Different trials have shown that fractional flow reserve (FFR) could successfully guide revascularization in patients undergoing percutaneous coronary intervention (PCI). It is conceivable that a similar revascularization guidance could be useful also for surgical revascularization i.e. coronary by-pass graft (CABG). Experience learns that grafts placed on vessels with hemodynamically non-significant stenosis often occlude due to competitive antegrade flow. Resting full-cycle Flow Ratio (RFR) is a measurement performed to evaluate the hemodynamic severity of coronary stenosis. Differently from FFR which is a measurement performed in maximal hyperemia, the RFR is a measurement that is performed in rest and therefore may predict better than FFR the baseline equilibriums that could lead to graft failure, while it has similar capacity to identify hemodynamically significant stenosis as FFR. It is unknown whether RFR guided CABG revascularization is superior as compared to angiography alone.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
500
All patients will undergo RFR and FFR measurement before CABG. RFR and FFR values will be blinded to the patients. In the experimental arm the decision to revascularize will be based on RFR.
All patients will undergo RFR and FFR measurement before CABG. RFR and FFR values will be blinded to the patients. In the control arm the RFR values will be blinded to the cardiothoracic surgeon.
Imelda ziekenhuis
Bonheiden, Belgium
RECRUITINGAZ Sint-Jan Brugge
Bruges, Belgium
ACTIVE_NOT_RECRUITINGMedical University of Silesia
Katowice, Poland
RECRUITINGSUSCCH
Banská Bystrica, Slovakia
RECRUITINGNumber of participants who deceased, had a Myocardial Infarction (MI), Clinically-Driven Target Vessel Revascularization (CD-TVR), Stroke or Graft Dysfunction at 3 months post CABG
Time frame: 3 months
Cut-off value for the RFR that best predicts graft occlusion
Time frame: Baseline
Number of participants with graft dysfunction at 3 months post CABG
Time frame: 3 months
Major adverse cardiac or cerebrovascular event (MACCE), a composite of Death, MI, CD-TVR and Stroke at 1 year
Time frame: 1 year
Major adverse cardiac or cerebrovascular event (MACCE), a composite of Death, MI, CD-TVR and Stroke at 3 years
Time frame: 3 years
CD-TVR at 3 months post CABG
Time frame: 1 year
CD-TVR at 1 year post CABG
Time frame: 1 year
CD-TVR at 3 years post CABG
Time frame: 3 years
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