Physio PCI: Impact of Coronary Angioplasty on Non-hyperaemic Pressure Ratio in Patients With Coronary Artery Disease

Study Overview
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Brief Summary
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The use of intra coronary physiological assessment with fractional flow reserve (FFR) is nowadays the standard approach to define ischemia-inducing stenosis and guide myocardial revascularization strategy in patients with coronary artery disease. Further, FFR has been shown to be a strong and independent predictor of major adverse cardiac events after stent implantation. A lower value of FFR after stent implantation is associated with a worse clinical prognosis, without a clearly defined threshold above which clinical follow up are similar for all FFR values. Among 750 patients in the Fractional Flow Reserve Post-Stent Registry, the event rate was 29.5% in patients with FFR<0.80 compared to 9 4.9% in patients with FFR>0.95 (p<0.001). However, FFR remains poorly adopted in many cathlabs, partly because of procedural time, discomfort or sides effect during hyperemia, non-uniform adenosine response and economical constraints. This leads to the validation of resting indices (instantaneous wave-free ratio (iFR), diastolic pressure ratio (dPR), and resting full-cycle ratio (RFR) among others). Those indices evaluate coronary physiology without the use of maximal hyperemia and have 15 slightly different threshold compared to FFR (≤0.89 vs 0.80, for iFR and RFR, and FFR 16 respectively).In the VALIDATE RFR study, a head-to-head comparison of RFR and iFR from a retrospective analysis, diagnostic accuracy of RFR was 97.4% with an area under the curve 1 (AUC) of 99.6%. In the more recent RE-VALIDATE RFR study, 431 patients with 501 lesions 2 were prospectively evaluated for the diagnostic performance of RFR in all-comers patients. Compared to iFR, RFR achieved high diagnostic accuracy, sensitivity and specificity. These are the reasons why we designed a prospective, non-randomized, clinical trial, to better 18 explore the value of RFR before and after PCI in real live and after optimization by post dilation 19 in all-comers patients with coronary artery disease in the Middle East region..

Official Title
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Impact of Coronary Angioplasty on Non-hyperaemic Pressure Ratio in Patients With Coronary Artery Disease.

Conditions
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Coronary Artery Disease

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient is ≥ 21 years The patient is deemed eligible for PCI of at least one coronary stenosis (RFRpre ≤0.89 or FFR≤0.80) The patient is able and is willing to comply with all study procedures and process. Exclusion Criteria: The patient is in cardiogenic shock The patient has a bifurcation lesion that requires a planned two stents technique The patient refuses to participate. The patient suffers acute coronary syndrome and should be treated by PCI in the culprit lesion (non-culprit lesions in non-culprit vessel could be included) The patient has an ostial stenosis to be treated by PCI

Ages Eligible for Study
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Minimum Age: 21 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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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| RFRpre vs. RFRfinal | comparison between RFR (Resting Full Cycle Ratio) before and after optimized PCI (RFRpre vs. RFRfinal) in all included lesions | Intra operative, up to 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| RFRpre vs. RFRpost | Comparison of RFR (Resting Full Cycle Ratio) value before and after PCI | Intra operative, up to 1 month | 
| RFRpost vs. RFRfinal | Comparison of RFR (Resting Full Cycle Ratio) value before and after PCI optimization | Intra operative, up to 1 month | 
| FFRpre vs. FFRpost | Comparison of FFR (Fractional Flow reserve) value before and after PCI | Intra operative, up to 1 month | 
| FFRpost vs. FFRfinal | Comparison of FFR (Fractional Flow reserve) value before and after optimized PCI | Intra operative, up to 1 month | 
| FFRpre vs. FFRfinal | Comparison of FFR (Fractional Flow reserve) value before and after PCI | Intra operative, up to 1 month | 
| RFRpre vs. FFRpre: % of lesions | Comparison of FFR (Fractional Flow reserve) and RFR (Resting Full Cycle Ratio) value before PCI: % of lesions with FFR≤0.80 compared to RFR≤0.89. | Intra operative, up to 1 month | 
| RFRpost vs. FFRpost/ % of lesions | Comparison of FFR (Fractional Flow reserve) and RFR (Resting Full Cycle Ratio) value after PCI : % of lesions with FFR≤0.80 compared to RFR≤0.89 | Intra operative, up to 1 month | 
| RFRfinal vs. FFRfinal/ % of lesions | Comparison of FFR (Fractional Flow reserve) and RFR (Resting Full Cycle Ratio) value after optimized PCI : % of lesions with FFR≤0.80 compared to RFR≤0.89. | Intra operative, up to 1 month | 
| Proc Timepost vs. Proc Timefinal. | Duration of the procedure (mn) after PCI optimization | Intra operative, up to 1 month | 
| Irradiationpost vs. Irradiationfinal. | Irradiation during the procedure in mGy after PCI and after optimization: | Intra operative, up to 1 month | 
| Contrastpost vs. Contrastfinal. | Volume of contrast dye load (cc) during the procedure after PCI and after optimization | Intra operative, up to 1 month | 
| % of patients: RFRpost vs. RFRfinal | % of patients with (Resting Full Cycle Ratio) RFR > 0.70, 0.80, 0.89 and 0.95 (in the treated vessel in case of 1 multivessel CAD) before and after optimization | Intra operative, up to 1 month | 
| The rate of Major Adverse Coronary Events | Major Adverse Coronary Events: cardiovascular mortality, myocardial infarction, ischemia driven target lesion revascularization | Day 1 and Day 30 | 
| The rate of all cause mortality | All-cause mortality | Day 1 and Day 30 | 
| The rate of Stent Thrombosis | Stent thrombosis according to the definition of ARC2 (definite or probable) | Day 1 and Day 30 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Percutaneous Coronary Intervention, Fractional Flow Reserve, Resting Full Cycle Ratio