To investigate whether instantaneous wave-Free Ratio(iFR)/Fractional Flow Reserve(FFR) guided treatment strategy makes the postulated treatment strategy by Coronary Angiogram(CAG) guide change and to analyze the cost-effectiveness of its dual diagnosis. To investigate difference between SYNTAX score evaluated CAG and functional SYNTAX score evaluated physiological assessment of coronary stenosis and its clinical effectiveness.
Study Type
OBSERVATIONAL
Enrollment
421
NPO Associations for Establishment of Evidence in Interventions
Minato, Tokyo, Japan
Medical economy
To evaluate the healthcare cost-effectiveness in QALY(Quality Adjusted Life Year)converted by Japanese functional score ; Quality of Life(QOL) questionnaire (EQ-5D) and the cost postulated by CAG strategy with its iFR/FFR hybrid strategy. To collect the healthcare cost related MACCE at the timing of 6 and 12 months FU point. (Included emergency visit) To collect QOL questionnaire (EQ-5D) at the timing of just after the treatment and 12 months follow up point.
Time frame: 1 year after the procedure
Physiological assessment
Alteration in treatment protocol. Change in SYNTAX score.
Time frame: baseline pocedure
Incidence of major adverse cardiac and cerebrovascular events(MACCE)
MACCE include all-cause death, cerebrovascular accident(CVA), myocardial infarction(MI), and repeat revascularization.
Time frame: 1year after the pocedure
correlated analysis
Area under receiver-operating characteristic curve(ROC) Classification agreement between iFR and FFR in this registry, Demonstrated using the area under the receiver-operating characteristic curve(FFR cut-off 0.8 or 0.75).
Time frame: baseline pocedure
evaluation of variance
Treatment categorization disagreements of iFR and FFR are analyzed by multi-variable analysis processing to calculate Characteristic factors.
Time frame: beseline procedure
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