Coronary Artery Disease
Conditions
Keywords
RFR guided CABG, angiography guided CABG, Graft dysfunction
Brief summary
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.
Interventions
PROCEDURERFR guided CABG
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.
PROCEDUREAngio guided CABG
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.
Sponsors
Diagram B.V.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
All patients will undergo RFR and FFR measurement before CABG. RFR and FFR values will be blinded to the patients in both arms. In the control arm (angiography guided CABG) the RFR values will be blinded to the cardiothoracic surgeon.
Intervention model description
International prospective randomized multicenter superiority trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* All patients between 18 or older undergoing CABG * Patients willing and capable to provide written informed consent
Exclusion criteria
* Previous CABG * Concomitant severe valvular disease intervention * Remaining (expected) coronary stenosis of \> 50% diameter stenosis distally to graft anastomosis * Left ventricular ejection fraction \<30% * Known transmural myocardial infarction * Documented microvascular disease * RFR/FFR measurement judged impossible * Life expectancy \<2 years * Participation in other investigational clinical trials
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number 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 | 3 months |
Secondary
| Measure | Time frame |
|---|---|
| Number of participants with graft dysfunction at 3 months post CABG | 3 months |
| Major adverse cardiac or cerebrovascular event (MACCE), a composite of Death, MI, CD-TVR and Stroke at 1 year | 1 year |
| Major adverse cardiac or cerebrovascular event (MACCE), a composite of Death, MI, CD-TVR and Stroke at 3 years | 3 years |
| Cut-off value for the RFR that best predicts graft occlusion | Baseline |
| CD-TVR at 1 year post CABG | 1 year |
| CD-TVR at 3 years post CABG | 3 years |
| CD-TVR at 3 months post CABG | 1 year |
Countries
Belgium, Poland, Slovakia
Contacts
Primary ContactProf. E. Kedhi, MD, PhD
Backup ContactS. Postma, PhD
Outcome results
None listed