Fractional Flow Reserve Versus Angiography Randomization for Graft Optimization Trial

Not Applicable

Completed

• Conditions: Myocardial Ischemia; Cardiovascular Diseases; Coronary Artery Disease; Coronary Disease; Arteriosclerosis
• Interventions: Procedure: Angiography-guided CABG; Procedure: Fractional flow reserve-guided CABG

• Registration Number: NCT02477371
• Lead Sponsor: Odense University Hospital

Brief Summary

The FARGO trial is a prospective, randomized (1:1), multicenter study. The aim of the study is to assess the importance of fractional flow reserve (FFR) assessment prior to coronary artery bypass grafting (CABG) with respect to planning and guiding the revascularization strategy. The study compares an FFR-guided strategy to an angiography-guided strategy in patients planned for surgical revascularization.

Detailed Description

FFR measurements are made on all patients that enters the study. FFR measurements on coronary arteries with intermediate stenoses, that are planned for grafting, are done before CABG is performed. Patients are randomized to either an FFR-guided CABG or an Angiography guided CABG.

Study Timeline

• Study Start: 2014-06
• Study First Submitted: 2015-01-19
• Study First Submitted QC: 2015-06-17
• Study First Posted: 2015-06-22
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-16
• Last Update Posted: 2018-10-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Stable angina or unstable angina / NSTEMI (Non ST segment elevation myocardial infarction) candidate to CABG
• At least one study lesion, which is an intermediate lesion planned for grafting at the Heart Team Meeting.(Definition of Study lesions: ≥ 50% stenosis of a major epicardiel artery (where the proximal reference segment has a diameter> 2.5 mm), which can be passed with a FFR-wire without significant risk. Study Lesions can be drawn from all coronary arteries.)
• Signed informed consent form

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Exclusion Criteria

• Significant valvular disease with indication to surgical treatment
• Previous open-heart-surgery
• Left main lesion without other intermediate lesions
• Treatment with Persantin Retard
• One vessel disease
• Renal impairment (creatinine ≥ 150 umol / l)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Angiography-guided CABG	Angiography-guided CABG	Patients are randomized to an angiography-guided CABG. FFR-measurements are made on coronary arteries with intermediate stenoses, that are planned for grafting. The FFR-values are blinded for both the operator, the patient and the heart team meeting. The graft plan are based on the coronary angiography.
Fractional flow reserve-guided CABG	Fractional flow reserve-guided CABG	Patients are randomized to an FFR-guided CABG. FFR-measurements are made on coronary arteries with intermediate stenoses, that are planned for grafting. The FFR-values are blinded for both the operator, the patient and the heart team meeting. The graft plan form the heart team meeting are changed by the study investigator according to the FFR-measurements and randomization, so that coronary arteries with FFR ≤ 0,8 receive grafting and coronary arteries with FFR \> 0,8 are deferred.

Primary Outcome Measures

Name	Time	Method
Percentage open grafts of all grafts	6 months	Open graft definition: graft with TIMI III flow with no anastomosis stenosis (TIMI flow grades based on results of the Thrombolysis In Myocardial Infarction trial)

Secondary Outcome Measures

Name	Time	Method
Change in Quality of life (EQ-5D) from index to FU	6 months
Graft stenosis (shaft and anastomoses)	6 months
Change in CCS class from index to follow-up (FU)	6 months	CCS class (Canadian Cardiovascular Society grading of angina)
MACCE (Major Adverse Cardiac and Cerebrovascular event: death, myocardial infarction, stroke, new revascularization by CABG or PCI (Percutaneous coronary intervention)	6 months
Procedural maximum Troponin I (cTnI), Troponin T (TnT) or creatinine kinase MB (CKMB) values depending on local conditions.	The first 24 hours after the operation
Procedure time	During surgery (minutes)

Trial Locations

Locations (3)

Anne Langhoff Thuesen; 🇩🇰 Odense, Odense C, Denmark

Department of Cardiology and Cardiothoracic surgery, Aarhus University Hospital, Skejby Sygehus; 🇩🇰 Aarhus, Aarhus N, Denmark

Department of Cardiology and Cardiothoracic surgery, Aalborg University Hospital; 🇩🇰 Aalborg, Denmark