Fractional Flow Reserve Versus Angiography Randomization for Graft Optimization Trial

Study Overview
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Brief Summary
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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
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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.

Official Title
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Fractional Flow Reserve Versus Angiography Randomization for Graft Optimization Trial

Conditions
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Coronary Artery Disease, Coronary Disease, Myocardial Ischemia, Arteriosclerosis, Cardiovascular Diseases

Intervention / Treatment
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* Procedure: Fractional flow reserve-guided CABG
* Procedure: Angiography-guided CABG


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fractional flow reserve-guided CABG<br>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. | Procedure: Fractional flow reserve-guided CABG<br>* Coronary arteries with angiographical significant stenoses, that are planned for grafting at the heart team meeting and where FFR-measurements are made, only receive grafting if FFR-value is ≤ 0,8. Arteries with FFR-values > 0,8 are deferred.<br>|
| Active Comparator: Angiography-guided CABG<br>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. | Procedure: Angiography-guided CABG<br>* Coronary arteries with angiographical significant stenoses, that are planned for grafting at the heart team meeting all receive grafting. FFR-measurements are still made, but not used for guidance of grafting.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage open grafts of all grafts | 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) | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Graft stenosis (shaft and anastomoses) |  | 6 months | 
| Change in CCS class from index to follow-up (FU) | CCS class (Canadian Cardiovascular Society grading of angina) | 6 months | 
| Change in Quality of life (EQ-5D) from index to FU |  | 6 months | 
| 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) |