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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fractional flow reserve-guided CABG | Experimental | 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. |
|
| Angiography-guided CABG | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fractional flow reserve-guided CABG | Procedure | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anne Langhoff Thuesen, MD | Department of Cardio-thoracic surgery, Odense University Hospital | Principal Investigator |
| Lisette Okkels Jensen, MD,PhD,DMSc | Department of Cardiology, Odense University Hospital | Study Director |
| Per Thayssen, MD, DMSc | Department of Cardiology, Odense University Hospital | Study Chair |
| Poul Erik Mortensen, MD | Department of Cardio-thoracic surgery, Odense University Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Cardiology and Cardiothoracic surgery, Aarhus University Hospital, Skejby Sygehus | Aarhus | Aarhus N | 8200 | Denmark | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34078097 | Derived | Thuesen AL, Riber LP, Veien KT, Christiansen EH, Jensen SE, Modrau I, Andreasen JJ, Borregaard B, Junker A, Mortensen PE, Jensen LO. Health-Related Quality of Life and Angina in Fractional Flow Reserve- Versus Angiography-Guided Coronary Artery Bypass Grafting: FARGO Trial (Fractional Flow Reserve Versus Angiography Randomization for Graft Optimization). Circ Cardiovasc Qual Outcomes. 2021 Jun;14(6):e007302. doi: 10.1161/CIRCOUTCOMES.120.007302. Epub 2021 Jun 3. | |
| 30497559 |
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|
| Angiography-guided CABG | Procedure | 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. |
|
| 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) |
| Anne Langhoff Thuesen |
| Odense |
| Odense C |
| 5000 |
| Denmark |
| Department of Cardiology and Cardiothoracic surgery, Aalborg University Hospital | Aalborg | 9100 | Denmark |
| Derived |
| Thuesen AL, Riber LP, Veien KT, Christiansen EH, Jensen SE, Modrau I, Andreasen JJ, Junker A, Mortensen PE, Jensen LO. Fractional Flow Reserve Versus Angiographically-Guided Coronary Artery Bypass Grafting. J Am Coll Cardiol. 2018 Dec 4;72(22):2732-2743. doi: 10.1016/j.jacc.2018.09.043. |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D001161 | Arteriosclerosis |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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