Coronary Artery Disease
Conditions
Keywords
Percutaneous Coronary Intervention, Fractional Flow Reserve, Resting Full Cycle Ratio
Brief summary
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..
Interventions
None listed
Sponsors
Ceric Sàrl
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| RFRpre vs. RFRfinal | Intra operative, up to 1 month | comparison between RFR (Resting Full Cycle Ratio) before and after optimized PCI (RFRpre vs. RFRfinal) in all included lesions |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| RFRpre vs. RFRpost | Intra operative, up to 1 month | Comparison of RFR (Resting Full Cycle Ratio) value before and after PCI |
| RFRpost vs. RFRfinal | Intra operative, up to 1 month | Comparison of RFR (Resting Full Cycle Ratio) value before and after PCI optimization |
| FFRpre vs. FFRpost | Intra operative, up to 1 month | Comparison of FFR (Fractional Flow reserve) value before and after PCI |
| FFRpost vs. FFRfinal | Intra operative, up to 1 month | Comparison of FFR (Fractional Flow reserve) value before and after optimized PCI |
| FFRpre vs. FFRfinal | Intra operative, up to 1 month | Comparison of FFR (Fractional Flow reserve) value before and after PCI |
| RFRpre vs. FFRpre: % of lesions | Intra operative, up to 1 month | 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. |
| RFRpost vs. FFRpost/ % of lesions | Intra operative, up to 1 month | 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 |
| The rate of Stent Thrombosis | Day 1 and Day 30 | Stent thrombosis according to the definition of ARC2 (definite or probable) |
| Proc Timepost vs. Proc Timefinal. | Intra operative, up to 1 month | Duration of the procedure (mn) after PCI optimization |
| Irradiationpost vs. Irradiationfinal. | Intra operative, up to 1 month | Irradiation during the procedure in mGy after PCI and after optimization: |
| Contrastpost vs. Contrastfinal. | Intra operative, up to 1 month | Volume of contrast dye load (cc) during the procedure after PCI and after optimization |
| % of patients: RFRpost vs. RFRfinal | Intra operative, up to 1 month | % 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 |
| The rate of Major Adverse Coronary Events | Day 1 and Day 30 | Major Adverse Coronary Events: cardiovascular mortality, myocardial infarction, ischemia driven target lesion revascularization |
| The rate of all cause mortality | Day 1 and Day 30 | All-cause mortality |
| RFRfinal vs. FFRfinal/ % of lesions | Intra operative, up to 1 month | 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. |
Countries
United Arab Emirates
Outcome results
None listed