Resting Full-cycle Flow Ratio (RFR) Versus Angiography to Guide Revascularization Strategy in Patients Undergoing Coronary Artery By-pass Grafting (CABG) (RFR-CABG)

Resting Full-cycle Flow Ratio (RFR) Versus Angiography to Guide Revascularization Strategy in Patients Undergoing Coronary Artery By-pass Grafting (CABG): RFR-CABG Trial

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 Overview

• Status: Recruiting
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Procedure: Angio guided CABG; Procedure: RFR guided CABG

• Study Type: Interventional
• Enrollment (Estimated): 500
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Prof. E. Kedhi, MD, PhD; Phone Number: +31 384262999; Email: ekedhi@me.com
• Study Contact Backup: Name: S. Postma, PhD; Phone Number: +31 384262999; Email: rfrcabg.trial@diagram-zwolle.nl

Study Locations

• Belgium
  • Bonheiden, Belgium
    • Recruiting
    • Imelda Ziekenhuis
    • Contact: Dr. Dewilde, MD, PhD
  • Brugge, Belgium
    • Active, not recruiting
    • AZ Sint-Jan Brugge
• Poland
  • Katowice, Poland
    • Recruiting
    • Medical University of Silesia
    • Contact: Pawel Gasior, MD
• Slovakia
  • Banská Bystrica, Slovakia
    • Recruiting
    • SÚSCCH
    • Contact: Martin Hudec, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: angiography guided CABG	Procedure: Angio 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.
Experimental: RFR guided CABG	Procedure: RFR 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.

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome Measure	Time Frame
Cut-off value for the RFR that best predicts graft occlusion	Baseline
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
CD-TVR at 3 months post CABG	1 year
CD-TVR at 1 year post CABG	1 year
CD-TVR at 3 years post CABG	3 years

Collaborators and Investigators

• Sponsor: Diagram B.V.

Study record dates

Study Major Dates

• Study Start (Actual): February 3, 2020
• Primary Completion (Estimated): October 31, 2024
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: May 1, 2020
• First Submitted That Met QC Criteria: May 1, 2020
• First Posted (Actual): May 5, 2020

Study Record Updates

• Last Update Posted (Estimated): February 1, 2024
• Last Update Submitted That Met QC Criteria: January 31, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: RFR guided CABG; angiography guided CABG; Graft dysfunction
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: 9333

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: This has not been decided yet.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No