Concordance Between FFR and iFR for the Assessment of Intermediate Lesions in the Left Main Coronary Artery. A Prospective Validation of a Default Value for iFR

Study Overview
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Brief Summary
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The assessment of Left Main Coronary Artery (LMCA) lesions by means of coronary angiography renders serious limitations. Studies with a limited number of patients have shown that a value of FFR (Fractional Flow Reserve) above 0.80 identify a low risk of events in case of not performing revascularization in patients with intermediate stenosis in the LMCA. Although iFR (Instant wave Free Ratio) has recently been found equivalent to FFR The demonstration of the prognostic utility of iFR in patients with LMCA intermediate lesions could have an important clinical impact and justify its systematic use for the treatment decision in these high-risk patients.

Detailed Description
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The assessment of Left Main Coronary Artery (LMCA) lesions by means of coronary angiography renders serious limitations. In the case of intermediate stenoses (25-60%), invasive imaging tests, intravascular ultrasound (IVUS) or optical coherence tomography (OCT) or functional by determining the Fractional Flow Reserve (FFR), have been proposed to identify those patients who could benefit from revascularization. Studies with a limited number of patients have shown that a value of FFR above 0.80 identify a low risk of events in case of not performing revascularization in patients with intermediate stenosis in the LMCA. Although iFR (Instant wave Free Ratio) has recently been found equivalent to FFR in assessing the prognosis of patients with intermediate lesions, the validation of the prognostic power of this index in patients with intermediate LMCA lesions has not been demonstrated, although it is used in clinical practice assuming the results in other locations of the lesions. The demonstration of the prognostic utility of iFR in patients with LMCA intermediate lesions could have an important clinical impact and justify its systematic use for the treatment decision in these high-risk patients.

Official Title
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Concordance Between FFR and iFR for the Assessment of Intermediate Lesions in the Left Main Coronary Artery. A Prospective Validation of a Default Value for iFR (iLITRO Study)

Conditions
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Coronary Artery Disease, Left Main Coronary Artery Stenosis, Left Main Coronary Artery Disease, Restenosis, Coronary

Intervention / Treatment
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* Other: Indication of revascularization


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with intermediate lesion in the LMCA (25-60% angiographic stenosis) by visual estimation) in which the realization of a study with guide of pressure for the determination of the iFR. Patients aged ≥18 years. Patients able of giving informed consent. Exclusion Criteria: Patients with indication for coronary surgery regardless of the significance of the LMCA lesion. Patients with a LMCA lesion presenting with ulceration, dissection or thrombus. Patients with previous arterial or venous graft lesion functioning in the territory irrigated by the LMCA (LMCA protected). Patients with ACS (Acute Coronary Syndrome) with a potentially guilty lesion in the LMCA. Patients unable to obtain informed consent. Patients with known terminal illness that conditions a life expectancy less than 1 year. Patients with hemodynamic instability with Killip III or IV class.

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 |
| --- | --- |
| Patients with intermediate lesions.<br>Patients with intermediate lesions (stenosis in angiography between 25% and 60%) in LMCA. | Other: Indication of revascularization<br>* Device: iFR/FFR<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment correlation between FFR>=0.80 and iFR >=0.89 | Efficacy and correlation of two invasive indexes of functional assessment by intracoronary pressure guidance in intermediate lesions of the LMCA with a cut-off point to defer the treatment of FFR> = 0.80 (with intravenous adenosine) and iFR > = 0.89. the LMCA. | 1 day | 
| Major Adverse Cardiac Events | Composite of death, myocardial infarction, unplanned revascularisation | 30 days | 
| Major Adverse Cardiac Events | Composite of death, myocardial infarction, unplanned revascularisation | 1 year | 
| Major Adverse Cardiac Events | Composite of death, myocardial infarction, unplanned revascularisation | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment correlation between iFR and IVUS | Assessment correlation between iFR and IVUS derived minimal luminal area | 5 years | 
| Death (all cause) | Death (all cause) | 30 days, 1 and 5 years | 
| Death (cardiovascular) | Death (cardiovascular) | 30 days, 1 and 5 years | 
| Non-fatal Myocardial Infarction | Non-fatal Myocardial Infarction | 30 days, 1 and 5 years | 
| Non-fatal Myocardial Infarction related to the LMCA lesion | Non-fatal Myocardial Infarction related to the LMCA lesion | 30 days, 1 and 5 years | 
| Revascularization | Revascularization | 30 days, 1 and 5 years | 
| Revascularization of the target lesion | Revascularization of the target lesion | 30 days, 1 and 5 years | 
| Myocardial Infarction related to target lesion revascularization | Myocardial Infarction related to target lesion revascularization | 30 days, 1 and 5 years | 
| Stent Thrombosis in the target lesion revascularization | Stent Thrombosis in the target lesion revascularization | 30 days, 1 and 5 years | 
| Restenosis of the stent in target lesion | Restenosis of the stent in target lesion | 30 days, 1 and 5 years | 
| New revascularization of the target lesion | New revascularization of the target lesion | 30 days, 1 and 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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iFR, Left Main Coronary Artery, Intermediate Coronary Lesions, Coronary Physiology, IVUS