Fractional Flow Reserve Versus Angiography Randomization for Graft Optimization Trial (FARGO)

Odense University Hospital

Status: Completed

Conditions: Coronary Artery Disease; Myocardial Ischemia; Cardiovascular Diseases; Arteriosclerosis; Coronary Disease

Treatments: Procedure: Fractional flow reserve-guided CABG; Procedure: Angiography-guided CABG

Study type: Interventional

Funder types: Other

Identifiers

NCT02477371

S-20130050

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups

Fractional flow reserve-guided CABG

Experimental group

Description:

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.

Treatment:

Procedure: Fractional flow reserve-guided CABG

Angiography-guided CABG

Active Comparator group

Description:

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.

Treatment:

Procedure: Angiography-guided CABG