unsafe or impossible.

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 |
| --- | --- |
| Group 1<br>Patients with negative invasive functional evaluation | Diagnostic Test: Invasive functional evaluation with either Pd/Pa, FFR, iFR or contrast FFR<br>* Enrolled patients will undergo invasive functional evaluation of coronary stenosis followed by percutaneous revascularization if appropriate. Patients in Group 3 will have target lesion re-assessed using either PdPa, FFR, iFR or contrast FFR.<br>|
| Group 2<br>Patients with positive invasive functional evaluation undergoing PCI | Diagnostic Test: Invasive functional evaluation with either Pd/Pa, FFR, iFR or contrast FFR<br>* Enrolled patients will undergo invasive functional evaluation of coronary stenosis followed by percutaneous revascularization if appropriate. Patients in Group 3 will have target lesion re-assessed using either PdPa, FFR, iFR or contrast FFR.<br>|
| Group 3<br>Patients with positive invasive functional evaluation undergoing PCI and subsequent retest of functional indexes | Diagnostic Test: Invasive functional evaluation with either Pd/Pa, FFR, iFR or contrast FFR<br>* Enrolled patients will undergo invasive functional evaluation of coronary stenosis followed by percutaneous revascularization if appropriate. Patients in Group 3 will have target lesion re-assessed using either PdPa, FFR, iFR or contrast FFR.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of composite of Major Adverse Cardiovascular Events (MACE) [ Cardiac Death/Myocardial Infarction/Target Vessel Failure (TVF)] |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of any component of MACE (Cardiac Death/Myocardial Infarction/Target Vessel Failure (TVF)] |  | 1 year, 3 years, 5 years | 
| Rate of all-cause Death |  | 1 year, 3 years, 5 years | 
| Rate of recurrent or persistent angina |  | 1 year, 3 years, 5 years | 
| Percentage of change in angina intensity assessed by shortened Seattle Angina Questionnaire-7 | A score ranging from 0 to 100, with the higher values associated with less severe symptoms | 1 year, 3 years, 5 years | 
| Rate of cardiac hospitalizations | Any hospitalization for cardiac causes | 1 year, 3 years, 5 years | 
| absolute and relative change in functional indexes measured before and after any step of the study procedure |  | intraprocedural | 
| post-procedural troponin level | ng/L | 24 hours and 48 hours | 
| post-procedural creatinine level | mg/dL | 24 hours and 48 hours | 
| procedural cost | Euro | intraprocedural | 
| fluoroscopy time | minutes | intraprocedural | 
| contrast dose | mL | intraprocedural | 
| number of stents implanted and balloon used for optimization |  | intraprocedural |