This study evaluates the prognostic value and therapeutic potential of combined pressure and flow measurements when evaluating a coronary artery stenosis. Lesions with intact coronary flow reserve (CFR) despite a reduced fractional flow reserve (FFR) will receive optimal medical therapy. Only lesions with a simultaneous reduction in both CFR and FFR will be treated with percutaneous coronary intervention (PCI).
Pressure and flow represent the two physiologic variables that can be measured directly inside a coronary artery. Already pressure measurements have proven their clinical value in the form of fractional flow reserve (FFR). However, myocardial function can remain intact with sufficient flow, even at a low perfusion pressure. Therefore, combined pressure and flow measurements provide a more complete description of physiologic stenosis severity as a guide to medical treatment versus revascularization. Based on existing work relating the most common flow measurement, coronary flow reserve (CFR), to FFR and linking both variables with subsequent prognosis, we hypothesize that lesions with an intact CFR\>=2.0 can be reasonably treated with medical therapy despite a reduced FFR\<=0.8.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
455
For lesions with both FFR\<=0.8 and CFR\<2.0
For lesions with FFR\>0.8 or CFR\>=2.0 or both
Aarhus University Hospital
Aarhus, Denmark
Catholic University of the Sacred Heart
Rome, Italy
Gifu Heart Center
Gifu, Japan
Toda Central General Hospital
Major adverse cardiac events
All-cause death, non-fatal myocardial infarction, urgent and elective revascularization
Time frame: 24 months
Angina (Canadian Cardiovascular Society (CCS) anginal class (or freedom from angina)
Canadian Cardiovascular Society (CCS) anginal class (or freedom from angina)
Time frame: 24 months
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Toda, Japan
Tokyo Medical University
Tokyo, Japan
Tsuchiura Kyodo
Tsuchiura, Japan
Amsterdam UMC - location AMC
Amsterdam, Netherlands
Amsterdam UMC - location VUmc
Amsterdam, Netherlands
Tergooi Hospital
Blaricum, Netherlands
Amphia Hospital
Breda, Netherlands
...and 2 more locations