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..
Study Type
OBSERVATIONAL
Enrollment
3
Al Qassimi Hospital
Sharjah city, United Arab Emirates
RFRpre vs. RFRfinal
comparison between RFR (Resting Full Cycle Ratio) before and after optimized PCI (RFRpre vs. RFRfinal) in all included lesions
Time frame: Intra operative, up to 1 month
RFRpre vs. RFRpost
Comparison of RFR (Resting Full Cycle Ratio) value before and after PCI
Time frame: Intra operative, up to 1 month
RFRpost vs. RFRfinal
Comparison of RFR (Resting Full Cycle Ratio) value before and after PCI optimization
Time frame: Intra operative, up to 1 month
FFRpre vs. FFRpost
Comparison of FFR (Fractional Flow reserve) value before and after PCI
Time frame: Intra operative, up to 1 month
FFRpost vs. FFRfinal
Comparison of FFR (Fractional Flow reserve) value before and after optimized PCI
Time frame: Intra operative, up to 1 month
FFRpre vs. FFRfinal
Comparison of FFR (Fractional Flow reserve) value before and after PCI
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: Intra operative, up to 1 month
Proc Timepost vs. Proc Timefinal.
Duration of the procedure (mn) after PCI optimization
Time frame: Intra operative, up to 1 month
Irradiationpost vs. Irradiationfinal.
Irradiation during the procedure in mGy after PCI and after optimization:
Time frame: Intra operative, up to 1 month
Contrastpost vs. Contrastfinal.
Volume of contrast dye load (cc) during the procedure after PCI and after optimization
Time frame: 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
Time frame: 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
Time frame: Day 1 and Day 30
The rate of all cause mortality
All-cause mortality
Time frame: Day 1 and Day 30
The rate of Stent Thrombosis
Stent thrombosis according to the definition of ARC2 (definite or probable)
Time frame: Day 1 and Day 30
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