Fractional Flow Reserve Versus Angiography Randomization for Graft Optimization Trial

Fractional Flow Reserve Versus Angiography Randomization for Graft Optimization Trial

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.

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.

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)